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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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29 Apr 2020

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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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29 Mar 2018

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Pfizer sues J&J; Generics under pressure; China’s Fosun resurrects deal to buyout India’s Gland

This week, Phispers brings you news on how a federal judge in the US revoked ‘pharma bro’ Martin Shkreli’s bail due to his misconduct on Facebook. Roche, the world leader in oncology treatments, has to contend with more competition from biosimilars, as Amgen and Allergan’s Avastin copy bags USFDA approval. China’s Fosun Pharma tweaked its Gland Pharma buyout deal in order to avoid a review by the Indian government. And, Teva starts selling assets to reduce its debt burden. Shkreli finally sees jail for putting a bounty on Hillary Clinton’s hair Martin Shkreli, former CEO of Turing Pharmaceutical, an entrepreneur and the founder of several hedge funds, was sent to jail last week, not for the financial frauds or for raising the sticker price of a life-saving drug (Daraprim) by 5,000 percent in 2015, but for offering US$ 5,000 for a strand of Hillary Clinton’s hair. The federal judge revoked his bail due to this misconduct on social media. Shkreli has been on a US$ 5 million bail, even as he is awaiting sentencing. He made two Facebook posts offering cash to anyone who could “grab a hair” from Clinton during her book tour. Shkreli has branded himself as one of social media’s ‘most notorious trolls’. At the hearing in Brooklyn, the judge said Shkreli’s post could be perceived as a threat. And now, Shkreli (34), who called his post satire, is cooling his heels at the Metropolitan Detention Centre in Brooklyn. Last month, Shkreli was convicted in three out of eight charges, including securities fraud. He was scheduled to be sentenced on January 16. Unless his lawyers prove he poses no threat to the community, Shkreli is not likely to be released from jail. China’s Fosun resurrects deal to buyout Gland by scaling down stake purchase Shanghai Fosun Pharmaceutical Group has reduced the amount of stake it wishes to buy into Indian drugmaker Gland Pharma from 86 percent to 74 percent, in order to avoid a review by the Indian government. This way, Fosun is potentially resurrecting a transaction that had been on hold for over a year. Backed by Chinese billionaire Guo Guangchang, Fosun Pharma will now buy 74 percent stake in Gland for US$ 1.09 billion, Fosun said in a statement to the stock exchanges. In June 2016, the Indian government had changed regulations pertaining to foreign direct investment (FDI) in existing pharmaceutical firms through the automatic route. Under the new rules, FDI involving more than 74 percent stake now requires an approval by the Indian government. The previous move, to buy 86 percent stake in Gland, would have required an approval by the Cabinet Committee on Economic Affairs (CCEA). The proposal was not taken up by the CCEA and was subsequently put in cold storage during the Doklam tensions between India and China. Hyderabad-based Gland specializes in injectable drugs such as antibiotics, oncology and cardiology treatments. Gland’s manufacturing facilities have been accepted by the US Food and Drug Administration (USFDA) and other regulatory agencies. The deal would give the Chinese firm access to Gland’s portfolio of generic injectable medicines and control of facilities to export to the US and other developed markets. The original acquisition offer (for 86 percent stake) valued Gland at about US$ 1.35 billion. The firm has also delayed the closing date for the deal to October 3, from September 26. Rise of biosimilars: Pfizer sues J&J; Roche faces more heat from biosimilars This week, Pfizer filed a lawsuit against Johnson & Johnson (J&J), alleging that J&J's contracts with health insurers for its blockbuster rheumatoid arthritis drug, Remicade, were anticompetitive and blocked sales of Pfizer’s newly-approved biosimilar (known as Inflectra). According to Pfizer, J&J has signed exclusionary contracts with health insurers, hospitals and doctor groups which exclude Pfizer’s Inflectra from insurance coverage. In the first quarter of 2017, J&J’s chief financial officer had mentioned that they saw “very little impact” from biosimilar competition to Remicade in the US. Roche, the world’s biggest maker of oncology treatments, also has more biosimilars to contend with. In the US, the FDA gave its nod to Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first anti-cancer biosimilar approved by the USFDA. Amgen and Allergan’s bevacizumab biosimilar is also undergoing review by the European Medicines Agency (EMA). The companies are collaborating on the development and commercialization of four oncology biosimilars. Roche received another blow last