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  • TABLET;ORAL - 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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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: 54752

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

#PharmaFlow by PHARMACOMPASS
29 Apr 2020
World looks for effective treatment to coronavirus, as drugmakers, regulators race ahead to find vaccines, cure
Now that the World Health Organization (WHO) has declared the new coronavirus (2019-nCoV) as a public health emergency of international concern, some of the biopharma industry’s biggest names are taking important steps to combat the disease. The death toll from the coronavirus outbreak is rising each day. As many as 563 people have died in China, and the virus has now spread to nearly 30 countries across the world, including Japan, Thailand, Singapore, Hong Kong, South Korea, Australia, Malaysia, Germany, India and the US. In fact, infectious disease specialists and scientists say the new coronavirus may be more contagious than what the current data suggests. The virus has spread from about 300 people on January 21 to over 28,000 people across the world. The numbers may be even higher as there is limited testing capacity. “The rapid acceleration of cases is of concern,” Dr. Mike Ryan, executive director of the WHO’s emergencies program said last week. Health authorities all over the world are trying to contain the outbreak. In the US, nearly 200 Americans were placed under quarantine at a US air base in California after being evacuated from Wuhan, China. Under the new restrictions, US citizens who have traveled to China within the last 14 days will be directed to one of the 11 airports designated for screening. The FDA is halting travel of all its employees to China and recalling its inspectors from the country. Shortage of face masks, body suits   The fear of the fast spreading coronavirus has led to an acute shortage of face masks in Asia, the US and the UK. Manufacturers are increasing production to meet surging demand. In fact, China is the source of most of the world’s masks and respirators. However, today it is using more masks than it ever has. As a result, fewer masks and respirators will be available to the countries that have been importing them from China. In fact, former FDA commissioner Scott Gottlieb tweeted that China is witnessing a shortage of protective body suits. “Since much of supply chain for masks, gowns, gloves is through China; we should prepare for potential of stretched supply chains and increased demand here in US in event of outbreaks or epidemic spread in America,” Gottlieb tweeted quoting a Bernstein analysis Meanwhile, India has banned the export of personal protection equipment such as masks and clothing amid the global coronavirus outbreak. In Hong Kong, which has been struggling with a shortage of face masks, toilet rolls became unavailable in some supermarkets. Social media posts showed empty shelves and shoppers lining up to buy rolls. Success of flu, HIV drugs on coronavirus: Though there is no formal cure discovered to treat the virus, the treatment protocol established in China and confirmed by physicians in Thailand shows that a combination of Lopanvir and Ritonavir, old generation drugs used to treat HIV, along with flu medication Oseltamivir, has worked on patients. Thai doctors have seen success of such a treatment. “This is not the cure, but the patient’s condition has vastly improved. From testing positive for 10 days under our care, after applying this combination of medicine the test result became negative within 48 hours,” Dr. Kriangska Atipornwanich, a lung specialist at Rajavithi Hospital in Bangkok said. Thailand has recorded 19 cases of coronavirus. Of the Thai patients, eight have recovered and gone home while 11 are still under treatment in hospitals. Meanwhile, Indian drug companies say they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus. Rise in screening tests: Roche has developed a test that can tell whether or not someone has the 2019-nCoV infection within a couple of hours. Roche’s coronavirus test hasn’t been approved for marketing as yet. Co-Diagnostics Inc has also said that the initial verification of its screening test designed to identify the presence of the coronavirus was successful. Healthcare company Novacyt has also launched a new molecular test for the Wuhan coronavirus. The company said its Primerdesign coronavirus test could detect the 2019 strain of the virus, adding it believed this would differentiate it from other current tests which it said were less specific. New coronavirus projects   There are multiple drugmakers and diagnostics companies making noise about their coronavirus projects. Here are some noteworthy projects: Gilead’s remdesivir: Gilead’s experimental anti-viral treatment — remdesivir — has shown some positive results as a patient in the US with worsening symptoms of a confirmed 2019-nCoV infection has been treated with the drug. Remdesivir appeared effective as a throat swab was tested negative for the virus