MARTINSRIED/MUNICH, Germany, June 26 /PRNewswire-FirstCall/ --
PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) today announced that its partner, Pharmion Corporation
(Nasdaq: PHRM), has submitted a Marketing Authorization Application (MAA)
to the European Medicines Agency (EMEA) for satraplatin in combination with
prednisone for the treatment of patients with metastatic hormone refractory
prostate cancer (HRPC) who have failed prior chemotherapy. This filing is
based primarily on data from the SPARC Phase 3 registrational trial.
"We are delighted that Pharmion has submitted the European marketing
application for satraplatin," said Bernd R. Seizinger, M.D., Ph.D., Chief
Executive Officer. "With over 60,000 people expected to die from prostate
cancer in the European Union this year, there is an urgent need for new
therapies. We believe that, if approved, satraplatin has the potential to
become an important new treatment option for advanced prostate cancer
patients who today have very little hope."
GPC Biotech will receive an $8 million milestone payment from Pharmion
in connection with EMEA's acceptance of this filing. Under the terms of GPC
Biotech's agreement with Spectrum Pharmaceuticals, the acceptance of the
MAA by the EMEA will also trigger payments by GPC Biotech to Spectrum in a
total amount of $3.2 million, representing a direct milestone payment plus
Spectrum's share of the $8 million milestone payment from Pharmion.
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 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 relating to results of the SPARC trial and statements
relating to the potential efficacy and safety profile of satraplatin. 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.
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; In the U.S.: Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609-524-5884,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; 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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