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Top drugs and pharmaceutical companies of 2019 by revenues

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

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29 Apr 2020

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US DMF filings indicate a robust API industry, with multiple first-to-file challenges

This week, PharmaCompass brings you a compilation of the Drug Master Files (DMFs) updates at the US Food and Drug Administration (FDA) over the past two quarters. These applications provide an overview of the products active pharmaceutical ingredient (API) manufacturers are investing in. And, they also give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs. Here are some key findings from our compilation of the FDA’s DMF updates over the second and third quarter of 2016, details of which were provided in July and October: India leads the pack, as the number of filings remain the same Over the period, there were a total of 379 updates of DMFs at the FDA. This number indicates a pace in filings that is nearly the same as the previous quarters. We had seen 180 DMFs updates in the last quarter (Q4) of 2015 and 190 in the first quarter (Q1) of 2016. During the last two quarters, the DMF updates were led by Indian companies, such as Macleods Pharmaceuticals (14 DMFs), MSN Labs (13 DMFs), Hetero (12 DMFs), Lupin (9 DMFs), Cipla and Biophore. The other prominent companies were Mylan and Teva. Companies with compliance issues stay away Unlike previous quarters, where companies with compliance problems continued to submit DMFs, the last two quarters were slightly different, since companies like Zhejiang Hisun and Ipca Laboratories did not submit DMFs. However, Emcure Pharmaceuticals — whose Pune facility was inspected by the FDA last year and a warning letter was issued to the company for violations of current good manufacturing practices (cGMPs) in March this year — submitted one DMF (for Phytonadione) While China shut down antibiotic manufacturing in the Shijiazhuang city, raising concerns about the global supply chain’s dependence on China, Sinopharm Weiqida Datong Pharmaceutical, located about 300 kilometers away from Shijiazhuang, filed DMFs for the key building blocks of antibiotic manufacturing — 6-APA and 7-ACA. Once again, this filing reinforces the dependence of global antibiotic manufacturing on China. Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE! Imminent FTF challenges The FTF challenges to Alvimopan Dihydrate (Merck’s Entereg), Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulib), Daclatasvir Dihydrochloride (Bristol-Myer Squibb’s Daklinza), Elvitegravir (an ingredient in Gilead’s Vitekta, Stribild, Genvoya), Ibrutinib (AbbVie’s Imbruvica), Ospemifene (Shionogi’s Osphena), Perampanel (Eisai’s Fycompa), Pomalidomide (Celgene’s Pomalyst), Regorafenib (Bayer’s Stivarga), Tofacitinib (Pfizer’s Xeljanz) and Vortioxetine Hydrobromide (Takeda’s Trintellix) seem to be imminent in view of the recent filings of DMFs. Roche’s 2014 acquisition of InterMune for US $ 8.3 billion to gain rights to Esbriet (pirfenidone) is likely to come under attack as three more DMFs were submitted during the period under review. The ink wasn’t dry on the deal papers of Pfizer’s US $1 4 billion acquisition of Medivation in August this year, when two more companies — Watson Pharma (now Allergan) and Scinopharm — submitted filings for Enzalutamide, the product for which Pfizer paid all that money. This takes the total number of US submissions for this product to seven. Apixaban and Canagliflozin are most actively filed products The most actively updated DMFs in the past six months were for the APIs of Bristol-Myer Squibb’s new-age anticoagulant Eliquis (Apixaban) and Johnson & Johnson’s diabetes treatment Invokana (Canagliflozin). Sixteen DMFs were submitted for Apixaban along with nine for Canagliflozin. Products like Dimethyl Fumarate and Teriflunomide — which were the most frequently filed DMFs in our previous reports — continued to see vigorous filing activity. Synbias Pharma made a submission for Nelarabine, the only submission for a Novartis product that was approved in 2005 and for which the only listed patent is expiring in June 2017. Similarly DSM’s submission of Dexpanthenol is the only DMF listed for a product used in a variety of injectable and intravenous solution products. Established pharmaceutical companies like Quimica Sintetica and Piramal Healthcare made submissions for products — Benznidazole and Norprostol — which are currently not approved in the United States, indicating the possibility of development projects being underway. Our view With drug filings ranging from multiple FTFs to cannabis derivatives, updates over the two quarters have shown that regardless of the compliance news, activity in the API industry is extremely robust. You can view the PharmaCompass compilation of the new DMF filings by clicking here or simply by sending us an email to get your own Excel version of the new submissions. Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!

