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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)   

Impressions: 54653

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

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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!  

Impressions: 58277

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

#PharmaFlow by PHARMACOMPASS
29 Mar 2018
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.  

Impressions: 2780

https://www.pharmacompass.com/radio-compass-blog/pfizer-sues-j-j-generics-under-pressure-china-s-fosun-resurrects-deal-to-buyout-india-s-gland

#Phispers by PHARMACOMPASS
21 Sep 2017
Trump tells FDA to fund itself fully through industry fees; Astra’s CEO dumps Teva offer
This week, Phispers brings you lots of regulatory news from the US, where the Trump administration has instructed FDA to fund itself entirely through industry fees; and the agency’s chief has pledged to accelerate generic reviews through two new policies. This was yet another bad week for Teva, as it faced charges in Europe, lost a patent battle in the US to Takeda, and AstraZeneca’s CEO reportedly tossed away an offer to head it. Plus, there is news on AstraZeneca’s investment in China and Novartis’ CAR-T cell therapy for cancer. Teva’s woes continue: Faces EC charges; loses patent battle; and Soriot drops offer   Teva’s troubles continued unabated. First, Pascal Soriot, the chief executive of AstraZeneca, who was rumored to be the next head of the Israeli drugmaker, decided not to leave AstraZeneca. He is reportedly forgoing an offer of a US$ 20 million bonus, and a chance to reorganize Teva, the world’s largest generic drug company. Last week, the UK-based drug firm confirmed that Soriot would be presenting AstraZeneca’s second-quarter earnings, on July 27. Rumors of Soriot’s likely appointment were floated by an Israeli financial website. Teva is likely to announce the name of its new CEO within a month, Chaim Hurvitz, a member of Teva’s founding family, said. Second, the European Commission (EC) charged Teva of doing an illegal deal with Cephalon to delay selling a cheaper generic version of Cephalon’s sleep disorder drug. In the past, the EU regulator has charged scores of other companies as well, including Denmark’s Lundbeck, USA’s Johnson & Johnson and France’s Servier. According to the regulator, the pay-for-delay deals cost European consumers billions of euros. Third, the Israeli pharma biggie lost a patent battle in the US appeals court to Takeda Pharmaceutical. The court said a patent on Takeda's cancer treatment — Velcade — is valid, pushing back the date when generic drug makers, including Teva and Mylan, will be allowed to launch lower-cost versions of the drug in the US. AZ invests US$ 79 million in Australia to cater to China’s demand for asthma drug   Air pollution is choking people in the big cities of China, raising demand for AstraZeneca’s asthma medicine — Pulmicort respules. As a result, the British pharmaceutical giant announced an investment of US$ 79.27 million (AUD $100 million)  last week at its Sydney site which manufactures the treatment.  The announcement was made in London on July 13, at a meeting between AstraZeneca CEO Pascal Soriot and Australia’s Prime Minister Malcolm Turnbull. AstraZeneca will add three production lines to the existing eight at its Sydney site, each with a capacity to produce over 70 million units of Pulmicort respules in a year. The company will bolster exports from the site to over US$ 1.9 billion (AUD 2.4 billion) in the next four years, with a further goal of doubling respules production to 1 billion by 2025. “The demand for this asthma product, particularly for children in China, is immense and we see that trend continuing,” Mark Morgan, manufacturing director of AstraZeneca Australia, said. Although labor costs are lower in China, the manufacturing technology “is difficult to replicate,” Morgan added. Over 50 percent of Pulmicort’s worldwide sales come from China. And its demand increased by 18 percent — from US$ 485 million in 2015 to US$ 570 million in 2016. White House tells FDA to fund itself via industry fees; FDA scouts for top talent   In the US last week, the House of Representatives passed the bill that reauthorizes US Food and Drug Administration (FDA) to levy user fees. Soon after that, the White House reiterated its earlier call to amend the agreements so that the FDA is entirely funded by the medical products industries. In a statement, the White House said: “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs… In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.” Last week’s statement said President Trump is “concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition.” Meanwhile, the FDA Commissioner Scott Gottlieb is embarking on a talent hunt to recruit new staffers for the Prescription Drug User Fee Act (PDUFA)-related positions in the drugs and biologics