Back-to-back FDA rejections leave Vernalis reeling

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. 


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

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.    

Suggested Articles

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.

Sensyne Health aims to bring its AI tools to America, and it’s enlisting IT giant Cognizant and data infrastructure specialist Agorai to help.

Californian RNA biotech Arrowhead will lose its COO and R&D head from next year but is hiring a new CMO and CSO to help steady its research exec team.