* Company Plans to Resubmit Application Pending Final Survival Analysis
MARTINSRIED/MUNICH, Germany, July 30 /PRNewswire-FirstCall/ --
PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) today announced that it has withdrawn the satraplatin
capsules New Drug Application (NDA) filed for accelerated approval for the
treatment of hormone- refractory prostate cancer patients whose prior
chemotherapy has failed. The Company based its decision on the vote by the
Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug
Administration (FDA) on July 24, 2007 that the FDA should wait for the
final survival analysis of the SPARC trial before deciding whether
satraplatin is approvable.
The Company anticipates overall survival results from the SPARC trial
to be available within six months. However, this timing is based on an
extrapolation of death rates in the trial and may change.
"While we were very surprised and disappointed by last week's ODAC
outcome, we need to move forward," said Bernd R. Seizinger, M.D., Ph.D.,
Chief Executive Officer of GPC Biotech. "Thus, we are focusing our efforts
on the overall survival results from the satraplatin SPARC trial and
integrating these data into the strongest possible NDA submission. If these
data are positive, we plan to submit an NDA to the FDA as quickly as
possible."
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.
Patients who have not progressed continue to be treated and all patients
are being followed for overall survival. In July 2007, ODAC recommended
that the FDA should wait for the final survival analysis of the SPARC trial
before deciding whether satraplatin is approvable.
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 in a Phase 3
registrational trial in second-line hormone-refractory prostate cancer. 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:
GPC Biotech AG - Martin Braendle, Director,
Investor Relations & Corporate Communications, +49 (0)89
8565-2693, ir@gpc-biotech.com; In the U.S. - Laurie Doyle,
Director, Investor Relations & Corporate Communications,
+1-609-524-5884, usinvestors@gpc-biotech.com; Additional Media
Contacts - In Europe - Brian Hudspith of Maitland, +44 (0)20 7379
5151, bhudspith@maitland.co.uk; In the U.S. - David Schull of
Russo Partners, LLC, +1-212-845-4271,
david.schull@russopartnersllc.com
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