programs. “To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” Gottlieb said in his blog. Novartis’ CAR-T cell therapy unanimously recommended for approval by FDA   The US FDA’s advisory committee has unanimously (10:0) recommended Novartis’ CAR-T cell therapy — CTL019 (tisagenlecleucel) — for approval to treat pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). CAR-T is short for chimeric antigen receptor T cell (CAR-T) therapy. In the US, ALL is the most common childhood cancer. This therapy is an immunotherapy approach to treat cancer, also considered the “fifth pillar” (after surgery, chemotherapy, radiation and targeted therapies like imatinib and trastuzumab) of cancer treatment. This approach, called adoptive cell transfer (ACT), uses engineered immune cells to generate remarkable responses in patients with advanced cancer. In several early stage trials, when ACT was tested in patients with advanced ALL (with few treatment options left before these patients), many reported a complete disappearance of the cancer. And these patients remained cancer free for extended periods. Therefore, Novartis’ CTL019 assumes tremendous importance. Meanwhile, the FDA advisory committee also unanimously recommended Biocon/Mylan’s and Amgen’s biosimilars for approval. The two recommendations imply a double whammy for Roche, with its drugs Avastin and Herceptin poised to get impacted by these biosimilars. The FDA’s Oncologic Drugs Advisory Committee (ODOC) voted 16-0 in favor of Milan’s proposed Herceptin biosimilar to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. The ODOC also voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. The uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma. Concord Biotech faces GMP concerns; FDA warning letters to firms in India, Italy   Ahmedabad-based Concord Biotech, a research and development-driven biotech firm that makes fermentation-based APIs, was placed on Health Canada’s Inspection Tracker due to “general GMP observations” shared by a regulatory partner. While no details of the observations were divulged, Health Canada did not mention any data integrity concerns and is “continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner).” The FDA also issued a warning letter to Tubilux Pharma SpA in Italy over concerns arising from an inspection conducted in December 2016. The investigators raised concerns over turbulent airflow on an aseptic processing line which “poses a significant contamination hazard” to the product. Limitations in Tubilux’s “current equipment and process design” also posed “a significant hazard” in the aseptic processing operation. The warning letter also highlights that some of the products manufactured at Tubilux were not tested for particulates prior to release. During the inspection, FDA “observed repeated instances of high particle count alarms during production”. Tubilux specializes in manufacturing various types of products used in ophthalmic applications. A September 2016, FDA inspection at Vista Pharmaceuticals in India highlighted concerns over the sale of isoxsuprine hydrochloride USP, 20 mg tablets, by the firm. Although isoxsuprine hydrochloride is sold in the US, the drug is not approved in the Orange Book. The firm had also not validated the manufacturing process for isoxsuprine hydrochloride USP, 20 mg tablets. The warning letter also mentions that during the walk through of the firm’s manufacturing areas, FDA investigators observed that the equipment was in a state of disrepair. “Specifically, our investigators saw holes and corrosion in three pieces of equipment,” the letter noted. FDA chief pledges to accelerate generic reviews through two new policies   This week, the US FDA Commissioner, Scott Gottlieb, made an announcement that by the end of 2017, the American drug regulator will issue two new documents to improve the review process for generic drugs. These documents are meant to streamline the submission and review of abbreviated new drug applications (ANDAs) under the FDA’s drug competition action plan. The first document is a planned internal manual of policies and procedures (MAPP) — titled “Good ANDA Assessment Practices”. It will look to reduce “unnecessary” and “duplicative” procedures from FDA’s reviews to make them more efficient. However, the document will not alter any of the review goals the FDA agreed to as part of the negotiations to reauthorize the GDUFA. For applications that aren’t approved, MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter (CRL), and provide follow up with sponsors over phone if the reasons in the letter are unclear, Gottlieb said. The second document will be a guidance on “Good ANDA Submission Practices”. It will be added to the Center for Drug Evaluation and Research’s ‘to-do list’ for the year, which already includes 13 other new and revised draft guidances for generic drugs. According to Gottlieb, this guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application.  

