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    Top drugs and pharmaceutical companies of 2019 by revenues

    Top drugs and pharmaceutical companies of 2019 by revenues

    Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

    #PharmaFlow by PHARMACOMPASS
    29 Apr 2020
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    Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

    Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

    This week, PharmaCompass reviews the recently released data on prescription drugs paid for under the Medicare Part D Prescription Drug Program in the United States in calendar year 2016. But first, let’s understand what is Medicare. Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled.  Prescription drug coverage under this program was started in 2006, and is known as Medicare Part D. As part of this coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance companies and other private companies, known as plan sponsors, that offer prescription drug plans to their beneficiaries with varying drug coverage and cost-sharing requirements. In 2017, the Congressional Budget Office (CBO) had estimated that spending on Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare expenditures for the year. Click here to access the compilation of Medicare Part D Prescriber Summary Report According to the CBO, Medicare Part D is the most significant expansion of the Medicare program since it was created by Congress in 1965. With more than 1.48 billion claims from beneficiaries enrolled under the Part D prescription drug benefit program under its umbrella, our analysis of Medicare Part D provides valuable insights into how elderly Americans use prescription drugs. Top 10 drugs by cost: The ones that bore the highest cost burden for Medicare   As in 2015, in 2016 too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion.  As Gilead continued to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down 37 percent from US$ 7.03 billion in 2015. Click here to access the compilation of Medicare Part D Prescriber Summary Report Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion. Generic Name Number of Medicare Part D Claims Number of Medicare Beneficiaries Number of Prescribers Aggregate Cost Paid for Part D Claims (In USD) LEDIPASVIR/ SOFOSBUVIR (HARVONI) 141,665 52,782 12,097 4,398,534,465 LENALIDOMIDE 239,049 35,368 10,382 2,661,106,127 LANTUS SOLOSTAR (INSULIN GLARGINE, HUM.REC.ANLOG ) 5,028,485 1,075,248 245,447 2,526,048,766 SITAGLIPTIN PHOSPHATE 4,742,505 864,442 206,223 2,440,013,513 ROSUVASTATIN CALCIUM 6,012,444 1,560,050 249,981 2,322,724,007 FLUTICASONE/SALMETEROL 5,194,391 1,196,007 275,442 2,319,808,482 PREGABALIN 4,940,115 852,497 267,532 2,098,953,250 RIVAROXABAN 4,403,332 807,820 252,141 1,954,748,890 APIXABAN 4,455,782 826,969 231,631 1,926,107,484 TIOTROPIUM BROMIDE 4,153,162 903,494 235,564 1,818,857,361 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by claims: The most commonly used drugs of 2016   With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016. The number of Medicare Part D claims includes original prescriptions and refills. Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that were filed by almost 9.4 million beneficiaries. Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 ATORVASTATIN CALCIUM 494,973 44,595,686 9,435,633 AMLODIPINE BESYLATE 497,017 39,913,468 7,802,905 LISINOPRIL 490,452 39,469,840 8,009,954 OMEPRAZOLE 492,951 32,909,236 7,001,160 METFORMIN HCL 611,700 31,007,932 6,394,014 SIMVASTATIN 380,560 29,687,947 6,201,911 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 FUROSEMIDE 488,352 27,878,243 5,421,598 GABAPENTIN 555,997 27,627,466 5,363,382 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by prescribers: Medicines that were most popular with doctors   Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had over 900,000 unique providers (or doctors) prescribing the drug. Albuterol (salbutamol) is used to provide quick relief from wheezing and shortness of breath while Diltiazem is used to prevent chest pain (angina). Also on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen. With more doctors prescribing Hydrocodone-Acetaminophen (an opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the series of new FDA initiatives to combat the epidemic of opioid misuse and abuse should change the position of opioids in the top 10 drugs by prescribers in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries ALBUTEROL SULFATE 985,427 13,100,354 5,417,718 DILTIAZEM HCL 931,159 8,142,004 1,982,550 POTASSIUM CHLORIDE 879,491 18,945,969 4,278,000 PEN NEEDLE, DIABETIC 677,210 5,281,778 1,795,046 LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 METFORMIN HCL 611,700 31,007,932 6,394,014 CEPHALEXIN 597,647 5,603,879 3,933,373 CIPROFLOXACIN HCL 594,129 7,000,081 4,851,657 AZITHROMYCIN 591,028 7,958,625 5,734,122   What does the future hold?   Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations.  Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries).   Click here to access the compilation of Medicare Part D Prescriber Summary Report Last month, the Office of the Inspector General (OIG) reviewed the Part D claims data for the years 2011 to 2015 for brand-name drugs. The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs.  With soaring drug prices being an issue for regular debate in the Unites States and President Trump announcing that his team will use strategies to strengthen the negotiating powers under Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under the Medicare Part D Prescription Drug Program will change in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report  

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    https://www.pharmacompass.com/radio-compass-blog/analyzing-over-us-90-billion-of-medicare-prescription-drug-part-d-spending-in-2016

    #PharmaFlow by PHARMACOMPASS
    05 Jul 2018
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    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    Top drugs by sales in 2017: Who sold the blockbuster drugs?

    The year 2017 was a landmark year for pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies. The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. Sales for most major pharmaceutical companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has generated investor hopes for accelerated dividend growth and share buyback plans. This week, PharmaCompass brings you a compilation of the top drugs of 2017 by sales revenue. Click here to Access All the 2017 Data (Excel version available) for FREE! Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second   There wasn’t any upheaval at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant Humira (adalimumab), which is approved to treat psoriasis and rheumatoid arthritis, added almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues. Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The company believes this drug will continue to be a significant cash contributor until 2025 and the US $21 billion sales forecast by 2020 is about US $3 billion higher than its expectation two years ago. In 2016, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) — received approval from the FDA and European authorities.  Click here to Access All the 2017 Data (Excel version available) for FREE! Enbrel (etanercept), the longest-used biologic medicine for the treatment of rheumatism around the world, was the second best-selling drug with US $8.262 billion in 2017 sales. The sales of the drug were down from US $9.366 billion in 2016 owing to lower selling prices and increased competition, which in turn hurt demand.  Since it was first approved in the United States in 1998, Enbrel has been approved in over 100 countries and the drug is promoted by Amgen, Pfizer and Takeda in different geographies. Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August 2016 for the treatment of patients with rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and other diseases is still not on the market because of a patent-protection challenge from Amgen. Amgen is arguing in the US federal court that its drug has patent protection until 2029. Click here to Access All the 2017 Data (Excel version available) for FREE! Fast-growing drugs: Eylea and Revlimid bring fortunes for Regeneron and Celgene   Regeneron’s flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in annual sales last year to record US $8.260 billion in total sales. Eylea net sales grew 11 percent year-on-year in the US and 19 percent year-over-year outside the US. The company believes much of the recent growth in the US was driven by demographic trends with an aging population as well as an overall increase in the prevalence of diabetes. These demographic trends are expected to continue in the coming years, providing an opportunity for continued growth. Eylea sales alone contribute 63 percent to Regeneron’s total sales.  Click here to Access All the 2017 Data (Excel version available) for FREE! Celgene’s Revlimid (lenalidomide) — a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.  Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion. Celgene received a setback this month as the USFDA refused to consider Celgene’s application for ozanimod, an experimental treatment for relapsing multiple sclerosis. The treatment was being seen as a key to the company’s fortunes as Celgene had said ozanimod is worth US $4 billion to US $6 billion a year in peak sales. Click here to Access All the 2017 Data (Excel version available) for FREE! Gilead’s Hepatitis C franchise enters free fall   Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the competitive heat as they registered US $9.137 billion in 2017 sales, down from US $14.834 billion the previous year. While reporting 2017 results, Gilead provided guidance for 2018 and said its sales of Hepatitis C drugs could fall further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated US $19.1 billion in sales. One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret at a deep price discount to the competition. AbbVie also claims to have the shortest treatment course at eight weeks, compared with 12 weeks or longer for other treatments.  AbbVie reported US $1.274 billion in Hepatitis C drug sales in 2017, down from US $1.522 billion in 2016. Click here to Access All the 2017 Data (Excel version available) for FREE! Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat   Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.  The US patents of  Merck’s cardiovascular drugs — Zetia (Ezetimibe) and Vytorin (Ezetimibe and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark Pharmaceuticals entered into an agreement that allowed Glenmark to launch a generic version of Zetia in late 2016. The drugs that had combined sales of US $3.701 billion in 2016 felt the generic heat in 2017 and the sales were US $1.606 billion lower at US $2.095 billion. Click here to Access All the 2017 Data (Excel version available) for FREE! GSK’s Advair, which was expected to encounter generic competition in 2017, continued to breathe easy as the FDA found deficiencies in the applications of Hikma, Mylan and Sandoz. All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.  Top 15 drugs by sales   Here is PharmaCompass’ compilation of the best-selling drugs of 2017. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2017 data (Excel version available) for FREE! S. No. Company / Companies Product Name Active Ingredient Main Therapeutic Indication 2017 Revenue in Millions (USD) 1 AbbVie Inc., Eisai Humira® Adalimumab Immunology (Organ Transplant, Arthritis etc.) 18,946 2 Amgen, Pfizer Inc., Takeda Enbrel® Etanercept Immunology (Organ Transplant, Arthritis etc.) 8,262 3 Regeneron, Bayer Eylea Aflibercept Ophthalmology 8,260 4 Celgene Revlimid Lenalidomide Oncology 8,187 5 Roche MabThera®/Rituxan® Rituximab   Oncology 7,831 6 Johnson & Johnson, Merck, Mitsubishi Tanabe Remicade®  Infliximab Autoimmune Disorders 7,784 7 Roche Herceptin® Trastuzumab Oncology 7,435 8 Bristol-Myers Squibb, Pfizer Inc. Eliquis®  Apixaban Cardiovascular Diseases 7,395 9 Roche Avastin®  Bevacizumab Oncology 7,089 10 Bayer, Johnson & Johnson XareltoTM Rivaroxaban Cardiovascular Diseases 6,590 11 Bristol Myers Squibb, Ono Pharmaceutical Opdivo Nivolumab Oncology 5,815 12 Sanofi Lantus Insulin Glargine Diabetes 5,731 13 Pfizer Inc. Prevnar 13/Prevenar 13 Pneumococcal 7-Valent Conjugate Anti-bacterial 5,601 14 Pfizer Inc., Eisai Lyrica Pregabalin Neurological/Mental Disorders 5,318 15 Amgen, Kyowa Hakko Kirin Neulasta® Pegfilgrastim Blood Disorders 4,553 Sign up, stay ahead In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2017 Data (Excel version available) for FREE!  

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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    29 Mar 2018
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    Teva to sell assets to reduce debt, lay-off 7,000 workers; Shkreli awaits sentence

    Teva to sell assets to reduce debt, lay-off 7,000 workers; Shkreli awaits sentence

    This week in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.   Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay debt   Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade. Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.  Teva had taken on the debt in order to dominate all facets of generic drugs, including a US$ 40.5 billion acquisition of Allergan’s generics business last year. The Allergan deal added more pressure on drug prices and margins. Teva also slashed its earnings goals for the second time this year. It warned investors it may have to renegotiate some debt agreements if cash flow worsens. Teva reduced its dividend by 75 percent. The company also mentioned that it is in the process of laying off 7,000 workers. Greater competition in the generic drug business due to increased approvals (of generic drugs) by the US Food and Drug Administration (USFDA) has led to poor results, the company said. The continued deterioration of its business environment in Venezuela has made matters worse. The plight of Teva has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months. Activist shareholder Benny Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said. Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges    Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his crime and on his antics on the social media, say legal experts. Back in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime. That could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors. While Shkreli was convicted on three securities fraud and conspiracy counts, he was acquitted of other charges, including the charge that he conspired to steal US$ 11 million in assets from Retrophin. What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”  Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.” According to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said. Diabetes drug exenatide could stop the progress of Parkinson’s disease      In future, clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying. In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease. In the trial, half the patients were given the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off. Exenatide, derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1) agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which triggers insulin secretion. According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s. Though the UCL team is “excited”, it has urged caution as any long-term benefit is uncertain and the drug needs more testing. FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks    Last week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the discounts bring the net price down to US$ 30,000. Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs Sovaldi and Harvoni, that have been at the centre of a controversy around their steep prices.  With a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer. J&J’s Invokana is CVS Caremark’s preferred diabetes drug   Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in, and those that are out. Express Scripts Holding is the largest PBM organization in the US. In the SGLT2 class of drugs to treat diabetes, CVS removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s Invokana as a preferred option. This, despite the fact that Invokana came with an increased risk for amputations in a cardiovascular outcomes study finished earlier this year. A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added. CVS removed 17 drugs in 10 classes, with Merck’s Zetia, Daiichi Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76 percent of members will be able to keep using their current treatments. US Senate overwhelmingly passes reauthorization of FDA’s user fees   In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval. The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare. The funding reauthorizations are based on recommendations from industry groups. This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years. The fee helps speed up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires. The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.    

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    https://www.pharmacompass.com/radio-compass-blog/teva-to-sell-assets-to-reduce-debt-lay-off-7-000-workers-shkreli-awaits-sentence

    #Phispers by PHARMACOMPASS
    10 Aug 2017
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    Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

    Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

    Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis. This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016. Click here to Access All the 2016 Data (Excel version available) for FREE! Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015. Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.  Here’s a list of drugs that witnessed the largest sales growth in 2016: 1. Opdivo (nivolumab) – Bristol-Myers Squibb   2016 sales: US$ 3,774 million 2015 sales: US$ 942 million Sales growth: US$ 2,832 million First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer. With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy. While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million. Click here to Access All the 2016 Data (Excel version available) for FREE! 2. Humira (adalimumab) – AbbVie   2016 sales: US$ 16,078 million 2015 sales: US$ 14,012 million Sales growth: US$ 2,066 million Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. 3. Epclusa (sofosbuvir and velpatasvir) – Gilead   2016 sales: US$ 1,752 million (new launch) Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion. Click here to Access All the 2016 Data (Excel version available) for FREE! 4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie   2016 sales: US$ 3,083 million 2015 sales: US$ 1,443 million Sales growth: US$ 1,640 million Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally. 5. Eliquis (apixaban) - Bristol-Myers Squibb / Pfizer   2016 sales: US$ 3,342 million 2015 sales: US$ 1,860 million Sales growth: US$ 1,483 million Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban's total 2016 sales were US$ 5.392 billion. While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban. 6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead   2016 sales: US$ 1,484 million 2015 sales: US$ 45 million Sales growth: US$ 1,439 million Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US.  Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market. Click here to Access All the 2016 Data (Excel version available) for FREE! 7. Ibrance (palbociclib) — Pfizer   2016 sales: US$ 2,135 million 2015 sales: US$ 723 million Sales growth: US$ 1,412 million Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. 8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline   2016 sales:US$ 2,151 million 2015 sales: US$ 905 million Sales growth: US$ 1,246 million GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine. 9. Revlimid (lenalidomide) – Celgene   2016 sales: US$ 6,974 million 2015 sales: US$ 5,801 million Sales growth: US$ 1,173 million Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion. 10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer   2016 sales: US$ 5,392 million 2015 sales: US$ 4,255 million Sales growth: US$ 1,137 million Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications. Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE). The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin.  Click here to Access All the 2016 Data (Excel version available) for FREE! Our view   In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year. A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years. It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore. Sign up, stay ahead    In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2016 Data (Excel version available) for FREE!  

