Vernalis hit with second CRL this year
- British biotech Vernalis plc announced Monday morning the Food and Drug Administration has issued the company a Complete Response Letter (CRL) for its cough and cold drug.
- Vernalis noted in a statement that "questions remain that preclude its approval at this time," but did not go into detail about what exactly led to the rejection for CCP-08.
- The biotech received in April a similar rejection from the FDA for another cold medication dubbed CCP-07.
After not being able to fulfill the conditions of a previous CRL from earlier this year, another drug in the Vernalis pipeline met the same fate.
"Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible," said Ian Garland, CEO of Vernalis.
Neither drug is expected to reach market in time for the U.S. cough and cold season this year.
Both drugs are part of a partnership with Tris Pharma Inc. that Vernalis entered into in February 2012 — the drugs both utilize Tris’ extended-release technology. The collaboration is taking already marketed immediate-release drugs and applying the long-acting technology to them for commercialization by Vernalis. The partners already have one product from the deal on the market.
In the statement about its previous CRL, Vernalis was also vague about the outstanding issues, but noted the rejection was not due to concerns with the formulation or pharmacokinetic profile of the drug.
- Vernalis Press release
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