Impressions: 3431

https://www.pharmacompass.com/radio-compass-blog/trump-tells-fda-to-fund-itself-fully-through-industry-fees-astra-s-ceo-dumps-teva-offer

#Phispers by PHARMACOMPASS
20 Jul 2017
GSK uses Apple’s ResearchKit for clinical research; India’s pharma exports drop in Q1
This week, Phispers has lots of interesting pharma news from the across the world, including an analyst’s take on why Pfizer should not split, Elder Pharma’s COO being caught bribing a government official and how Teva’s entry into PhRMA is being resented by other players. And, don’t miss the news on next-generation women who are changing the face of pharma and healthcare in India.  GSK’s uses Apple’s ResearchKit, while Roche and Valeant face problems with clinical trials When it comes to clinical trials, this was certainly a week of action. First, Swiss drug maker Roche reported that a late-stage clinical trial showed its new blood cancer drug – Gazyva – failed to deliver significant improvements over its older Rituxan medicine. And then there was news regarding suicide risks linked to an experimental Valeant Pharmaceuticals drug used to treat psoriasis. The US Food and Drug Administration (FDA) reviewers raised concern over the suicide risk. This news followed similar news about the FDA allowing Juno Therapeutics to resume its clinical trial after the death of three patients.When it comes to clinical trials there was some exciting news from GlaxoSmithKline last week. GSK announced it is taking the next-generation approach to clinical trials by initiating a study on rheumatoid arthritis using Apple’s ResearchKit. This is the first time a drug maker is using the health system for the iPhone to conduct clinical research.GSK intends to record the mobility of 300 participants over three months. The company will also ask these patients to input both physical and emotional symptoms, such as pain and mood. The application created by GSK using ResearchKit comes with a guided wrist exercise that uses the phone’s sensors to record motion. This gives the drug company a standardized measurement across all users. The company will use the results to help design better clinical trials. GSK’s bulk drug plant in UK receives FDA’s warning letter for making contaminated drugs While still on GSK, there was some bad news too for the British drug maker. FDA investigators at GSK’s API manufacturing facility in Worthing, UK, found penicillin in non-penicillin manufacturing areas approximately 69 times in 2012, 72 times in 2013, 30 times in 2014, and 16 times through July 7, 2015.Contamination of non-beta-lactam drugs with beta-lactam drugs (such as penicillin) presents great risks to patient safety, including anaphylaxis and death. There is no safe level of penicillin contamination, as no level has been determined to be tolerable risk.As a follow up to the FDA inspection, GSK had to recall various lots of Bactroban® (mupirocin calcium) products due to potential contamination with penicillin and foreign substances such as glass, paint fragments, and fibers.This is not the first time a facility has had manufacturing compliance issues. In late 2015, a European regulatory body suspended marketing of its drug – Zantac – across Europe for not dealing with a decade-old problem of manufacturing the drug at this facility.  To split or not to split – that may no longer be the question before PfizerThere has been a lot of talk around Pfizer executives indicating that the American pharmaceutical bigwig may be split into different companies in order to bolster shareholder value. This talk gathered momentum three months back, when it scrapped the US $ 160 billion deal to acquire Allergan.However, the idea to split Pfizer was floated five years ago. It was intended to create two different companies – one would produce older drugs, while the other would focus on newer medicines. While a decision on splitting Pfizer is likely to be taken later this year, one Wall Street analyst questioned whether the big drug maker should actually be split. In a note to investors, Sanford Bernstein analyst Tim Anderson suggested a split may not unlock “substantial additional” value for shareholders. Anderson forecasts a value of about US $ 36 a share, which is roughly in line with the current stock price. And unlike in 2011, when growth prospects seemed fuzzy, Pfizer seems to be in a better position today. Competitors resent Teva’s entry into trade associationTeva – the world’s largest generics player – was made a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) last week. The trade association announced it had admitted Teva along with rare-disease manufacturer Alexion and specialty pharma Jazz. AMAG Pharmaceuticals and Horizon Pharma also became full members, transitioning from research associates.However, Teva’s peers are not exactly happy