21st Dec 2016 09:21
LONDON (Alliance News) - Vernalis PLC on Wednesday said the US Food & Drug Administration has accepted the CCP-08 new drug application for full review, triggering a milestone payment from Vernalis to Tris Pharma Inc.
Under their licensing and collaboration agreement, Tris is developing up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments for the US market.
CCP-08 is the third product from the pipeline to be accepted for full NDA review. The first product, Tuzistra XR, was approved by the FDA in April 2015 and launched by Vernalis in September the same year. The second product, CCP-07, was accepted for full review by the FDA last September, with a target date for conclusion of August 4, 2017.
The target date for conclusion of the review of CCP-08 also is August 4.
"Today's announcement confirms that both CCP-07 and CCP-08 are on-track for potential launch in the 2017-18 cough cold season, which will further leverage our existing sales force and accelerate our transition to a profitable specialty pharmaceutical business," Vernalis Chief Executive Ian Garland said in a statement.
Vernalis did not say how much the milestone payment was.
Shares in Vernalis were trading up 2.6% at 34.75 pence on Wednesday.
By Karolina Kaminska; [email protected]; @KarolinaAllNews
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