Date: 2015-10-12
Type of information: Development agreement
Compound: up to six unique extended release equivalents to existing immediate release prescription cough cold treatments
Company: Vernalis (UK) Tris Pharma (USA - NJ)
Therapeutic area: Respiratory diseases
Type agreement: development
Action mechanism:
Disease: cough
Details: * On February 10, 2012, Vernalis, a UK development stage pharmaceutical company listed on the London Stock Exchange,and Tris Pharma, a privately held US specialty pharmaceutical company based in Monmouth Junction, New Jersey, announced an exclusive licensing agreement to develop and commercialize multiple novel products focused on the US prescription cough/cold market. Under the terms of the agreement Tris, using its proprietary technology, will develop, on behalf of Vernalis, up to six New Drug Applications (NDAs). Tris will undertake and fund the development work and Vernalis will pay development milestones to Tris on each product as they successfully progress through clinical development. Vernalis will acquire and then commercialize these products on approval in the US and pay a sales-based royalty to Tris.
Financial terms:
Latest news: * On December 21, 2016, Vernalis and Tris Pharma, announced that the FDA has accepted the CCP-008 New Drug Application for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date for conclusion of its review of 4 August 2017. CCP-08 is the third product from this pipeline to be accepted for full NDA review. * On June 11, 2015, Vernalis announced that its partner, Tris Pharma, has successfully manufactured 3 registration batches of CCP-07 and material from these batches is now up on stability. CCP-07 is the second programme in Vernalis’ cough cold pipeline from its exclusive licensing agreement with Tris Pharma. The first product, Tuzistra™ XR was approved by the FDA on 30 April 2015. 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.
* On October 12, 2015, Vernalis announced that its partner, Tris Pharma, has successfully manufactured 3 registration batches of CCP-08 and material from these batches is now up on stability. CCP-08 is the third programme in Vernalis’ cough cold pipeline from its exclusive licensing agreement with Tris Pharma. The CCP-08 NDA submission will include 12 months of stability data and, therefore, Tris anticipates the filing with the FDA to occur during 2016.
