Glenmark has wind knocked out of NDA for respiratory drug by FDA

India’s Glenmark, a generic drug maker that intends to make a splash in the branded drug market, will later this year spin off the unit that will develop and manufacture its new drug offerings. An early development effort, however, has stumbled on manufacturing issues, prompting the FDA to seek fixes ahead of an approval.

Glenmark reported (PDF) Saturday that the FDA has issued a complete response letter (CRL) for its New Drug Application for Ryaltris, a nasal spray to treat seasonal allergic rhinitis and Glenmark’s leading respiratory pipeline candidate. It said the CRL cites deficiencies in the Drug Master File relating to one of the active pharmaceutical ingredients as well as in the manufacturing facilities.

Glenmark pointed out the FDA didn’t mention concerns with clinical data, so it should be able to deal with the issues in six to nine months.

The Indian drugmaker this year announced plans to package the new molecular entities in its pipeline, two R&D centers and a biologics manufacturing facility in Switzerland into a separate U.S. company in an effort to speed its new drug programs to market.

Glenmark will own the subsidiary, but it will have an independent board and its own CEO. Glenmark enticed Alessandro Riva from Gilead Sciences to take on leadership of the 400-person unit. Riva was Gilead’s oncology leader and oversaw its takeover of Kite Pharma and push into chimeric antigen receptor T cell therapies.

Glenmark’s new operation is primarily focused on treatments for cancer, immunology and pain management.

The problem also arises just as Glenmark is expanding its respiratory efforts globally. It announced today that it has stuck a deal to distribute in Brazil three drugs for COPD that Novartis will manufacture.

Jun 24, 2019

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