week, when the EMA’s Committee for Medicinal Products for Human Use recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant. It is the first biosimilar copy of Herceptin to obtain such a backing in Europe. In June this year, the European Commission had approved Rixathon — a biosimilar for Roche’s MabThera (or Rituximab, a drug for blood cancer). These approvals are expected to herald in a gradual erosion in sales of patented cancer drugs. Rituximab, Herceptin and Avastin together had 2016 revenue of US$ 21.8 billion. But their combined sales are expected to fall more than 40 percent by 2022, says a forecast compiled by Thomson Reuters. Roche needs to offset this ‘anticipated’ drop in sales by making a success of its new cancer drugs, such as Perjeta, Gazyva and Tecentriq. Biosimilars (medicines that are highly similar to the original drug) offer a route to more affordable cancer care at a time when the price of modern therapies to fight tumors is going through the roof. Generics under pressure: Teva sells assets to reduce debt; new M&A head at Lupin Last week, there was finally some good news from Teva Pharmaceutical Industries, when it announced the name of Kare Schultz as its new CEO. Soon after that, the Israeli drugmaker announced it has sold its Paragard intrauterine copper contraceptive to CooperSurgical for US$ 1.1 billion in cash in order to bring down its debt load. Teva will also sell the remaining assets in its specialty women’s health business for US$ 1.38 billion in two separate transactions. CVC Capital Partners Fund VI will pay US$ 703 million in cash for a portfolio in Teva’s global women’s health business including contraception, fertility, menopause and osteoporosis products. Teva also agreed to sell its Plan B One-Step and its brands of emergency contraception to Foundation Consumer Healthcare for US$ 675 million in cash. Combined annual net sales of these products were US$ 140 million last year. However, even after these sales, Teva will continue to remain highly indebted. Last year, Teva had purchased Allergan’s generic unit for US$ 40.5 billion, taking its debt load to US$ 35 billion. Teva is actively pursuing divestitures and expects to garner at least $2 billion in total asset sales for the year. Meanwhile, Mumbai-headquartered Lupin has hired Jim Loerop to drive its global M&A strategy. He will also lead Lupin’s overall corporate development efforts, besides being responsible for its M&A and business development functions. Loerop joins Lupin from Alexion Pharmaceuticals. FDA wants more compounding pharmacies to register under law The USFDA Commissioner Scott Gottlieb said the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company. The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can’t be met by commercially available drugs. Back in 2012, a compounding pharmacy known as the New England Compounding Center (NECC) had triggered a meningitis outbreak by using contaminated steroids. NECC is now defunct. But prosecutors are preparing for the second criminal trial over contaminated steroids manufactured by NECC. Glenn Chin, a former supervisory pharmacist at NECC, is facing trial this week for second-degree murder and fraud. He has pleaded not guilty. The 2012 meningitis outbreak had affected 778 patients across the US, out of which 76 had died after receiving contaminated steroids. After the outbreak, the US had passed the Drug Quality and Security Act in 2013, which aimed to bring more compounding pharmacies under the FDA (rather than under the state pharmacy boards). The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients. Today, around 70 firms have registered as outsourcing facilities. According to the American Pharmacists Association, there are about 7,500 pharmacies that specialize in compounding services. Gottlieb said in order to encourage more compounders to register, the FDA would release draft guidance in the next two months. FDA nod for GSK’s triple drug inhaler for COPD puts it ahead of rivals The USFDA has approved British pharma giant GlaxoSmithKline’s three-in-one inhaler — Trelegy Ellipta — for chronic obstructive pulmonary disease (COPD). This is a key new product for GSK as it strives to keep its lead in respiratory medicine, despite falling sales of Advair (an asthma and COPD treatment). Trelegy Ellipta is the first once-daily triple medicine for COPD. The inhaler puts GSK ahead of rivals such as AstraZeneca and Novartis. GSK developed this inhaler along with Innoviva, an American drug company. Last week, the inhaler, also won a recommendation for approval from the EMA. GSK’s CEO Emma Walmsley sees Trelegy Ellipta as one of three “critical” launches that would fill in the revenue gap left by the sagging sales of Advair, which is expected to face generic competition in the US sometime next year. Walmsley’s other two key new products are Shingrix, a shingles vaccine that was unanimously recommended for approval by a USFDA advisory panel last week, and a novel dual-drug regimen for HIV.

