Vernalis plc and Tris Pharma, Inc. are pleased to announce that the US 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 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.”