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    https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016

    #Phispers by PHARMACOMPASS
    17 May 2017
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    Top drugs by sales in 2016: Who sold the blockbuster drugs?

    Top drugs by sales in 2016: Who sold the blockbuster drugs?

    The year 2016 finished with a whimper insofar as mergers and acquisitions (M&As) were concerned. The preceding year — 2015 — had gone down in history as a record year for M&As in the pharmaceutical and biotech space, when deals worth US $300 billion were announced. While drug companies were not as active on the M&A front, the product sales growth in 2016 continued to stay extremely robust and the order of the top ranked drugs changed little from the previous year. This week, PharmaCompass brings you a compilation of the top drugs of 2016 by sales revenue. Click here to Access All the 2016 Data (Excel version available) for FREE!   The top-sellers   Abbvie’s Humira (adalimumab) continued to remain the best-selling drug in the world and added another US $2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year also saw the US Food and Drug Administration (FDA) approve Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to Access All the 2016 Data (Excel version available) for FREE! Gilead’s Harvoni (ledipasvir and sofosbuvir), with record sales of US $13.864 billion in 2015, had a slightly muted performance in 2016 as sales fell to US $9.081 billion (a drop of US $4.783 billion). Gilead failed to maintain its initial rate of new prescriptions, and competition from Merck and AbbVie forced it to offer major discounts to health insurers.  While Gilead executives still believe there is lots of growth left in the hepatitis C market, this year Gilead will continue to face headwinds as Merck's new combination pill — Zepatier — entered the market with a list price at US $54,600 for a 12-week regimen, well below the US $94,500 for Harvoni. Biological drugs, Enbrel (etanercept), Remicade (infliximab) and MabThera (rituximab), held onto their positions of 2015, although their combined sales increased a little over US $300 million. This means that for yet another year, the four best-selling drugs in the world are from biological origin. Celgene’s Revlimid (lenalidomide) — a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US $5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to the company's total sales of US $11.229 billion. With almost identical sales of US $6.7 billion, Roche’s cancer treatments Herceptin and Avastin were also into the top 10 best selling drugs in 2016, making Roche have the most number of products, three of which made it to the list. Click here to Access All the 2016 Data (Excel version available) for FREE! Facing onslaught of generics, biosimilars   Against the backdrop of questions being raised about insulin pricing and possible collusion in the United States, Sanofi saw its insulin treatment Lantus (insulin glargine) drop from number six on the 2015 list to number 9 in 2016 as sales fell by US $717 million to a little over US $6 billion. Sanofi’s competitors in the diabetes space — Novo Nordisk and Eli Lilly — also registered a drop in their insulin sales.  In addition to the pricing pressure, Sanofi will continue to contend with Lilly and Boehringer Ingelheim’s FDA approved biosimilar of insulin glargine — Basaglar — which was approved in December 2015. Click here to Access All the 2016 Data (Excel version available) for FREE! Basaglar is biologically similar to Sanofi’s Lantus and was announced at a price 15 percent lower than that of Lantus. GSK’s Advair, which is preparing for generic competition in 2017, saw its sales drop 5 percent in British Pounds to £3,485. However, the dollar value was significantly lower in view of the fall in the Pound’s value after Brexit.  AstraZeneca’s Crestor (rosuvastatin calcium), Otsuka’s Abilify (aripiprazole) and Novartis’ Gleevec (imatinib) all saw their sales crash in 2016 as a result of generic onslaught. The three drugs together witnessed a combined sales drop of US $5.7 billion. Top 20 drugs by sales   Here is PharmaCompass’ compilation of the best-selling drugs of 2016. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2016 data (Excel version available) for FREE!   S. No Product Active Ingredient Main Therapeutic Indication Company 2016 Revenue in Millions (USD) 2015 Revenue in Millions (USD) Sales Difference in Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) Abbvie 16,078 14,012 2,066 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead 9,081 13,864 (4,783) 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen/Pfizer Inc. 8875 8697 178 4 Remicade  Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson/Merck & Co 8,234 8,355 (121) 5 MabThera/Rituxan Rituximab  Oncology Roche 7227 6974.55 252 6 Revlimid Lenalidomide Oncology Celgene 6,974 5,801 1,173 7 Avastin Bevacizumab Oncology Roche 6,715 6,617 98 8 Herceptin Trastuzumab Oncology Roche 6,714 6,473 242 9 Lantus Insulin Glargine Diabetes Sanofi 6,057 6,773 (717) 10 Prevnar/Prevenar 13 Pneumococcal 13-Valent Conjugate Anti-bacterial Pfizer Inc. 5,718 6,246 (528) 11 Xarelto Rivaroxaban Cardiovascular Diseases Bayer/Johnson & Johnson 5,392 4,255 1,137 12 Eylea Aflibercept Ophthalmology Regeneron Pharmaceuticals, Inc./Bayer 5,046 3,978 1,068 13 Lyrica Pregabalin Neurological/Mental Disorders Pfizer Inc. 4,966 4,839 127 14 Neulasta Pegfilgrastim Blood Disorders Amgen 4,648 4,715 (67) 15 Seretide/Advair Salmeterol Respiratory Disorders GlaxoSmithKline 4,252 4,491 (239) 16 Copaxone Glatiramer Neurological/Mental Disorders Teva 4,223 4,023 200 17 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead 4,001 5,276 (1,275) 18 Tecfidera Dimethyl Fumarate Neurological/Mental Disorders Biogen 3,968 3,638 330 19 Januvia Sitagliptin  Diabetes Merck & Co 3,908 3,864 44 20 Opdivo Nivolumab Oncology Bristol-Myers Squibb 3,774 942 2,832   Blockbusters in the making   With almost US $5 billion in sales, a 14 percent growth over the previous year, Pfizer’s Lyrica enjoyed its last year before generic competition enters the market as Generics (UK) Limited (Mylan) and Actavis Group PTC ehf won a patent challenge in the United Kingdom. Lyrica generics are expected in the United States in late 2018. Click here to Access All the 2016 Data (Excel version available) for FREE! As Abbvie’s Humira begins to face competition from Amgen, Abbvie’s US $21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), which generated total 2016 sales of US $3.083 billion — an increase of US $1.64 billion over the previous year.  Anticoagulants, Xarelto (rivaroxaban), Eliquis (apixaban), Pradaxa (dabigatran) all registered significant positive growth with a combined increase of almost US $ 2.75 billion. Gilead and GSK’s combination HIV treatments — Genvoya and Triumeq — also reported sales increase of over a billion dollars each. Sign up, stay ahead   In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2016 Data (Excel version available) for FREE!  

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    https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2016-who-sold-the-blockbuster-drugs

    #PharmaFlow by PHARMACOMPASS
    19 Apr 2017
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    FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

    FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

    After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines. This week, PharmaCompass, shares its analysis of the new drug approvals by the FDA in 2016. Reasons behind the low approvals in 2016   Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications.   The 9 orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013. The reasons for the low 2016 approval count, have been attributed to the agency approving five drugs in 2015 that actually had approval action dates in 2016 and an increase in the number of drugs that the agency rejected. A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Gilead’s Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, is expected to become the most profitable approval of 2016 with expected sales of $ 8.4 billion by 2022.  2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States.  Approvals of three biosimilars which target $ 33 billion in brand drug sales   In a giant leap for the generic pharmaceutical industry, three biosimilar applications were approved in 2016 that target brand drugs which generated more than $ 33 billion in sales last year.   All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions.  Pfizer and Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016. After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $ 9.1 billion). On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   Kim Kardashian’s pregnancy drug is now available in a new strength   Diclegis, a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’ Duchesnay, the company which produces Diclegis, got approval for Bonjesta which combines twice the amount of doxylamine and pyridoxine when compared with Diclegis which contains 10mg of each ingredient. Indian generic companies get approvals for differentiated products   As the generic industry in the U.S. continues to face severe pricing pressure, Indian generic companies are attempting to overcome these challenges by trying to move up the value chain by supplying differentiated generic products. Consistent with this strategy, the applications of Sun Pharmaceuticals for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   Pfizer launches an opioid treatment with abuse-deterrent properties   The abuse of opioids, including prescription painkillers and drugs like heroin, is something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release opioid painkillers such as oxycodone and fentanyl will have to carry a "black box" warning about the risk of abuse, addiction, overdose and death. Pfizer got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. In it, the oxycodone releases slowly over several hours. If the capsules are crushed, the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric effects. Pfizer also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   A dietary supplement gets approved along with new forms of commonly used drugs    In 2016, Endoceutics got Intarosa, a once-daily vaginal insert, approved which is the first FDA approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Lisinopril, the most commonly used drug by U.S. Medicare patients, was approved as an Oral Solution for the first time.   Diabetes treatments, one of the most commonly prescribed drug categories in the U.S., saw the addition of Sanofi and Novo Nordisk’s fixed-dose, long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combinations to the list of options available to treat adult type-2 diabetes.  Our View   The approval of new drugs ensures that the world has access to improved healthcare solutions and breakthrough medical therapies. With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug approval scenario will be shaken up for time to come. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!    

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    #PharmaFlow by PHARMACOMPASS
    09 Feb 2017
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    Trump’s comments on drug prices sink pharma stocks; Teva lowers guidance by $ 1 billion

    Trump’s comments on drug prices sink pharma stocks; Teva lowers guidance by $ 1 billion

    The New Year began with the JP Morgan Healthcare Conference— the drug industry’s annual investor meet — where industry leaders were busy announcing deals, until Donald Trump accused the industry of “getting away with murder”. His comments sent shockwaves within the industry as pharma and biotech stocks tanked. In the first Phispers of 2017, we also bring you a compilation of the likely patent conflicts this year. And, there is news on Aurobindo Pharma’s acquisition, Teva's revised guidance for 2017, lowering of growth prospects for Mylan, fresh bribery charges against Novartis and more.   Trump promises aggressive federal bidding process to slash drug prices   Donald Trump, America’s president-elect dropped a bombshell in his first news conference held Wednesday, accusing the pharmaceutical industry of “getting away with murder”. He said he would bring down drug prices, as well as government spending on drugs by changing the way the country bids for drugs. During the event held at Trump Tower in New York, Trump said: “Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly.” The country’s federal law forbids the government from negotiating drug prices with drug companies in order to lower the price of drugs for seniors using Medicare. Trump, however, did not announce how he will address the issue of high drug prices. In the past though, he has called for ending the policy. His comment came in the midst of the JP Morgan Healthcare Conference, a major annual investor meeting taking place in San Francisco, and knocked down the stocks of biotech and pharmaceutical companies by around 2 percent. “If anybody is walking away from this conference thinking ‘business as usual,’ I think that’s a mistake,” Heather Bresch, chief executive of Mylan Pharmaceuticals said at the JP Morgan meet. “The pricing model has got to change. It’s not incremental change; I don’t think that’s what this country needs. I think it’s truly rethinking the business model,” she added. Mylan was under scrutiny recently for repeated list price increases on its lifesaving allergy drug EpiPen. RECOMMENDED READ: Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend   Teva lowers guidance, Mylan expected to lose US $ 800 million in 2018   Israeli drugmaker Teva revised the predictions it made in July 2016, about its financial expectations for 2017. And these are considerably below its previous expectations. For instance, it laid out a revenue forecast of US $ 23.8 billion to US $ 24.5 billion for 2017, well below the US $ 25.2 billion to US $ 26.2 billion guidance it had previously estimated. Teva now expects its earnings per share (EPS) to be between US $ 4.90 and US $ 5.30 — another big drop from its July guidance of US $ 6.00 to US $ 6.50. Several industry observers had expected this downward revision. “I think it’s pretty clear that management’s prior expectations for 2017 were very inflated,” Umer Raffat, an Evercore ISI analyst, said.  Meanwhile, Teva began the new year by forking out over US $ 520 million in order to resolve a bribery lawsuit in the US filed by its shareholders. It pertained to its operations in Russia, Ukraine and Mexico.   The year gone by was a turbulent one for Teva. For instance, its US $ 2.3 billion acquisition of Rimsa (short for Representaciones e Investigaciones Médicas, SA de CV), a leading pharmaceutical manufacturing and distribution company in Mexico, went the Ranbaxy way, with the former owners filing a legal complaint against Teva. The complaint mentioned that Teva is suffering from “buyer’s remorse” and is trying to undo the transaction “by any desperate measure” after destroying the Rimsa companies with firings and manufacturing shutdowns. It’s not just Teva which is set to see a downtrend. Mylan's EpiPen — which hogged the headlines last year for its price hikes — is projected to face substantial decline, until 2018, say analysts. EpiPen is all set to face competition from Kaleo’s Auvi-Q (another epinephrine injection), which is due for launch in the first half of 2017, Ronny Gal of Bernstein Research said. EpiPen (excluding the generic version) will bring in only US $ 300 million in 2018 for Mylan, down from its US $ 1.1 billion estimate for 2016, Bernstein Research said.   Aurobindo to acquire Portugal’s Generis Farmaceutica   The New Year began with a bang for India’s Aurobindo Pharma. The company said it has inked a pact to acquire Portugal’s Generis Farmaceutica SA from Magnum Capital Partners for a consideration of US $ 143 million (or €135 million). In a statement, Aurobindo Pharma said the binding agreement has been inked through Aurobindo’s wholly-owned subsidiary — Agile Pharma BV Netherlands. Generis produces and sells pharmaceutical products in Portugal.  The combined entity will benefit from a robust pipeline covering all major molecules coming off patent in the next five years, V Muralidharan, Senior Vice President of European Operations at Aurobindo Pharma, said. “The acquisition of Generis, by leveraging its strong portfolio and unrivalled brand recognition will allow us to establish ourselves as the top generics player in the Portuguese market,” he added.  The deal, however, is conditional, and depends on obtaining necessary approvals from Portuguese authorities. The acquisition deal includes Generis’ manufacturing facility in Amadora (Portugal) with a capacity to produce 1.2 billion tablets/capsules/sachets annually.   Patent battles between the Big Pharma could dominate 2017   This year may well be the year of big patent battles between pharmaceutical giants. It began with a ruling on a patent infringement case involving partners Sanofi-Regeneron and Amgen. A US federal judge ordered French pharmaceutical giant Sanofi and partner Regeneron to stop selling their latest cholesterol treatment — Praluent — due to patent infringement. After the court order, the stocks of Regeneron and Sanofi got hammered. Sanofi and Regeneron plan to immediately appeal that decision. According to the ruling, Sanofi and Regeneron had infringed biotech giant Amgen’s patents for a rival cholesterol fighting drug — Repatha. Both Praluent and Repatha are the only approved ‘PCSK9 inhibiting’ therapies known to considerably reduce bad cholesterol levels in patients during clinical trials. Both won FDA approval in 2015 and both are expensive — priced at US $ 14,000 per year. Sanofi is also in a battle with Novo Nordisk. In the last week of December, there was news that Sanofi filed a lawsuit in the US accusing Novo Nordisk of making the false claim that Sanofi’s insulin drugs would no longer be available for many US patients. According to Sanofi, Novo made that claim in order to promote its own competing drug. The complaint seeks an order forcing Novo to pay damages and withdraw marketing materials for its drug Tresiba. Both Sanofi and Novo have been tied in a regulatory race for their basal insulin/GLP-1 combo diabetes products. But Sanofi is already ahead in the race, as last week it rolled out Soliqua, a combination of (insulin) Lantus and GLP-1 drug Adlyxin, at a list price of US $ 127 for a 300-unit pen. Novo’s Xultophy—which received regulatory approval on November 21—won’t be in the market until early May. And then there is the battle between Merck and Gilead. The latter ended the year on a sour note after a federal jury in the US ordered Gilead to pay US $ 2.5 billion in royalties to Merck in an ongoing dispute. The legal battle between Merck and Gilead centres around Gilead's flagship hepatitis C cures — Sovaldi and Harvoni. Both these drugs gained disrepute for their lofty prices. Yet they dominated the hepatitis C drug market (before they ran into trouble with insurers and benefits managers who demanded better deals). Lastly, there is a significant patent battle brewing in experimental biopharma technology in the form of a spat between the University of California and the University of Vienna on one side and the Broad Institute of MIT and Harvard University on the other. The battle centers around CRISPR-Cas9 — an early-stage gene-editing platform that significantly simplifies the process of slicing and dicing problematic genetic material. It is being tested as a treatment option for cancer, sickle cell, and a host of other diseases.    The dispute is around who owns the patent right to CRISPR. While University of California at Berkeley professor Jennifer Doudna and the University of Vienna’s Emannuelle Charpentier were first to announce their discoveries, MIT's Feng Zhang actually won the patent after going through an expedited process.    After Korea, US and China, Novartis faces bribery charges in Greece   In the last one year, Swiss drugmaker Novartis has faced three sets of bribery charges. The fourth one came in the New Year, with Greek officials announcing they are investigating Novartis for bribery in the wake of local media reports raising questions about the company. Greek corruption prosecutors raided the Athens offices of Novartis last week, as part of the probe over bribery allegations. Greek authorities have reportedly interviewed scores of sources. In March 2016, Novartis paid US $ 25 million to settle a US Securities and Exchange Commission (SEC) case that claimed the Swiss drug maker paid bribes to health professionals in China to increase sales during 2009 and 2013.    While the US case got settled, Novartis has been accused by a whistleblower in Turkey of paying bribes through a consulting firm to secure business advantages. In August 2016, PharmaCompass had reported that six former and current Novartis executives at its unit in South Korea allegedly paid more than US $ 2 million to doctors in return for prescribing its medicines. Among those indicted was the former CEO of Novartis’ Korea unit. Twitter bans Martin Shkreli for making unwanted advances at journalist   In September 2015, Martin Shkreli, the former CEO of Turing Pharmaceuticals, had received widespread flak for raising the price of anti-parasitic drug Daraprim by a factor of 56. Since the Daraprim episode, Shkreli has also been indicted on unrelated fraud charges. Well, Shkreli is back in news. And once again for all the wrong reasons. A few days back, he was temporarily kicked off Twitter and its live-streaming platform — Periscope — for making unwanted advances toward Lauren Duca, the weekend editor of Teen Vogue. In a tweet to Twitter’s CEO Jack Dorsey, Duca said: “How is this allowed?” She included two screenshots of Shkreli's Twitter profile page. Apparently, Shkreli manipulated a photograph of Duca with her husband, wherein he had put his face in place of Duca’s husband. Duca also posted another screenshot wherein Shkreli had put up a montage of Duca’s photos as his Twitter background image, with the text: “For better or worse, till death do us part, I love you with every single beat of my heart.” Moreover, Shkreli’s Twitter bio said that he had a “small crush” on Duca. “Hope she doesn't find out,” it said. According to the Twitter spokesperson, Twitter’s rules prohibit “targeted harassment”. Oncology deals: Takeda acquires Ariad; Daiichi ties up with Kite; Ipsen with Merrimack   The JP Morgan conference saw some major deals being announced in the field of oncology. Japan’s Takeda Pharmaceutical Company and Massachusetts-headquartered Ariad Pharmaceuticals recently entered into a definitive agreement under which Takeda will acquire all outstanding shares in Ariad for US $24 per share in cash, in a deal valued at US $ 5.2 billion. Ariad Pharmaceuticals is a cancer-focused drugmaker. The agreement has been unanimously approved by the boards of directors of both companies. It is likely to close by the end of February this year, subject to required regulatory approvals and other conditions.   Kite Pharma — a California-based, clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products — has entered into a deal with Daiichi Sankyo of Japan.  Kite Pharma will enter the Japanese market, along with Daiichi, which has lined up US $ 250 million deal. Kite Pharma’s new drug application for the pioneering CAR-T drug —KTE-C19 — is in the final weeks of being completed and shipped to regulators in search of an accelerated approval. CAR-T (short for chimeric antigen receptors-T cell) is a therapy for cancer, using a technique called adoptive cell transfer. The T cells, which can recognize and kill cancer cells, are reintroduced into the patient.  Under the deal, Kite will be taking US $ 50 million upfront and US $ 200 million in milestones for the deal, while Daiichi Sankyo is reserving another US $ 200 million in additional milestones for each new drug candidate that Kite takes to the FDA over the next three years.   Meanwhile, French pharmaceutical company Ipsen has entered into a US $ 1 billion deal to acquire oncology assets from Massachusetts-headquartered Merrimack Pharmaceuticals, including the pancreatic cancer drug Onivyde. The deal is broken down into two steps, involving an upfront fee of US $ 575 million, to be followed by a potential US $450 million that would depend on approvals for Onivyde in the US. With this deal, Merrimack is likely to pay off US $ 195 million in debts, return US $ 200 million to stockholders and make a further payment of US $ 450 million to shareholders. Merrimack would also plough US $ 125 million into the development of three experimental cancer drugs.    