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21 Sep 2017

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Dr. Reddy’s fails EU inspection; Trump disbands business councils after Merck CEO and others quit it over intolerance

This week, Phispers brings you the high-pitched drama from President Trump’s American Manufacturing Council, with Merck CEO Ken Frazier leading the pack of CEOs who abandoned it over the Charlottesville unrest, even as J&J’s CEO said he’ll stay on. But then, Trump disbanded the council. We bring you news on more generic companies in distress due to a drop in their business in the US and compliance problems. Meanwhile, companies like Intas and Aurobindo Pharma from India and Fosun from China are looking for growth via acquisitions. And Softbank has invested US$ 1.1 billion in Roivant. Read on. Merck CEO’s Trump council resignation over ‘intolerance’ has others follow; council disbanded The US President Donald Trump’s American Manufacturing Council has been in the news for the last few days. First, Merck CEO Kenneth Frazier resigned from the council, after urging American leaders to reject expressions of ‘hatred, bigotry and group supremacy’ on Twitter. In a statement, Trump had blamed “many sides” for the violence in Charlottesville, Virginia, over the last weekend. A white nationalist rally had turned violent in the city when a car rammed into many people who were protesting peacefully against the demonstration. White supremacists and other hate groups had assembled in the city to protest the removal of a statue of Confederate General Robert E. Lee. Trump has since faced widespread criticism for not specifically denouncing the white supremacists. Following Frazier’s resignation, many CEOs — including Intel Corp’s Brian Krzanich, Under Armour Inc’s Kevin Plank and AFL-CIO chief Richard Trumka — quit Trump’s council over his ‘response to the Charlottesville violence’. Though Frazier said he was taking a stand “against intolerance and extremism”, Trump mocked at him on Twitter, and said he will now “have more time to LOWER RIPOFF DRUG PRICES!” Later, Trump did condemn the hate groups, but it seemed too little to late. Only three weeks back, Trump had called Frazier a “business genius” and a “great, great business leader” and had thanked Merck for investing in American jobs. Frazier is one of the few African-Americans to head a Fortune 500 company. Meanwhile, on Tuesday, Johnson & Johnson’s CEO Alex Gorsky said he isn’t abandoning Trump’s council. In a statement, Gorsky said he’ll stick with the council as a way to express “the values of Our Credo as crucial public policy is discussed and developed.” He said J&J is “an important voice on healthcare.” However, as the CEO resignations continued to mount, Trump tweeted, “Rather than putting pressure on the business people of the Manufacturing Council & Strategy & Policy Forum, I am ending both. Thank you all!” Trump made the announcement on Twitter, less than an hour after one of the groups was planning to inform the White House that it would disband, a CNBC report said. Dr. Reddy’s fails EU GMP inspection; can’t export to EU until it clears next inspection Less than two months after providing positive inspection updates with regard to the status of its manufacturing compliance, Dr. Reddy’s Laboratories (DRL) failed a European cGMP manufacturing inspection last week. The inspection, by the German regulatory authority, at DRL’s FTO 2 finished formulation plant (situated in Hyderabad) uncovered critical deficiencies. The inspectors concluded that the ‘essential elements of the Pharmaceutical Quality System’ were not effective. Due to this, the plant will not be able to make any further dispatches to the European Union until the next inspection, “to be initiated by an invitation from betapharm,” DRL said in a filing. Betapharm Arzneimittel GmbH is DRL’s wholly-owned subsidiary in Germany and the Hyderabad plant produces tablets and capsules. Previously, PharmaCompass had observed that the inspection focus of regulators has moved beyond audit trails. In the case of DRL, the inspectors found that out of specification (OOS) results were “systematically invalidated in hundreds of cases”. The integrity of the batch manufacturing/packaging record at the Hyderabad facility was also questioned. The absence of recording “negative events” on the “clean” batch manufacturing records prevented successful investigation into market-complaints. In addition to the integrity of the cleaning being questioned, the design, condition and maintenance of rooms and equipment were also major concerns at DRL. The inspectors found dirty rooms and equipment, along with unsuitable doors and dispensing equipment for manufacturing. Generics in distress: Sun reports its first loss in 12 years; Mylan cuts forecast Generic drugmakers have seen their US businesses plummet as the US Food and Drug Administration (USFDA) has stepped up product approvals, ushering in more competition and prompting a steady erosion in prices. As a result, generic drug stocks have been under pressure. Last week, Phispers reported on how Teva Pharmaceutical had reduced its earnings goal. Well, companies like Mylan NV and Sun Pharmaceutical Industries have joined the pack by reporting lackluster quarterly results and cutting guidance. After a gap of 12 years or more, Sun Pharma reported its first quarterly loss last week, after it settled an antitrust case in the US. Sun Pharma paid US$ 148 million (INR 9.5 billion) to plaintiffs including Canadian rival Apotex in July to settle an antitrust lawsuit in the US over sleep-disorder drug modafinil. Sun, which is India’s biggest drugmaker, posted a total loss of US$ 66.3 million (INR 4.25 billion) in the three months ended June 30, 2017. Last week, Mylan also said it is likely to see a decline in its profitability due to delays in the launch of key new drugs and erosion in the prices for generics in the US. Though the FDA is speeding up generics approvals, it’s just not speeding up the ones that Mylan badly needs. Mylan said it plans to remove copies of big drugs like Copaxone from Teva and Advair from GlaxoSmithKline—from its 2017 guidance, pushing them into 2018. It now