Tenofovir Disoproxil Fumarate
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
Teva sues ex-exec romantically involved with Apotex’s CEO; Pfizer bids adieu to Brazil`s Teuto
This week, Phispers brings you two tales of alleged misuse of information involving former employees of Teva and AstraZeneca. Latin America is presenting more challenges for pharma MNCs, especially with Brazil under recession. Meanwhile, FDA is investing US$ 500 million under the Cures Act, passed by the Obama Administration in December last year. And Eli Lilly has won a long-drawn patent dispute against Actavis over its cancer best-seller. Teva sues ex-exec romantically involved with Apotex’s CEO   Last week, Teva filed a lawsuit against its ex-employee Barinder Sandhu who was Senior Director, Regulatory Affairs, US Generics at Teva USA, until her termination in October, 2016. Also named in the lawsuit is Jeremy Desai, who is President and CEO of Teva’s direct competitor — Apotex, a Canada-headquartered drug firm. Teva has claimed that Sandhu breached her confidentiality agreement by sharing trade secrets and other confidential information to benefit Apotex’s own competitive product development.  According to the lawsuit, Sandhu “emailed Teva USA documents containing trade secrets and other confidential information, many specifically marked ‘Confidential’, to Desai at his Apotex email account.” She also allegedly sent information to her personal email account, in violation of Teva USA’s policies, used USB flash drives on her work-issued computer laptop and used a cloud-based drive to share “hundreds of Teva USA documents”. The information shared by Sandhu relates to a project whose identity has been concealed in the lawsuit as ‘Product X’. Teva claims that Desai and/or Apotex used the “misappropriated information to gain a competitive advantage over Teva USA”. According to the complaint, Apotex employees openly discussed Teva USA’s trade secrets and other confidential information related to ‘Product X’ and participated in roundtable discussions in an effort to advance Apotex’s potential market position of its competing generic product. The lawsuit mentions that in the summer of 2016, Teva USA learned through a former Apotex employee that Sandhu had provided Desai with a copy of highly confidential correspondence from the FDA to Teva USA known as a Complete Response Letter (“CRL”).  This letter from the FDA provided comment on an application for ‘Product X’, which was circulated amongst Apotex employees. After accusing former protege of info misuse, is AstraZeneca’s CEO leaving to take the top job at Teva?   There was more news last week, pertaining to the potential misuse of confidential information — AstraZeneca accused former executive Luke Miels of misusing confidential information and documents to win the top pharma job at GlaxoSmithKline. According to court documents obtained by the Times, Miels alleged that Pascal Soriot, AstraZeneca CEO and Miels’ former mentor, took Miels' decision to resign and join GSK very personally and “sought to threaten and punish” him by enforcing a 12-month notice period. AstraZeneca, on the other hand, alleged that Miels, who was paid US$ 1.67 million (£1.3 million) last year, “had access to information that was confidential beyond his 12-month notice period” that would damage Astra if it was obtained by a competitor. Miels’ lawyers responded by stating that AstraZeneca was in no position to complain about him using AstraZeneca’s documents in his job negotiations since AstraZeneca had shared  confidential information with Soriot before he left Roche to become Astra’s CEO. The story may take another unexpected twist as Israeli news reports say that AstraZeneca CEO Pascal Soriot has agreed to take the top job at Teva. Soriot is expected to earn twice as much as Teva’s previous CEO and receive a bonus upon signing the contract, estimated at about $20 million. Pfizer bows out with sale of Teuto in Brazil   Not long ago, Brazil was one of the hottest emerging markets for drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that has dampened drug demand. Back in 2010, when the going was good, Pfizer had struck a US$ 240 million deal for a 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro. But the joint venture never really took off. And recently, Pfizer has accepted a payment of 1 Brazilian Real — or US$ 0.30 — to relinquish its stake to the heirs of Laboratório Teuto’s founder. For nearly a year, Pfizer had been trying to offload Teuto. A spokesperson for Pfizer said: “Since 2010, both companies have worked together to improve access to medicines in Brazil.” However, Pfizer arrived at this decision as a result of a “desire to focus resources on ensuring the success of its existing portfolio and pipeline.” Pfizer’s exit follows challenging acquisition experiences by Sanofi and Teva in Latin America. Eli Lilly wins patent dispute against Actavis over its best-selling cancer drug   Last week, Eli Lilly won a long-drawn patent dispute with Actavis after the UK Supreme Court ruled that the generic drugmaker's versions of Lilly's top-selling cancer drug — Alimta — directly infringes on certain Lilly patents in Britain, France, Italy and Spain. The generic version of Alimta (pemetrexed) is now owned by Teva, after it bought Allergan's generic business — Actavis — in August last year. Alimta is Lilly's top-selling oncology treatment. It generated sales of US$ 2.3 billion last year. This decision reportedly applies to about US$ 300 million worth of annual sales. Merck’s purchase of Sigma Aldrich under EU scanner   The European Commission has raised objections to the purchase of Sigma Aldrich by German drugmaker Merck. In a Statement of Objections sent out to Merck and Sigma-Aldrich, the Commission alleged that these companies breached EU merger rules. The companies could face a fine equivalent to 1 percent of the combined firm’s annual revenue, the Commission said. According to the Commission, when Merck and Sigma-Aldrich disclosed their merger plan in 2015 they did not share details of a project “with relevance for certain laboratory chemicals at the core of the Commission’s analysis.” The Commission said the project was being developed by one of the parts of the Sigma business that was acquired by Honeywell in October 2015. The technology developed as a result of the project was subsequently licensed to Honeywell, the Commission added. “Honeywell now has the technology it should have received with the divested business. However, this happened with a delay of almost one year and only because the Commission was subsequently made aware of the issue by a third party,” the Commission said. FDA to invest US$ 500 million innovation fund under Cures Act   Last week, the FDA laid out its plans of investing the US$ 500 million innovation fund earmarked in the 21st Century Cures Act, passed last year under the Obama Administration. The fund will be spent from this year, until 2025, and is subject to annual appropriations from the US Congress. Scott Gottlieb, FDA’s Commissioner, in a blog post, said the agency’s plans for investing the innovation fund are steps that will both improve public health (by facilitating biomedical innovation) and reduce drug costs (by cutting the burden of unnecessary regulation). FDA’s plans for the innovation fund include allocating US$ 25.8 million to advance patient-focused drug development, and US$ 95.3 million to regulatory science initiatives, including qualification of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases, and to award grants to advance continuous manufacturing technology. The largest expenditure from the innovation fund — US$ 168.2 million — is earmarked for FDA’s initiatives designed to improve the collection of evidence about safety and efficacy. “FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit,” Gottlieb said in his blog. Did Gilead use Chinese API claiming it came from an approved South Korean manufacturer?   The United States Court of Appeals for the Ninth Circuit reversed a federal judge’s 2015 ruling in the Gilead Sciences’ case. The US drugmaker is back in court to defend accusations that it made false statements about complying with federal regulations on HIV drugs. There were allegations that Gilead had netted billions of dollars in government purchases, and that it had fired a whistleblower — a senior employee who spoke against the company’s illicit conduct. The ex-employees claim that Gilead used a company called Synthetics China to produce unapproved emtricitabine, at unregistered facilities, to save money. For almost one and a half years, beginning in 2007, Gilead imported emtricitabine API from Synthetics China to use in its finished drugs, claiming that the API had come from its approved South Korean manufacturer. Emtricitabine is used by Gilead to produce several HIV drugs, such as Atripla, Emtriva and Truvada. The Ninth Circuit three-judge appeals panel held that former Gilead employees Jeff and Sherilyn Campie had adequately pleaded that Gilead’s conduct opened it to liability under the False Claims Act (FCA). In 2008 and 2009, the government paid more than US$ 5 billion for the HIV drugs, the court held.  

