Vernalis Announces Start of 12-Month Stability Testing of CCP-07

Vernalis plc (LSE:VER,OTCMKTS:VNLPY) announced that its partner Tris Pharma has successfully manufactured three batches of CCP-07 are now up on stability. The first product, Tuzistra™ XR was approved by the FDA on 30 April 2015.

As quoted in the press release:

CCP-07 is the second programme in Vernalis’ cough cold pipeline from its exclusive licensing agreement with Tris Pharma.

The CCP-07 NDA submission will include 12 months of stability data and so Tris now anticipates the filing with the FDA to occur during 2016. Further news flow will follow the completion of the pivotal single-dose and multi-dose bioavailability studies anticipated to take place between now and NDA filing.

Tris is developing, on behalf of Vernalis, 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 extremely pleased with the continued progression of CCP-07 and look forward to further positive news flow from our cough cold pipeline.

Click here to read the full Vernalis plc (LSE:VER,OTCMKTS:VNLPY) press release.