15th Sep 2014 07:59
LONDON (Alliance News) - Vernalis PLC and partner Tris Pharma Inc Monday said the US Food and Drug Administration has confirmed the New Drug Application for Tuzistra XR has been accepted for full review, trigging a milestone payment to Tris.
The FDA has set up a Prescription Drug User Fee Act target date for conclusion of the review of April 30, 2015, Vernalis said.
Under the deal between the two companies, signed in February 2012, Tris is working on the development of up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments. Tuzistra is the first product in the pipeline to reach the NDA stage.
The confirmation from the FDA will trigger a milestone payment by Vernalis to Tris, Vernalis said, though it did not provide a financial details of the payment.
"Today's announcement is in line with our target timelines and importantly Tuzistra XR remains on-track for potential launch ahead of the 2015-16 cough cold season," said Vernalis Chief Executive Ian Garland.
Vernalis shares were up 8.4% to 46.35 pence in early trade on Monday.
By Sam Unsted; [email protected]; @SamUAtAlliance
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