Published on July 29, 2010 at 6:13 AM
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.
SOURCE Bionovo, Inc.