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Bionovo Receives Positive Guidance from FDA on Menerba®
Date:8/30/2010

es, prior to clinical dosing, Bionovo will complete a 28 day bioequivalence study in rats. The agency also requested that Bionovo provide selected batch records for review. It is important to remember that Menerba was effective in Phase 2 and showed no signs of safety concerns in human or animal studies to date."

"With the CMC preparations complete, we can now turn our attention to finalizing the communication on the clinical trial design with the FDA in the coming weeks," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "We expect to be able to initiate pivotal trials by year end."

Previously, the Company received final guidance from the European Medicines Agency (EMA) in order to advance Menerba to Phase 3 clinical trials in Europe. The EMA guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba. With this EMA guidance, and the FDA guidance, the Company is now preparing for pivotal clinical trials in the U.S. and Europe.

About Menerba

Menerba is an oral, botanical-derived drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market, which have been shown to increase the risk for breast and uterine cancers. Clinical tests conducted thus far, following the specific guidance of the FDA, have indicated that Menerba is effective and safe.

About Bionovo, Inc.

Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of
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SOURCE Bionovo, Inc.
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