expects revenues to hit between US$ 11.5 billion and US$ 12.5 billion for the year, down from a previous range of US$ 12.25 billion to US$ 13.75 billion. Chip Davis, CEO of the Association of Accessible Medicines — a trade group for generic and biosimilar drugs — said some of the (demand-supply) imbalances in the generic marketplace haven’t happened overnight. But the “reality is that the sustainable, robust competitive market is at risk now.” He expects generic drugmakers to continue to feel the pressure, amid declining prices and flat revenues. From June 2016 to June 2017, the number of generic prescriptions is nearly flat, with an increase of only around 1 percent; while revenue is down 12 percent, Davis said. However, one generic company that bucked the trend was Perrigo. It reported US$ 1.24 billion in sales and adjusted earnings of US$ 1.22 per share, topping the consensus for US$ 1.18 billion and 92 cents, respectively. However, this performance too did not come on the back of generics — Perrigo’s generic business declined 13 percent year-on-year. The company performed well due to its consumer business. India’s Intas and Aurobindo, PE player SK Capital and China’s Fosun in acquisition mode Even during these bad times for generics, some pharma companies are on the prowl. For instance, Ahmedabad-based Intas Pharmaceuticals is on the look out for buying into a larger piece of Israeli-drugmaker Teva’s existing operations in Europe. Last year, it had bought out Teva’s UK and Ireland assets. Intas — with Temasek and Chrys Capital as its investors — is bidding for Teva’s women's health, oncology and pain management divisions in Europe for US$ 1.5 billion. The company has reportedly reached out to several Indian and global banks, such as ICICI, Axis, Citi, Bank of Tokyo Mitsubishi UFJ, HSBC among others, to finalize the financing before putting in a bid by the month-end. If successful, this will be the largest cross-border M&A involving an Indian pharma company. PharmaCompass has been routinely covering the troubles at Teva, the world’s largest maker of generic drugs. Teva plans to sell off its assets, in order to reduce its US$ 36 billion debt. There is another company that Intas has set its eyes on — Mallinckrodt's US generic business. According to a news report, India’s Aurobindo Pharma and Intas are in the race to buy UK-based Mallinckrodt’s generic drugs business in the US valued at US$ 2 billion. Once complete, this will be the biggest-ever overseas acquisition made by an Indian drug company. The generic business of Mallinckrodt generates sales of around US$ 1 billion. The companies have submitted an initial bid for Mallinckrodt’s generic business, which has been up for sale for the last couple of months. Meanwhile, US specialty drugmaker — Arbor Pharmaceuticals — too is up for grabs. And amongst the bidders for a stake in Arbor are companies like Fosun International Limited’s healthcare business and Shanghai Pharmaceuticals Holding. The two companies are competing to buy a stake of at least 20 to 30 percent, sources said. The holding in the Atlanta-based Arbor could fetch around US$ 600 to US$ 700 million. In the US, SK Capital, a private investment firm focused on specialty materials, chemicals and pharmaceuticals, said it has signed a definitive agreement to acquire Perrigo API, the active pharmaceutical ingredients (API) business of Perrigo Company Plc. The two parties have agreed to enter into a long-term supply agreement for Perrigo API to supply multiple existing commercial and pipeline APIs to Perrigo. The transaction is expected to close during the last quarter of this year. Softbank invests US$ 1.1 billion in Vivek Ramaswamy’s abandoned drug venture —Roivant Last week, Roivant Sciences announced that Japanese conglomerate — SoftBank Group — is leading a US$ 1.1 billion investment to fund its expansion. SoftBank is the largest private financier in healthcare. Roivant was founded by Vivek Ramaswamy, a 32-year old American entrepreneur who began his career as an investor in the biotechnology sector. Roivant is a holding company with companies like Axovant Sciences and Myovant Sciences under its umbrella, along with private-subsidiaries like Dermavant, Urovant and Enzyyant. According to Endpoints News, SoftBank’s US$ 1.1 billion mega-investment in Roivant won’t likely be its last in biotech. Quoting reports, it says SoftBank group’s global US$ 100 billion equity fund has begun a recruitment campaign for scientists with an eye to backing more companies that use new data technology to identify drugs with solid development potential. Ramaswamy’s business model has relied on therapies that have been taken off the shelves of some big players. Back in December 2014, Ramaswamy had bought an old Alzheimer’s drug that GSK had dropped for US$ 5 million. Six months after purchasing the compound from GSK, and without doing any clinical development, the drug resulted in the biggest biotech IPO ever for Axovant, which got valued at US$ 2 billion. Since then, Ramaswamy has been setting up more companies. Biocon, Mylan suffer another setback as European biosimilar applications are withdrawn Last month, PharmaCompass broke the story about Biocon’s biosimilar program suffering a serious setback as a current Good Manufacturing Practices (cGMP) inspection by the French health agency — ANSM — in March 2017 of its drug product site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major. The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine). This week, in a stock exchange filing, Biocon said it has withdrawn the dossier for two of these products. Since the approval of its trastuzumab and pegfilgrastim applications would require a re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon said in the statement. The announcement comes two weeks before the FDA is supposed to take a decision on the trastuzumab application. Although Roche’s European patents on Herceptin (trastuzumab) expired in 2014, it is still the third-biggest drug, with 2016 sales of US$ 6.7 billion (CHF 6.8 billion) for the Swiss Group. Until the news of the ANSM inspection surfaced, Mylan and Biocon were expected to be the first to bring a Herceptin biosimilar to market.

