{"id":1658,"date":"2016-09-05T22:58:40","date_gmt":"2016-09-05T21:58:40","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/fda-accepts-ccp-07-nda-for-full-review\/"},"modified":"2023-08-23T15:13:17","modified_gmt":"2023-08-23T14:13:17","slug":"fda-accepts-ccp-07-nda-for-full-review","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/fda-accepts-ccp-07-nda-for-full-review\/","title":{"rendered":"FDA Accepts CCP-07 NDA for Full Review"},"content":{"rendered":"
Published on September 05, 2016<\/p>\n
PDUFA date of 20 April 2017<\/p>\n
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.<\/p>\n
The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date for conclusion of its review of 20 April 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. CCP-07 is the second product from this pipeline to be accepted for full NDA review. The first product, Tuzistra\u00ae<\/sup>\u00a0XR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force.<\/p>\n 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”.<\/p>\n 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.”<\/p>\n This announcement contains inside information.<\/p>\n — ends —<\/p>\n Notes to Editors<\/strong><\/p>\n About Tris Pharma:<\/u><\/strong><\/p>\n Tris Pharma 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. For more information, please visit\u00a0https:\/\/www.trispharma.com<\/a><\/p>\n About Vernalis:<\/u><\/strong><\/p>\n Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has three approved products: Tuzistra\u00ae<\/sup> XR targeting the US prescription cough-cold market; Moxatag\u00ae<\/sup>, a once-a-day formulation of the antibiotic, amoxicillin, indicated for the treatment of tonsillitis and\/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older; and frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough-cold market as well as eight programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company’s technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including Asahi Kasei Pharma, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier, Taisho, and Tris.<\/p>\n