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    #Phispers by PHARMACOMPASS
    12 Jan 2017
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    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

    In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017.   Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).  The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed.   Top Ten Drugs by Cost, 2014 [Most expensive for Medicare]    Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13     $1,224,835 $94,218 Elaprase 100     $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60     $2,901,115 $48,352 Naglazyme 129     $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15     $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]   Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.  Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember.   View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!    

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    #PharmaFlow by PHARMACOMPASS
    05 Jan 2017
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    India steps up efforts to improve drug quality; Allergan vows to limit price hikes

    India steps up efforts to improve drug quality; Allergan vows to limit price hikes

    This week, Phispers has two news items that demonstrate Indian government’s keenness to improve drug quality and reduce bribing of doctors by drug companies. There is more news on Mylan’s EpiPen and Novo Nordisk’s combination drug for diabetes. Read on. Indian government takes steps to improve drug quality standardsThe Indian government is firm on improving the quality standards in the pharmaceutical industry. As a first step, it is working on enhancing the skills of the workforce employed in the industry. Through a notice issued last week by the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, the government has made it “imperative that all personnel employed in pharmaceutical manufacturing units undergo certification programs developed by the Life Science Skill Sector Development Council”. With effect from January 1, 2018, no person shall be employed in any pharmaceutical manufacturing unit unless the person has obtained a formal diploma or degree in the relevant area, the notice said.Meanwhile, the CDSCO is planning to recruit 500 drug inspectors in the coming year in order to double its manpower by the end of 2017. The organization has already recruited 147 drug inspectors, who will enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP) In EpiPen aftermath, Allergan CEO promises to limit price hikesIn the wake of Mylan’s EpiPen fiasco, Allergan’s CEO Brent Saunders has committed to rebuilding its “social contract” with patients by promising to avoid price gouging and limiting price hikes on brand-name medicines.In a blog posted on the company website this week, Saunders said Allergan would not raise prices more than once a year. And that any price hike will be limited to single-digit percentage increases.Saunders also said the company will avoid “major” price hikes without any corresponding increases in costs as products near patent-expiration. Condemning price gouging, Saunders said: “Recently, the actions of these outliers have shifted attention away from the increasingly vibrant medical innovation ecosystem focused on finding new medicines, improving outcomes for patients and, by doing so, lowering the overall cost of disease.”  Mylan now under antitrust investigation over marketing of EpiPens to schools  It seems more trouble awaits Mylan Pharmaceuticals over the EpiPen price increase. Mylan is now being investigated by the New York attorney general for potential antitrust violations involving the marketing of these allergy auto-injectors to schools. The attorney general’s office began looking into this matter last week and has issued subpoenas to Mylan for information about its policy of offering discounted EpiPens to schools on the condition that these schools would not purchase competitive products.Since 2004, the price of EpiPens has been increased by 450 percent, after adjusting for inflation. A two-pack now sells for more than US $ 600. Mylan has announced several steps to reduce the cost of EpiPen, including introducing a generic version. But it continues to face political flak.According to an analyst at Sanford C. Bernstein & Co, Mylan’s financial incentive plans are to be blamed for its EpiPen price hike. In 2014, Mylan announced it would reward some 100 employees and executives for not only hitting, but exceeding aggressive profit targets. The company’s top five executives could earn as much as US $ 82 million through the price increases.According to another news report, Mylan has increased its branded ad spending on the EpiPen by 357 percent over five years. During the same time, it hiked the price of EpiPen by 179 percent. FDA puts off decision on Novo’s combination diabetes drug The competition between Sanofi and Novo Nordisk over FDA approval for their combination diabetes drugs is getting interesting. Two weeks after the FDA put off approval of Sanofi’s insulin-plus-GLP-1 combo, the FDA has put off a decision on Novo Nordisk’s combination drug too. The FDA will now review Novo’s drug in December. The drug – which is a marriage of Tresiba and Victoza – has already been approved in the EU as Xultophy. Sanofi’s LixiLan is a combination of Lixisenatide and Lantus.Both Xultophy and LixiLan have prospects of becoming blockbuster drugs, with a US $ 6 billion market potential between them. Both companies are counting on these drugs to increase sales, since their diabetes products are being subject to increased competition and pricing pressure. However, a decision on Sanofi’s combination drug is expected to be taken before Novo’s Xultophy. This news has come at nearly the same time as news about its long-time CEO, Rebien Sorensen, stepping down. From January, Sorensen will be succeeded by Lars Fruergaard Jorgensen, currently executive vice president and head of corporate development. India plans penal provisions to deter drug companies from bribing doctors The Indian government plans to deter pharmaceutical companies from bribing doctors with freebies by replacing the voluntary code, brought into place in January 2015, with a strong mandatory code that has penal provisions.The voluntary code was to expire in June 2015. But it has been given four extensions, even though it wasn’t deterring drug companies from giving freebies to doctors. According to a report published in The Economic Times, the chemicals and fertilizers ministry is reworking on the toothless voluntary code to come out with a mandatory one, with penal provisions. The ministry has sought legal opinion on the new code, which will be applicable to both pharmaceutical and medical devices companies. Gilead urged to drop legal action against generic Sovaldi in UkraineIn June, Gilead Sciences had filed a claim against a Ukrainian drug wholesaler, the Ukrainian Drug Regulation Authority, and the Ministry of Health, alleging several of its patents prevent generic drug makers from marketing a version of its Hepatitis C drug – Sovaldi – for the next few years.This week, International humanitarian-aid non-governmental organization – Doctors Without Borders – has urged Gilead Sciences to drop the case that prevents Pharco Pharmaceuticals – a generic drug maker – from selling a copycat version of Gilead’s Sovaldi in Ukraine.If Gilead wins the case, generic versions of Sovaldi will not be available in Ukraine. According to the World Health Organization, more than 1.3 million people are believed to be infected with Hepatitis C in Ukraine.In a letter, dated September 5, the organization has urged Gilead to “reconsider its business strategy in high-burden, middle-income countries, especially Ukraine,” since its strategies “threaten sustainable access to Hepatitis C treatment in a number of countries” where the advocacy group treats patients. A hearing in this case is scheduled for September 12.In March 2015, a US $ 10 version of Sovaldi was made available in Bangladesh by Incepta Pharmaceuticals. Sovaldi sells for US $1 ,000 a pill in the US. FDA’s letters to Pan Drugs and Zhejiang Hisoar explain reasons behind import alerts India’s Pan Drugs had two of its facilities placed on FDA’s import alert list last year. Recently, the FDA posted the warning letter issued to Pan Drugs on its website. The letter explains why the finished formulations unit failed an inspection.For instance, Pan Drugs’ quality unit allowed the use of adulterated API ‘dated May 25–31, 2015’ which was manufactured at Pan Drugs’ Nandesari facility. The Nandesari facility was placed on FDA import alert on May 5, 2015, for egregious cGMP deviations. “Your firm used this API for the manufacture of drugs which were then shipped to the US market from October 7 to November 23, 2015,” the warning letter said.Additionally, the quality unit of Pan Drugs approved certificates of analysis for several API as well as finished products, prior to conducting all quality control and release testing. The production manager “falsified the documents,” the warning letter said.In the case of Hisoar, whose facility was also placed on import alert, FDA investigators discovered that the facility lacked basic laboratory controls to prevent changes to its electronically-stored data and paper records. “When you encountered suspect and out-of-specification (OOS) results, you retested samples until you obtained desirable results,” the warning letter said. 

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    #Phispers by PHARMACOMPASS
    08 Sep 2016
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    Ranbaxy’s path of deception revealed in Singapore court order; Chinese, Indian, American and Spanish firms in compliance troubles

    Ranbaxy’s path of deception revealed in Singapore court order; Chinese, Indian, American and Spanish firms in compliance troubles

