Vernalis plc announces successful completion of the CCP-01 Pivotal Single Dose comparative bioavailability study.
CCP-01 is the first product being developed for Vernalis by Tris Pharma for the US prescription cough cold market. It will now move into a multi-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-01 with the FDA remains on track to be made in mid-2014.
Under the deal announced in February 2012, Vernalis is paying Tris Pharma to develop up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. The financial terms of this licensing deal are not disclosed.
Ian Garland, CEO of Vernalis commented "We are delighted with these results and the continued progression of this project and our collaboration with Tris".