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17 Aug 2017

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FDA reorganizes inspection staff; Thermo Fisher buys Patheon for $ 5.2 billion

This week in Phispers, read about the extortion cyberattack and how it impacted hospitals in the UK. There is news on GSK, and its plans to buyout Novartis’ stake in their consumer health JV. Its blockbuster Advair got a shot in the arm as another generic failed endpoints. There is also news on mergers, acquisitions and layoffs and how the US FDA’s new commissioner is reorganizing its inspection staff. Ransomware attack cripples NHS in the UK; such threats likely to grow The ‘ransomware’ extortion cyberattack took the world by a storm last week. And if the UK’s National Cyber Security Centre is to be believed, more cases of the ransomware are expected to come to light, “possibly at a significant scale”. Last weekend, a huge extortion cyberattack hit countries across the globe, holding computer data for ransom at hospitals and several firms. Two security firms — Kaspersky Lab and Avast —said they had identified the malware behind the attack that impacted over 70 countries. Russia was hit hardest. The attack hit National Health Service (NHS) — UK’s health service — forcing hospitals to close wards and emergency rooms. Across the country, hospitals found themselves without access to their computers and phone systems. Many patients were sent home as their records could not be accessed. While there has not been any fresh attack so far, according to a BBC news report, at least 16 trusts out of 47 of the NHS that were hit are still facing issues, leading to further cancellations and delays to services. Ransomware is a type of malicious software that blocks access to a computer system until a sum of money is paid, usually via bitcoin (the digital currency), to release it. According to news reports, the ransomware threats are likely to grow across private and public sectors. Thermo Fisher buys Patheon; INC merges with inVentiv; Paraxel plans layoffs Thermo Fisher Scientific Inc continued its acquisition spree last week with the US$ 5.2 billion purchase of drug-development technology company Patheon NV. Thermo Fisher has emerged as one of the world’s biggest manufacturers of diagnostic and testing equipment through deals. Over the last five years, Thermo Fisher has made acquisitions worth US$ 22 billion. It will pay US$ 35 a share in cash for Patheon — a 35 percent increase over Patheon’s closing price on Friday last. Meanwhile, INC Research Holdings Inc announced last week that it would merge with private equity-owned inVentiv Health Inc, another contract research organization (CRO), in a US$ 4.6 billion all-stock deal. The deal is expected to help INC win contracts with large pharma companies. Another CRO — Paraxel — plans to lay off staff, as rumors of a potential buyout gather steam after the company projected lower revenues. In a filing with the SEC on May 4, the Massachusetts-based company outlined plans to cut 1,200 jobs at the global clinical trial operation. Weeks after staff plotted to destroy drugs, EU probes Aspen for price gouging Last month, Phispers had carried a news nugget on Africa’s leading drug company — Aspen Pharmacare — and how its employees had reportedly plotted to destroy stocks of life-saving medicines during a price dispute with the Spanish health service in 2014. This week, the European Commission initiated a formal probe into concerns that Aspen Pharma is charging excessive prices for five life-saving cancer medicines. The Commission will investigate whether Aspen has abused a dominant market position and breached EU antitrust rules. If found guilty, this could lead to a hefty fine for Aspen. The investigation is around Aspen's pricing practices for niche medicines containing the active pharmaceutical ingredients (APIs) — chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan. These APIs are used for treating cancer and are sold with different formulations and under multiple brand names. Aspen acquired these drugs after their patents expired. The investigation will cover all of Europe except Italy, which hit the company with a Euro 5 million fine in October last year for price hikes up to 1,500 percent for some key drugs. Investors fume over GSK’s plan to buyout Novartis stake in consumer health GlaxoSmithKline has informed its shareholders that it plans to buy out Swiss drugmaker Novartis’ 36.5 per cent stake in GSK Consumer Healthcare. GSK is planning to offer £8 billion (US$ 10.3 billion) to Novartis for this stake and industry observers say Novartis could use the gains to fund a megatakeover. And its potential target is AstraZeneca. Novartis’ buyout of AstraZeneca, if realized, could reshape the oncology landscape. Buying out Novartis would give GSK control over the world’s biggest consumer health operations. And a firm control over its strong brands like Horlicks, Nicorette and Beechams. The move is in line with GSK’s new CEO Emma Walmsley’s recent statements. However, GSK’s shareholders have not taken the news well. GSK’s star investor Neil Woodford was pushing for a company-wide breakup. GSK, however, preferred to hang onto the business, and Walmsley—who was the former head of the JV—confirmed the strategy on the company’s first-quarter earnings call. As a result, Woodford decided to sell his (£1.2 billion) GSK holding. Woodford held his shares in GSK for more than 15 years. ‘The sum of the parts is significantly greater than the whole,” he said. “My viewpoint, and that of other like-minded institutional investors, has been heard but ultimately ignored – repeatedly,” he added. Woodford wanted GSK to split into more focused businesses. New FDA Commissioner reorganizing inspection staff The US Food and Drug Administration’s new commissioner — Scott Gottlieb — wants federal inspectors to specialize in certain areas, in order to ensure the safety of America’s food and medical products. In a memo, Gottlied announced that workers in the US FDA’s Office of Regulatory Affairs will begin focusing on overseeing specific product areas — such as pharmaceuticals or medical devices — rather than activities in their US geographic regions. “This organizational approach replaces a management structure based on geographic regions,” says the FDA website. The US FDA’s staff of 4,000 probes consumer complaints, oversees imported goods, and inspects domestic and foreign facilities to ensure compliance with the agency’s standards. The refocusing “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work,” Gottlieb said in the memo. “We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have,” he added. The initiative was proposed four years ago, with implementation set to start this month. Merck’s Keytruda approved for lung cancer; AstraZeneca, Roche suffer setbacks Merck’s Keytruda got approved by the US FDA for treatment of advanced lung cancer, when used in combination with chemotherapy. This bolsters Merck's lead position in the field of medicines that help the immune system fight cancer. Lung cancer is by far the largest oncology market and the approval significantly expands the number of patients available for the Keytruda therapy, in combination with Eli Lilly's Alimta. Roche, AstraZeneca drugs fail trial: AstraZeneca suffered a setback last week when its Phase III asthma drug tralokinumab — IL13 — saw a late-stage failure. This drug had already failed a Phase IIb trial for asthma, raising questions why the company went ahead with the trial and plans to continue a major late-stage effort. But the researchers at the time said they were encouraged by a subgroup analysis that pointed to success. Roche too suffered a setback as its drug tecentriq (atezolizumab) failed the late-stage confirmatory study in bladder cancer. The drug failed to significantly improve overall survival. The blow raises questions about the fate of this drug. After Mylan, Hikma’s Advair generic runs into “major” problems GSK’s blockbuster lung drug Advair may escape generic competition in the United States this year. In March, Mylan’s application for a cut-price equivalent was turned down by the US FDA. And last week, the application of Hikma Pharmaceuticals and its partner Vectura was turned down by the American regulator. Industry analysts believe the generic threat has now been pushed back until mid-2018, providing GSK with a short-term profit boost. According to Hikma, there were major issues with the application, which is why the US FDA decided not to approve its version of the inhaled treatment for asthma and chronic lung disease at this time. The firm said it was unlikely to receive approval this year. Hikma and Mylan have received complete response letters from the FDA that were categorized as ‘major’. Dealing with a major amendment to a generic drug application means a delay of 10 months for an FDA response. Meanwhile, Mylan President Rajiv Malik said last week that the company disagrees with US FDA’s reasoning behind not approving its generic for GSK’s Advair in March. Malik said the FDA was asking it to comply with standards set out in draft guidance the agency had issued. But the company believes it is not required to do so. Mylan made the comments while reporting its first-quarter earnings.

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18 May 2017

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Sanofi lawsuit highlights Mylan’s unfair trade practices; Fresenius goes on multi-billion dollar spending spree