    This week, Phispers brings you the latest on the Ranbaxy-Daiichi and Merck-Gilead cases. There is also news on Medtronics, which faces a whistleblower lawsuit. And Valeant, which has come under the scanner for allegedly defrauding insurers. Our compliance roundup updates you on companies across the world that faced regulatory action recently. Singapore court’s 373-page order reveals how Ranbaxy withheld information from DaiichiLast week, a report in The Indian Express brought to light how Ranbaxy deliberately withheld information from Japan’s Daiichi Sankyo in the Ranbaxy-Daiichi case. The information was based on a copy of the Singapore International Arbitration Centre’s (SIAC) order, passed in April 2016. The former owners of Ranbaxy – Malvinder Singh and Shivinder Singh – face a penalty of Rs 35 billion (US $ 523 million) and have until August 22 to challenge the SIAC order. The information implicates the Ranbaxy top brass in a “in a slew of irregularities, from fraud to falsehood.” In over 373 pages, the SIAC order lays out what it calls “the path of deception that Ranbaxy took and how it kept Japan’s Daiichi Sankyo — which bought Ranbaxy in 2008 for Rs 198 billion (US $ 2.96 billion) — in the dark even a year after its purchase”. The SAIC order was based on a 2004 Self-Assessment Report (SAR) prepared by the then head of research and development of Ranbaxy, Rajinder Kumar, for the company’s internal use. The contents of an internal report were not shared with Daiichi. The SAR listed over 200 drugs, including antiretroviral drugs for treating AIDS patients, for which Ranbaxy allegedly used fabricated data to bag approvals from regulators and authorities of more than 40 countries. Compliance roundup: Chinese, Indian, American and Spanish firms in compliance troubles Notice of non-compliance to Artemis Biotech: Artemis Biotech, a division of Themis Medicare in India, received a notice of non-compliance from European regulators. According to the regulators, the company had violated basic principles of data integrity within its instrument laboratory. And the relevant GMP data was outside the control of the quality management system. As an outcome of the inspection, the Certificates of Suitability (CEPs) granted for popular cholesterol lowering ingredient – simvastatin – have been suspended. Just three months ago another Indian manufacturer – Krebs Biochemicals & Industries – had its CEPs suspended for the same product.Alcor found to have unsuitable facilities: A Spanish manufacturer – Alcor SL – that manufactures liquid syrups for use in Spain was found not to have suitable facilities, personnel and materials to ensure proper compliance with GMP during an inspection in June this year. Although the company responded with a corrective action plan, it was found “insufficient”.Claris recalls injections in the UK: Indian manufacturer Claris Lifesciences recalled Furosemide injections in the United Kingdom as they had been inadvertently distributed in the country. The product was intended for sale in Australia.  FDA’s warning letters to Zhejiang Medicine, Concept Products: While there was activity in Europe, the FDA issued a warning letter to Zhejiang Medicine (Xinchang Pharmaceutical Factory), a manufacturer of antibiotics like levofloxacin, daptomycin and vancomycin, for data integrity violations. Laboratory personnel were found “disguising testing”. The personnel were conducting unofficial testing that was being recorded in separate ‘R&D’ folders before conducting the officially reported sample analyses. Analysts were also found signing and dating microbiological testing laboratory worksheets five days before the test results were available and backdating laboratory worksheets for impurities and content testing by four days.The FDA also issued a warning letter to a Chinese manufacturer, Concept Products Limited, for “significant violations of cGMP regulations for finished pharmaceuticals”. It placed yet another Indian company Laxachem Organics and Chinese firm Yangzhou Hengyuan on import alert. Warning letter to Noven: A US-based patch manufacturer – Noven Pharmaceuticals – received a warning letter over quality concerns uncovered in its transdermal drug delivery systems (TDDS) such as Minivelle and Daytrana. The FDA expressed concerns over the scientific soundness of the company’s measurement method since the FDA stated that “your unsound methods could be masking product failures” and leading “to product detachment, expose the drug to other people, and other safety issues.” Now, Merck has to pay Gilead’s US $ 200 million legal feeIn March this year, Merck had won a legal dispute over sofosbuvir, the API in Gilead's multibillion-dollar drugs Sovaldi and Harvoni. The federal jury had ordered Gilead to pay Merck US $ 200 million in damages for infringing on patents for the hepatitis C drugs. But in June, the US Dristrict Judge Beth Labson Freeman threw out Merck’s victory and snatched back the US $ 200 million Merck had been awarded. Last week, the same judge added insult to Merck’s US $ 200 million-injury. Freeman said Gilead was entitled to relief from legal fees it had incurred while defending its case.Merck has been handed a US $200 million bill for Gilead's legal fees. Merck now intends to appeal in the case, saying the judge’s ruling “does not reflect the facts of the case.”  FDA launches improved web-based version of its Orange BookThis week, the US Food and Drug Administration (FDA) launched an improved web-based version of its Orange Book – a publication on drugs approved on the basis of safety and effectiveness. The Orange Book is widely used by doctors and by the regulatory community for identifying which drug products are substitutable for one another. The improved Orange Book has an updated design and has more user-friendly search optionsFormerly known as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book had first appeared as a published list in 1980. It came online in 1997. Valeant allegedly defrauded insurers, may be under criminal investigation In one of the most serious probes faced by Valeant Pharmaceuticals, the Canada-headquartered company may be under criminal investigation over allegations that it defrauded insurers by hiding its ties with a mail-order pharmacy – Philidor – that boosted its sales. Prosecutors are probing whether Philidor made false statements to insurers about its ties with Valeant, while helping patients get coverage for the higher-priced Valeant drugs. According to a report published in The Wall Street Journal, criminal charges are likely to be levied against former Philidor executives and against Valeant as a company. The relationship between Philidor and Valeant has been under the scanner since October 2015, when questions were raised about Valeant's accounting.  Novartis to expand capacity of monoclonal antibody plant in EuropeNovartis is investing US $ 100 million to expand its monoclonal antibody (mAb) capacity at a plant in Europe. The Swiss drugmaker has committed about US $ 1 billion to boost its biosimilar production in order to emerge a leading player in biosimilars. Novartis is beginning work on the mAb project that will boost capacity by 70 percent at the Novartis biotechnology center in Huningue, France. Meanwhile, the company has acknowledged that employees in South Korea may have been involved in rebate trickeries. But it says an investigation of similar accusations in Turkey uncovered no problems. In Turkey, Novartis considers the matter closed.In April, a prosecutor in Turkey had reportedly opened an investigation after receiving a copy of an email sent by an anonymous whistleblower to Novartis CEO saying the unit there paid consultants US $ 290,000 in 2013 and 2014 to win about US $ 85 million in business from government hospitals.Matters in South Korea are a lot serious. In South Korea, prosecutors want the government to suspend the company’s operations there after they indicted half-dozen executives for issuing improper rebates. German watchdog criticizes efforts to accelerate new drug approvalsGermany’s cost-effectiveness watchdog – the German Institute for Quality and Efficiency in Health Care – has criticized an effort by European regulators to accelerate approval for new medicines based on limited evidence. These concerns come at a time when regulators on both sides of the Atlantic are looking for new approaches to fulfill unmet medical needs through faster approval of drugs.Adaptive pathways approach is a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago, the European Medicines Agency (EMA) had launched a specific pilot program in this direction. However, the German watchdog maintained that the EMA failed to make its case that this approach for approving drugs can make a demonstrable difference. Medtronic faces whistleblower lawsuit for using devices under false pretensesMedtronic, a major medical device manufacturer, is facing a whistleblower lawsuit that claims it sought FDA approval for its devices under false pretenses. The devices were being regularly used for a purpose they weren’t intended to be used by the regulators.According to Dr. Vikas Saini, president of the Lown Institute, a Boston healthcare think tank, who has been following the case, the devices had been labelled ‘not for cervical spine use’. “Yet, in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine,” Saini said.Medical devices are lightly regulated by the FDA. Once cleared by the FDA, physicians used medical devices however they deem fit. Questions being raised on health of Clinton, Trump Donald Trump and Hillary Clinton are two of the oldest presidential candidates in the US history. While Clinton’s doctor certified that she “is in excellent physical condition” and Trump’s physician declared he would be “the healthiest president – ever”, these testaments are not being taken seriously in the absence of detailed medical records. Both Trump’s and Clinton’s doctors released brief assessments of their health recently. Television host Sean Hannity has aired a series of segments on Fox that cast doubts on Clinton’s health. Democrats, on the other hand, have been questioning Trump’s mental health. One congresswoman recently suggested he should undergo a “mental fitness test.”  

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    18 Aug 2016
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    M&A activity in pharma picks up; Cadila, Lupin, Alembic close issues with FDA

    M&A activity in pharma picks up; Cadila, Lupin, Alembic close issues with FDA

    This week, Phispers brings you news on FDA meeting its generic drug approval goal, M&A deals in the world of pharma, Obama’s article in JAMA, Abbott’s new bio-degradable stent for heart patients, Amgen’s predicament in the field of biosimilars and more.   FDA meets generic drug approval goal a year ahead of schedule The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog.  The GDUFA required the FDA to meet this goal by September 30, 2017, which is the end of the five-year funding period authorized under the GDUFA. This way, the FDA has achieved its backlog commitment more than one year ahead of schedule. This information was provided by Janet Woodcock, director of the CDER.   Amgen’s double-standards on biosimilars; China to lead the biotech boom Amgen is playing on the offense as well as on defense insofar as biosimilars are concerned. Last week, the FDA approved Amgen’s biosimilar of AbbVie’s Humira. And, if FDA insiders are to be believed, Novartis’ generics division Sandoz may soon get the nod for its biosimilar of the US $ 9 billion drug Enbrel. Amgen sells Enbrel in the US. Amgen’s Humira biosimilar threatens AbbVie’s US $ 14 billion franchise. While Amgen is fighting to get its biosimilar on the market, it’s also fighting Novartis tooth and nail to guard its drug Enbrel. It has waged a legal war against Novartis’ development strategy, which studied the drug only for psoriasis but is now looking for an approval on a full slate of indications. Meanwhile, a survey of international companies found that 85 percent of the respondents believe that China is set to have the fastest growing biologics sector over the next decade, while 65 percent predict patented new chemical entities (NCEs) will be discovered and developed within China in as little as five years. The driving force behind these findings is the growing biotechnology and R&D industry, which is heavily supported by the Chinese government.   2016 shows lively M&A activity, but deal sizes are smaller Merger and acquisitions in the world of pharma picked up in the April-June quarter of 2016.  According to market intelligence firm EvaluatePharma, pharma and biotech companies announced transactions worth US $ 22.1 billion. However, the size of the M&A deals were a lot smaller, with AbbVie’s US $ 9.8 billion acquisition of Stemcentrx being the largest deal in the April-June quarter.  The pickup in M&A activity is an encouraging sign for the industry that has been concerned about fears of a slowdown. This week also saw Japanese drug maker Nichi-iko acquire Sagent Pharmaceuticals in an all-cash deal of US $ 736 million. Yet, 2016 might not match the last two years in terms of deal value.   Theresa May says Britain will defend its pharma sector from takeovers While Britain mulls a second Brexit referendum, Theresa May, the new prime minister of the UK, indicated in a press conference that she would help shield the nation’s pharmaceutical industry from takeovers, considering it an important sector for Britain.  This announcement comes after US giant Pfizer failed in its bid to acquire AstraZeneca and GlaxoSmithKline has been rumored to be a takeover target. British drug companies Shire, AstraZeneca and GSK have been picked as potential takeover targets by Pfizer, which had earlier tied up with Ireland's Allergan before the deal got cancelled. Analysts say Pfizer needs to find a partner in its quest to relocate its headquarters and lower its tax burden. And the three British drug companies fit the bill. A new industrial strategy is needed to enable the government to “defend a sector that is as important as pharmaceuticals is to Britain,” May said in a press conference in London this week.   Abbott’s dissolving stent offers long-term benefits to heart patients Cardiologists and heart patients in the US now have a new option for treating blockages in coronary arteries. Last week, cardiologists began implanting Absorb – Abbott Laboratories’ new biodegradable stent – in patients after it got FDA’s approval on July 5.  Unlike the permanent metal devices that have been used to prop open clogged vessels for more than 20 years, Absorb is designed to fully dissolve within two to three years of its deployment. Proponents of the new device say it holds the potential for long-term benefits over metal stents, including widely used drug-coated stents that have dominated the market since 2003.   Drug makers financially supported lawmakers who opposed Medicare Part B overhaul Four months ago, the Obama administration had unveiled a proposal to overhaul Medicare Part B, a medical insurance that covers necessary services and supplies for American citizens. A large number of lawmakers had opposed the effort. This week, a new analysis has revealed that drug makers, who were worried that the Obama administration’s proposal to overhaul Medicare Part B will cut into their revenues, gave lawmakers who opposed the overhaul considerably more financial support than lawmakers who have not raised objections. According to an analysis by a consumer advocacy group, 310 lawmakers who opposed the overhaul or were critical of it received a total of more than US $7.2 million from drug and health product firms for their 2016 campaigns. The amount given to each representative averaged more than US $ 23,300.   Obama tells drug makers to renew their commitment to improving public health US President Barack Obama has written a game plan on healthcare for the next president, including a crackdown on prices of prescription drugs. In a first for a sitting president, Obama wrote a scholarly article in the Journal of the American Medical Association (JAMA) that examines the passage of the Affordable Care Act – his landmark health law.  He also proposes future improvements to the US healthcare system. Obama reprimanded drug makers for their stance on pharmaceutical pricing and challenged companies to renew their commitment to improving public health. He also castigated the Congress for refusing to work with him to provide health coverage more quickly.   Cadila, Lupin, Alembic close issues with the FDA After weeks of news pertaining to non-compliance by India’s drug companies, the country’s pharmaceutical industry heaved a sigh of relief as Cadila, Lupin and Alembic reported closure of some issues with the FDA. “This receipt of EIR (Establishment Inspection Report) only indicates closure of the inspection points (483s) raised, based on the inspection carried out between August 28, 2014 and September 05, 2014. What is ‘closed’ is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said in a regulatory filing.   Gilead wins lawsuit against AIDS activist group; gets approval for hepatitis C drug It’s been a good fortnight for Gilead Sciences. Last week, a lawsuit against the drug maker by an AIDS activist group was dismissed by a US federal court judge. The lawsuit accused Gilead Sciences of manipulating the patent system in order to thwart competition for its HIV medicines. In its lawsuit, the AIDS Healthcare Foundation had charged that Gilead not only violated antitrust laws, but also prevented countless HIV patients from access to a newer and safer treatment. Gilead Sciences also recently won FDA approval for another groundbreaking hepatitis C drug. This first of its kind oral, once-a-day drug – known as Epclusa – can treat all six major subtypes of hepatitis without patients taking any other drug, including the debilitating ribavirin. But the cost of Epclusa is prohibitive. The company said Epclusa would be priced at US $ 74,760 for a 12-week course of treatment, which works out to US $ 900 per tablet. In 2013, Gilead was criticized for initially pricing its first hepatitis C drug – Sovaldi – at US $ 1,000 a pill. Its second-generation drug Harvoni was also launched at around the same price.  

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    #Phispers by PHARMACOMPASS
    14 Jul 2016
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    Dr. Reddy’s faces penalties in the US; metformin found in American waters; Interpol seizes illicit medicines

    Dr. Reddy’s faces penalties in the US; metformin found in American waters; Interpol seizes illicit medicines

