UPDATE 1-BioSante says panel recommends drug trial to continue

Mon Feb 22, 2010 8:57am EST

* Still sees submitting NDA by mid-2011

* Shares rise 5 pct in premarket trade

Feb 22 (Reuters) - BioSante Pharmaceuticals Inc (BPAX.O) said an independent panel recommended, for the second time, the continuation of a late-stage study on its lead candidate LibiGel to treat sexual dysfunction in menopausal women, sending its shares up 5 percent in premarket trade.

The company said the data monitoring committee unanimously recommended that the study, which follows the U.S. Food and Drug Administration's protocol, to continue with no modifications.

There have been no deaths, with six adjudicated cardiovascular events and only four breast cancers reported, BioSante said in a statement.

The specialty pharmaceutical company said it still expects to file a new drug application with the FDA by mid-2011.

Shares of BioSante were up 5 percent at $1.93 Monday in trading before the bell. They had closed at $1.83 Friday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Aradhana Aravindan)

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