just a few days after receiving the infusion. Incidentally, Gilead is developing remdesivir to combat the Ebola virus, not 2019-nCoV. Success from a single patient is great news, but the company needs more evidence to prove its case. Gilead is also expediting laboratory testing of remdesivir against samples of the new coronavirus. Last week, Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said his agency was working with Gilead to test remdesivir. Gilead is also working with Chinese authorities to begin a controlled, randomized study. However, such a study is bound to take months. Meanwhile, China has kick-started a clinical trial to speedily test remdesivir for 2019-nCoV. In fact, the virology institute in Wuhan has applied for a patent on this experimental Gilead drug. Scientists have found remdesivir and chloroquine, an 80-year-old malaria drug, to be highly effective in laboratory settings to thwart the novel coronavirus. However, the two drugs’ efficacies on humans required further clinical tests, the institute said. Remdesivir will also be tested by a medical team from Beijing-based China-Japan Friendship Hospital for efficacy in treating the deadly new strain of coronavirus. Gilead said the drug was shown to be active in animals with Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which are closely related to the current virus. Moderna, J&J, GSK work on vaccines: Moderna, a Massachusetts-headquartered biotechnology firm, is developing a vaccine to prevent the coronavirus from spreading. Though there isn’t any accomplishment as yet, the Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund the manufacturing of a 2019-nCoV vaccine that uses the company’s proprietary messenger RNA (mRNA) platform. Last week, Johnson & Johnson also said it would begin work on developing a vaccine for the virus. GlaxoSmithKline and CEPI also said they would work to accelerate the creation of a vaccine. The goal is then to provide many vaccine doses rapidly, a statement said. The project will rely on GSK’s adjuvant system, designed to enhance the body’s immune response and create a stronger and longer lasting protection against infection. However, developing a preventive and confirming that it is safe and useful in humans could take 12 to 18 months Regulators, WHO prepare for new cures   The European Medicines Agency (EMA), US Food and Drug Administration (FDA) and the WHO have taken various precautions and are preparing themselves for new medicines, vaccines and in-vitro diagnostics (IVDs). FDA has issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the “presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet CDC criteria for 2019-nCoV testing.” To date, this test has been limited to use at CDC laboratories, but FDA said today’s authorization allows the use of the test at any CDC-qualified lab nationwide. Similarly, EMA said it is ready to support drug developers with all available regulatory tools (i.e., scientific advice, the PRIME scheme, the accelerated assessment and conditional marketing authorization) to advance and expedite the development of ways to fight and prevent the spread of this virus. WHO says ‘no effective treatment’ yet   The WHO has played down reports that talk of effective drugs that could treat the new coronavirus. Television reports in China have pointed to an effective drug for the virus. And Britain’s Sky News said researchers had made a “significant breakthrough” in developing a vaccine. WHO spokesman Tarik Jasarevic said: “There are no known effective therapeutics against this 2019-nCoV (virus) and the WHO recommends enrollment into a randomized controlled trial to test efficacy and safety.” “Even at the accelerated pace enabled by new technologies, the earliest that scientists hope to be able to start initial human trials of a new coronavirus vaccine is by June this year,” a Reuters news report said. Our view   According to the WHO website, there have been multiple disease outbreaks over the last 20 years, including diseases like dengue, avian flu, zika virus, SARS, MERS and many others. Till date, most of these diseases don’t have a cure or a vaccine. These diseases are being treated by various antiviral drugs, and the treatments are largely symptomatic. “The process of developing and testing drugs or vaccines against a new pathogen normally takes many years and is often fraught with pitfalls and failures,” a Reuters report said.Most of the viruses are mutating at a fast pace, creating newer strains each year. Scientists are concerned that the 2019-nCoV has mutated to adapt to its new human hosts far more quickly than SARS. Data on the virus is changing by the day, and some infectious disease specialists say it will take weeks before they can see just how contagious it is. Scientists believe the virus is more contagious than what the current data suggests.Clearly then, this is a race between a fast-spreading and fast-mutating virus and the skills of the biopharmaceutical industry to contain its spread. This time though, the pharmaceutical industry is showing a lot of urgency in finding a vaccine as well as a cure. 