This week, Phispers brings you an update on M&As in the drug and medical equipment industry, along with verdicts of lawsuits against GSK and Mylan. There is also news on Samsung Bioepis’ biosimilar —Renflexis; a directive from the Medical Council of India for doctors to prescribe generics; and news that Marathon may soon wind up. Read on. M&A update: Fresenius buys Akorn; Becton Dickinson to acquire C R Bard Fresenius Kabi-Akorn: Fresenius Kabi is buying US-based manufacturer and marketer of prescription and over-the-counter drugs — Akorn — for around US $ 4.3 billion, or US $ 34.00 a share. Kabi will also assume approximately US $ 450 million of Akorn’s debt. The transaction, which is likely to close by early 2018, has the support of Akorn's largest shareholder, who controls approximately 25 percent of its shares. Akorn is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multi-source and branded pharmaceuticals. Sawai to buy Upsher Smith: A leading generics manufacturer in Japan — Sawai Pharmaceutical — and US-based generics manufacturer — Upsher-Smith Laboratories — announced an agreement whereby Sawai will buy the generic pharmaceuticals business of Upsher-Smith, from its parent — Acova for $ 1.05 billion. Upsher-Smith is a privately held drug company, based in Minnesota. It’s owned by the Evenstad family through their company, Acova. It has a diversified product portfolio of over 30 pharmaceutical products. Becton Dickinson to acquire C R Bard: Becton Dickinson and Co, a medical equipment supplier, will acquire C R Bard Inc in a US $24 billion cash-and-stock deal. This way, Becton Dickson will add Bard's devices to its portfolio in the high-growth sectors of oncology and surgery. This is the latest in a string of deals in the medical technology sector. Two years ago, Becton Dickinson had acquired CareFusion Corp for US $ 12 billion. This acquisition will strengthen Becton Dickinson’s position in the markets for catheters, pumps and other items. FDA approves Samsung Bioepis’ biosimilar; Merck to sell it in US This week, the US Food and Drug Administration (FDA) approved Samsung Bioepis' Renflexis (infliximab-abda) — a biosimilar referencing Remicade (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. The FDA approval comes as a blow to Johnson & Johnson’s top earning drug Remicade, which may finally begin to experience greater competition at lower prices. Samsung Bioepis is a big player in the field of biosimilars. It has arrived in the US market close to a year after the EMA approved it for Europe. While Merck KGaA, the German Merck that specializes in chemical, pharmaceutical and life sciences sectors, sold its biosimilars business to Fresenius Kabi this week, in the US, Merck will be marketing Samsung Bioepis’ Renflexis. In Germany, Merck KGaA is selling off its entire development pipeline and an experienced team of more than 70 employees located in Aubonne and Vevey (Switzerland) to Fresenius Kabi for Euro 670 million. The product pipeline has a focus on oncology and autoimmune diseases. Confused about the two Mercks? Read: Merck vs Merck: A ‘Mercky’ Tale Doctors in India to prescribe generics; to face action if found violating norms Last week, Phispers carried news that India’s Prime Minister Narendra Modi indicated his government may bring in a legal framework under which doctors will have to prescribe generic medicines. And soon, the Medical Council of India asked all registered medical practitioners to ensure they prescribe drugs with generic names only. The MCI has asked the medical community to follow its 2016 notification in which it amended the clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mandating the doctors to prescribe medicines by generic names in place of brand names. Therefore, if a patient is complaining of fever, the doctor must prescribe ‘paracetamol’ (the generic name drug), and not Crocin or Dolo (which are brand name drugs). This move will prevent doctors from prescribing brand-name drugs that are costlier. India’s medical regulator has also warned doctors of action against those found violating these regulations. This news comes at a time when price control on stents in India has led to companies withdrawing their innovative products from the market. A stent is a tiny expandable tube shaped mesh to open up narrowed or weakened coronary arteries. It is performed in a cath lab, using a less-invasive procedure known as angioplasty. Last week, Abbott announced it is withdrawing two of its latest coronary stents from India as they were not commercially viable. This includes a bio-absorbable stent that was introduced by the company four years back. In February this year, the National Pharmaceutical Pricing Authority had effected up to 80 percent price cuts on stents under the Drug Price Control Order (DPCO). The price of a bare metal stent was fixed at around US $113 (Rs 7,260) and drug