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TABLET;ORAL - 18MG
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Top Pharma & Biotech Deals, Investments, M&As – July 2018

July may not have seen any big-ticket deals — i.e. deals in excess of US$ 1 billion — in the pharma and biotech space. Yet, deal making remained robust last month as well. Companies like Novartis, Roche, Lilly and Sanofi bolstered their R&D pipelines by striking deals which may result in billion-dollar payouts if they achieve their milestones. However, major investments were announced in the manufacturing and contract services arena which indicate that pharma job creation could be heading back to the United States. Click here to view the major deals in July 2018 (FREE Excel version available) Trump’s tax cuts make Pfizer announce major US manufacturing investment Earlier this year, President Donald Trump announced a reduction in the US corporate tax rate from 35 percent to 21 percent. The tax cuts were designed to promote employment and grow manufacturing in the United States. In January, Pfizer announced its plan to invest approximately US$ 5 billion in US-based capital projects as a result of the enactment of the Tax Cuts and Jobs Act. Click here to view the major deals in July 2018 (FREE Excel version available) Last month, weeks after agreeing to roll back its drug price increases, Pfizer announced it will make a US$ 465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. Known as Modular Aseptic Processing (MAP), the new, multi-story, 400,000-square-foot production facility will also create an estimated 450 new jobs over the next several years. This investment will expand Pfizer’s presence in Portage, located in Kalamazoo County, where the company currently employs more than 2,200 people and is one of its largest plants. During the next six years, Pfizer expects to invest approximately US$ 1.1 billion in Kalamazoo County. Click here to view the major deals in July 2018 (FREE Excel version available) Rubius’ IPO: Last month saw an uptick in IPO activity, and the biggest biotech IPO at Nasdaq so far in 2018 came from Cambridge, Massachusetts-based Rubius Therapeutics, as it raised a whopping US$ 277.3 million to support its approach of engineering red blood cells into off-the-shelf treatments for several diseases across multiple therapeutic areas. The firm also announced that it had signed an agreement for the acquisition of a 135,000-square foot manufacturing facility located in Smithfield, Rhode Island. The company plans to invest up to US$ 95 million through 2020, and up to US$ 155 million in total over a period five years or more, and it expects to hire approximately 150 people at the facility. Click here to view the major deals in July 2018 (FREE Excel version available) Cambrex acquires Halo Pharma: US-based Cambrex Corporation, a leading manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), acquired Halo Pharma, a leading dosage form contract development and manufacturing organization (CDMO) for approximately US$ 425 million. Halo operates two facilities located in Whippany, New Jersey, USA and Montreal, Québec, Canada and is expected to generate over US$ 100 million in annual revenue in 2018. With the acquisition of Halo, Cambrex will enter the growing finished dosage form CDMO market. Halo provides drug product development and commercial manufacturing services, specializing in oral solids, liquids, creams, sterile and non-sterile ointments. Halo’s core competencies include developing and manufacturing highly complex and difficult to produce formulations, products for pediatric indications and controlled substances. Click here to view the major deals in July 2018 (FREE Excel version available) Catalent acquires Juniper: Also expanding its presence in the CDMO space was Catalent, which acquired Juniper Pharmaceuticals. While Catalent is a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, Juniper is a company with two core businesses, the first being its Crinone (progesterone gel) franchise and the other a fee-for-service CDMO known as Juniper Pharma Services (JPS). The transaction was valued at approximately US$ 139.6 million. Click here to view the major deals in July 2018 (FREE Excel version available) Novartis continues to bet big on dermatology A month after Swiss drugmaker Novartis Pharmaceuticals Corporation announced it plans to spin off Alcon eye care business into a separately traded standalone company and buy back up to US$ 5 billion in stock, Novartis signed a licensing agreement with MorphoSys and Galapagos covering the development and commercialization of their investigational, fully human, IgG1 monoclonal antibody – MOR106. MOR106 is directed against the target IL-17C that was generated in a collaboration between MorphoSys and Galapagos. IL-17C is believed to contribute significantly to atopic dermatitis (AD), a form of eczema and a severe dermatologic condition with high prevalence. Click here to view the major deals in July 2018 (FREE Excel version available) MOR106 will be an extension of Novartis’ AD pipeline portfolio that includes oral ZPL389 that is currently in phase II clinical trials. Atopic Dermatitis, a form of eczema, is a dermatologic disease that can cause intense itching and recurring lesions. AD affects approximately 8 percent of adults and 14 percent of children worldwide. Novartis also has a blockbuster drug, Cosentyx (secukinumab), a human IgG1κ monoclonal antibody that binds to the protein interleukin-17A, and is marketed for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis. Cosentyx generated sales of over US$ 2 billion in 2017. Click here to view the major deals in July 2018 (FREE Excel version available) In addition to the funding of the current and future MOR106 program by Novartis, MorphoSys and Galapagos will jointly receive an upfront payment of Euro 95 million. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, MorphoSys and Galapagos would jointly be eligible to receive significant milestone payments, potentially amounting to approximately Euro 850 million, in addition to tiered royalties on net commercial sales. Under the terms of their agreement from 2008, Galapagos and MorphoSys will share all payments equally. Click here to view the major deals in July 2018 (FREE Excel version available) Roche strikes a deal to develop drugs using milk-derived exosomes Milk naturally contains small lipid vesicles called exosomes that deliver biochemical packages from the mother to her offspring. A research group led by Dr. Ramesh Gupta from the University of Louisville recently highlighted a new approach for improving therapeutic drug effectiveness by artificially packaging drugs in bovine milk-derived exosomes. It is believed that milk exosomes represent a significant opportunity to potentially resolve the long-standing challenge of oral bioavailability of macromolecules and complex small molecules. Milk-derived exosomes form the basis for PureTech’s