MARTINSRIED/MUNICH, Germany, May 15 /PRNewswire-FirstCall/ --
PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX
index; Nasdaq: GPCB) today announced that the Company has been informed by
the U.S. Food and Drug Administration (FDA) that the New Drug Application
(NDA) for satraplatin for patients with hormone-refractory prostate cancer
(HRPC) whose prior chemotherapy has failed will be reviewed by the
Oncologic Drugs Advisory Committee (ODAC) on July 24, 2007. Advisory
committees provide the FDA with independent advice from outside experts on
issues related to human drugs and other regulated areas. Although the
committees provide advice to the agency, final decisions are made by the
FDA. Earlier, the FDA had accepted for filing the Company's NDA and had
granted the NDA priority review status. An action from the FDA on the
application is expected in August of this year.
"Presentation of the satraplatin data to the Oncologic Drugs Advisory
Committee is the next important milestone in the NDA review process. We
remain committed to successfully completing this review as quickly as
possible," said Marcel Rozencweig, M.D., Chief Medical Officer and Senior
Vice President, Drug Development of GPC Biotech. "We expect an action on
the application from the FDA in August of this year and are thus moving
forward with commercialization plans for satraplatin. If approved, we
believe that satraplatin has the potential to become an important therapy
for hormone-refractory prostate cancer patients whose disease has
progressed after prior chemotherapy, an area of significant unmet medical
need."
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.
Unlike the platinum drugs currently on the market, all of which require
intravenous administration, satraplatin is an orally bioavailable compound
and is given as capsules that patients can take at home.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin
plus prednisone versus placebo plus prednisone in 950 patients with
hormone- refractory prostate cancer who have failed prior chemotherapy.
Data from the trial have been presented at recent medical conferences. In
accordance with the recommendation of the independent Data Monitoring Board
for the SPARC trial, patients who have not progressed continue to be
treated and all patients will be followed for overall survival.
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. Pharmion has indicated it expects
to complete the Marketing Authorization Application (MAA) for satraplatin
for Europe in the second quarter of 2007. 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.
In addition, GPC Biotech launched in February the Satraplatin Expanded
Rapid Access protocol (SPERA) in the U.S. Expanded access programs are
intended to give patients access to investigational drugs to treat serious
or life-threatening diseases or conditions for which there are no adequate
therapies available. Under the SPERA protocol, satraplatin will be provided
to hormone-refractory prostate cancer patients who have failed prior
chemotherapy free of charge until satraplatin is cleared for marketing in
the U.S. U.S. physicians interested in receiving more information about
SPERA can contact 1-800-349-8086.
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, 2005 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.
Investor and Media Contacts:
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.: Russo Partners, LLC
David Schull
Phone: +1 212 845-4271
david.schull@russopartnersllc.com
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 Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609-524-5884,
usinvestors@gpc-biotech.com , both of GPC Biotech AG; or In the
U.S., David Schull of Russo Partners, LLC, +1-212-845-4271,
david.schull@russopartnersllc.com , or In Europe, Brian Hudspith
of Maitland, +44 (0)20 7379 5151, bhudspith@maitland.co.uk
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