PDUFA date of 20 April 2017
Vernalis plc and Tris Pharma, Inc. (“Tris”) are pleased to announce that the U.S. Food and Drug Administration (“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.
Ian Garland, CEO of Vernalis, commented “Today’s announcement confirms CCP-07 is on track for potential launch ahead of the 2017-18 cough cold season and we remain extremely excited about the commercial prospects of this cough cold franchise”.
Ketan Mehta, CEO of Tris, commented “This is our second NDA for Vernalis and Tris is excited with the continued progress and look forward to an expanded cough/cold commercial footprint.”
This announcement contains inside information.