Impressions: 2136

https://www.pharmacompass.com/radio-compass-blog/world-looks-for-effective-treatment-to-coronavirus-as-drugmakers-regulators-race-ahead-to-find-vaccines-cure

#Phispers by PHARMACOMPASS
06 Feb 2020
Mysterious coronavirus outbreak may disrupt global drug supply chains
The new coronavirus—named 2019-nCoV—has raised concerns across the world, and the reported cases and deaths due to mysterious pneumonia is doubling every couple of days. So far, 170 people in China have died due to this new virus, and 7,711 confirmed cases of the virus have been reported in the country. In fact, according to a BBC report, the virus has now spread to every region in mainland China. Moreover, there have been more than 80 cases of the virus reported outside mainland China. Deaths and cases are likely to rise until the outbreak is contained. According to a CNN report, the number of confirmed cases of the Wuhan coronavirus has overtaken the 2003 SARS outbreak inside of mainland China. Patients of the mysterious disease have now been reported from many Asian countries, as well as the Middle East, Europe, Australia and the US. During the 2003 SARS outbreak, there were 5,327 confirmed cases of the disease in mainland China, with 349 deaths. In comparison, the Wuhan virus has reported nearly 7,800 cases worldwide. Experts say the Wuhan virus figures could be vastly under-reported, making the novel coronavirus far more contagious, though less deadly than SARS.   China on high-alert   The outbreak has put health authorities on high alert in China and around the world. The alarm is an outcome of lack of adequate information on the newly identified coronavirus. Questions still linger on how dangerous is this virus and how easily it can spread from one person to another. The incubation period for the virus can range from one to 14 days. During this period, the patient can acquire pneumonia which has proven to be fatal in several recent cases in China. Most of the deaths have been in the Hubei province of China, whose capital is Wuhan, a city whose population is larger than that of New York, London and Hong Kong. Chinese authorities have restricted some travel to try and stop the illness from spreading during the Lunar New Year, which started on January 25. The holiday break has been extended for three more days (until February 2), and China’s financial markets will also remain closed until then. The Shanghai government has said that companies in the city are not allowed to resume operations before February 9. Countries across the world are also taking all sorts of precautions. In the US, the Centers for Disease Control and Prevention (CDC) said it is closely monitoring the outbreak. In Singapore, a multi-ministry task force was set up to fight the disease on all fronts. According to Scott Gottlieb, former commissioner of the US Food and Drug Administration, the epidemic in China is likely to be much broader than what the official statistics currently suggest. And a lot of mild cases have probably gone unrecognized. Moreover, he feels that a global spread of the virus is inevitable. While the World Health Organization stopped short of calling the outbreak a global health emergency, discussions are currently underway which may change that status.   Researchers look for cure   Health authorities are exploring repurposing untested antivirals in a desperate bid to contain the outbreak. Drugmakers in the US are shipping antiviral drugs to Chinese health authorities to assess whether these medicines could help contain the spread of this disease. A Chinese government commission has recommended that doctors administer Kaletra — AbbVie’s HIV drug — to patients who have been tested positive for the new illness. Kaletra is a combination of lopinavir and ritonavir. The other treatment is nebulized alpha-interferon. AbbVie and Johnson & Johnson have begun shipping drugs approved to treat HIV. AbbVie is donating more than US$ 1 million worth of Kaletra to help combat the disease in China. There is uncertainty over whether drugs approved to treat other infectious diseases would help patients infected with the new coronavirus.    Disrupting API supplies   As the virus proliferates and takes more lives, questions are likely to be raised about the adequate production and supplies of APIs, as well as the extent to which shipments can be made if transit hubs are out of commission. There are a limited number of generic drug facilities registered with the FDA in the Hubei province. However, as the containment initiatives spread across China, especially near the regions around Shanghai and Guangzhou, the disruption possibilities are likely to increase substantially. In the US, approximately 80 percent of APIs used to produce finished products come from China and other non-TAA compliant countries. The production cost of APIs in China is estimated to be about 20 to 30 percent lower than that in India. According to reports, India imports around 80 per cent of APIs from China on volume basis. So the world’s reliance on China for APIs is very high. “The time to worry is now,” said Steven Lynn, a former director of the FDA Office of Pharmaceutical Quality. As of now, FDA has said it has not received any shortage notifications from manufacturers that make products for the US market due to the current coronavirus outbreak.   Our view   The spread of this new virus has bearings on the global supply chain for pharmaceuticals. Over the past decade, China has become an even bigger player in the market for antibiotics and the key building blocks of APIs. The global pharmaceutical supply chain is extremely interlinked and a lot of pharmaceutical manufacturing is dependent on chemical and excipient producers which are not listed on the generic facilities list. As there is restricted movement within parts of China, companies need to assess their supply chains in detail to determine the likelihood of disruption. They also need to speak to producers outside China to build the necessary contingencies in case this problem is not resolved quickly.  