internally-developed technology to accomplish the task of oral transport of complex biological molecules. The technology is based on research conducted by PureTech Health and its academic collaborators, which including Dr. Ramesh Gupta. Click here to view the major deals in July 2018 (FREE Excel version available) PureTech Health announced that it has entered into a multiyear collaboration with Swiss drugmaker Roche, to advance PureTech’s milk-derived exosome platform technology for the oral administration of Roche’s antisense oligonucleotide platform. Under the terms of the agreement, PureTech Health will receive up to $36 million, including upfront payments, research support, and early preclinical milestones. PureTech Health will be eligible to potentially receive development milestone payments of over $1 billion and additional sales milestones and royalties for an undisclosed number of products. Click here to view the major deals in July 2018 (FREE Excel version available) Lilly ties up with Anima Biotech for novel strategy against undruggable targets Anima Biotech’s Translation Control Therapeutics platform got a huge vote of confidence as it struck a deal with Eli Lilly that has the potential to exceed US$ 1 billion. Anima Biotech is pioneering a new class of drugs that specifically control protein translation as a novel strategy against hard and undruggable targets. The term ‘undruggable' was coined to describe proteins that could not be targeted pharmacologically. However, companies such as Anima have made considerable progress to ‘drug’ many hard and undruggable targets. The company claims that its novel platform enables for the first time to visualize and specifically control the synthesis of target proteins. By targeting the mechanisms that specifically regulate the process of mRNA translation, they can discover small molecules that either decrease or increase a target protein’s production, enabling a new strategy and new hope against hard and undruggable targets. Anima’s platform was validated by its fast-growing pipeline programs in multiple therapeutic areas including fibrosis, viral infections, oncology and neuroscience. The collaboration with Lilly is to discover and develop translation inhibitors for several target proteins using Anima’s Translation Control Therapeutics platform. It is a multi-year deal set around undisclosed Lilly targets. Anima will use its platform to discover lead candidates that affect the translation of the Lilly targets. Lilly will then handle clinical development and commercialization. Click here to view the major deals in July 2018 (FREE Excel version available) Under the terms of the deal, Lilly is paying Anima US$ 30 million upfront and US$ 14 million in research funding. Anima is eligible for up to US$ 1.05 billion in development and commercial milestones. Anima is also entitled to tiered royalties on any products that result from the collaboration in the low to mid-single digits. PTC broadens drug pipeline with gene therapy buy Founded almost 20 years ago, PTC Therapeutics is focused on the discovery, development and commercialization of medicines for patients with rare disorders. With two drugs on the market including the contentious Emflaza (deflazacort), PTC announced last month that it had entered into an agreement to acquire Agilis Biotherapeutics, Inc., a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system. Click here to view the major deals in July 2018 (FREE Excel version available) The lead gene therapy candidate, GT-AADC, has compelling clinical data in treating a rare central nervous system disorder which is an outcome of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency. Under the terms of the merger agreement, PTC will pay an upfront consideration of US$ 50 million in cash and approximately US$ 150 million in PTC common stock. In addition to the upfront payments, potential future consideration includes US$ 60 million in development milestones to be paid over the next two years (including the acceptance of a biologics license application or BLA). Additionally, the transaction includes up to US$ 535 million in success-based milestones in connection with regulatory approvals on the three most advanced programs and receipt of a priority review voucher, as well as tiered commercial milestones. The priority review vouchers, which the FDA awards to companies that develop drugs for neglected diseases and rare pediatric disorders, ensure a speedier review from the FDA once a company files for approval. These vouchers have become valuable commodities themselves, having been bought and sold at prices topping US$ 100 million. Click here to view the major deals in July 2018 (FREE Excel version available) Sanofi buys into early-stage therapy for non-small cell lung cancer Sanofi paid an upfront fee of US$ 50 million to develop and commercialize Revolution Medicines’ targeted cancer therapies for patients with non-small cell lung cancer (NSCLC) and other types of cancers carrying certain mutations. In a deal where Revolution Medicines could receive more than US$ 500 million in development and regulatory milestone payments, Sanofi will apply its expertise in oncology research and drug development to bring Revolution’s lead candidate RMC-4630 to the market. Click here to view the major deals in July 2018 (FREE Excel version available) For a molecule which will only enter into human clinicals in the second half of this year, Sanofi’s bet is on RMC-4630 fighting cancer in two separate ways. First, the drug inhibits SHP2, a cellular enzyme in the protein tyrosine phosphatase family that plays a key role in several types of cancer. And second, the molecule has the “potential to stall — or even shrink — the tumor itself, and also neutralize the immune-suppressing environment in which the tumor thrives,” Revolution’s president and CEO Mark Goldsmith said in an interview with Endpoints News. Click here to view the major deals in July 2018 (FREE Excel version available) Our view Although major investments were announced by companies based in the US and Europe, there has been a significant uptick in deal making by Chinese companies as well. Chinese biotech companies Innovent Biologics and Ascletis Pharma applied to list on the Hong Kong Exchange. In its IPO, Ascletis, which makes anti-viral, cancer and liver disease drugs, was valued at US$ 2 billion. The IPOs are seen as a test for Hong Kong, which is seeking to establish itself as a financing center for the growing number of Chinese drug developers. While it remains to be seen if Hong Kong can dislodge New York as the established center of biotech IPOs, with nine biotechs having so far filed for Hong Kong listings, and at least another four planning to follow suit, we hope you would keep following PharmaCompass’ compilation of top pharma and biotech deals — PharmaFlow — to keep track of key happenings in this area. Click here to view the major deals in July 2018 (FREE Excel version available)