Impressions: 8759

https://www.pharmacompass.com/radio-compass-blog/teva-sues-ex-exec-romantically-involved-with-apotex-s-ceo-pfizer-bids-adieu-to-brazil-s-teuto

#PharmaFlow by PHARMACOMPASS
13 Jul 2017
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: 56503

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
The future of API manufacturing at Dr. Reddy’s
Almost immediately after our analysis on why “Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States”, a stock analyst stated that there were “hopes of US FDA resolution of Srikakulam plant”. What does the future hold for API manufacturing at Dr. Reddy’s, currently the third largest API seller in the world? As part of the Reuters story, CLSA, a stock brokerage covering Dr. Reddy’s, based their assessment that Dr. Reddy’s troubles are behind them as “one of its customers has received approval for a product, referencing a drug master file from this facility”.  While the CLSA report is very positive for Dr. Reddy’s, it’s strange that other than CLSA nobody else has covered this important event. In an attempt to verify CLSA’s statement, we compiled a list of all recent generic approvals (since March 15) which were cross referenced using the Dr. Reddy’s @ PharmaCompass database to determine the active ingredients produced at their Srikakulam facility.  Date Product Application Holder March 26, 2015 Tolcapone Par Pharma March 23, 2015 Argatoban Injection Fresenius Kabi USA March 19, 2015 Zoledronic Acid Hospira Inc March 18, 2015 Tenofovir Disoproxil Fumarate Teva Pharmaceutical USA March 17, 2015 Lacosamide (Tentative Approval) Aurobindo Pharma March 16, 2015 Celecoxib Lupin March 16, 2015 Fluoxetine Hydrochloride Sciegen Pharmaceuticals While Dr. Reddy’s produces 4 out of these 7 recently approved products (Zoledronic Acid, Lacosamide, Celecoxib and Fluoxetine Hydrochloride), only Lacosamide is produced at the Srikakulam facility.  The assessment is based on the Written Confirmations granted by the Indian Drug Regulator which serve as a good guide to know which products are being manufactured in which facility. The issuance of the Written Confirmation requires physical verification of production at the site by the local authorities, which is not necessarily true in the case of DMFs and CEPs.  The possibility of Aurobindo Pharma’s generic approval of Lacosamide being dependent on Dr. Reddy’s active ingredient is low, as Aurobindo Pharma supports their own USDMF. However, Aurobindo doesn’t have a Written Confirmation for Lacosamide.In their 2014 annual report, Dr. Reddy’s, defined their revenues from the Pharmaceutical Services and Active Ingredients (PSAI) division, which declined 21.9%, as a “low point” of their overall business.  However, Dr. Reddy’s also acknowledges that PSAI is a strength, as it provides vertical integration to their global generics business. While Dr. Reddy’s has announced plans to the Ministry of Environment, to triple the size of their manufacturing capacity across three different production facilities, the facility in question, Srikakulam, is not part of the announced expansion plan. There still seems to be significant risk to Dr. Reddy’s North American business on account of the USFDA inspection of their Srikakulam API facility. Read more about: Dr. Reddy’s expansion plans for API production  

Impressions: 4963

https://www.pharmacompass.com/radio-compass-blog/the-future-of-api-manufacturing-at-dr-reddy-s

#PharmaFlow by PHARMACOMPASS
03 Apr 2015