{"id":1680,"date":"2016-12-20T22:58:41","date_gmt":"2016-12-20T22:58:41","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/fda-accepts-ccp-08-nda-for-full-review\/"},"modified":"2024-06-03T11:15:33","modified_gmt":"2024-06-03T10:15:33","slug":"fda-accepts-ccp-08-nda-for-full-review","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/fda-accepts-ccp-08-nda-for-full-review\/","title":{"rendered":"FDA accepts CCP-08 NDA for full review"},"content":{"rendered":"
Published on December 20, 2016<\/p>\n
PDUFA date of 4 August 2017<\/p>\n
Vernalis plc and Tris Pharma, Inc. (\u201cTris\u201d) are pleased to announce that the U.S. Food and Drug Administration (\u201cFDA\u201d) has accepted the CCP-08 New Drug Application (\u201cNDA\u201d) for full review. This triggers a milestone payment from Vernalis to Tris.<\/p>\n
The FDA has set a Prescription Drug User Fee Act (\u201cPDUFA\u201d) target date for conclusion of its review of 4 August 2017.<\/p>\n
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.<\/p>\n
CCP-08 is the third product from this pipeline to be accepted for full NDA review. The first product, Tuzistra\u00ae<\/sup> 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.<\/p>\n Ian Garland, CEO of Vernalis, commented \u201cToday\u2019s 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.\u201d<\/p>\n Ketan Mehta, CEO of Tris, commented, \u201cWith 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.\u201d<\/p>\n This announcement contains inside information.<\/p>\n — ends —<\/p>\n Enquiries<\/strong>:<\/p>\n Notes to Editors\u00a0<\/strong><\/p>\n About Tris Pharma, Inc.\u00a0<\/strong><\/p>\n Tris Pharma, Inc. is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable\/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse\u2122<\/sup> technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, U.S.A.<\/p>\n\n\n
\n Vernalis plc:<\/strong>
\nIan Garland, Chief Executive Officer
\nDavid Mackney, Chief Financial Officer<\/td>\n+44 (0) 118 938 0015<\/strong><\/td>\n<\/tr>\n \n <\/td>\n<\/tr>\n \n Tris Pharma, Inc:<\/strong>
\nPeter Ciano, Acting CFO & SVP Corporate Development<\/td>\n+1 732 823 4950<\/strong><\/td>\n<\/tr>\n \n <\/td>\n<\/tr>\n \n Canaccord Genuity Limited (Nominated Adviser):<\/strong>
\nRupert Winckler
\nHenry Fitzgerald-O\u2019Connor
\nEmma Gabriel<\/td>\n+44 (0) 20 7523 8000<\/strong><\/td>\n<\/tr>\n \n <\/td>\n<\/tr>\n \n Shore Capital (Joint Broker):<\/strong>
\nBidhi Bhoma
\nToby Gibbs<\/td>\n+44 (0)20 7408 4090<\/strong><\/td>\n<\/tr>\n \n <\/td>\n<\/tr>\n \n FTI Consulting:<\/strong>
\nBen Atwell
\nSimon Conway
\nStephanie Cuthbert<\/td>\n+44 (0) 20 3727 1000<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n