EMERYVILLE, Calif., July 29 Bionovo, Inc. (Nasdaq: BNVI) announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba.
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"We are pleased with the outcome of our Scientific Advice meetings with the European Medicines Agency. We are eager to put this guidance to use and to start our late stage pivotal studies for Menerba," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer.
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"There are 37 million menopausal women in Europe and, with a European marketing authorization, we expect the European market demand to be strong for a safe and efficacious alternative to hormone therapy for the treatment of hot flashes," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
The Company has also had a meeting with the U.S. Food and Drug Administration (FDA) on the development of Menerba in the U.S., and looks forward to providing more details when the minutes of the meeting are released.
About Menerba
Menerba is an oral, botanically-derived drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-beta) selective drug, developed as a safer 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 early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
SOURCE Bionovo, Inc.
