UPDATE 2-FDA asks for more preclinical data on XenoPort RLS drug

Wed May 26, 2010 10:45am EDT

* Says no new clinical trials expected at this time

* Expects to resubmit response in H2 2010

* Shares up 4 pct (Adds analyst comments, updates share movement)

May 26 (Reuters) - XenoPort Inc (XNPT.O) said U.S. health regulators have asked the company to submit additional preclinical data on its key drug for restless leg syndrome, and no new clinical trials are expected at this time.

"We believe this is an incremental positive for the company as a path toward an approval of Horizant has been identified," said Leerink Swann analyst Steve Yoo.

In February, the U.S. Food and Drug Administration (FDA) declined to approve the drug Horizant from XenoPort and its partner GlaxoSmithKline (GSK.L) because of a potential link to cancer found in rats. [ID:nN17134046]

Yoo said the worst case scenario of Glaxo dropping the partnership program appears remote now and the lack of additional clinical trials greatly reduces the potential time lines.

In a regulatory filing, XenoPort said it expects the complete response letter resubmission to be filed with the FDA in the second half of 2010.

Shares of XenoPort were up 4 percent at $9.90 Wednesday morning on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Aradhana Aravindan)