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

FDA Strikes More Than 40 Drugs Approvals In 2014

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