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16 Aug 2018

FDA to strengthen drug manufacturing inspections; A person of Indian origin to head Novartis

This week in Phispers, we introduce you to Vas Narasimhan, the new CEO set to head Novartis in February next year. The appointment comes days after the Swiss drugmaker’s CAR-T cell therapy — Kymriah — won the FDA nod. Meanwhile, the US agency wants to improve its inspection efficiency; and Doctors Without Borders has opposed the priority review voucher given by the FDA to an old drug it approved for Chagas disease. Daiichi Sankyo denies receiving a takeover bid from AstraZeneca in 2016; and US dumps its tie-up with Sanofi to develop a vaccine for Zika virus. Post FDA nod for its CAR-T therapy, Novartis names drug development chief as CEO Swiss drugmaker Novartis’ CEO Joe Jimenez will step down on February 1, 2018. He will hand over the baton to Vasant (Vas) Narasimhan (41), who is currently heading the company’s drug development and is also its chief medical officer. This will make Narasimhan the first person of Indian origin to head a large pharma multinational. Narasimhan is the youngest amongst the new CEOs at large drug companies. For instance, Emma Walmsley, the new global CEO of GlaxoSmithKline, is 48. And David Ricks, who became the CEO of Eli Lilly in January this year, is 50. Narasimhan is a doctor from the Harvard Medical School and a second-generation immigrant in the US. He joined Novartis in 2005. Jimenez will retire next year, after being at the helm for eight years. Though Jimenez undertook several steps to focus on more profitable prescription medicines, particularly in cancer, Novartis saw its sales being hit as its top-selling drugs (such as blood cancer treatment Gleevec) lost patent protection. Its eye business Alcon has lagged expectations and generics arm Sandoz has faced intense price pressures in the US. However, Novartis got a boost last week, when the US Food and Drug Administration (USFDA) approved its US$ 475,000-per-patient Kymriah treatment for young people with B-cell acute lymphoblastic leukemia. Known as CAR-T (short for chimeric antigen receptor T-cell) therapy for cancer, Kymriah is seen as one of a series of new drugs that can revive sales beginning next year. “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” FDA commissioner Scott Gottlieb said in a statement announcing the approval of Kymriah. CAR-T therapy also got a shot in the arm when Gilead announced a US$ 11.9 billion acquisition of Kite Pharma, which is said to be just months away from the first approval of its own CAR-T therapy. Ironically, the same week as Kymriah got approved, Johnson & Johnson (through its subsidiary Janssen Biotech Inc) ended its deal with MacroGenics, a Rockville-based biotech company that was working on another CAR-T therapy (duvortuxizumab), after patients in the study experienced neurotoxicity. MacroGenics said enrollment in a Phase I trial of duvortuxizumab to treat B cell malignancies will be discontinued. FDA to strengthen inspections and oversight of drug manufacturing Through an official blog, the FDA commissioner Scott Gottlieb made known the US agency’s intentions to improve its inspection efficiency and reach. As a step toward towards this, the FDA had earlier announced it is restructuring its field activities, to direct its focus and organization around the programs it regulates, instead of its previous structure wherein its activities and resources were organized based on geographic regions. In the blog dated August 31, Gottlieb said the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new, historic concept of operations agreement to fully integrate the drug review programs with the facility evaluations and inspections for human drugs. As part of the commitments made by the FDA in the context of the Generic Drug User Fee Amendments II (GDUFA II), the agency agreed to communicate final surveillance inspection classifications to facility owners within 90 days of an inspection. The new operating model will be a key element of meeting these promises. The FDA will start operationalizing this agreement in fall of this year, in order to more quickly meet this commitment. The new measures are bound to effect generic firms based in India and China. This could also mean stricter inspections, D G Shah, secretary general of industry lobby group Indian Pharmaceutical Alliance, told Mint. “USFDA’s inspections are likely to get more coordinated and broader,” Rahul Guha, partner and director at the Boston Consulting Group, told the publication. Daiichi Sankyo denies it received takeover bid from AstraZeneca in 2016 Last week, Daiichi Sankyo denied it received a takeover bid in 2016 from British drugmaker AstraZeneca. The online version of the magazine Nikkei Business had reported that AstraZeneca had offered to buy the Japanese drug major Daiichi Sankyo in 2016, which has a market value of about US$ 16 billion. “It was today reported by Nikkei Business that Daiichi Sankyo Co Ltd received the acquisition offer