Bavarian Nordic Receives FDA Fast Track Designation for PROSTVAC™
29 April 2010
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Kvistgård, Denmark, April 29, 2010 - Bavarian
Nordic A/S (OMX: 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."
About PROSTVAC™
PROSTVAC™ is a therapeutic vaccine moving into late stage
clinical development that has the potential to extend the lives of
people with advanced prostate cancer. Administered subcutaneously,
it induces a specific, targeted immune response that attacks
prostate cancer cells. Conventional chemotherapy currently used to
treat prostate cancer has limited survival rates and is often
associated with serious side effects. In contrast, PROSTVAC™
has the potential to extend survival with minimal toxicity.
PROSTVAC™ is being developed in collaboration with the
National Cancer Institute under a Cooperative Research and
Development Agreement with Bavarian Nordic's U.S.-based subsidiary,
BN ImmunoTherapeutics.
In clinical trials to date PROSTVAC™ and related PSA
containing poxviral vaccines have been investigated and in more
than 500 patients.
Prostate cancer is more common than any other cancer in men. An
estimated more than 780,000 new cases of prostate cancer are
diagnosed worldwide every year and more than 250,000 people die
each year from the condition.
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64