MARTINSRIED/MUNICH, Germany, July 24 /PRNewswire-FirstCall/ -- U.S.
Subsidiary Headquarters at Princeton, N.J. -- GPC Biotech AG (Frankfurt
Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the
Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug
Administration (FDA) recommended (12-0) that the FDA should wait for the
final survival analysis of the SPARC trial before deciding whether the
satraplatin application is approvable for the treatment of
hormone-refractory prostate cancer patients whose prior chemotherapy has
failed. The FDA is not bound by the recommendations of advisory committees
but will consider their advice when reviewing an applicant's NDA.
The Company said that, due to a recent slowing in the reported rate of
deaths in the SPARC trial, final overall survival results could take longer
than the previously communicated timeframe of the fall of this year.
"While we are extremely disappointed that ODAC has recommended that the
FDA wait for the results of the overall survival analysis, we will continue
to work with the FDA as the agency continues its review of the satraplatin
application," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer
of GPC Biotech. "We continue to believe strongly in the potential for
satraplatin to help hormone-refractory prostate cancer patients who today
have very limited treatment options."
Conference call scheduled
As previously announced, the Company has scheduled a conference call to
which participants may listen via live webcast, accessible through the GPC
Biotech Web site at http://www.gpc-biotech.com or via telephone. A replay
will be available via the Web site following the live event. The call,
which will be conducted in English, will be held tomorrow, July 25th at
7:00 CET/1:00 AM ET, prior to the opening of the German markets. The
dial-in numbers for the call are as follows:
Participants from Europe: +49 (0)89 9982 99910 or +44 (0)20 7806 1950
Participants from the U.S.: 1-718-354-1385
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Platinum-based drugs are a critical part of modern
chemotherapy treatments and are used to treat a wide variety of cancers.
All platinum drugs currently on the market require intravenous
administration. Satraplatin is an oral compound that clinical trial
patients are able to take at home. Satraplatin is not currently approved by
the FDA in the United States, by the EMEA in the European Union or any
other regulatory authority, and no conclusions can or should be drawn
regarding its safety and efficacy.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin
plus prednisone versus placebo plus prednisone in 950 patients with
hormone- refractory prostate cancer whose prior chemotherapy has failed.
Data from the trial on progression-free survival and on safety have been
presented at recent medical conferences. Satraplatin is currently under
review by the U.S. FDA for hormone-refractory prostate cancer patients
whose prior chemotherapy has failed.
GPC Biotech has a co-development and license agreement with Pharmion
GmbH, a wholly owned subsidiary of Pharmion Corporation, under which
Pharmion has been granted exclusive commercialization rights to satraplatin
for Europe and certain other territories. GPC Biotech has also entered into
an agreement with Yakult Honsha Co. Ltd. under which Yakult has been
granted exclusive commercialization rights to satraplatin for Japan. GPC
Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in
2002.
Satraplatin has been studied in clinical trials involving a range of
tumors. Trials evaluating the effects of satraplatin in combination with
radiation therapy, in combination with other cancer therapies and in a
number of cancer types are underway or planned.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused
on discovering, developing and commercializing new anticancer drugs. GPC
Biotech's lead product candidate satraplatin is currently under review by
the U.S. FDA for hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. GPC Biotech is also developing a monoclonal
antibody with a novel mechanism-of-action against a variety of lymphoid
tumors, currently in Phase 1 clinical development, and has ongoing drug
development and discovery programs that leverage its expertise in kinase
inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany)
and has a wholly owned U.S. subsidiary headquartered in Princeton, New
Jersey. For additional information, please visit GPC Biotech's Web site at
http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG,
including statements about the status of the FDA review process. Such
statements are based on current expectations and are subject to risks and
uncertainties, many of which are beyond our control, that could cause
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Actual results could differ materially
depending on a number of factors, and we caution investors not to place
undue reliance on the forward- looking statements contained in this press
release. In particular, there can be no guarantee that additional
information relating to the safety, efficacy or tolerability of satraplatin
may be discovered upon further analysis of data from the SPARC trial or
analysis of additional data from other ongoing clinical trials for
satraplatin. Furthermore, we cannot guarantee that satraplatin will be
approved for marketing in a timely manner, if at all, by regulatory
authorities nor that, if marketed, satraplatin will be a successful
commercial product. We direct you to GPC Biotech's Annual Report on Form
20-F for the fiscal year ended December 31, 2006 and other reports filed
with the U.S. Securities and Exchange Commission for additional details on
the important factors that may affect the future results, performance and
achievements of GPC Biotech. Forward-looking statements speak only as of
the date on which they are made and GPC Biotech undertakes no obligation to
update these forward-looking statements, even if new information becomes
available in the future.
Satraplatin has not yet been approved by the FDA in the U.S., the EMEA
in Europe or any other regulatory authority and no conclusions can or
should be drawn regarding its safety or effectiveness. Only the relevant
regulatory authorities can determine whether satraplatin is safe and
effective for the use(s) being investigated.
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49-0-89-8565-2693,
ir@gpc-biotech.com, or U.S.: Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609-524-5884,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or Europe:
Brian Hudspith of Maitland, +44-0-20-7379-5151,
bhudspith@maitland.co.uk, or U.S.: David Schull of Russo
Partners, LLC, +1-212-845-4271,
david.schull@russopartnersllc.com, both for GPC Biotech AG
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