     This week, Phispers brings to you the latest news from the world of pharma where Merck was found lying under oath, Mylan’s “exceptionally large” drug price hikes reignited the price-gouging debate and data integrity issues surfaced in China. And, a lot more.Dr. Reddy’s acquires products from Teva; but faces penalties in the USThis has been a mixed week for Dr. Reddy’s Laboratories. The company has signed a deal with Israeli drug maker Teva to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US for US $ 350 million. In April 2015, Teva had entered into a deal with Allergan to buy its generics products for US $ 40.5 billion, soon after it failed in its bid to buy Mylan. On the flip side, the US Consumer Product Safety Commission (CPSC) has sought civil penalties against Dr. Reddy’s for failing to report problems with packaging of several medicines. In a 4-1 vote held two weeks ago, CPSC said Dr. Reddy’s knowingly violated federal law as issues with child-resistant blister packs for five prescription drugs were not reported within the mandated 24 hours. The violations had occurred between 2002 and 2011.  After antibiotics in Chinese rivers, it’s metformin in American watersIn June last year, we reported on how antibiotics were found in the rivers of China. This week, a new study has found traces of the widely-used diabetes drug – metformin – and other medicines in dozens of streams throughout southeastern United States. The survey was done on 59 streams and it found an average of six different drugs. The findings suggest the cause of contamination was unrelated to discharges from wastewater treatment facilities. Metformin appeared in 89 percent of the samples and 97 percent of the sample sites. Researchers also found traces of tramadol (opioid); carbamazepine (anti-seizure drug) and Allegra (antihistamine). At some of the sample sites, the concentrations of these medicines are expected to affect aquatic life. There was also some good news about metformin this week. Research has suggested that metformin may exert a long-term protective effect against neurodegenerative diseases, including Alzheimer's and Parkinson's. Court overturns US $ 200 million jury award; says Merck ‘lied under oath’A federal judge in San Jose found Merck lied to a business partner and to the court. As a result, the judge threw out a patent infringement judgment Merck had won against Gilead Sciences. He also overturned a US $ 200-million jury award. This judgement is considered a landmark one, considering it involves Gilead’s blockbuster drug Sovaldi, a treatment for the hepatitis C virus, and Merck – the world’s fourth-largest drug company. “Merck's misconduct includes...misusing Pharmasset's confidential information..., and lying under oath at deposition and trial,” the federal judge, Beth Labson Freeman, said. This news comes at a time when a review by the US Food and Drug Administration (FDA) staffers questioned whether an experimental Merck drug is effective in treating Clostridium difficile, or C. difficile, the most common cause of infectious diarrhea in hospitals and nursing homes. Mylan’s ‘exceptionally large’ drug price rise brings pricing debate back in focusPrice gouging has been plaguing the global pharma industry for quite some time now. During the week, there was news about Mylan and Pfizer increasing prices. Over the last six months, Mylan has raised prices by more than 20 percent on 24 products. Meanwhile, Pfizer was in news for increasing the list prices of its medicines in the US by an average of 8.8 percent. This is the second time this year that Pfizer has substantially boosted prices for its prescription drugs. On January 1, Pfizer had raised prices by an average of 10.4 percent. Mylan boosted prices by more that 100 percent on seven other products. Wells Fargo analyst David Maris termed the price hikes as “exceptionally large.” In Europe, the high price of drugs is straining its cash-strapped health systems and depriving patients of the latest products. Ergo, the European pharmaceutical industry is considering a radical shift in the way it prices drugs so that companies are rewarded for the clinical benefit of treatments rather than the number of pills sold. An internal report prepared by the European Federation of Pharmaceutical Industries and Association has called for the removal of external reference pricing and placing curbs on parallel imports. Interpol’s Operation Pangea IX seizes US $ 53 million worth of illicit medicinesInterpol seized potentially life-threating drugs and goods, including fake cancer medication, substandard HIV and diabetes testing kits, counterfeit dental equipment and illicit surgical equipment, through its Operation Pangea IX. The operation involved targeting illicit online sale of medicines and medical devices. It involved 193 police, customs and health regulatory authorities from 103 countries. Operation Pangea resulted in 393 arrests worldwide and the seizure of more than US $ 53 million worth of potentially dangerous medicines. The operation was supported by private partners from the Internet and payment industries and saw the suspension of 4,932 websites selling illicit pharmaceuticals. India’s pharma industry growth dips to two-year lowThe impact of Indian health ministry’s gazette notification banning the immediate manufacture, sale and distribution of 344 fixed dose combination (FDC) drugs has begun to reflect in growth numbers. The Indian pharmaceuticals market’s growth this May was the lowest in two years, impacted by a drop in sales of FDC drugs, fresh price cuts and a lower than expected uptake, according to pharmaceutical market research company AIOCD PharmaTrack. For May, the pharmaceuticals market grew by 7.7 percent compared to 11.6 percent during the same month last year, reaching sales of Rs 994.76 billion (US $ 14.8 billion) over a 12-month period. India’s FDC market dropped 14.6 percent and is now valued at Rs 1.96 billion (US $ 29.1 million). Valeant may sell stake in Egypt’s largest drug company AmounValeant Pharmaceuticals International plans to step up its debt-reduction plans and is considering the sale of Egyptian drug maker Amoun Pharmaceutical. According to a report, Amoun may attract drug companies with an interest in expanding in emerging markets. Valeant is reportedly working with Goldman Sachs Group on the sale. Last year, Valeant had acquired Amoun’s holding company – Mercury Holdings – for around US $ 800 million, along with some contingent payments. Valeant’s intentions at the time were to use Amoun as a platform to further expand in the Middle East and Africa.  GMP problems roundup: Fresh cases emerge in China, India Beijing Taiyang Pharmaceutical Industry, a Chinese manufacturer of diphenyhydramine hydrochloride, a commonly used antihistamine, was placed on the FDA import alert list in April 2016. Last week, Beijing Taiyang was also placed on Health Canada’s Inspection Tracker List as the regulatory agency evaluated the risk the company’s products posed to patients. The primary reason given for the action was data integrity concerns. Akums Drugs & Pharmaceutical Limited is a major Indian contract manufacturer with nine facilities that mostly supply to the domestic market. Akums’ international expansion plans suffered a setback as its facility in Haridwar (India) failed its first EDQM (European Directorate for the Quality of Medicines & HealthCare) inspection.  The critical deficiency observed by the inspectors was the “lack of sterility assurance as there was insufficient evidence during validation to confirm that all ampoules in the load met the sterilizing conditions”. There were also deficiencies observed across all aspects of the quality management system. Akums’ failure is a setback for the Netherlands-based Nordic Pharma Limited for whom Akums was manufacturing progesterone injection 50mg/mL ampoules (Gestone). The inspection failure will result in the recall of four batches from the UK and Ireland and will most likely have Nordic Pharma retain their existing contract manufacturer, Hikma Italia SPA. 

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    16 Jun 2016
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    Capsugel’s U.S. plant has data-integrity issues, billion dollar Chinese bid for Indian sterile manufacturer, Pfizer & Mylan’s dermatology bet

    Capsugel’s U.S. plant has data-integrity issues, billion dollar Chinese bid for Indian sterile manufacturer, Pfizer & Mylan’s dermatology bet

    This week’s Phispers has regulatory and M&A news from across the world as Pfizer ends its support to drugs used in lethal injections, Endo’s problems get compounded and Thalidomide’s Nazi war criminal links are uncovered. European regulators to ‘rely more’ on FDA inspectionsSince the US Department of Justice imposed a US $ 500 million fine on Indian drug manufacturer Ranbaxy in 2013, we have seen regulatory concerns over globalization of drug manufacturing. The Ranbaxy controversy also demonstrated differences in the approaches of regulators in the EU and the US. While the US FDA banned the import of products from two of Ranbaxy’s factories into the US, no such move was taken by the European regulator, the European Medicines Agency (EMA). “A legal framework will allow us to be able to rely more on US inspections,” Emer Cooke, head of international affairs at the EMA, said in a news report. “That will allow us to release resources to adopt a more risk-based approach.” This statement manifests that European regulators rely more on FDA inspections, than on their own. Cooke was referring to the need for Transatlantic Trade and Investment Partnership, a partnership between the EU and the US to better channel scarce resources between the two regions. Data-integrity issues uncovered at Capsugel’s U.S. plant Problems of data-integrity don’t seem limited only to Asia as Sweden’s regulator, Medical Products Agency (MPA), uncovered “two critical and one major concerns” related to data-integrity at Capsugel’s Bend Research Inc. facility in Oregon. The inspectors also found that several findings, from two previous MPA inspections, had not been corrected and concluded that the facility had an “unacceptable level of GMP compliance”.Bend Research makes oral solid dose products, primarily for clinical trials and was acquired by Capsugel in 2013. Capsugel subsequently invested $20m in to add commercial spray drying capacity at the Oregon site.    Mylan and Pfizer put skin in the game by investing billionsThis week, both Mylan NV and Pfizer made acquisitions in the dermatology/topicals space.  Mylan NV announced its decision to buy skin drug assets from Renaissance Acquisition Holdings LLC for around US $ 1 billion to complement its existing products. Pfizer, on the other hand, will buy Anacor Pharmaceuticals – a biopharmaceutical company – for US $ 4.5 billion. This is said to be Pfizer’s Plan B, post the collapse of the Allergan mega deal. Pfizer CEO Ian Read had earlier said Pfizer will shop for deals to beef up the “innovative” side of its business. Anacor is “a strong fit” with Pfizer’s inflammation and immunology group, said Albert Bourla, group president of the Pfizer division that includes innovative pharma. The acquisition is “expected to enhance near-term revenue growth for the innovative business.” For instance, Anacor’s eczema therapy, crisaborole, should bring in US $ 2 billion in annual sales. “The dermatology/topicals space has long been an area of focus for Mylan and one that we have targeted for expansion,” Heather Bresch, Mylan’s chief executive officer, said. Pfizer ends support to drugs used in lethal injectionsLast week, Pfizer took a milestone step and announced it had imposed sweeping controls on the distribution of its products to ensure that none are used in lethal injections. This is a step that closes the last remaining open-market source of drugs used in executions. Such restrictions have already been adopted by over 20 American and European drug companies. They have cited moral or business reasons to take such steps. “With Pfizer’s announcement, all FDA-approved manufacturers of any potential execution drug have now blocked their sale for this purpose,” said Maya Foa, who tracks drug companies for Reprieve, a London-based human rights advocacy group.  Thalidomide’s inventor knew about its risks before marketing it, says filmVancouver documentary director John Zaritsky who has made his third film this year on Thalidomide – the devastating drug that caused thousands of birth defects before being pulled out of the market in the early 1960s – has revealed an interesting finding in his latest film ‘No Limits’.  The world premiere of the film took place on May 7, as part of Vancouver’s DOXA festival. According to the film, developers of the drug were war criminals in Nazi Germany. It also shows how today’s developing world is still marketing thalidomide as treatment for leprosy — leading to the birth of deformed babies. The drug maker – Grunenthal – continues to operate. According to the film, Grunenthal researcher and Thalidomide’s inventor, Heinrich Mueckter, had been a doctor at the Buchenwald concentration camp, performing experiments on prisoners. Mueckter became a multi-millionaire through Thalidomide sales. The documents revealed that Grunenthal knew months before putting Thalidomide on the market that their drug would produce malformed babies. They still went ahead and made fortunes off the drug.  China’s Fosun group makes billion dollar bid for India’s Gland PharmaThis week, Shanghai Fosun Pharmaceutical (Group) announced it has made a non-binding bid for India’s Gland Pharma Ltd, the Hyderabad-based injectable drugs manufacturer. According to a Reuters news report, Gland Pharma founders and KKR, which jointly own about 96 percent of the company, are selling their combined stake, which is valued at US $ 1 billion and US $ 1.5 billion respectively. Global buyout firm Advent International and US-based Baxter International are also said to be among the companies interested in buying out Gland Pharma. Shanghai Fosun said the proposal was made through its unit Fosun Industrial Co Ltd. More trouble for Endo as Mylan, Novartis eye Teva’s generic portfolioAfter the disappointing guidance which caused Endo’s stock price to crash last week, the Federal Trade Commission (FTC) attacked Endo for delaying the launch of an authorized generic. The FTC filed a complaint in a district court in Pennsylvania against Endo, Impax, Watson Laboratories and others, alleging the companies violated the FTC Act by entering into no-AG commitments, among other things on two of its “most important branded prescription drug products,’’ Opana ER, an opioid drug, and Lidoderm, a lidocaine patch.Meanwhile Endo’s arch rival Teva’s drug portfolio in the UK, Ireland and Iceland is attracting bidders such as Mylan NV and Novartis AG. According to reports, private equity firms such as Apollo Global Management and Cinven are weighing bids for Teva, which could fetch US $ 1.5 to US $ 2 billion. Teva is selling assets as it works to get regulatory approval for its US $ 40.5 billion acquisition of Allergan Plc’s generics business. Envoy warns Colombia government about its efforts to override Novartis patentLast month, a Colombian embassy official sent a memo to the foreign minister of his country warning the government about its efforts to override a patent on a cancer drug made by Novartis. According to the official, such efforts could harm US support for peace initiative in Colombia. According to reports, the Colombian health ministry has been planning to issue a compulsory license for Gleevec (also marketed as Glivec) – a leukemia treatment – which would allow generic drug makers to manufacture a cheaper version of the drug. Novartis has strongly opposed the move. The leaked memo was posted by Knowledge Ecology International and states that the US Trade Representative and staffers from the Senate Finance Committee requested to meet embassy officials to discuss US concerns with Colombia's plans. Gilead gets Sovaldi patent in India amid protests by patient groupsIn a politically sensitive move, the Indian Patent Office (IPO) reversed course and granted a patent to Gilead Sciences for its Sovaldi hepatitis C treatment. This way, the IPO earned the wrath of many patient groups, while handing Gilead an unexpected victory. The decision came in response to a challenge to the Gilead patent filed by several patient advocacy groups and companies that make pharmaceutical ingredients. Last year, the IPO had rejected the company’s patent application on grounds that it was not a significant improvement over an earlier compound developed by Gilead.  

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    #Phispers by PHARMACOMPASS
    19 May 2016
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    Phispers: IMS Health merges with Quintiles, FDA Compliance Director’s pay package, J&J’s Talcum Powder’s cancer risk

    Phispers: IMS Health merges with Quintiles, FDA Compliance Director’s pay package, J&J’s Talcum Powder’s cancer risk