that the Israeli drug maker has joined their exclusive club. For instance, AbbVie argued against letting the copycat giant in. AbbVie claimed that by admitting Teva into PhRMA, the association would dilute its “emphasis on innovation” and spur “internal conflicts” between Teva and companies whose patents it seeks to invalidate.Apart from being a top generics player, Teva is also into branded sales, thanks to multiple sclerosis blockbuster drug Copaxone, and to a lesser extent, the brands it acquired in its Cephalon buyout. Teva had acquired the generics business of Allergan last year for US $ 40.5 billion. As a result, it is selling generic brands in the United States and Europe. In fact, all generic majors – including Dr. Reddy’s, Impax, Mayne, Zydus Cadila, Aurobindo, Intas and Torrent – have queued up to acquire a band of products put on the block by Teva in Europe.  FDA puts four companies that didn’t pay GDUFA fee on import alert. Over the last two years, companies like China’s Jiangsu ZW Pharmaceuticals and Wuxi Kaili Pharmaceutical Company, and India-based Fleming Laboratories and Sharon Bio-Medicine had received warning letters from the FDA for failing to pay the GDUFA (Generic Drug User Fee Amendments) fees.This week, for the first time, the FDA used the authority provided by the Congress to enforce GDUFA’s user fee provisions and placed these firms on import alerts. The FDA added the four companies (mentioned above) to a list of generic drug facilities that are banned from shipping products to the US since they have not paid the GDUFA fee and have failed to meet identification requirements stipulated in the GDUFA of 2012. Next-generation women in Indian pharma and healthcareIndia’s pharmaceutical and healthcare industry has traditionally been a male bastion. This is true of many other countries as well. However, according to a news report published this week, a big change is sweeping across this immensely technical and challenging business landscape. And a new crop of business leaders has emerged in India that is coming up with game-changing ideas. “These women have added tremendous value in shaping these organisations,” says the news report.The story profiled five next-generation women – Namita Thapar (39), CFO of Emcure Pharmaceuticals, Zahabiya Khorakiwala (33), Managing Director of Wockhardt Hospitals, Tara Singh Vachani (29), CEO and Managing Director of Antara Senior Living, Ameera Shah (36), Managing Director of Metropolis Labs and Samina Vaziralli (37), Executive Director of Cipla. Elder Pharma’s COO bribes government official for preventing SFIO probeWhile the next-generation women are busy adding value to their pharma business, another next-generation promoter of a pharma company was indicted for bribing a government official.  Last week, the Central Bureau of Investigation arrested a senior Ministry of Corporate Affairs (MCA) officer – B K Bansal – in Delhi for allegedly taking a bribe of Rs 9 lakh from Anuj Saxena, COO of Elder Pharma, through a middleman for preventing a Serious Frauds Investigation Office (SFIO) investigation pending against the company.Bansal was director general of MCA. At first, Bansal demanded Rs 50 lakh, but later settled for Rs 20 lakh to prevent the investigation. He was caught accepting the second tranche of the payment. Elder Pharma has been going through a crisis recently, after the MCA red-flagged several discrepancies in its finances. The company had only recently sold a major stake in the company.  India’s pharma exports to US, Europe decline by 7 percent in Q1Over the last several months, we have been reading a lot of news regarding compliance issues being faced by Indian pharma companies. Well, all those compliance issues have begun to have a bearing on the financials of Indian pharmaceutical companies. According to figures released by the Pharmaceuticals Export Promotion Council (Pharmexcil), the exports of Indian pharmaceuticals to Europe and the US witnessed a negative growth of 6 to 7 per cent in the April to June quarter this year.Pharmexil will organise an interactive meeting with the joint secretary of the Department of Commerce (DoC) to discuss the reasons behind this decline in exports.Says P V Appaji, director general of Pharmexcil: “Though the Indian pharma exports performed well last year, we have seen a decline in pharma exports, particularly to the US market, in last three months.” 

Impressions: 4536

https://www.pharmacompass.com/radio-compass-blog/gsk-uses-apple-s-researchkit-for-clinical-research-india-s-pharma-exports-drop-in-q1

#Phispers by PHARMACOMPASS
21 Jul 2016
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.   

Impressions: 56361

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#PharmaFlow by PHARMACOMPASS
10 Mar 2016
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