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    India leads DMF submissions to the FDA during Q4 of 2016 and Q1 of 2017

    India leads DMF submissions to the FDA during Q4 of 2016 and Q1 of 2017

    A review of the Drug Master Files (DMFs) submitted to the United States Food and Drug Administration (FDA) from October 2016 to March 2017 (the fourth quarter of 2016 and the first quarter of 2017) indicates an extremely robust pharmaceutical industry in India. However, the filing make one question an article we had carried earlier this month on the end of India’s pharma honeymoon. India filed more than half the DMFs submitted   Indian companies filed more than half (176) of the 345 DMFs submitted with the FDA. China (60) came a distant second, followed by the United States (40). While DMF submissions were made from 26 other countries, the activity levels seen were a far cry from what was seen in India and China.  In our past compilation for the second and third quarters of 2016, Macleods Pharmaceuticals (14 DMFs) had pipped MSN Laboratories (13 DMFs) to become the leading filer from India. However, in the recent review period, MSN bounced back with 41 DMF submissions, compared to six for Macleod. Leading Indian pharmaceutical majors such as Aurobindo, Sun Pharma, Amneal, Mylan’s India operations, Hetero, Cipla and Jubilant had six or more filings each. Ajinomoto’s North American operations filed 11 DMFs for various amino acids and led the submissions for products manufactured in the United States.  Tianjin Weijie Pharmaceutical led the pack from China, with eight DMF submissions.   Over the review period, a total of 345 submissions were made to the FDA, almost similar to the 379 DMFs filed during the second and third quarters of 2016. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! The next FTF challenges  Since APIs form the building blocks of finished formulations, DMF submissions give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.  In December 2016, Indian drug major Sun Pharmaceutical Industries announced it will acquire a branded oncology product, Odomzo, from Novartis for an upfront payment of US$ 175 million. A little over three months after the announcement, MSN Labs filed the first DMF for Odomzo’s active pharmaceutical ingredient (API), sonidegib phosphate. Odomzo was approved by the FDA in July 2015 and is indicated for the treatment of adult patients with locally advanced basal cell carcinoma. While patents for Novartis’ drugs Tafinlar and Mekinist are not scheduled to expire until 2029, Novartis should prepare for a generic competitor as DMFs were filed for the APIs used in both drugs by MSN Labs. The drugs had combined sales in 2016 of US$ 672 million. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! In addition, MSN Labs also filed the first DMF for nintedanib esylate, the API used in Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment, Ofev, and for cabozatinib (S)-malate, the API used by Exelixis for its kidney cancer treatment — Cabometyx. While in most cases MSN’s DMF is the first one to get filed, in the case of Helsinn’s Akynzeo, which is used to prevent chemotherapy-induced nausea and vomiting, Apicore US also filed a DMF along with MSN. Although sales forecasts for Bayer’s pulmonary arterial hypertension treatment — Adempas (riociguat) — were lowered as the drug did not get the expected sales start and planned label expansions did not materialize, this did not stop MSN Labs from filing the first DMF for this product as well. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Another drug which is struggling to meet analyst expectations is Novartis’ Entresto. Once considered “one of the most important products in the company's history” with an expectation to reach US$ 10 billion in peak sales, the drug generated sales of only US$ 170 million in 2016. Regardless, Mylan filed the first DMF for the API.  Another drug where MSN Labs did not file the first DMF was for AstraZeneca’s ovarian cancer treatment, Lynparza (olaparib). Alp Pharm Beijing submitted the DMF for the drug which generated US$ 218 million in sales in 2016 and a figure Bernstein Research analyst Timothy Anderson forecasts will grow to US$ 684 million by 2020. The onslaught on Novartis’ portfolio is not limited to only patented products as Lamprene, a product which has been on the market since 1986, and not had any generic competitor, had Zhejiang Huahai file a DMF indicating a generic competitor maybe on the horizon soon. Mylan’s Sotradecol has been the only injectable form of sodium tetradecyl sulfate on the market since 2004. That monopoly may end soon as the FDA completed the review of a DMF filed for the API early this year. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Most actively filed products — vortioxetine hydrobromide and dolutegravir sodium  The most actively filed DMFs, with seven filings each, were those for Takeda’s depression drug Trintellix (vortioxetine hydrobromide) and GSK’s HIV treatment dolutegravir sodium. Johnson & Johnson’s diabetes treatment Invokana (canagliflozin), which recently demonstrated that it decreased the risk of heart attacks and strokes, while increasing the risk of amputation, particularly of toes, had six new DMFs filed. There were also six new DMFs filed for apremilast, five for darunavir and four each for dapagliflozin and rivaroxaban. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Filings for new drugs under development  Helsinn is moving ahead with the filing of anamorelin hydrochloride, as it filed DMFs for the API and the 100 mg tablets, a product which was welcomed enthusiastically by oncology experts as it raised hopes to be a drug for cancer cachexia, the extreme wasting seen at the end stages of the disease. But those hopes were recently dashed, as a review of the clinical data by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) found only "marginal" effects and recommended that the product be refused marketing authorization in Europe. Now it remains to be seen what the FDA’s verdict on this drug will be.  Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! AB Science’s Masitinib has been in the news recently as an EMA committee announced the drug, developed for a range of cancers, could not be approved due to “serious failings” in the way clinical studies were conducted.  However, this did not stop Excella GmbH from filing its second DMF for the API. Multiple sclerosis treatment dimethyl fumarate (Biogen’s Tecfidera) generated sales of US$ 3.97 billion in 2016 and is projected to achieve US$ 5.56 billion by 2020.  While there are now 28 DMFs filed for dimethyl fumarate, in March this year Alkermes announced the initiation of a new phase 3 study of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis. It remains to be seen when Alkermes’ product will get approved. However, MSN Labs followed Honour Labs to file the second DMF for this product. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! A new submission for deslorelin acetate (an injectable gonadotropin releasing hormone super-agonist) indicates there maybe a new drug development underway for this age-old peptide as currently there are no approved drugs in the US. A similar situation seems to exist for taurolidine, an antimicrobial that seeks to prevent infections in catheters. Vasudha Pharma’s filing of cisapride monohydrate comes as a surprise. The product, which was launched by Janssen for increased motility of the gastrointestinal tract, was later withdrawn from the US market due to concerns of fatalities linked to cardiac arrhythmias. The product, however, continues to be exported from India to countries like Switzerland, Thailand, Mexico, China and Canada. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE! Our view  The last quarter of 2016 and the first quarter of 2017 clearly demonstrate an API industry in India and China, which is extremely active with new product development, regardless of disappointing financial results posted by major pharma companies and growing concerns over regulatory non-compliances. Given the market headwinds and increased compliance expectations, it remains to be seen how many of these DMFs filed actually result in drugs reaching the market. Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!  