from AstraZeneca. However, this is not the fact,” the company said in a statement. AstraZeneca has declined to comment on Daiichi’s statement. Both Daiichi and Astra go back a long way — they have an agreement to jointly commercialize constipation drug Movantik in the US, and have also entered into a deal to supply and promote blockbuster heartburn treatment Nexium in Japan. There are some commonalities too — both have interests in cancer drugs. However, last month, Astra’s prospects in cancer suffered a setback when a closely watched immunotherapy combination treatment failed to help patients. That led to speculation that Astra has itself become a target for takeover. US backs away from tie-up with Sanofi to develop Zika vaccine French drug major Sanofi received a setback recently when the US government said it is backing away from a collaboration with it to develop a vaccine for the Zika virus. Sanofi said in a statement: “On August 17, 2017, Sanofi Pasteur was informed by The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services that they completed an assessment of all Zika-related projects they were funding and have decided to focus on a more limited set of goals and deliverables.” This decision means Sanofi won’t further develop or license the US Army’s promising Zika candidate. BARDA had committed US$ 43 million in research funding, with another US$ 130 million available if the vaccine advanced into later-stage testing. After a rather explosive early outbreak, the spread of Zika virus has slowed down. And both BARDA and Sanofi blamed Zika’s “evolving epidemiology” for their change in focus for developing a vaccine. The development of the vaccine has been paused indefinitely, but could be “restarted if the epidemic re-emerges,” Sanofi said. The collaboration had come under intense scrutiny this year as critics demanded pricing guarantees if a commercial vaccine grew out of the taxpayer-funded research. Zika virus may kill brain cancer cells: A study supported by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, says that the Zika virus (ZIKV) may infect and kill a specific type of brain cancer cells while leaving normal adult brain tissue minimally affected. In the paper, published online on September 5 in The Journal of Experimental Medicine, researchers say ZIKV may behave differently when introduced to an active glioblastoma (an aggressive cancer that begins in the brain) in a living person. A word of caution though: Even if further studies continue to yield promising results, any potential treatment derived from ZIKV would need several years of thorough testing for safety and efficacy. MSF opposes priority review voucher given to old drug approved for Chagas disease Earlier this year, Marathon Pharmaceuticals was in the spotlight after it received an FDA approval for Emflaza (deflazacort) tablets and oral suspension to treat patients aged five years and older with Duchenne muscular dystrophy (DMD) — a rare genetic disorder that causes progressive muscle deterioration and weakness. Marathon had planned a list price of US$ 89,000 for a year’s supply of Emflaza. Since the drug has been available outside the US for decades, patients in the US imported the drug from Canada and the UK, where it’s available at a price between US$ 1,000 or US$ 2,000 a year. Last week, the FDA approved another old drug — benznidazole — as treatment for Chagas disease. The drug has been used outside the United States for years. In the US, benznidazole is the first treatment approved for Chagas disease. This time the point of contention is not the price of the drug but the issuance of a priority review voucher (PRV) which can get sold for hundreds of millions of dollars. A nonprofit group including Chemo Group won this FDA approval and pledged to make it available at low cost to patients. “The fact that a company can receive an innovation award for registering a medicine that has been used to treat Chagas for years shows how far removed we are from the original intent of this program,” said Jennifer Reid, advocacy and research officer at Doctors Without Borders (MSF). Chagas disease, or American trypanosomiasis, is a parasitic infection that can be transmitted through contact with the feces of a certain insect, through blood transfusions, or in the womb from the mother to the child. After years of infection, the disease can cause serious heart ailment, and can also affect swallowing and digestion. Chagas disease primarily affects people living in rural parts of Latin America. According to estimates, around 300,000 persons in the US suffer from Chagas disease. “People suffering from Chagas and other neglected diseases still desperately need innovation and new research to save their lives and improve treatment and prevention options. They should be able to use and afford these medicines no matter where they live. Before a company can receive this prize, US Congress should mandate that only new medicines receive a PRV and that companies ensure access and affordability for all patients,” she added.

