Bavarian Nordic receives SPA for Phase 3 study of PROSTVAC for advanced prostate cancer

Bavarian Nordic A/S (Copenhagen:BAVA) announced today that the company has received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC(R), for the treatment of patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. This agreement reached with the FDA on this SPA means that the Phase 3 study can proceed as designed and, if successful, could form the primary clinical basis of product approval under a Biologics Licence Application.

"We are very pleased with the agreement on the Special Protocol Assessment with FDA. It not only represents a significant milestone in the development of PROSTVAC(R), but also marks the key step in the regulatory process before the initiation of the Phase 3 study, anticipated to start enrolment late summer 2011, upon release of clinical trial material. We believe that PROSTVAC(R) will provide important benefits in survival and quality of life, compared to existing treatments in advanced prostate cancer," commented Anders Hedegaard, President & CEO of Bavarian Nordic.