DMF Submissions Reveal No Slowdown in India & China

DMF submissions reveal no slowdown in India & China

Every quarter, PharmaCompass compiles the latest Drug Master Files (DMFs) submitted to the US Food and Drug Administration (FDA). These applications provide an overview of products which active pharmaceutical ingredient (API) manufacturers are investing their resources in and also give a sneak preview into the next possible first-to-file (FoF) generic challenges to patented drugs.

Here are the key findings from the compilation for the first quarter of 2016:

Compliance problems aside, India tops the DMF submissions

If news about compliance problems faced by pharma companies in India and China are making you believe that there is a slowdown in these countries, think again.

A total of 190 DMF submissions were made in the first quarter of 2016, up from 180 in the previous quarter. And over two-thirds of the submissions were for products from facilities based in either India or China with more than 100 filings from India alone.

Companies that have been on the compliance radar recently – such as Ipca Laboratories, Emcure Pharmaceuticals, Minsheng Group Shaoxing Pharmaceutical and Yincheng Goto – also made submissions to the FDA. Besides these, Qilu Pharmaceutical, which was in the news recently for the controversy in China involving school children, also submitted its DMFs this quarter.

Teriflunomide leads DMF race; Carfilzomib is the new molecule on the block

Last quarter, Teriflunomide saw the maximum number of DMF submissions – four. This quarter too, Teriflunomide led the pack with maximum submissions – six. This is an indication that Sanofi’s multiple sclerosis drug will be subject to severe competition in the coming future.

Amgen acquired Onyx Pharmaceuticals for US $ 10.4 billion in 2013 primarily to cash in on the potential of Kyprolis (carfilzomib), a cancer-treatment drug. While analysts had estimated peak sales of US $ 1.6 billion as a result of this acquisition, sales in 2014 turned out to be only US $ 331 million – a fifth of their estimates. However, things looked up in 2015 as Kyprolis brought in US $ 512 million in sales. Amgen needs to quickly capitalize on the opportunity as six more DMFs were submitted this quarter, indicating a severe generic onslaught whenever the drug goes off patent.

Enzalutamide has been in news recently as Medivation, the US cancer drug company that discovered the molecule, has finally become open to a sell-off after Sanofi offered US $ 9.3 billion to buy the cancer drug maker. Even as Sanofi tries to acquire Medivation, generic activity is underway with three more DMF submissions this quarter.

MSN Labs leads the FoF challenges and filings

MSN Laboratories may not be well-known in the Indian pharmaceutical industry, but the company is growing from strength to strength each quarter with its capabilities of developing non-infringing routes for APIs and being one of the first companies to submit DMFs.

This quarter, MSN Laboratories and its subsidiaries submitted 20 DMFs, which is more than 10 percent of all applications filed. MSN’s filings include Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulif), Macitentan (Actelion’s Opsumit) and Vortioxetine Hydrobromide (Takeda’s Brintellix)

Innovative filings In the works

Biotin, a water soluble Vitamin B, is claimed to aid nail and hair growth. If French biotech startup -- Medday Pharmaceuticals – succeeds in its Phase III trials, its lead product MD1003, a pharmaceutical grade D-Biotin, would improve the lives of patients suffering from progressive multiple sclerosis (MS).

MedDay and DSM Nutritional Products had earlier announced a partnership and co-investment for manufacturing pharmaceutical grade D-Biotin. This quarter DSM submitted its DMF for Biotin.

Switzerland-based biopharmaceutical company Debiopharm’s Salvacyl®, Moapar® has been used mainly for the treatment of prostate cancer. Now, armed with a new indication, the three-month formulation of triptorelin – which has been registered in several European countries to treat severe sexual deviation in adult men (for instance, paedophilia) – saw a DMF submission this quarter indicating a potential launch of this product in the US.

Dimethyl fumarate (Biogen’s Tecfidera) led the list of DMF filings last quarter as the brand product generated sales of US $ 3.64 billion in 2015 and is projected to achieve US $ 5.56 billion by 2020.

While generic companies have been targeting Dimethyl Fumarate, Hyderabad-headquartered Honour Labs – a company promoted by Dr B Parthasaradhi Reddy who is also the promoter of generic major Hetero Drugs – filed a DMF for Monomethyl Fumarate.

It would be interesting to see if this minor tweaking in the molecular structure could lead to a windfall gain for Hetero.

Our view

With drug filings ranging from cannabis extract to amphetamines to generic paracetamol, the first quarter of 2016 displayed that the API industry is extremely active with new product development.

You can view the PharmaCompass compilation of the new DMF filings by clicking here or simply by sending us an email to get your own Excel version of the new submissions.

Click here to view all the submissions of the first quarter of 2016 (Excel version available) for FREE!

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Image Credit : China India flag graphic via shutterstock.com by Times Asi is licensed under CC BY 2.0

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