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08 Dec 2016

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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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10 Mar 2016

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Did a 29 year-old show GlaxoSmithKline that it made a billion dollar mistake?

29 year-old healthcare investor, Vivek Ramaswamy, bought an old Alzheimer's drug that GlaxoSmithKline (GSK) had dropped for $5 million. Six months later, without doing any clinical development at all, the drug resulted in the biggest biotech IPO ever (Initial Public Offering), two weeks ago and got valued at over $2 billion!It’s clear that either GSK, or Wall Street, have no idea what they are talking about. Indian American, Vivek Ramaswamy left “hedge fund QVT in May 2014 to form what is essentially a shell company, Roivant Sciences. In October 2014, Roivant spins off a subsidiary Axovant Sciences”. Axovant then bought an Alzheimer’s experimental drug for $5m in December from GSK, which had shelved the compound four years ago after testing it in 13 trials and 1,250 patients. Is the world really crazy to trust a 29 year-old more than GSK?The miracle drugSetting aside allegations that the IPO was designed to favor Ramaswamy’s hedge fund friends and family, the drug: 3-Phenylsulfonyl-8-(piperazin-1-yl) quinolone (also known as SB-742457 and RVT-101), failed to meet the desired endpoints in the several clinical trials that GSK ran. However, there was one exception that when the drug is taken with widely used, Alzheimer’s treatment, Aricept, it showed a slower decline in cognition than Aricept alone. So what’s the big deal?Alzheimer's disease offers one of the most lucrative markets in the pharma business, with one analyst estimating the opportunity to be $20 billion. However, the drug research is also considered to be a “wild-goose chase” given the limited understanding of the disease’s biology, which in turn makes clinical trials very expensive to run. From 2002 to 2012, there was just a .04% success rate (or 99.6% failure rate) of Alzheimer’s drugs meeting the standard. It’s all about the people!Axovant has assembled a team, which includes Aricept developer, Lawrence Friedhoff (developer of the second-most widely used drug to treat Alzheimer’s disease, Namenda) and Atul Pande (former head of the neurosciences unit of GSK that led the development of RVT-101). Axovant’s all-star team has taken on the responsibility to bring the drug to market and Wall Street valuation believes this will be possible. Wall Street expectations aside, could Glaxo really be this wrong?Drugs under clinical research constantly get picked up and dropped. Rejection is really no big deal since many molecules get rejected by the FDA in the first review only to be approved years later. The list is surprisingly long for products, which got rejected before being approved and includes: thrice rejected Aveed (testosterone) by Endo Pharmaceuticals, weight loss pill Belviq (lorcaserin), almost approved “female Viagra” Flibanserin and many more. In the case of the antibiotic oritavancin (Orbactiv), it took more than 20 years to come to market and involved four ownership changes before it got final approval. The big question however is always whether the fate will be surreal like that of pirfenidone, or a horror story like Diapep277. InterMune’s pirfenidone, got rejected by the FDA in 2010 due to the drug’s unconvincing efficacy at the time, only to be approved last year and get acquired by Roche for $8.5 billion. Potential type I diabetes treatment DiaPep277 is however a horror story. Licensed to Sanofi by the originator, Peptor Ltd., it got returned by the French pharma giant two years later, only to generate Teva’s interest. Teva invested $170 million to fund further clinical trials. However, the drug underwent a series of changes in ownership and finally, when Hyperion acquired rights to the drug last year, for an amount that could have reached $570 million, they found that the clinical data had been falsified…Hyperion subsequently cancelled the acquisition! Wish to join the Axovant party?It’s clear that rejection of a drug at any stage is never the end of the road for that particular molecule since it can always emerge in a different format to get approval. There is a significant shift, where a significant amount of clinical trial data is going to be made public by pharmaceutical companies. It may be worthwhile to adopt an Axovant model and move some resources from the lab bench to the computer screen! The other reason to look for once-rejected drugs is that their valid patent life would be effectively shorter, when compared with ‘first-time-through’ products.Axovant’s success will benefit patients of Alzheimer’s and certainly make GSK conduct a serious internal review on how they handle their drug development programs.

