.gif)
Vernalis plc and Tris Pharma, Inc. are pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the CCP-08 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 4 August 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-08 is the third 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. The second product, CCP-07, was accepted for full review by FDA in September 2016 and has a PDUFA date of 20 April 2017.
Ian Garland, CEO of Vernalis, commented "Today's announcement confirms that both CCP-07 and CCP-08 are on-track for potential launch in the 2017-18 cough cold season, which will further leverage our existing sales force and accelerate our transition to a profitable specialty pharmaceutical business."
Ketan Mehta, CEO of Tris, commented, "With this third NDA accepted for Vernalis, we are well positioned to achieve our collective goal of offering patients a portfolio of long acting liquid prescription medication to provide all day, and all night, cough cold relief."