    Phispers, our news capsule, brings you the latest recap from the world of pharma, such as up to 20 percent drugs sold in India could be counterfeit, Reckitt Benckiser’s killer disinfectants, after $200 million fine Gilead accuses Merck lawyer of lying, China’s multi-billion pharma opportunity and more.   FDA Compliance Director’s pay package pales in comparison with Clinton’s DCAT speaking fee PharmaCompass noticed a job opening at the US Food and Drug Administrations (FDA) – Director, Office of Compliance. The annual salary for this post mentioned was US $ 123,175 to US $ 185,100. Now compare this to what Hillary Clinton was paid to speak at DCAT’s Annual Dinner in 2014 – US $ 250,000. Or with Valeant’s new CEO Joseph Papa’s US $ 67 million package which could be worth US $ 500 million if Valeant shares reach their previous record high levels. The price that the department pays for a post that ‘touches the lives of every American’ certainly seems measly!   IMS Health in US $ 9 billion merger deal with Quintiles In an announcement which caught the market by surprise, industry leaders, contract medical research provider Quintiles Transnational announced a merger with healthcare information company IMS Health Holdings in a deal worth about US $ 9 billion. The combined company, which will have a market value of nearly US $ 18 billion, will offer services to drug and medical device makers, ranging from helping run clinical trials to tracking sales once a product has hit the market. The combined company – Quintiles IMS Holdings – will be led by IMS Health chief executive Ari Bousbib.    China’s blood plasma shortage throws opportunities for pharma companies While China’s blue-chip firms maybe sinking at the bourses, Shanghai RAAS Blood Products, a seller of treatments made from human blood plasma, is rallying new highs. It’s now China’s largest healthcare company by valuation with a market cap of almost US $16 billion (compare that with an IMS & Quintiles combination which is worth $ 18 billion). The big driver of growth is China’s surging demand for plasma-based therapies. Even though millions in China need these treatments, there’s scarcity of the blood plasma used to make them, partly because Beijing strictly controls the number of companies that have licenses to collect blood. GSK should definitely look into this opportunity as its sales in China have been tumbling. At the same time Biogen considers hemophilia to be a serious opportunity and plans to spin the division into a separate entity   Up to 20 percent drugs sold in India could be counterfeit In a special report, the office of the US Trade Representative (USTR) has raised major concerns about counterfeit drugs and devices. According to the report, 97 percent of all counterfeit pharmaceuticals seized at the US border in 2015 were shipped from four economies – China, Hong Kong, India and Singapore. Particularly, the USTR has raised concern about the proliferation of counterfeit pharmaceuticals manufactured, sold, and distributed in trading partners such as Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru and Russia.  While it is impossible to determine an exact figure, studies have suggested that up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety.   Court orders J&J to pay US $ 55 million to woman who alleged talc caused cancer In February, J&J was ordered to pay US $ 72 million, in a St. Louis courthouse, to the family of a woman who died of ovarian cancer after having used J&J’s baby powder and another talc-based product for years. In another loss, Johnson & Johnson needs to pay US $55 million to a 62-year-old South Dakota woman who put the blame for her ovarian cancer on the company’s talcum powder. In the US, J&J is accused in more than 1,000 lawsuits in state and federal courts of ignoring studies linking its Shower-to-Shower product and Johnson’s Baby Powder to ovarian cancer. Women contend the company knew the risk and failed to warn customers. J&J, on the other hand, has denied any link between talc and ovarian cancer or any need to warn women.   After US $200 million fine, Gilead accuses Merck lawyer of lying In March, a federal jury in San Jose ordered Gilead to pay Merck US $200 million after finding that two US patents held by Merck and its partner, Ionis Pharmaceuticals, were valid and infringed by Gilead’s multibillion-dollar hepatitis C drugs – Sovaldi and Harvoni. The patents cover a range of compounds treating hepatitis C. Merck recently began selling its own hepatitis C drug – Zepatier. After the jury verdict, Gilead argued it shouldn’t have had to pay Merck because Merck was dishonest in obtaining its patents. Gilead said in 2004, Merck patent attorney Philippe Durette had a conference call with employees of Pharmasset, in which he learned the chemical structure of an experimental hepatitis C drug being developed by Pharmasset, code-named PSI-6130.  Gilead later spent more than US$11 billion to acquire Pharmasset and its hepatitis C drugs. Gilead said Durette misused what he learned on the call to subsequently change claims in pending Merck patent applications in a way that would cover Pharmasset’s technology.    Reckitt Benckiser apologizes for killer disinfectants, even as it misled patients in Australia Ataur Safdar, head of the Reckitt Benckiser’s Korean division, apologized for selling deadly disinfectants that killed or injured hundreds of people, five years after the government ordered the company to remove the products from shelves for health risks. Safdar said the company wanted to make amends, even as he was interrupted by angry and tearful victims and their family members. Meanwhile, an Australian court has ordered Reckitt Benckiser to pay 1.7 million Australian dollars in penalties after a ruling that the company misled consumers about the effectiveness of a popular painkiller.   Eli Lilly warns of job losses due to ban on carcinogen used to produce raloxifene Eli Lilly, one of Ireland’s largest pharmaceutical employers, has warned of job losses at its Kinsale plant if the EU does not exempt it from a forthcoming ban on ethylene dichloride (EDC) – a carcinogenic chemical. Eli Lilly uses the chemical to produce raloxifene, marketed as Evista, a prescription drug to prevent osteoporosis in post-menopausal women. The drug is currently used by 1.7 million patients worldwide. EDC will be banned within the EU from November 2017.   Goggles, hair, insects, dirt in APIs, reveals FDA warning letter to Polydrug Labs Polydrug Laboratories has been on FDA’s Import Alert List since September 2015. The warning letter issued by the FDA was posted on the regulator’s website and it talks about all kinds of uninvestigated complaints found on a torn sheet of paper recovered during the inspection.  Amongst these were complaints like low assay value in API and particles and hair, insect and dirt and safety googles found in API. According to the FDA, Polydrug failed to comply with current good manufacturing practices for the manufacture of APIs and also failed to record and investigate all quality-related customer complaints according to an established procedure. More details are available at Barbara Unger’s blog entry.   Effort to regulate drug pricing reaches G7 Summit In March, the French President Francois Hollande had said he would push for international regulation of drug prices when he meets leaders from other G7 countries in Ise-Shima (Japan) on May 26-27. News reports point that the issue is now on the agenda for the G7 Summit and health ministers will continue work on it in Kobe in September when other parties, such as the pharmaceutical companies themselves, could potentially be involved. France plans to press its G7 partners to launch an ‘irreversible’ process to control the prices of new medicines as part of a global drive to make life-saving drugs more affordable.  This news has come at a time when the UK too (like the US) is witnessing debates on price gouging, after the price of eye-drops used for bacterial conjunctivitis underwent a 14-fold price increase recently.   FDA’s generic drug approval report card  For the past few weeks, we have been mentioning an acceleration in the review process of generic drug applications filed with the FDA. The FDA recently released its Generic Drug Review Dashboard for the first quarter of 2016. It wasn’t surprising that the review process has been accelerated as the number of applications pending with the FDA have reduced by almost 10 percent with the burden of work now shifting to the industry which has to respond to the FDA’s comments or concerns.   

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    #Phispers by PHARMACOMPASS
    05 May 2016
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    Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

    Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

    This week, the biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs. But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed countries to make its drugs and Valeant terminated the salesforce for its female libido pill. Pharmaceutical Whispers (Phispers) brings you the latest news from across the world. Pfizer-Allergan terminate merger; Allergan signs licensing deal with HeptaresOn Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate the deal.  Allergan, which is run from New Jersey but has a legal domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger would have moved the Pfizer headquarters from New York to Dublin, saving the pharma behemoth billions of dollars in taxes. As per news reports, Pfizer will need to pay a US $ 400 million fee to Allergan for expenses relating to the deal. Though the US Treasury decision and the termination of the Pfizer-Allergan deal represents a victory for President Barack Obama, whose administration proposed tougher rules aimed at curbing tax inversions, Allergan is not wasting time. Just hours after Allergan backed away from the US $ 160 billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global rights to a portfolio of drugs for neurological disorders from the UK's Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans to barrel ahead with new pacts to bolster the company's pipeline.  Pfizer, Celltrion win approval for biosimilar of J&J’s RemicadeNot all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade. The product will be co-marketed by Pfizer in the United States, a relationship Pfizer accessed through its acquisition of Hospira last year. Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug. The European Medicines Agency also issued a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint venture between a unit of the Samsung group and Biogen, has become a force in the biosimilar drugs industry. In fact, South Korea too is emerging as a hub for biosimilar production. Last week, Bioepis filed a lawsuit against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales were US $ 6.5 billion.  Glaxo not to patent drugs in poorer countriesIn an unusual step, GlaxoSmithKline said it wants to make it easier for manufacturers in the world's 48 least-developed countries to copy its medicines. The company said it would not file patents in these countries in the hope that by removing the fear of patent litigation and by allowing independent companies to make and sell versions of its drugs in those areas, it would widen public access to these drugs. In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead has adopted a similar model, of granting generic licensing agreements in developing countries, for its blockbuster Hepatitis C treatment, Sovaldi. The end of the female Viagra?Valeant Pharmaceutical, still reeling from all its accounting and price-gouging problems, has terminated the sales force for the female libido pill that it acquired last year for US $ 1 billion. The drug – Addyi  (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report. In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees. Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India Inspection at Alkem: In July 2015, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. And this year, another laboratory is under the lens of EU regulators.A routine inspection by the European Medicines Agency in March 2015 of the Department of Bioequivalence of Alkem Laboratories, a major generic drugs manufacturer in India, raised concerns regarding study data used to support the marketing authorization applications of some drugs in the EU.  Rusan Pharma back in news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs). The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices. This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.”  Non-compliant sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin from a non-EU GMP compliant source (Hebei Dongfeng Pharmaceutical Company Limited, China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma. In addition, several documents were found within a pile of rubble which included an original batch repacking record. A large number of active substances were manufactured at the site, such as chloramphenicol, chloramphenicol palmitate, erythromycin, erythromycin ethylsuccinate, roxithromycin, ciprofloxacin HCl etc.    Catalent’s compliance problems delay OPKO’s new drug launchWith more than 40 manufacturing facilities around the world, Catalent is a preferred manufacturing partner for several major pharmaceutical companies across the world. OPKO Health, Inc., one of Catalent’s customers submitted its application for RAYALDEE® (calcifediol) to the FDA. In the complete response letter (CRL) issued to the company, the FDA indicated observations of deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval. According to a news report, OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25. Meanwhile, Catalent began production of essential drugs at its French plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches. Safety warnings for new age diabetes drugs -- saxagliptin and alogliptin Last year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass had asked the question, “Diabetes: Which new drug is the safest?”. At the time Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). This week the FDA issued a safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the evaluation of two clinical trials determined that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo. Blockbuster drug approval expected soon for non-alcoholic fatty liver The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high likelihood that it will get approved. While the drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease, late-stage studies are underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which has no approved treatment. Obeticholic acid (OCA) is listed as one of the top 10 possible blockbuster drugs by FierceBiotech with an expected sales in 2020 of US $ 1.6 billion. Gilead is also actively building its liver disease pipeline and this week, the company paid US $ 400 million upfront to acquire an early-stage pipeline of liver disease drugs from privately held Nimbus Therapeutics. Heart-disease science turns over its headScience is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol. If a drug lowers the bad cholesterol and increases the good one, the risk of heart disease should reduce significantly. Specialists were stunned by the results of a study of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.” The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision. As per the study, participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 mg per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.   

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    #Phispers by PHARMACOMPASS
    07 Apr 2016
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    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?

    The year 2015 has gone down in history as a record year for mergers and acquisitions in the pharmaceutical and biotech space with deals worth US $ 300 billion being announced. The highlight of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.  Pharma Letter tracked transactions through the year and found the number of deals exceeding US $1 billion at 30 in 2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A deals were announced in 2015 (out of which some are yet to be completed), compared to 137 in 2014.   This week, PharmaCompass brings you a compilation of the top drugs of 2015 by sales revenue and growth. Sofosbuvir – the outright winner of 2015 2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion. The PharmaCompass prediction that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment of infectious diseases like hepatitis and HIV) would become the best-selling drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864 billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira. Humira retained its place as the best-selling drug with US $ 14.012 billion in sales in 2015. However, with sales growth of US $ 11.737 billion in a single year, Harvoni is poised to become the best-selling drug by the end of 2016. Top 20 Drugs by Sales Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2015 data (Excel version available) for FREE!   Product Active Ingredient Main Therapeutic Indication Company 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) AbbVie 12,543 14,012 1,469 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 2,127 13,864 11,737 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen / Pfizer 4,688 8,697 4009 4 Remicade Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson / Merck 6,868 8,355 1487 5 MabThera/Rituxan Rituximab Oncology Roche 5,659 7,115 1,456 6 Lantus Insulin Glargine Diabetes Sanofi 6,978 7,029 51 7 Avastin Bevacizumab Oncology Roche 6,481 6,751 270 8 Herceptin Trastuzumab Oncology Roche 6,338 6,603 265 9 Revlimid Lenalidomide Blood Related Disorders Celgene Corpoartion 4,980 5,801 821 10 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 10,283 5,276 (5,007) 11 Seretide / Advair Salmeterol Respiratory Disorders GlaxoSmithKline 6,005 5,227 (778) 12 Crestor Rosuvastatin Calcium Cardiovascular AstraZeneca 5,512 5,017 (495) 13 Lyrica Pregabalin Neuroscience and Mental Health Pfizer Inc. 5,168 4,839 (329) 14 Neulasta Pegfilgrastim Blood Related Disorders Amgen 4,596 4,715 119 15 Gleevec / Glivec Imatinib Oncology Novartis 4,746 4,658 (88) 16 Xarelto Rivaroxaban Anticoagulants Bayer / Johnson & Johnson 3,369 4,345 976 17 Copaxone Glatiramer Neuroscience and Mental Health Teva 4,237 4,023 (214) 18 Januvia Sitagliptin Diabetes Merck & Co 3,931 3,863 (68) 19 Abilify Aripiprazole Neuroscience and Mental Health Bristol-Myers Squibb/ Otsuka Holdings 6,485 3,804 (2681) 20 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health Biogen 2,909 3,638 729 Click here to access all the 2015 data (Excel version available) for FREE! A year of record FDA approvals 2015 was also the year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information. PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant variation in estimates.  However, in our view, drugs that saw highest sales growth in 2015 are likely to do well this year as well. Top 20 drugs by sales growth (in USD, millions)   Product Active Ingredient Main Therapeutic Indication 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) 2,127 13,864 11,737 2 Viekira Pak Ombitasvir/Paritaprevir/Ritonavir Infectious Diseases (HIV, Hepatitis etc.) 48 1,639 1,591 3 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) 12,543 14,012 1,469 4 Hepatits C Franchise Daclatasvir and Asunaprevir Infectious Diseases (HIV, Hepatitis etc.) 256 1,603 1,347 5 Imbruvica Ibrutinib Chronic lymphocytic leukemia 200 1,443 1,243  6 Cubicin Daptomycin Anti-bacterial 25 1,127 1,102 7 Eliquis Apixaban Anticoagulants 774 1,860 1,086 8 Triumeq Abacavir, Dolutegravir and Lamivudine Infectious Diseases (HIV, Hepatitis etc.) - 1,037 1,037 9 Xarelto Rivaroxaban Anticoagulants 3,369 4,345 976 10 Opdivo Nivolumab Oncology 6 942 936 11 Revlimid Lenalidomide Blood Related Disorders 4,980 5,801 821 12 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health 2,909 3,638 729 13 Xtandi Enzalutamide Oncology 480 1,207 727 14 Ibrance Palbociclib Oncology - 723 723 15 Invokana / Invokamet Canagliflozin Type 2 diabetes 586 1,308 722 16 Victoza Liraglutide Diabetes 2,014 2,704 690 17 Stribild Cobicistat, Elvitegravir, Emtricitabine and Tenofovir Disoproxil Fumarate Infectious Diseases (HIV, Hepatitis etc.) 1,197 1,825 628 18 Levemir Insulin Diabetes 2,133 2,745 612 19 Votrient Pazopanib Oncology 565 565 20 Perjeta Pertuzumab Oncology 927 1459 532   Hepatitis C products, which had three of the four highest sales growths in 2015, clearly show the impact these revolutionary treatments will have on the global healthcare landscape in time to come. Cancer immunotherapy treatments, a new generation of blood thinners and novel diabetes treatments were some of the others which demonstrated stellar growth in 2015. Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they have not been included in the compilation of drugs. Click here to access all the 2015 data (Excel version available) for FREE!   Sign Up, Stay Ahead While some companies like Boehringer and Valeant are yet to release their annual reports. In order to stay informed, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to access all the 2015 data (Excel version available) for FREE!   CORRECTION, April 12, 2016: An earlier version of this compilation did not account for cases where the same drug is sold by multiple companies (e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top 20 Drugs by Sales and Sales Growth has been done.   

