Date: 2016-07-08
Type of information: Completion of the trial
phase: preclinical
Announcement: completion of the trial
Company: Vernalis (UK) Tris Pharma (USA - NJ)
Product: CCP-08
Action mechanism:
Disease: cough cold
Therapeutic area: Respiratory diseases
Country:
Trial details:
Latest
news: * On July 8, 2016, Vernalis announced the completion of the CCP-08 pivotal multiple-dose comparative bioavailability study. CCP-08 continues in 12-month stability studies and subject to the successful outcome of these studies, filing of the NDA with the FDA, remains on track for 2016. * On April 13, 2016, Vernalis announced successful completion of the CCP-08 pivotal single-dose comparative bioavailability study. CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma for the US prescription cough-cold market. The first product, Tuzistra® XR was approved by the FDA in April 2015 and was launched by Vernalis in September 2015, through a focused US primary care sales force. CCP-08 will now move into a multiple-dose comparative bioavailability study and continues in 12-month stability studies. Subject to the successful outcome of these studies, filing of the NDA for CCP-08 with the FDA, remains on track for 2016. Under the licensing and development collaboration announced on 10 February 2012, Vernalis is paying Tris to develop up to six unique extended-release equivalents to existing immediate-release prescription cough-cold treatments. * On July 22, 2014, Vernalis and Tris Pharma announced the achievement of proof-of-concept (POC) for CCP-08, the third programme to achieve this milestone in their US prescription cough cold collaboration. Under this collaboration, POC requires the successful completion of several activities, including a successful human pilot comparative study against an immediate release reference product. As a result of achieving POC, Vernalis will make a milestone payment to Tris. Under the deal announced in February 2012,Vernalis is paying Tris to develop up to six unique OralXR+™ based extended release liquid equivalents to existing immediate release prescription cough/cold treatments. The financial terms of this licensing deal are not disclosed.
