* Says more data needed before filing new drug application
* Says awaits confirmation from FDA and feedback from EMA
* Shares close down 12.3 percent
(Adds details, quotes, share price)
COPENHAGEN, March 23 (Reuters) - Shares in Danish biopharma firm Neurosearch (NEUR.CO) plunged after the company said U.S. regulators would require more clinical data on its Huntington’s disease drug Huntexil before it can file a new drug application.
Shares in Neurosearch slumped on the news just before the market closed and ended down 12.3 percent at 64 crowns on Wednesday.
Chief Executive Patrik Dahlen told Reuters that Neurosearch would continue developing Huntexil and that it would keep all funding options open, including finding a partner to help pay for the development or turning to shareholders for more capital. Huntexil is Neurosearch’s main product under development, and in January the company said it would focus its resources behind the drug to ensure its commercialisation. [ID:nLDE70A0AB]
“Based on the preliminary feedback from the (Food and Drug Administration), a U.S. regulatory submission will require additional clinical data to support the effect of Huntexil in the treatment of Huntington’s disease,” Neurosearch said in a statement.
The company is now developing a plan for producing additional clinical evidence for Huntexil in Huntington’s disease, it said.
“However, before defining the global development and regulatory strategies, Neurosearch will await the final meeting minutes from the FDA and feedback from (the European Medicines Agency), which is expected in the second quarter of 2011,” it said.
Neurosearch has funded the Huntexil development out of its own pocket, missing out on the advantage that can come to a small biotech firm of having a large pharmaceuticals company as a partner for drug development.
“Now that the launch of the product seems to have moved into the future, we need to review that -- if a U.S. partnering strategy could be interesting to us in the future,” Dahlen told Reuters.
Asked if Neurosearch would turn to shareholders for more capital, Dahlen said: “I think there are alternatives to that, including a partnership deal.”
But he said issuing more stock was also an alternative. “Obviously it is,” he said. “But we need to keep all options open.” (Reporting by John Acher; Editing by Mike Nesbit)