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    #PharmaFlow by PHARMACOMPASS
    10 Mar 2016
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    Phispers: Ranbaxy whistleblower takes Indian govt to court; Merck claims US $ 3 billion from Gilead & more

    Phispers: Ranbaxy whistleblower takes Indian govt to court; Merck claims US $ 3 billion from Gilead & more

    This week, Pharmaceutical Whispers (Phispers) looks at Ranbaxy whistleblower’s public interest litigation (PIL) against the Indian government, Bristol-Myers’ clampdown on doctor payments in China and how Jimmy Carter won the battle against cancer. Ranbaxy whistleblower takes government to court over harmful drugs being sold in India Dinesh Thakur got almost US $ 48 million as a whistleblower award, when American regulators fined Ranbaxy US $ 500 million for violating federal drug safety laws and making false statements to the Food and Drug Administration (FDA). Thakur has now filed a fresh case – a public interest litigation (PIL) alleging responses provided to him by the Indian government show how lax regulation can lead to potentially harmful medicines being sold in India without proper approvals. Thakur's suit refers to the case of Buclizine, a drug made by Belgian firm UCB, but since sold to Mankind Pharma for marketing in India. The Central Drugs Standard Control Organization (CDSCO) allowed UCB to sell Buclizine as an appetite stimulant in 2006, though it wasn’t approved for the purpose in Belgium and is banned in many other countries. The case is scheduled for a Supreme Court hearing on March 11. Evergreen pharma sector is facing some serious headwindsLast week, we heard some not-so good news about the pharmaceutical sector. First, Moody's Investors Service reduced its outlook from ‘positive’ to ‘stable’ for both the pharmaceutical and medical device industries. The reasons cited are: One, a strong dollar is reducing company sales outside of the US. Two, there is pressure on drug-makers to reduce price in the US. And three, drug-makers have also been hurt by slower uptake of many drugs. Back in India, there was news that pharma companies in the state of Gujarat have witnessed a dip in exports to the African countries. Most of the countries in Africa have seen their currencies depreciate against the dollar, making imports costlier. As a result, Gujarat’s pharma exports dipped 40 percent in the last six months. And then there was news that Venezuela settled debts with at least three global drug companies by giving them bonds that trade at a heavy discount. Merck claims US $ 3 billion from Gilead as patent royalties from Hepatitis C franchise Gilead Sciences is trying to fend off an over US $ 3 billion demand by Merck in a patent dispute over the treatment of hepatitis C, a disease for which the former had pioneered a cure. Last month, a judge found a compound in Gilead's blockbuster drugs Sovaldi and Harvoni may have infringed Merck's patents. A jury will now decide whether those patents are valid or not. In case they are valid, how much does Gilead owe Merck in royalties? Gilead, on the other hand, plans to show jurors that scientists were working on the medicine as early as 2001, a year before Merck got the patent rights it’s seeking to enforce in this case. According to Gilead’s lawyer, the company owes the success of its drug not to Merck but to laboratory research done 15 years ago by Pharmasset, a company Gilead acquired in 2011 for US $ 11 billion. Bristol-Myers curbs doctor payments in China Novartis got raided in Korea over bribery concerns two weeks ago, and now Bristol-Myers Squibb has clamped down on the use of expenses and speaker fees for doctors, after the issue got reported in Chinese social media. Although the news could not be confirmed, an emailed statement to Reuters said “Bristol-Myers Squibb has voluntarily stopped certain initiatives in China as the company continues to review its activities and build upon its business model in China.” In October 2015, Bristol-Myers had agreed to pay US $ 14 million to resolve allegations that it violated the Foreign Corrupt Practices Act. Government’s authority to override patents makes headlines in India, US and ColombiaOf late, the authority to override patents in order to make medicines accessible to more people has been making headlines across the world. In a stunning revelation, the US-India Business Council (USIBC), in a report, said the Indian government had “privately reassured” them it would not use compulsory licences (CLs) for commercial purposes. This indicates that India’s patent office will take a more restrained approach in handing out licences to domestic players to produce cheaper versions of patented drugs. A CL allows a company to make a patent-protected product without the consent of the patent holder. This news comes at a time when the same issue is being debated in the United States and even in Colombia. Last week, Obama administration rejected a request from dozens of Congressional Democrats to develop guidelines that would require drug makers to license their patents and put a lid on “price gouging.” Similarly, in Colombia, a government committee in February-end recommended that a CL should be issued for a cancer treatment drug – Gleevec – sold by Novartis. Across the world, several patients turn to countries like India for cheaper, generic versions of life-saving patented drugs. Billions worth of cancer drugs wasted due to their packagingPackaging plays a large role in determining how drugs get used. A new study (undertaken by researchers at Memorial Sloan Kettering Cancer Center and the University of Chicago) projects US $ 3 billion worth of the most common cancer medicines will go to waste this year in the US. According to the study, the drugs are wasted because manufacturers sell them in vials that are not practical to reuse. Experts have asked for policies that require pharmaceutical companies to package drugs differently or buy back unused drugs.  Jimmy Carter says his cancer has gone into remission, thanks to immunotherapyIf you are one of those who is skeptical of immunotherapy, think again. Recently, former US President Jimmy Carter said he will no longer need treatment for melanoma, a type of skin cancer that had spread to his liver and brain. The 91-year-old Nobel Peace Prize winner will continue to be observed by doctors, but will not need treatment. The reason – a promising immunotherapy drug has helped his body’s immune system target cancer cells. Ten years back, Japan’s Ono Pharmaceutical had tried convincing doctors to test a drug that helped the body’s immune system fight cancer. No one got convinced back then. They had dismissed immunotherapy as a fad. But now, Ono’s CEO Gyo Sagara says he received plenty of apologies when Opdivo – the drug the Japanese company worked on with Bristol-Myers Squibb – got the green light from regulators.  Prostate cancer drug to fund UCLA scholarships, stipendsThe University of California, Los Angeles (UCLA) took US $ 520 million pay-out as part of a deal announced last week that transferred royalty rights for a prostate cancer drug originally discovered in one of its science laboratories. The UCLA innovation is transforming cancer treatments. UCLA says it will spend the money until 2027 supporting research, scholarships for undergraduates, and stipends for graduate students. Khloé Kardashian to promote Allergan’s double-chin treatment KybellaReality TV star Khloé Kardashian hosted the kick-off event for Allergan’s Live Chin Up campaign. Khloé moderated a panel of experts who talked about how Allergan's injection -- Kybella – can treat chin fat. We hope her involvement with the pharma company doesn’t trigger a warning letter from the FDA, akin to how her sister Kim received one when her media posts promoted Diclegis, a prescription-only drug used to treat nausea and vomiting during pregnancy. Kim Kardashian had shared a selfie on Instagram and Twitter, holding a bottle of Diclegis, which invited a warning letter issued to Duchesnay USA, the company which produces the drug. The FDA’s warning letter said the media posts did not communicate the medical risks of the drug. Deal round-up: Sanofi-Merck, Alvogen-County Line, AbbVie-Boehringer & Amgen Alvogen has signed an agreement to acquire County Line Pharmaceuticals, a specialty generic pharma company based in Wisconsin. The transaction is likely to provide annual revenues of more than US $ 100 million per year for Alvogen.AbbVie will pay Boehringer Ingelheim nearly US $ 595 million to collaborate in developing drugs aimed at treating psoriasis, Crohn’s disease, asthma and other diseases affecting the immune system.After sitting out for most of the biotech acquisition frenzy of 2015, Amgen is ready to do a deal. According to Amgen’s Chief Financial Officer David Meline, the time is ripe for bigger targets. Sanofi and Merck ended a 22-year-old joint venture to sell vaccines in Europe, arguing they would do better by managing their product portfolios independently. Sanofi and Merck said they expected the unwinding of the vaccines joint venture to be completed by 2016-end. 

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    #Phispers by PHARMACOMPASS
    10 Mar 2016
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    Phispers: Another Heparin scandal in China, GSK may have a new CEO, Female libido pill problems

    Phispers: Another Heparin scandal in China, GSK may have a new CEO, Female libido pill problems

    Pharmaceutical Whispers (Phispers) this week cover another major heparin scandal emanating from China, GSK may have a new CEO in 2017, the pharma world reducing dependence on China for antibiotics, regulatory moves to accelerate drug approvals in the US and China and a lot more. Chinese heparin producer fails European inspection Last week, heparin producer Dongying Tianyong in China failed a European Directorate for the Quality of Medicines (EDQM) inspection. Heparin is a substance widely used as an injectable anticoagulant and as an intermediate. Results obtained from suppliers of crude heparin appeared to be manipulated and the quality system was identified as very weak and deficient, and not in compliance with the EU GMPs. The inspection was conducted in December while the summary report was posted February 25, 2016. Back in 2008, major recalls of heparin were announced by the US Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China, causing 81 deaths. The FDA had also indicated the contamination may have been deliberate and had identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. The contaminant – oversulfated chondroitin sulfate – cost US $ 9 a pound compared with US $ 900 a pound for heparin, creating one of the biggest pharmaceutical quality scandals in history. Dongying Tianyong also manufactures Enoxaparin Sodium, an active pharmaceutical ingredient (API) produced from heparin, for which a ‘recall of product’ has been considered and the company’s regulatory filing has been suspended. Is there going to be a repeat of the scrutiny on heparin manufacturers in China once again? World’s antibiotic supply chain will not rely completely on ChinaIn July 2015, Novartis announced it is shutting down three of its plants, one of which produced the antibiotic intermediate 7-ACA (7-aminocephalosporanic acid) – the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. At the time, PharmaCompass had expressed concern that the Novartis’ plant shut down has created an urgency to find alternatives to Chinese APIs, since the global supply of 7-ACA would be dependent on China in view of the announced closure. However, the global imbalance will not occur any time soon as International Chemical Investors Group (ICIG) announced the acquisition of Novartis’, Frankfurt-Höchst-based site which produces 7-ACA. With this acquisition, CordenPharma Group (the pharma platform of ICIG) will become one of the major suppliers of 7-ACA to customers worldwide. Expect accelerated drug approvals in China and the USThe China Food and Drug Administration (CFDA) said in a statement it would accelerate the approval of drugs. For pharmaceutical firms, the approval of drugs has been a headache for long and they complain it takes too long to get drugs to market.The newly appointed FDA commissioner, Dr. Robert Califf, mentioned that accelerated generic drug approvals will be high on his list of priorities. In addition, policy leaders in the United States have suggested speedy reviews of generic drugs that lack competition. This is one of the two specific actions aimed at reducing generic drug shortages more rapidly and price gouging. The other action suggested by the policy leaders is to give the FDA permission to clear a generic product based on an equivalent approval from a foreign country. Mylan breathes a sigh of relief, Teva’s Epipen launch “significantly delayed”While on the topic of accelerated approvals, Mylan breathed a sigh of relief as their billion-dollar allergy-reaction injector, Epipen will not see Teva as a competitor until at least 2017. Teva’s launch has been “significantly delayed” as the FDA found “major deficiencies” in its application. Epipen contributed 13% to Mylan’s global revenues last year.   Libido pill problems greet Valeant CEO on return from leaveOne of the pharmaceutical industry’s poster boys for high prescription drug prices – Valeant Pharmaceuticals’ CEO Michael Pearson – returned to work after a nine-week medical leave owing to pneumonia. Valeant is known to acquire medicines and then hike the prices.While Valeant’s business practices have been under close scrutiny and its shares are trading at the lowest level in two and a half years, now bad news is emerging about Addyi, the female libido pill Valeant acquired in 2015. A Dutch study found that, Addyi “gives limited gain in sex” and the benefits were slightly “more modest than those submitted to the F.D.A. during the approval process”. Not the kind of issue Pearson would have liked to deal with after returning to work post illness. GSK may have a new CEO in 2017GlaxoSmithKline’s chairman Sir Philip Hampton is believed to have instructed recruiters Egon Zehnder to identify a replacement for GSK CEO, Sir Andrew Witty. Some of the drug giant’s biggest investors have been demanding a split of GSK since they believe the sum of GSK’s parts is worth more than the current stock market value. It remains to be seen if Witty’s successor will be an internal or an external person. To keep him from leaving, IMS Health pays Its CEO more than IBM IMS Health Holdings paid its Chief Executive Officer Ari Bousbib US $ 34.8 million in 2015 to prevent him from leaving to a bigger rival of the data-services firm. In comparison, Accenture paid CEO Pierre Nanterme US $ 15.9 million for 2014. And IBM gave Ginni Rometty US $ 19.3 million. Both Accenture and IBM also provide data services to healthcare clients and have market valuations more than seven times IMS Health’s US $ 8.5 billion. Gilead’s sofosbuvir battles on patents and prices continue in IndiaGilead’s Hepatitis C treatment – Sofosbuvir – has been one of the most spectacular drug launches in pharmaceutical history. Sold as Sovaldi (sofosbuvir) and Harvoni (combination of sofosbuvir and lepidasvir), it generated 2015 sales of over US $ 19 billion. However, with the price in the United States at almost US $ 1,000 per pill and as little as US $ 4.29 per pill in India, Gilead made headlines again as the Indian Patent Office began hearings to determine whether Gilead Sciences “deserves a patent” for sofosbuvir.For those interested in this topic, a detailed report on the “Patent Situation of Key Products for the Treatment of Hepatitis C” is available on the World Health Organization (WHO) website.  Otsuka’s innovative TB drug under fire for high priceOne of the first new tuberculosis (TB) drugs in decades made by Japanese drug maker Otsuka Pharmaceutical got slammed this week for a ‘ridiculously high’ price tag. While Otsuka is charging US $ 1,700 for a six-month course of treatment, delamanid, which is known commercially as Deltyba, must be taken with other medicines, which make the complete regimen cost anywhere from US $ 1,000 to US $ 4,500 in developing countries. Unlike Gilead’s problems with Sofosbuvir, this drug won’t be available in India anytime soon as Otsuka still has not applied for regulatory approvals.  Deal-making round-up: AstraZeneca, Pfizer, Baxalta, Sanofi, AbbVie and Boehringer’s Astra Zeneca’s US $ 4 billion buy of Acerta got endorsed by the award of special “orphan” status to the key drug, acalabrutinib. However, the amount pales in comparison to the US $ 35 billion Pfizer is expected to avoid in taxes through its Allergan merger.The European Medicines Agency had recommended acalabrutinib as an orphan product for chronic lymphocytic leukaemia or small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma.Cancer deal-making remained in focus as Baxalta and Precision Biosciences announced a partnership to develop allogeneic chimeric antigen receptor T cell (CAR-T) therapies. The collaboration could generate up to US $ 1.7 billion for Precision Bioscience. However, another multi-billion oncology deal is being anticipated between AbbVie and Boehringer and should be announced soon.While deals are being announced, Sanofi’s divesture of its European generic unit, planned to begin this quarter, may get delayed. France’s largest drug maker needs more time to determine which assets should be included in the sale.  However, it seems like all roads lead to China – AstraZeneca divested rights to two ageing heart drugs for US $ 500 million to China Medical System Holdings. China Medical will pay AstraZeneca US $ 310 million for a licence to sell Plendil (a blood pressure pill) in China. It will also pay AstraZeneca US $ 190 million for the global rights of Imdur (a drug for angina treatment) outside of the US. 

