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Bionovo Announces 2010 Highlights and Year-End Financial Results
Date:3/15/2011

EMERYVILLE, Calif., March 15, 2011 /PRNewswire/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced financial results for the year ended December 31, 2010.

"2010 was a year of important progress, especially on the regulatory front," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "Bionovo advanced the lead drug Menerba with both the FDA and EMA. Reaching agreement with the Agencies on the CMC and the overall clinical development plan to NDA clears the way forward and provides accurate development costs and timelines to potential partners. We expect to be able to initiate the Phase 3 clinical trials for Menerba early in the 3rd quarter of this year.

Key Events and Milestones

  • In 2010, the Company announced the following regarding Menerba™, its lead drug candidate for the treatment of menopausal hot flashes:
  • In December, the Company received minutes from its successful meeting with the FDA in November, confirming agreements reached on the clinical development plan for Menerba.
  • In September,  an "End of Phase 2" Type B meeting with the FDA resulted in a binding agreement on the Chemistry, Manufacturing and Control (CMC) plan for Menerba.
  • In July, the Company received formal guidance from the European Medicines Agency (EMA), defining and approving a regulatory pathway to marketing approval for Menerba in Europe.
  • The Company also had continued progress in terms of basic science and other pipeline candidates:
  • Studies were published describing:
  • how metabolic adaptability contributes to the metastasis of tumors. This work is integral to the Company's development of drugs that disrupt metabolic pathways as a mechanism.
  • the cancer prevention mech
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  • SOURCE Bionovo, Inc.
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