Inc. announced today that the 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 U.S.
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.