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    #Phispers by PHARMACOMPASS
    03 Mar 2016
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    The secret drug pricing formula

    The secret drug pricing formula

    Why do “Americans pay, by far, the highest prices in the world for prescription drugs”? This concern has reached an unprecedented level where government and non-government lawmakers are taking a very serious view of this problem. Hilary Clinton has already made it “a campaign priority” for her 2016 presidential election bid. * Valeant pharmaceuticals buys two heart drugs in February and increased their list prices by 525% and 212%. The reason, company was doing “our duty is to our shareholders and to maximize the value”   * Study published in the journal Neurology on the cost of multiple sclerosis treatments, found drugs originally costing $8,000 to $11,000, now cost about $60,000 per year. The cost of increase is at rates 5 to 7 times higher than prescription drug inflation. Drug costs in the United States currently are 2 to 3 times higher than Canada, the U.K. and Australia. * The Wall Street Journal wrote about “lawmakers in a handful of states stretching from California to Massachusetts, have introduced bills in a bid to force the pharmaceutical industry” to disclose their costs. * In response to pressure by Senators Bernie Sanders and Elijah Cummings, the inspector general of Health & Human Services (HHS) will investigate how recent increases in generic drug prices, have impacted the Medicaid rebate program (for better understanding of the program and the reason why IMS data is different to company sales data, read this Forbes article . * Massachusetts Attorney General, Maura Healey demands why prices of naloxone, which is used to reverse heroin overdoses, has “skyrocketed ” since a public health emergency was declared a year ago. * The JAMA Oncology Study found that price of cancer drugs is independent of novelty and yet cancer drug prices have risen faster than prices in other sectors of health care.   The pharmaceutical defense: * The historical response, of the pharmaceutical industry, for the reason behind high cost of drugs is that funds are needed to continuously research and develop novel medicines. * “The price charged for an individual drug is not a reflection of development costs,” says Ken Kaitin, director of the Tufts Center for the Study of Drug Development. * The Generic Pharmaceutical Association also states that “since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.”    The counter argument: In an interview , Dr. Steve Miller CMO at Express Scripts said, “The industry is still innovating, but on a financial model of drug development that has little to do with science. The acquisition of Pharmasset by Gilead Sciences solely to obtain the rights to the HCV blockbuster Sovaldi is a good example. The drug was already through Phase III trials and Pharmasset had determined $36,000 per treatment was the right price; then Gilead bought the company, for $11 billion, and promptly added $50,000 to the asking price for Sovaldi. That’s not what is meant in recognizing an “innovative step.” Pharmaceutical giant Actavis CEO, Brenton Saunders “growth pharma” model, which believes “the idea that to play in the big leagues you have to do drug discovery is really a fallacy” will not help win public sympathy. When assessing the price increase of generic drugs, the United State Senators mentioned that the prices of “certain dosages or dose forms of a product have increased rapidly while prices for other doses remained flat or declined”. An example given is Fluconazole 100mg tablet having experienced a price increase of 954%, while the 150mg actually had a price decline of 8%.   The reality: Consistent with the conclusion in the JAMA Oncology study “that current pricing models are not rational, but simply reflect what the market will bear".   Expected action: HHS conducted an investigation on generic drug price increases in 2007 and recommended that generic drug makers pay rebates to state Medicaid programs. The practice is currently standard for branded pharmaceuticals. Although lawmakers are pushing this course of action, the inaction since 2007 and study on multiple sclerosis drugs shows limited benefit if generic drugs are made to pay rebates.   A far more likely outcome will be a European model, where federal health care programs like Medicare and Medicaid negotiate directly with drug makers to get lower prices. This provision was added in the recent budget of President Obama, but currently there is no progress. While regulators create their legislation, the pharmaceutical industry is in serious consolidation mode. If the Teva, Mylan deal comes through, and they combine, the options of negotiating with generic companies are going to seriously reduce.  

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    #Phispers by PHARMACOMPASS
    29 Apr 2015
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    Who has the biggest one? Sales of the top pharma products by revenue.

    Who has the biggest one? Sales of the top pharma products by revenue.

    We always knew math was fuzzy, but never imagined addition could get so complicated.  A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best selling products along with the top therapy areas. The list, based on data published by IMS Health, caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical companies.  As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics. Which pharmaceutical company is the largest? Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.  Should divisions like diagnostics, animal health, vaccines, consumer health be counted when determining the size of a pharmaceutical company? FiercePharma, in their analysis, used the total revenue of all divisions of the organizations to determine the largest organization; in their case it is Johnson & Johnson. IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest company. As currency exchange rate fluctuations have their own, big role, in determining the size of organizations, we believed it would be best to share the revenues, as presented, so that you can draw your own conclusions. Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)  Big Pharma IMS Rank IMS Sales (US $Mn) Fierce Pharma Rank Fierce Pharma Sales (US $Mn) Group Sales based on the Annual Report (Currency as reported, Mn)    Novartis 1 51,307 2 57,996 USD 57,996 Pfizer 2 44,929 4 49,605 USD 49,605 Sanofi 3 40,037 5 43,070 Euro 33,770 Roche 4 37,607 3 49,866 CHF 49,866 Merck & Co 5 36,550 6 42,237 USD 42,237 Johnson & Johnson 6 36,422 1 74,331 USD 74,331 AstraZeneca 7 33,313 8 26,095 USD 26,095 Glaxo SmithKline 8 31,470 7 37,960 GBP 23,006 Teva 9 26,001 11 20,272 USD 20,272 Gilead Sciences 10 23,673 10 24,474 USD 24,890 Amgen 11 20,473 12 20,063 USD 20,063 Lilly 12 19,909 14 19,615 USD 19,615 AbbVie 13 19,049 13 19,960 USD 19,960 Bayer 14 18,347 9 25,470 Euro 42,239 Bristol-Myers Squibb Not in Top 20 15 15,879 USD 15,879 NB: Mn is million Click here to access and download all the 2014 data (Excel version available) for FREE! Since each group has multiple divisions, we further split the sales for you to brainstorm: Table 2/ Sales comparison of the different divisions of top pharmaceutical companies in 2014 (Annual Reports in Mn)  Big Pharma Pharma Division Vaccine Division Generics Consumer Health Other Divisions Medical Devices/ Diagnostics Division Animal Health Division Divestures/ Other adjustments Novartis USD 31,791   Sandoz USD 9,562   Alcon USD 10,827     USD 5,816 Pfizer USD 45,708     USD 3,446 USD 451       Sanofi Euro 22,578 Euro 3,974 Euro 1,805 Euro 3,337     Euro 2,076   Roche CHF 38,969         CHF 10,897     Merck & Co USD 30,740 USD 5,302     USD 6,195       Johnson & Johnson USD 32,313     USD 14,496   USD 27,522     AstraZeneca USD 26,095               Glaxo SmithKline GBP 18,670     GBP 4,336         Teva USD 10,458   USD 9,814           Gilead Sciences USD 24,474             USD 416 Amgen USD 19,327       USD 736       Lilly USD 16,481       USD 788   USD 2,346   AbbVie USD 19,960               Bayer Euro 12,052     Euro 7,923       Euro 22,264 Bristol-Myers Squibb USD 15,879               Click here to access and download all the 2014 data (Excel version available) for FREE! Not sure that it adds any extra clarity on what should define a global pharmaceutical company… Since the various divisions make companies complicated to assess, what about product sales? The good news is that we have a winner!  Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason. Unfortunately, things stopped making sense the moment we reached the number-two product on the IMS list. Lantus®, Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.   So unless the Euro/Dollar exchange rate moves back towards the 1.5 range, there seems to be a serious difference in the way the product sales are calculated by companies and by IMS.    Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications! Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports) Products IMS Rank IMS Sales (US $Mn) Annual Reports Sales (US $Mn) Pharma Compass Rank Big Pharma Currency Annual Reports Sales in Mn Marketing Partner Marketing Partner Annual Report Sales (US $Mn) Humira® 1 11,844 12,543 1 Abbvie USD 12,543     Lantus® 2 10,331 7,676 5 Sanofi Euro 6,344     Sovaldi® 3 9,375 10,283 2 Gilead Sciences USD 10,283     Abilify® 4 9,285 7,556 6 Bristol Myers-Squibb USD 2,020 Otsuka 5,536 Enbrel®   5 8,707 8,538 4 Amgen USD 4,688 Pfizer 3,850 Seretide® 6 8,652 6,589 8 GSK GBP 4,229     Crestor® 7 8,473 5,512 11 AstraZeneca USD 5,512     Remicade®   8 8,097 9,880 3 Johnson & Johnson USD 6,868 Merck & Co. 2,372 Mitsubishi Tanabe 640 Nexium® 9 7,681 3,655 19 AstraZeneca USD 3,655     Mabthera®   10 6,552 6,936 7 Roche CHF 5,603 Roche 1,305 Avastin®   11 6,070 6,449 9 Roche CHF 6,417     Lyrica® 12 6,002 5,168 12 Pfizer USD 5,168     Herceptin®   13 5,564 6,306 10 Roche CHF 6,275     Spiriva® 14 5,483 3,917 17 Boehringer Euro 3,237     Januvia® 15 4,991 3,931 16 Merck & Co. USD 3,931     Copaxone® 16 4,788 4,237 14 Teva USD 4,237     Novorapid® 17 4,718 2,835 20 Novo Nordisk DKK 17,449     Neulasta® 18 4,627 4,596 13 Amgen USD 4,596     Symbicort® 19 4,535 3,801 18 AstraZeneca USD 3,801     Lucentis®   20 4,437 4,152 15 Novartis USD 2,441 Roche 1,711 Click here to access and download all the 2014 data (Excel version available) for FREE! It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view. Our take: With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing upon and others, which may not be worthwhile to pursue. While the assessment of pharmaceutical sales is far more complicated than what we had originally imaged, the focus of Big Pharma on small molecules is on Hepatitis C drugs (Sofosbuvir,­ Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments. Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports) Products Big Pharma Sales (US $Mn) 2013 Sales (US $Mn) 2014 Growth (%) Ibrutinib Pharmacyclics, Inc (now AbbVie) 14 492 3414% Dasatinib Bristol-Myers Squibb 1280 1493 17% Trametinib GSK 10 68 580% Nilotinib Novartis 1266 1529 21% Ruxolitinib Novartis 163 279 71% Ceritinib Novartis Not launched 31   Sunitinib Maleate Pfizer 1204 1174 -2% Crizotinib Pfizer 282 438 55% Axitinib Pfizer 319 410 29% Tofacitinib Citrate Pfizer 114 308 170% Click here to access and download all the 2014 data (Excel version available) for FREE! However, Big Pharma is now all about biologics. IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.  The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis). Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!  

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    #PharmaFlow by PHARMACOMPASS
    23 Apr 2015
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    FDA Strikes More Than 40 Drugs Approvals In 2014

    FDA Strikes More Than 40 Drugs Approvals In 2014

    Unless you are like Voltaire and think that “The art of medicine consists of amusing patients while nature cures the disease”, you will be thrilled with the new drugs approval (NDAs) list of the FDA: about 40 new drugs in 10 therapeutic areas! It has been 18 years since the FDA approved so many new drugs, so let’s quickly take a tour at the Olympic podium:   OLYMPIC PODIUM The golden medal comes to AstraZeneca with 4 NDAs: Farxiga (diabetes), Movantik (constipation), Lynparza (ovarian cancer) and Myalept (lipodystrophy, also called fat reduction, which is common in patients with HIV and AIDS).  Then come the silver medals with 3 NDAs each: Biogen Idec with Alprolix (hemophilia B), Eloctate (hemophilia A), Plegridy (multiple sclerosis). Lilly with Cyramza (gastric cancer), Jardiance (diabetes), Trulicity (diabetes). Merck&Co with Zontivity (coronary artery disease), Belsomra (insomnia), Keytruda (melanoma). And the bronze medals with 2 NDAs each:  Boehringer-Ingelheim with Striverdi Respimat (chronic obstructive pulmonary disease), Ofev (idiopathic pulmonary fibrosis). Cubist with Sivextro (skin infection), Zerbaxa (urinary and abdominal infections). Gilead with Zydelig (leukemia), Harvoni (hepatitis C –“first combination pill approved to treat chronic hepatitis C virus genotype 1 infection and the first approved regimen that does not require administration with interferon or ribavirin”). Novartis with Xtoro (acute otitis externa), Zykadia (lung cancer). THERAPEUTIC AREAS  In terms of therapeutic areas, infectious diseases come first with 27% of the NDAs, followed by cancer with 18% and then rare diseases with 11% according to Forbes. Knowing that a disease is classified as ‘rare’ when it affects 200,000 people maximum in the US, the pharmaceutical industry and the FDA have done a fantastic job because overall it is 25 millions American whom are concerned by orphan diseases. And how many more around the world?  According to EvaluatePharma, in 2020 orphan drugs are expected to account for 19% of the total share of prescription drug sales excluding generics, reaching $176 billion in annual sales in America alone.   Here are the main NDAs 2014 for rare diseases: Amgen with Blincyto (Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia- leads to cancer). Anacor with Kerydin (fungal infection). BioCryst with Rapivab (influenza- infectious disease caused by the influenza virus). Biomarin with Vimizim (Morquio A syndrome- the body is missing or doesn't have enough of a substance needed to break down long chains of sugar molecules).  Boehringer-Ingelheim with Ofev (idiopathic pulmonary fibrosis).  Chelsea with Northera (neurogenetic orthostatic hypotension- often associated with Parkinson’s disease). Hoffman la Roche with Esbriet (idiopathic pulmonary fibrosis). Johnson & Johnson with Sylvant (multicentric Castleman’s disease- involves hyper activation of the immune system). Paladin with Impavido (leishmaniasis- disease caused by protozoan parasites). Sanofi with Cerdelga (Gaucher’s disease- genetic disease in which fatty substance accumulate in cells and certain organs). Spectrum with Beleodaq (non-Hodgkin lymphoma- group of blood cancers that includes any kind of lymphoma except Hodgkin's lymphomas). Takeda with Entyvio (ulcerative colitis ; Crohn’s disease- inflammatory disease that affects any part of the gastrointestinal tract from mouth to anus) Valeant with Jublia (fungal infection).  Vanda with Hetlioz (non stop 24 hour sleep wake disorder).   The huge impact after the release of the 2014 NDAs list was the pharma exchange-traded funds flared up (Nasdaq Biotechnology Index and S&P 500 Health Care Index 34 percent and 23 percent respectively. However, finance is not everything, as we have all learned during the 2008 financial crisis, and NDAs are not the only conditions for a new strategy to success anymore, as proven by a lot of pharmaceutical companies in the past years who haven’t achieved enough revenues despite NDAs.  It seems that pricing is going to be key as competition is becoming fiercer. Look at the 2014 NDAs batch for anti bacterial drugs to treat skin infections; 3 brand new drugs for this year only.  Cubist with Sivextro Durata with Dalvance The Medecine Companies with Orbactiv Same for the idiopathic pulmonary fibrosis as we just saw in the rare diseases approval list above: 2 NDAs for 2014. According to Fierce Pharma, there are 8 therapeutic areas where competition is going to be even fiercer in the future: hepatitis C, diabetes, cholesterol, hemophilia, hemo-oncology, psoriasis, melanoma and obesity. And it is not like patents are not going to continue dropping; generics represent now more than 40% of the products sales. Moreover, premium prices following NDAs have been implicating confrontations with insurers and governments in regards to diabetes and respiratory drugs in the past.  Therefore, new tactics have to be found!  AbbVie offered their new anti hepatitis C drug, Viekira Pak, at a discount price to Express Script (the largest pharmacy benefit management organization in the United States) for an exclusive distribution. Even if Viekira Pak is said to be a less convenient dosing regiment when compared to Gilead’s anti hepatitis C drug (Sovaldi), the deal was closed as Sovaldi’s premium price actually chocked the payers. It is a perfect move for AbbVie, who just lost their patent on one of their main drug: Humira (rheumatoid arthritis).  Biotech are said to be an excellent area for successful strategy as well.  If there is more success at R&D projects (as it looks to be the case in the biotech field) then R&D department cost less and the overall financial risk should be lowered.  Here are the main NDAs 2014 for biotech/ cancer:  Baxter with Obizur (hemophilia). Biogen Idec with Plegridy (multiple sclerosis), and Alprolix and Eloctate (hemophilia). Celgene with Otezla (psoriasis) Gilead with Zydelig (anti-cancer treatment). Helsinn with Akynzeo (emesis- prevent nausea and vomiting caused by cancer drug treatment).  Salix with Ruconest and Pfizer with Trumenba (meningitides type B). Bristol-Myers Squibb with Opdivo (melanoma) and Merck & Co with Keytruda (melanoma as well), which work by blocking a protein called Programmed Death receptor (PD-1), are the first in a coming wave of immunotherapies and are said to have the potential of generating more than 30 million USD/ year.       So in case all these new strategies don’t work and definitely become a financial matter only instead of a medical focus to help the world to live a little better, don’t forget to “always laugh when you can, it is cheap medicine” as George Gordon Byron liked to advise.    

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    https://www.pharmacompass.com/radio-compass-blog/fda-strikes-more-than-40-drugs-approvals-in-2014

    #Phispers by PHARMACOMPASS
    05 Mar 2015
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