Bionovo, Inc. announced today that the US Food and Drug Administration (FDA) accepted the company's chemistry, manufacturing and controls (CMC) plan for its lead drug candidate, Menerba, in a Type "B" or "End of phase 2" meeting. With this designation, the decisions and agreements are now considered binding on the company and the FDA.

"This CMC approval represents a revolutionary set of 'firsts'," said Dr Isaac Cohen, Bionovo's chairman and chief executive officer. "This is the first time that the FDA's botanical drug development CMC guidance has been applied to an oral drug in a major indication. This is also the first time in recent history that the FDA has reviewed and approved a manufacturing plan for a drug with multiple actives derived from botanical source. In addition, Menerba, may be the first in class selective estrogen receptor beta modulator to go into late stage development. After long effort, innovations and interaction, Bionovo has now opened the door for a new paradigm in drug development."

With the FDA's approval of the company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the phase 3 pivotal trials in the US. Having just successfully concluded a non-binding teleconference with the FDA, the Company has requested a face-to-face meeting, for the approval of the clinical development plan. The FDA is expected to grant such a meeting shortly.

As previously disclosed, the company also received approval of the clinical and CMC development plan from the European Medicines Agency (EMA) for Menerba. The EMA "final guidance" defines the clinical and regulatory pathway to a European marketing authorization for Menerba, and is also considered binding and definitive.

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-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.

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.