Back-to-back FDA rejections leave Vernalis reeling

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The FDA has rejected two applications from Vernalis in 4 months.

The FDA has rejected Vernalis’ filing for approval of CCP-08. Vernalis wanted to bring CCP-08 and CCP-07 to market in time for the 2017-18 cough-cold season, but back-to-back FDA rejections have scuttled its plans.

Officials at the FDA issued a complete response letter in response to the CCP-07 NDA in April. They have now followed that up with a CRL regarding the NDA for CCP-08. The reasons for the setbacks are related.    

“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,” Vernalis CEO Ian Garland said in a statement. 

The failure of CCP-07 to win approval had primed investors to expect the rejection of CCP-08, but the news still came as a blow. Shares in Vernalis traded down 10% following the news. The stock is down 50% this year. 

Vernalis hopes to bounce back by filing for approval of both drugs. This will entail working with Tris Pharma, which provides the extended-release technology that is the key differentiating feature of CCP-07 and CCP-08. The collaboration scored an early success when Tuzistra XR came to market in 2015. But the FDA rejections have hindered Vernalis’ attempt to build a cough-cold portfolio upon the Tris technology.

British biopharma Vernalis has yet to commit to a timeline for either refiling, saying only that it will provide an update “in the coming months.” The seasonal nature of the cough-cold business means Vernalis can take some time over the submissions without losing future revenues but risks missing out on some or all of the 2018-19 sales window if it takes too long. 

Vernalis got the original August PDUFA date for CCP-08 with a filing the FDA accepted for review in December of the preceding year.