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07 Sep 2017

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

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

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27 Apr 2017

Singh bros hit back at Daiichi in Ranbaxy case; New drug shortages legislation in Canada

This week, Phispers brings you the latest twist in the Singh brothers-Daiichi 2008 Ranbaxy sell-off saga. There is also news on the benefits of new diabetes and cholesterol drugs to the heart; amendments to drug regulations in Canada; a class action suit against Sun and Mylan in the US; and the sale of the controversial DMD drug by Marathon. Read on. Singhs fight back; say Daiichi’s profits outweigh losses incurred in buying Ranbaxy Last year, a Singapore tribunal had ordered the former promoters of Ranbaxy — Malvinder and Shivinder Singh — to pay Daiichi Sankyo US $ 391 million (Rs 25.62 billion) in damages for concealing information regarding wrongdoings at Ranbaxy. The Singh brothers had sold their majority stake in Ranbaxy to the Japanese drug maker in 2008 for US$ 4.6 billion. Last week, the Singh brothers hit back at Daiichi. The Singh brothers now claim Daiichi has made profits that far outweigh the losses it incurred in buying Ranbaxy in 2008. According to a new application filed in the Delhi High Court, the Singhs claim Daiichi had availed monetary benefits of around US$ 1.2 billion (Rs 80 billion) during the time it bought and sold Ranbaxy. This amount is more than twice the damages Daiichi is seeking through its arbitration enforcement case against the brothers. The application further states that such monetary benefits should have been factored in by the Singapore tribunal in assessing the damages. According to this new application, Daiichi made further profits from the sale of its shares in Ranbaxy to Sun Pharma in 2015. Singhs have appealed in both the Delhi High Court as well as in Singapore. The brothers claim “substantive objections” exist under India’s arbitration law to make the order unenforceable. Data-integrity violations uncovered at USV in India; more violations at Jinan Jinda in China USV Private Limited: Another major Indian pharmaceutical company — 55 year-old USV Private Limited — received an FDA warning letter after shortcomings were uncovered at its finished pharmaceuticals manufacturing facility in Dabhel (in Daman) during a June 2016 inspection. While the FDA questioned the practices at USV’s microbiological laboratory and its way of conducting smoke studies, data integrity violations were yet again cited in the warning letter. According to the warning letter, at USV “all users could delete or modify files” and investigators uncovered six deleted tests on two different equipment. In another instance, where a sample had “failed identity testing”, USV accepted a passing retest result “without any investigation of the failed result”. The warning letter goes on to mention that the “FDA cited similar CGMP violations at other facilities in USV’s network.” In the financial year 2015-16, USV’s total income was US$ 388 million (Rs 25.4 billion). USV’s Indian business contributed 82 percent to the revenue and the rest was from export of APIs and finished dosages. Jinan Jinda Pharmaceutical: The US FDA had placed Jinan Jinda Pharmaceutical Chemistry Company Ltd on its Import Alert list in November 2015. An inspection conducted six months earlier, by the Italian Ministry of Health, had uncovered an unofficial and non-controlled storage area that contained mainly raw materials and finished products, and was made inaccessible to the inspectors. Since the door of the area had been removed and replaced with a panel fixed with screws to the wall, the inspection team concluded that there was a serious risk of data falsification. A June 2016 inspection by the FDA uncovered that when an out of specification (OOS) unknown impurity peak was found during high performance liquid chromatography (HPLC) testing, the chemists terminated the analysis. When repeat testing also showed the OOS impurity peak, the chromatogram was manually edited to hide the presence of the peak. In another case, where seven sample injections were required to test for impurities, the analysts permanently deleted the first five sample injections and then renamed the last two injections and reported that they met specifications. With repeated concerns of data-integrity, FDA’s warning letter clearly spells out what is expected from the firm going forward. This includes — “a comprehensive investigation into the extent of the inaccuracies in data records and reporting”; and “a current risk assessment of the potential effects of the observed failures on the quality” of drugs manufactured by