FDA accepts NDA for CCP-07as a treatment for cough cold.- Vernalis + Tris Pharma

Vernalis plc and Tris Pharma, Inc. announce that the FDA has accepted the CCP-07 New Drug Application (�NDA�) for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 20 April 2017.

Under the exclusive licensing and collaboration agreement announced in February 2012, Tris is developing, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments for the US market. CCP-07 is the second product from this pipeline to be accepted for full NDA review. The first product, Tuzistra XR was approved by the FDA in April 2015 and was launched by Vernalis in September 2015, by a dedicated sales force.