Bionovo to Advance Menerba to Phase 3 Clinical Testing in Europe
By Bionovo Inc., PRNEWednesday, July 28, 2010
EMERYVILLE, California, July 29, 2010 - 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.
"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.
"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 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
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.
Tom Chesterman, +1-510-601-2000, investor at bionovo.com; or Investors, Joe Diaz, Robert Blum or Joe Dorame, all of Lytham Partners, LLC, +1-602-889-9700, bnvi at lythampartners.com, for Bionovo, Inc.
Tags: Bionovo Inc., california, Emeryville, Italy, July 29, United Kingdom