Impressions: 4479

https://www.pharmacompass.com/radio-compass-blog/mysterious-coronavirus-outbreak-may-disrupt-global-drug-supply-chains

#Phispers by PHARMACOMPASS
30 Jan 2020
Top drugs by sales revenue in 2015: Who sold the biggest blockbuster drugs?
The year 2015 has gone down in history as a record year for mergers and acquisitions in the pharmaceutical and biotech space with deals worth US $ 300 billion being announced. The highlight of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.  Pharma Letter tracked transactions through the year and found the number of deals exceeding US $1 billion at 30 in 2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A deals were announced in 2015 (out of which some are yet to be completed), compared to 137 in 2014.   This week, PharmaCompass brings you a compilation of the top drugs of 2015 by sales revenue and growth. Sofosbuvir – the outright winner of 2015 2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion. The PharmaCompass prediction that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment of infectious diseases like hepatitis and HIV) would become the best-selling drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864 billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira. Humira retained its place as the best-selling drug with US $ 14.012 billion in sales in 2015. However, with sales growth of US $ 11.737 billion in a single year, Harvoni is poised to become the best-selling drug by the end of 2016. Top 20 Drugs by Sales Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information extracted from annual reports and US Securities and Exchange Commission (SEC) filings of major pharmaceutical companies. If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version. Click here to access all the 2015 data (Excel version available) for FREE!   Product Active Ingredient Main Therapeutic Indication Company 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) AbbVie 12,543 14,012 1,469 2 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 2,127 13,864 11,737 3 Enbrel Etanercept Immunology (Organ Transplant, Arthritis etc.) Amgen / Pfizer 4,688 8,697 4009 4 Remicade Infliximab Immunology (Organ Transplant, Arthritis etc.) Johnson & Johnson / Merck 6,868 8,355 1487 5 MabThera/Rituxan Rituximab Oncology Roche 5,659 7,115 1,456 6 Lantus Insulin Glargine Diabetes Sanofi 6,978 7,029 51 7 Avastin Bevacizumab Oncology Roche 6,481 6,751 270 8 Herceptin Trastuzumab Oncology Roche 6,338 6,603 265 9 Revlimid Lenalidomide Blood Related Disorders Celgene Corpoartion 4,980 5,801 821 10 Sovaldi Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) Gilead Sciences 10,283 5,276 (5,007) 11 Seretide / Advair Salmeterol Respiratory Disorders GlaxoSmithKline 6,005 5,227 (778) 12 Crestor Rosuvastatin Calcium Cardiovascular AstraZeneca 5,512 5,017 (495) 13 Lyrica Pregabalin Neuroscience and Mental Health Pfizer Inc. 5,168 4,839 (329) 14 Neulasta Pegfilgrastim Blood Related Disorders Amgen 4,596 4,715 119 15 Gleevec / Glivec Imatinib Oncology Novartis 4,746 4,658 (88) 16 Xarelto Rivaroxaban Anticoagulants Bayer / Johnson & Johnson 3,369 4,345 976 17 Copaxone Glatiramer Neuroscience and Mental Health Teva 4,237 4,023 (214) 18 Januvia Sitagliptin Diabetes Merck & Co 3,931 3,863 (68) 19 Abilify Aripiprazole Neuroscience and Mental Health Bristol-Myers Squibb/ Otsuka Holdings 6,485 3,804 (2681) 20 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health Biogen 2,909 3,638 729 Click here to access all the 2015 data (Excel version available) for FREE! A year of record FDA approvals 2015 was also the year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information. PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant variation in estimates.  