Kvistgård, Denmark, April 29, 2010 - Bavarian Nordic A/S (OMX: BAVA) announced
today that PROSTVAC(TM) 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(TM) 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(TM) 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(TM). We believe that
PROSTVAC(TM) 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."
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About PROSTVAC(TM)
PROSTVAC(TM) 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(TM) has the
potential to extend survival with minimal toxicity. PROSTVAC(TM) 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(TM) 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.
About Bavarian Nordic
Bavarian Nordic A/S is a leading industrial biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline is focused in
the three areas; cancer, biodefence and infectious diseases, and includes seven
development programmes. Two programmes are under preparation for Phase III:
PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being
developed under a collaboration agreement with the National Cancer Institute,
and IMVAMUNE®, a third-generation smallpox vaccine is being developed under a
contract with the US government.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit www.bavarian-nordic.com
<http://www.bavarian-nordic.com/>
Forward-looking statements
This announcement includes "forward-looking statements" that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.
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