eluting stent (DES) and biodegradable stents at around US $462 (Rs 29,600). After the controversy around DMD drug, Marathon may wind up next month After creating much hype and controversy around its effort to market a cheap overseas steroid — deflazacort — to the Duchenne muscular dystrophy (DMD) community in the US at a list price of US $ 89,000, Marathon Pharmaceuticals is now quietly planning to shut down its operations. On February 9 this year, Marathon had received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients aged 5 years and older with DMD, a rare genetic disorder that causes progressive muscle deterioration and weakness. Since the drug has been approved outside the US for decades, patients in the US imported the drug from Canada and the UK, where it’s available at a price between US $1,000 or US $2,000 a year. An article published in Endpoints News cites the divestiture of deflazacort to PTC as the main reason why Marathon may not exist past May 1, 2017. When the author of the article contacted Marathon, he received the statement: “With the wind down of our Emflaza business following the close of the PTC transaction on April 20, we will continue to manage the legacy matters of Marathon Pharmaceuticals.” This news comes at a time when PTC, the company that purchased the rights for the drug from Marathon, suffered a setback as the Washington State Drug Utilization Review Board decided to recommend another medicine for the treatment of the disorder. The board endorsed a policy by the Washington State Health Care Authority, which administers the state Medicaid program, that prednisone is the “lower cost, equally effective alternative” to Emflaza, the drug that PTC bought for around US $140 million last month from Marathon. Sanofi highlights Mylan’s unfair trade practices in lawsuit Earlier this week, Sanofi SA sued Mylan NV, accusing it of engaging in illegal conduct to suppress competition to its EpiPen allergy treatment. Mylan’s EpiPen has been at the centre of a public debate on the pricing of drugs. The lawsuit was filed in Trenton, New Jersey. According to Sanofi, Mylan caused it a loss of hundreds of millions of dollars in sales by erecting barriers that denied American consumers access to and use of a rival product — Sanofi’s Auvi-Q. Auvi-Q had been introduced by the French drugmaker in 2013 to treat anaphylaxis in patients who are at risk of or have a history of the potentially fatal allergic reaction. The company ceased marketing of the product in 2015 following a recall. In a statement, Sanofi sought damages for Mylan's conduct in the market for epinephrine auto-injectors. With the lawsuit filed by Sanofi, Mylan appears to be getting a taste of its own medicine, Back in 2015, in a bold and unusual move, Mylan had sued West Virginia to keep its EpiPens on the state’s “preferred drug list”. The move failed. However, it revealed yet another way in which Mylan can use aggressive marketing and legal tactics to boost profits from EpiPens. Since Mylan acquired rights to EpiPen in 2007, the company raised its price by more than 400 percent. While Sanofi is fighting Mylan in the US, in its home country it has to address regulator’s concerns over Valproate, its treatment against epilepsy and bipolar disorders. According to the French drug regulator, up to 4,100 children in France suffered major malformations in the womb after their mothers took Valproate between 1967 and 2016. Valproate, which is manufactured in France by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development. GSK to pay US $3m in suicide case; Teva introduces competition to Advair GlaxoSmithKline must fork out US $3 million to a woman who sued the British drug maker because her husband committed suicide after taking a generic equivalent of GSK’s antidepressant — Paxil, a federal court in the US ruled. Back in 2010, Stewart Dolin (a partner at law firm Reed Smith LLP) jumped in front of an ongoing commuter train after taking the generic version of Paxil. The verdict in favor of his wife — Wendy Dolin — was confirmed by GSK. However, the company said it should not be made liable since GSK did not manufacture or market the medicine. The lawsuit had been filed by Wendy Dolin in 2012 against GSK and Mylan — which manufactured the generic version of Paxil. However, a federal judge dismissed Mylan from the lawsuit in 2014. There was more bad news for GSK, as Israeli drugmaker Teva Pharmaceutical Industries launched the first direct competition to GSK’s best-selling Advair (an inhaler with APIs — fluticasone propionate and salmeterol). Teva had won the US regulatory nod to make an inhaler that’s similar to Advair in January this year. However, Teva also launched a generic version of its own inhaler, AirDuo RespiClick. AirDuo is not a true generic of Advair, but contains the same two APIs. However, it delivers a lower dose of salmeterol.