Jinan Jinda. The letter states that Jinan Jinda’s assessment should include “analyses of the risks to patients”. It goes on to add that the company’s management strategy should include the details of the company’s “global corrective action and preventive action plan.” Drug makers in Canada to publicly disclose drug shortages Last week, amendments to Canada’s Food and Drug Regulations came into force, making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations. These will now have to be reported to two websites — DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. The public-facing website of Canada — www.drugshortages.ca — said: “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a shortage on the communications platform.” According to Health Canada, the posting of discontinuances on the shortages website “does not alter nor affect regulatory obligations under the Food and Drug Act Regulations to inform Health Canada within 30 days of any drug discontinuances.” Sun, Mylan face class action suit in US over price fixing of asthma drug A class action suit was filed in the Pennsylvania federal court last week by the New York grocery workers’ union against Sun Pharmaceutical Industries and Mylan. The lawsuit alleged that the two companies conspired to raise the price of a generic asthma medicine — Albuterol, or albuterol sulfate tablets. Albuterol is a bronchodilator, used by patients suffering from wheezing. The suit — filed by the United Food and Commercial Workers local unit — stated that Sun and Mylan had raised their prices for albuterol sulfate over 3,000 per cent between October 2013 and April 2014. “Beginning in May 2013, defendants caused the price of albuterol sulfate to dramatically increase in unison. The increases were the result of an agreement among them to increase pricing and restrain competition for the sale of albuterol sulfate in the US,” the complaint alleged. The New York union also filed another suit for similar charges against Mylan and Sandoz for colluding to raise the cost of another generic asthma medicine — Benazepril HCTZ. New age diabetes and cholesterol drugs will also protect your heart There are new drugs that significantly protect your heart, and reduce the risk of death and hospitalization. Take the case of a newer class of type 2 diabetes drugs — known as SGLT-2 inhibitors — that significantly reduce the risk of death and hospitalization for heart failure as compared to other medicines for diabetes. This was brought out by a study sponsored by AstraZeneca. SGLT-2 inhibitors work by removing blood sugar via the urine. They are sold under various brand names such as AstraZeneca’s Farxiga, Eli Lilly and Boehringer Ingelheim’s Jardiance and Johnson & Johnson’s Invokana. Similar breakthrough was reached by Amgen through its cardio research that highlighted health benefits of its PCSK9 cholesterol drug — Repatha. This drug was studied by Amgen for two years, across 27,564 patients. “Repatha was able to lower a composite of cardio risks by an average of 20 percent. And the improvement increased with time, growing from a 16 percent risk advantage in year one to 25 percent after 12 months,” a news report said. In 2015, a clinical trial conducted on Eli Lilly and Boehringer Ingelheim’s Jardiance to reassure it does not cause heart problems instead showed it reduced the combined risk of hospitalization for heart failure or death from heart failure by 39 percent in high risk patients. Since then, this heart benefit has been incorporated in Jardiance’s label. Meanwhile, AstraZeneca is conducting its own large clinical trials to determine the heart effect of Farxiga. The results of these trials are expected in 2019. After pricing outrage, Marathon sells DMD drug to PTC Therapeutics After weeks of public and political outrage over the pricing of its Duchenne muscular dystrophy (DMD) drug — Emflaza — Illinois-based Marathon Pharmaceuticals said it will sell the drug to PTC Therapeutics. PTC Therapeutics will pay US $140 million in cash and stock for Emflaza. Marathon will also receive payments from the New Jersey-based PTC on sales of the drug, starting in 2018. DMD is a rare genetic disorder that causes progressive muscle deterioration and weakness. On February 9 this year, Marathon received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients of DMD, aged five years and older. Subsequently, Marathon announced it would charge a list price of US $ 89,000 a year in the United States for Emflaza. Outside the US, the drug is available for US $ 1,000 a year. This led to public outrage, and even the FDA — which had approved Emflaza only in February this year — questioned the drug’s approval. This was the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use in the US.

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23 Mar 2017

US introduces bills to let FDA recall unsafe drugs, allow drug imports from Canada

In Phispers this week, we bring you news on two new bills in the US that seek to bring in cheaper medicines from Canada, and allow FDA to recall unsafe drugs. We also bring you the real reason why Sanofi, even after offering US$ 30 billion, could not bag Actelion. And, there is news on gene-editing technology CRISPR and Mylan and Biocon’s application for Pegfilgrastim, a proposed biosimilar. Read on. US introduces bill to allow FDA to recall unsafe drugs In the United States, Republican Rosa DeLauro introduced a new bill last week that will allow the US Food and Drug Administration (FDA) to do what many assume it already can require pharmaceutical or over-the-counter drug (OTC) companies to stop marketing unsafe products. The law will also cover homeopathic products. The bill, once passed, will be known as the Recall Unsafe Drugs Act. Once enacted, this law will give FDA mandatory recall authority over drugs and homeopathic products. “Most people would be shocked to learn that while the FDA has the authority to order a recall of medical devices and biologic products, such as vaccines and blood products, the agency cannot order recalls of prescription and over-the-counter medications,” DeLauro said. This loophole is problematic, as some companies can refuse FDA’s calls to remove their pharmaceutical products from the market because they are unsafe. New bill in US pushes for drug imports from Canada, while industry resists it The Trump administration appears committed to providing cheaper medicines. A new bill the Safe and Affordable Drugs from Canada Act would require the FDA to set up a “personal importation program” to allow individuals to import 90-day supplies of their medicines from Canadian pharmacies. The bill has been drafted by Senators Amy Klobuchar, Chuck Grassley and John McCain. However, the pharmaceutical industry is pushing back. In a statement to FiercePharma, the Pharmaceutical Research and Manufacturers of America (PhRMA) pointed to a Drug Enforcement Administration report last year that mentioned to how counterfeit fentanyl from China made its way to the US through Canada and Mexico, worsening the current opioid crisis. Imports “would exacerbate these threats,” a PhRMA spokesperson said. Imported drugs wouldn’t “be subject to the US FDA’s robust safety requirements, and there would be no way to trace the country of origin for the imported products. Even Canada has said it does not and would not be able to guarantee that US citizens would receive products that are safe, effective and of high quality,” the spokesperson added. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.” A fortnight back, PharmaCompass carried a news on Marathon Pharmaceuticals, which received FDA approval for Emflaza (deflazacort) to treat rare genetic disorder Duchenne muscular dystrophy (DMD). The drug carries a list price of US$ 89,000 for a year’s supply, when patients in the US are importing it from Canada and the UK for around US$ 1,000 to US$ 2,000. Prospectus highlights Sanofi’s struggles in J&J’s US$ 30 billion acquisition of Actelion Sanofi made headlines recently, not for the acquisitions it made, but for the one it wasn’t able to close. Late last year, the French pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion, which had started back in January 2016. The Actelion-J&J deal prospectus offers insights into why Sanofi (identified as Company A) failed in its US$ 30 billion acquisition even though it would have delivered “approximately equivalent value to Actelion’s shareholders”. According to the deal prospectus, even though Sanofi had bid a higher indicative price, the board of directors of Actelion perceived ‘significant uncertainty’ posed by a potential transaction with Sanofi. The uncertainty was created when, “Sanofi indicated that it would only be willing to proceed with a transaction on the basis of a price lower than its previously communicated offer price and on different terms”. While the deliberations have been on since January 2016, last month the board of Actelion felt “J&J’s proposal offered significantly greater transaction certainty because the transaction documentation was nearly final and because J&J had already completed the required due diligence”. Sarepta sells priority review voucher to Gilead for US$ 125 million Sarepta Therapeutics has sold its priority review voucher (PRV) to Gilead for US$ 125 million. The voucher is awarded under the rare pediatric PRV program. It speeds up the US FDA approval process for any future drug or biologic from 10 months to six months. For Gilead, this is the third PRV it has purchased. Last year, it bought PaxVax’s PRV for about US$ 200 million and in 2014 it bought Knight Therapeutics’ PRV for US$ 125 million. The voucher was awarded to Sarepta after it won FDA approval for its DMD drug Exondys 51 (eteplirsen) in September 2016. Sarepta’s pricing is a far-cry from the most expensive PRV ever sold by United Therapeutics to AbbVie for US$ 350 million in August 2015. It will be interesting to see what Marathon Pharmaceuticals who also received the most recently awarded PRV for its DMD drug Emflaza (deflazacort) uses their voucher for after an “outrageous” pricing controversy paused the sales of their product. With the passage of the 21st Century Cures law, the number of PRVs on the market is likely to increase. This legislation reauthorizes the rare pediatric PRV program until October 2020. Broad Institute to keep valuable patents on gene-editing technology — CRISPR A biological and genomic research center affiliated with MIT and Harvard known as the Broad Institute will keep valuable patents on a revolutionary gene-editing technology known as CRISPR. A US patent agency Patent Trial and Appeal Board in Alexandria, Virginia rejected a claim by a rival team associated with the University of California at Berkeley and University of Vienna in Austria that they invented the technology first. CRISPR is a biotechnology innovation that makes it easier for scientists to edit DNA in living cells. It works as a type of molecular scissors that can trim away unwanted pieces of genetic material, and replace them with new ones. The patent rights for Broad Institute could be worth billions of dollars, as the technology could revolutionize treatment of genetic diseases, crop engineering and other areas. In 2012, a research team led by Berkeley’s Jennifer Doudna and Vienna’s Emmanuelle Charpentier was first to apply for a CRISPR patent. Months later, a team at Broad Institute, led by MIT’s Feng Zhang, applied for a patent by opting for a fast-track review process. It obtained a CRISPR patent in 2014, and has since obtained additional patents. Meanwhile, Berkeley is not the least bit happy with the ruling and may appeal. USFDA accepts Mylan and Biocon’s second biosimilar application of Amgen’s Neulasta Last week, Mylan and Biocon announced that the US FDA has accepted Mylan’s Biologics License Application (BLA) for Pegfilgrastim, a proposed biosimilar. This product is a biosimilar version of Amgen Inc’s branded drug Neulasta, which is used to reduce the chance of infection due to low white blood cell count and incidence of fever in patients treated with chemotherapy in certain types of cancer. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. Pegfilgrastim is one of the six biologic products co-developed by the companies. The FDA goal date set under the Biosimilar User Fee Act is October 9, 2017. The two companies have already filed biosimilar pegfilgrastim with regulators in Europe, Australia and Canada. Mylan President Rajiv Malik commented: “We’re proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.”

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23 Feb 2017

Will a Spanish drug, retailing for under 10 euros, get sold in the U.S. for $89,000/year?

On February 9, 2017 Marathon Pharmaceuticals LLC received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients aged 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Why did this drug approval create headlines? At a time when pharmaceutical companies face growing pressure to hold down drug prices, Marathon had plans that the drug would carry a list price of $89,000 for a year's supply. As the drug has been approved outside the U.S. for decades, patients in the U.S. have imported the drug from Canada and the U.K., where it’s available at a price between $1,000 or $2,000 a year. Oh! Come on. Getting FDA approval is hard, Marathon must have done some serious value addition to improve the science on this decade-old drug? In a detailed analysis performed, Endpoints News uncovered that, of the two clinical studies done to prove the effectiveness of deflazacort, one study involved 196 DMD patients and indicated that deflazacort could improve the strength of patients with this disease. In another trial with 29 male patients that lasted 104 weeks, the FDA reported, “deflazacort demonstrated a numerical advantage over placebo on an assessment of average muscle strength.” The larger of those two studies was published last year although it was “completed in 1995, the data are being published now due to the efforts of the authors and Marathon Pharmaceuticals since the original sponsor of the study gave up the rights to the data and compound.” While the company maintains that it conducted 17 preclinical and clinical studies to get this drug approved, along with in-licensing two older studies, the pivotal trial was the study completed originally in 1995. Marathon’s clinical program involved no new registrational studies, the primary driver behind R&D costs. Endpoints tried to determine the cost of Marathon’s efforts by speaking with industry experts and received estimates that “puts the entire package at $65-75 million.” After Hillary Clinton’s ‘price-gouging’ tweet, what did the U.S. politicians do this time? Senator Bernie Sanders and Representative Elijah Cummings, Democrats who have been critical of high drug costs in the past, said that “Marathon acquired the rights to historical clinical trial data from the 1990s and completed some additional analyses to gain approval from the Food and Drug Administration (FDA) to sell the drug in the U.S.” Sanders and Cummings, wrote to Marathon’s Chief Executive Officer Jeffrey Aronin, calling the price “outrageous” and asking the company to provide documents and information about how much it spent developing the drug and how it set the price. Cummings also said that he’s scheduled to meet with President Donald Trump this week to discuss prescription drug prices. How did Marathon respond to the media coverage and political pressure? The company announced that it will delay the introduction of its $89,000 drug for the deadly muscle disease. In the released statement, Marathon’s CEO expects patients to pay a standard co-pay of $20 per prescription. He has also said, “Our preliminary meetings with the payer/insurer community have gone well and many have acknowledged the price was appropriate given the very small patient population”. How else can Marathon make money if they don’t sell this drug at a high price? In addition to the approval, Marathon also won a rare pediatric disease priority review voucher from the FDA. In the past, these vouchers have fetched hundreds of millions of dollars from drug companies looking for a quick and sure way to slash months off on one of their own drug reviews. A little over a year and a half ago, AbbVie paid $350 million to purchase one of these vouchers. How does Faes Farma in Spain fit into the Marathon story? The package insert approved by the FDA of EMFLAZA states “Oral Suspension made in Spain”. In May 2015, Faes Farma in Spain, a publicly listed company with revenues in excess of Euro 200 million, had announced that it reached an agreement to market one of the drugs in its portfolio through Marathon Pharmaceuticals. The announcement stated that Marathon planned to submit the application for registration of the drug in question at the beginning of 2016. Neither the name of the drug nor the economic value of the agreement were revealed. A review of Marathon’s product portfolio and press releases, shows Deflazacort as the only potential product which was ready for filing in 2016. While Marathon got approval for the 6 mg, 18 mg, 30 mg and 36 mg tablets along with an oral suspension containing 22.75 mg/mL of the active substance, Faes Farma markets the 6 mg and 30 mg tablets along with the oral suspension of the same dosage strength in Spain under the brand name, Dezacor. According to the Ministry of Health Database in Spain, Dezacor’s 30 mg tablets were approved in 1990 while the 6 mg version and the oral suspension were approved in 1996. How does the oral suspension sold in Europe differ from the product approved in the U.S.? The FDA approved oral suspension contains deflazacort along with the following inactive ingredients - acetic acid, aluminum magnesium silicate, benzyl alcohol, carboxymethylcellulose sodium, polysorbate 80, purified water, and sorbitol. The inactive ingredients listed on the package insert of the oral suspension sold in Spain are the same as that of the U.S. product. What is the price of Faes Farma’s Deflazacort in Spain? The drug price information available from the Ministry of Health in Spain indicates a retail price of under Euro 10. Medicinal Product Selling price 2017 Retail price (VAT) 2017 Dezacor 22.75 mg/ml Gotas Orales EN Suspension - N.R.: 61049 5.99 9.35 Dezacor 6 mg Comprimidos 2.43 3.79 Dezacor 30 mg Comprimidos 6.08 9.49 Our View Until last year, no drugs had been approved by the FDA to treat Duchenne muscular dystrophy and the last drug approved by the FDA for this disease, Exondys 51™ (eteplirsen), had a contentious approval due to concerns over the science. In a time when Donald Trump is “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, Emflaza’s approval will certainly bring into question on why drugs which are approved and demonstrated to be safe in Europe cannot be simply imported into the United States?

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15 Feb 2017

Find PharmaFlow Article for Deflazacort

Deflazacort

Deflazacort

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

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DRUG PRODUCT COMPOSITION

TABLET;ORAL - 18MG

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SUSPENSION;ORAL - 22.75MG/ML

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