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    https://www.pharmacompass.com/radio-compass-blog/india-leads-dmf-submissions-to-the-fda-during-q4-of-2016-and-q1-of-2017

    #PharmaFlow by PHARMACOMPASS
    22 Jun 2017
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    FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

    FDA’s Drug Approvals in 2015: Novel Drugs & New Versions of Existing Drugs

    Each year, the US Food and Drug Administration (FDA) approve hundreds of new medications. A small subset of approvals, classified as novel drugs, are considered to be truly innovative products that often help advance clinical care.  In 2015, the FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).    This week, PharmaCompass focuses on the new dosage forms of existing drugs that got approved last year.   Modified blockbusters Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:  Jadenu (deferasirox): With almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a tablet for use in a suspension. Novartis, the innovator, got approval in March 2015 for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has simplified daily treatment administration for patients with chronic iron overload. Nexium 24HR (esomeprazole magnesium): Also known as the Purple Pill, Nexium – Astra Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went  generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as Nexium 24HR. Last year, the FDA granted approval to the tablet form of the drug.  Iressa (gefitinib): AstraZeneca re-introduced Iressa in the US market in 2015. The FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets from the market, as post-marketing studies had failed to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted. Onivyde (irinotecan): Liposomal formulation of anti-cancer drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the treatment of patients with metastatic pancreatic cancer, sold under the brand name Onivyde.  Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.  Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines because of its high price (more than US $ 300,000 a year). Price concerns aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.   Extended release versions Many of the approvals granted by the FDA last year were to extended release formulations (a pill formulated so that the drug is released slowly) of existing drugs. Kremers Urban’s extended release version of Methylphenidate capsules made headlines last year because of a reclassification of the drug by the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc. In addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus and Morphine Sulphate also received green signals for a market launch.   First generic opportunities Last year, PharmaCompass shared the names of some drugs which had no generic competition and were also not protected by patents. (Read: “Litigation Free, first generic opportunities list”). Deferiprone (a drug that chelates iron and is used to treat iron overload in thalassemia major) met the criteria. But it still has no generic competitor and is now available as a new dosage form. Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades without generic competition in the US. Albendazole is a medication used for the treatment of a variety of parasitic worm infestations. In 2015, patients were provided access to chewable tablets of Albendazole.   New combinations at work The FDA also approved multiple combination drugs where the individual active ingredients had been brought to market previously. Most of the combination drugs approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc. Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and Tradjenta (linagliptin) approved in 2011, were combined and the combination drug product Glyxambi was approved in 2015. Another combination of empagliflozin, with metformin – Synjardy – was also approved in August last year. Lesser known companies also got combination drugs approved.  UK-based development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine polistirex. Similarly, US-based biopharmaceutical startup, Spriaso LLC, also working in the cold and cough therapeutic area, got an extended release tablet containing codeine phosphate and chlorpheniramine maleate approved. Symplmed, a company which is developing various forms of Perindopril, got approval for Prestalia (a combination of perindopril arginine and amlodipine besylate) for the treatment of hypertension. Our view Each year, the FDA approves several pharmaceutical drugs in order to improve patient care; and often versions of these drugs are marketed and distributed across the globe. PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy. Accelerate your drug development PharmaCompass has also launched the Drug Development Assistance tool on its platform. Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate the various drug products approved in the United States.  

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    https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs

    #PharmaFlow by PHARMACOMPASS
    14 Jan 2016
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