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27 Apr 2017

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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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05 Jan 2017

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GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics. GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field. Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs. FDA continues to race ahead with generic approvals The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million.. The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.

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04 Aug 2016

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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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23 Apr 2015

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Find PharmaFlow Article for Fluticasone

Fluticasone

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

66 API Suppliers

29 USDMF

27 CEP/COS

6 JDMF

7 EU WC

1 KDMF

25 NDC API

42 Listed Suppliers

DEVELOPMENTS

44 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

1 Suppliers

DOSSIERs // Finished Dosage Formulations

342 Dossiers

69 FDA Orange Book

134 Europe

32 Canada

13 Australia

43 South Africa

51 Listed Dossiers

DRUG PRODUCT COMPOSITION

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY

SPRAY, METERED;NASAL - 0.05MG/SPRAY

POWDER;INHALATION - 0.05MG/INH

POWDER;INHALATION - 0.1MG/INH

POWDER;INHALATION - 0.25MG/INH

POWDER;INHALATION - 0.03MG/INH

POWDER;INHALATION - 0.055MG/INH

POWDER;INHALATION - 0.113MG/INH

POWDER;INHALATION - 0.232MG/INH

POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH

POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH

POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH

LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.044MG/INH

AEROSOL, METERED;INHALATION - 0.11MG/INH

AEROSOL, METERED;INHALATION - 0.22MG/INH

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OINTMENT;TOPICAL - 0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - 0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

LOTION;TOPICAL - 0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons