FDA grants Bavarian Nordic Fast Track designation for PROSTVAC

Bavarian Nordic A/S (Copenhagen:BAVA) announced today that PROSTVAC™ has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for its proposed use in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

The FDA determined that PROSTVAC™ meets the criteria for Fast Track designation as it has demonstrated a potential survival benefit and an excellent safety profile in the intended patient population of men with asymptomatic or minimally symptomatic mCRPC. With an estimated more than 780,000 new cases every year worldwide, prostate cancer is more common than any other cancer in men, and more than 250,000 people die each year from the condition. The potential of PROSTVAC™ to provide a survival benefit with minimal toxicity was based on results from the double-blind, randomized, placebo controlled Phase II trial in which 122 men with mCRPC were enrolled and evaluated.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Under Fast Track, Bavarian Nordic would also be eligible to submit a biologics license application (BLA) on a rolling basis. This permits the FDA to review sections of the BLA in advance of receiving the complete submission.

Anders Hedegaard, President & CEO commented: "We are very pleased to receive this Fast Track designation from the FDA for PROSTVAC™. We believe that PROSTVAC™ holds great promise as an improved treatment for patients suffering from prostate cancer. The potential benefit is currently most apparent in the treatment of metastatic prostate cancer where approved therapies only provide a survival benefit of a few months and with severe side effects. We look forward to continue working closely with the FDA on the further evaluation of this minimally toxic and off-the-shelf investigational immunotherapy."

SOURCE Bavarian Nordic A/S

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