Shares in Vernalis have moved up again on the news that the firm and partner Endo Pharmaceuticals have finally been given a date by US regulators when a decision will be made on a new indication for their migraine drug Frova.
Vernalis stock ended the day up 5.5% at just shy of 48 pence after the US Food and Drug Administration informed the companies that it is now targeting September 30 as the date for issuing an action letter for their supplemental New Drug Application for Frova (frovatriptan) 2.5mg tablets. This is in contrast to the fall the UK firm’s shares suffered last month when the agency requested an extension of an August 19 review date to have more time to review the sNDA for the additional indication as short-term, ie six days, prevention of menstrual migraine.
The latter was the second time that the FDA has asked for more time to look at the application but the agency did not ask for any additional information or clinical trial data to be supplied. Vernalis and Endo seem encouraged that they now have a date and said they intend to continue with their existing commercial plan, which includes a launch in January 2008 if the sNDA is approved.
The news comes days after Vernalis received a financial boost with the receipt of a $1.5 million milestone payment from Novartis, under the groups’ R&D pact for the oncology target Hsp90. That deal provided some good news following the departure of its development director John Hutchison, who resigned at the end of August to take up the newly-created position of chief medical officer and executive board director at Renovo.