However, in our view, drugs that saw highest sales growth in 2015 are likely to do well this year as well. Top 20 drugs by sales growth (in USD, millions)   Product Active Ingredient Main Therapeutic Indication 2014 Revenue in Millions (USD) 2015 Revenue in Millions (USD) 2015 Sales Difference Millions (USD) 1 Harvoni Ledipasvir and Sofosbuvir Infectious Diseases (HIV, Hepatitis etc.) 2,127 13,864 11,737 2 Viekira Pak Ombitasvir/Paritaprevir/Ritonavir Infectious Diseases (HIV, Hepatitis etc.) 48 1,639 1,591 3 Humira Adalimumab Immunology (Organ Transplant, Arthritis etc.) 12,543 14,012 1,469 4 Hepatits C Franchise Daclatasvir and Asunaprevir Infectious Diseases (HIV, Hepatitis etc.) 256 1,603 1,347 5 Imbruvica Ibrutinib Chronic lymphocytic leukemia 200 1,443 1,243  6 Cubicin Daptomycin Anti-bacterial 25 1,127 1,102 7 Eliquis Apixaban Anticoagulants 774 1,860 1,086 8 Triumeq Abacavir, Dolutegravir and Lamivudine Infectious Diseases (HIV, Hepatitis etc.) - 1,037 1,037 9 Xarelto Rivaroxaban Anticoagulants 3,369 4,345 976 10 Opdivo Nivolumab Oncology 6 942 936 11 Revlimid Lenalidomide Blood Related Disorders 4,980 5,801 821 12 Tecfidera Dimethyl Fumarate Neuroscience and Mental Health 2,909 3,638 729 13 Xtandi Enzalutamide Oncology 480 1,207 727 14 Ibrance Palbociclib Oncology - 723 723 15 Invokana / Invokamet Canagliflozin Type 2 diabetes 586 1,308 722 16 Victoza Liraglutide Diabetes 2,014 2,704 690 17 Stribild Cobicistat, Elvitegravir, Emtricitabine and Tenofovir Disoproxil Fumarate Infectious Diseases (HIV, Hepatitis etc.) 1,197 1,825 628 18 Levemir Insulin Diabetes 2,133 2,745 612 19 Votrient Pazopanib Oncology 565 565 20 Perjeta Pertuzumab Oncology 927 1459 532   Hepatitis C products, which had three of the four highest sales growths in 2015, clearly show the impact these revolutionary treatments will have on the global healthcare landscape in time to come. Cancer immunotherapy treatments, a new generation of blood thinners and novel diabetes treatments were some of the others which demonstrated stellar growth in 2015. Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they have not been included in the compilation of drugs. Click here to access all the 2015 data (Excel version available) for FREE!   Sign Up, Stay Ahead While some companies like Boehringer and Valeant are yet to release their annual reports. In order to stay informed, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to access all the 2015 data (Excel version available) for FREE!   CORRECTION, April 12, 2016: An earlier version of this compilation did not account for cases where the same drug is sold by multiple companies (e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top 20 Drugs by Sales and Sales Growth has been done.   

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https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs

#PharmaFlow by PHARMACOMPASS
10 Mar 2016
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