FDA accepts Tuzistra XR NDA for full review

15 September 2014

The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR (CCP-01), a prescription cough/cold candidate from UK biotech company Vernalis (LSE: VER) and privately-held USA-based Tris Pharma, has been accepted for full review.

This triggers a milestone payment from Vernalis to Tris under the companies’ development and licensing accord. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of April 30, 2015.

Under the exclusive licensing agreement Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.

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