Vernalis receives next veto by FDA

According to analyst Joseph Hedden from Rx Securities this is a disappointing development, but not a significant surprise. Earlier this year Vernalis received a complete response letter (CRL) for CCP-07. Such letters are issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval.  Hedden believes similar issues reside around the new drug application (NDA) for CCP-08.  "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 plc.

Vernalis entered into a development and licensing deal with Tris Pharma, Inc, in February 2012, obtaining exclusive rights to Tris’ extended-release technology for use in the US prescription cough and cold market. Drug candidates CCP-07 and CCP-08 are two of the four cough and cold treatments covered by the deal.

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