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25 Jun 2015

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Teva and Otsuka’s Multi-Billion dollar plan when blockbusters turn Generic: Deuterium Chemistry

Two blockbusters, Otsuka’s Abilify® (aripiprazole) and Teva’s Copaxone® (glatiramer acetate), with combined sales of more than $10 billion in 2014 are going to face severe generic competition this year. Interestingly, both companies have turned to a new technology platform, which uses deuterium chemistry analogs of old, off-patent drugs to secure their future profits. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine or SD-809. This improved version breaks down more slowly in the body, allowing physicians to give it less often and at lower doses. The worth was established, when Teva paid $3.5 billion for the company Auspex, which developed SD-809. SD-809 is expected to be approved in 2016 for the potential treatment of chorea (abnormal involuntary writhing movements), associated with central nervous system disorders like Huntington’s disease, tardive dyskinesia, and Tourette syndrome. Now, while this may have sounded like complex chemistry, you’ll be surprised by the simplicity of the concept. What is this deuterium that replaced the hydrogen? Deuterium is a non-radioactive, stable and naturally occurring hydrogen isotope. The atomic mass of hydrogen is approximately 1.0 atomic mass unit (AMU), while that of deuterium is approximately 2.0 AMU. We all have 1-2g of deuterium in our bodies. Why does a deuterium swap make a difference? Replacing some hydrogen atoms with deuterium does not change the shape or electronic structure of the molecule, but it can make a big difference in how it behaves. The reason: chemical bonds formed with deuterium are generally stronger and longer-lasting than those with hydrogen. Stronger bonds allow for small molecule drugs to resist to metabolic enzymes in the body that break down weaker hydrogen bonds. The result: the drug is broken down slower in the body, stays longer and hence is not required in high doses or as often. In addition, the deuterated drug is more stable in the presence of other drugs, resulting in reduced drug-drug interactions. What did Teva & Otsuka buy? Teva: In addition to Auspex’s lead compound, SD-809, Teva also procured other pipeline candidates, which include deuterated versions of levodopa for Parkinson’s disease and pirfenidone for idiopathic pulmonary fibrosis. As Roche purchased InterMune® $8.3 billion last year needs to get changed to “As Roche purchase Intermune for $8.3 billion last year” Otsuka’s $3.5 billion acquisition of Avanir Pharmaceuticals involved a pipeline of products, which are combinations of common, cough syrup ingredient, dextromethorphan with an old-heart drug, quinidine. The promise of deuterated dextromethorphan for Alzheimer’s disease (Avanir compound AVR-786) was a key driver for Otsuka to purchase Avanir. The challenges and opportunities It can be difficult and not always clear to figure out where exactly to swap the deuterium for maximum effect. Legally, a deuterated compound is only considered a new drug if there is sufficient difference in the “active moiety” structure because initially the FDA had considered tetrabenzaine and deutetrabenzaine (SD-809) to be the same drug! However, deuterium chemistry, while simple, requires specialization, which serves as an opportunity for chemical companies to consider developing. With almost $7 billion in acquisitions in under 6 months, deuterium chemistry does deserve attention.

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21 May 2015

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FDA Strikes More Than 40 Drugs Approvals In 2014

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

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