Biotech Values

[genisi]

NeuroSearch/Huntexil - another one bites the dust in Huntington’s disease

NeuroSearch shares fall 41 pct on key drug study

http://www.cnbc.com/id/36820860

COPENHAGEN, April 28 (Reuters) - Shares in Danish biopharma firm NeuroSearch plunged as much as 41 percent after a new study on its Huntington's disease drug, Huntexil, heightened uncertainty about whether the drug would come to market. When NeuroSearch announced preliminary positive results from a Huntexil clinical Phase 3 study in early February, the shares almost tripled in value. On Wednesday new findings from the same study were released and they showed, contrary to the preliminary findings, results did not meet the "primary endpoint" which the company had set out for the drug to achieve. But the company said the results were still positive. "Overall, the study results confirm the unique and clinically meaningful effect and good safety profile of Huntexil," NeuroSearch said in the statement. Sydbank analyst Rune Dahl said it was bad that the study had not reached the primary endpoint. "This obviously increases the uncertainty as to whether they can get this (Huntexil) approved," he said, adding NeuroSearch may have to launch new studies, which would push forward the point in time when the company might start generating revenue. NeuroSearch Chief Executive Flemming Pedersen told a conference call that the company was not planning any new studies and was "confident about bringing Huntexil to market". "Changes in the significance level are always inconvenient but that does not change the overall picture for Huntexil," he said. On Wednesday, NeuroSearch did not give a timeline for when it hoped to get regulatory approval from the U.S. Food and Drug Administration, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency in Japan. In February, NeuroSearch said Huntexil could win regulatory approval by end-2011 and that the drug could be launched at the start of 2012. Separately, NeuroSearch said in its first-quarter report that its capital resources totalled 907.3 million Danish crowns ($162.4 million) at end-March. It raised more than 400 million crowns through a rights issue in November. The company's shares trimmed some losses to trade 20.93 percent lower by 1036 GMT.