MARTINSRIED/MUNICH, Germany, Feb. 16 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in WALTHAM, Mass. and PRINCETON, N.J.
-- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq:
GPCB) today announced that the Company has completed the rolling submission
of a New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for satraplatin for the treatment of patients with androgen
independent (hormone refractory) prostate cancer (HRPC) who have failed
prior chemotherapy. The Company submitted the third and final portion of
the NDA -- the clinical section, which is based primarily on data from the
SPARC Phase 3 registrational trial. The trial enrolled 950 patients and
showed highly statistically significant results for prolonging
progression-free survival (PFS). The FDA has up to 60 days to determine
whether the application meets the regulatory requirements for filing and
thus will be reviewed by the agency. The Company will also be notified
during that timeframe if priority review status has been granted.
"The submission of the NDA for satraplatin capsules is a major
milestone in the corporate history of GPC Biotech," said Bernd R.
Seizinger, M.D., Ph.D., Chief Executive Officer. "We will work closely with
the FDA during the review process to move the application forward as
expeditiously as possible. 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. We are currently
building our commercial infrastructure in the U.S. to prepare for the
potential launch of satraplatin so that it will be available for these
patients as quickly as possible."
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and
Europe. Approximately 219,000 men in the U.S. are expected to be diagnosed
with the disease in 2007 and over 27,000 men are expected to die from the
disease. In the European Union, over 200,000 new cases are expected to be
diagnosed, and over 60,000 patients are expected to die each year. Since
the incidence of prostate cancer increases with age, the aging of the
overall population is expected to further increase the number of prostate
cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery
or radiation therapy, and some of these patients are cured. For many
others, though, the disease recurs. At this point, the recurrent disease is
treated with hormone therapy, and most patients initially respond well to
this treatment. Eventually, however, the tumor cells become resistant to
the hormones -- or "hormone-refractory" -- and the tumor again progresses.
Increasingly, chemotherapy is being used as an effective first-line
treatment for hormone-refractory prostate cancer. However, it is not a
cure, and so this is creating a need for effective therapeutic options for
these patients once they have progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs have
become 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.
In September 2006, GPC Biotech announced positive topline results from
the double-blinded, randomized satraplatin Phase 3 registrational trial,
the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The
trial is evaluating satraplatin plus prednisone versus placebo plus
prednisone as a second-line treatment in 950 patients with
hormone-refractory prostate cancer. The study data show that the results
for PFS are highly statistically significant (p<0.00001) using the
protocol-specified log-rank test. PFS is the primary endpoint for
submission for accelerated approval in the U.S. and will also serve as the
primary basis for a Marketing Authorization Application (MAA) in Europe.
The Company 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.
The most common adverse reactions in the SPARC trial consisted of
myelosuppression (bone marrow functions, such as lowered platelet count or
lowered white blood cell count); gastrointestinal events, such as nausea,
constipation and diarrhea; and fatigue. These adverse reactions were mostly
mild to moderate in severity. No significant degradation of renal function
or worsening of neuropathy was noted.
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. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional
information on satraplatin can be found in the Anticancer Programs section
of the Company's Web site at http://www.gpc-biotech.com.
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 an oral
platinum-based compound that has shown highly statistically significant
results for progression-free survival in a Phase 3 registrational trial as
a second-line chemotherapy treatment in hormone-refractory prostate cancer.
The U.S. FDA has granted fast track designation to satraplatin for this
indication, and the rolling NDA submission process for this compound has
been completed. 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 its wholly
owned U.S. subsidiary has sites in Waltham, Massachusetts and 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 summary statements relating to results of the SPARC trial and
summary 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, 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. 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 does not undertake any obligation to update these forward-
looking statements, even if new information becomes available in the
future.
The scientific information discussed in this press release related to
satraplatin is preliminary and investigative. 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.
For further information, please contact:
GPC Biotech AG
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: +1 781-890-9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe: Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.: Noonan Russo
David Schull
Phone: +1 212-845-4271
david.schull@eurorscg.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, or
ir@gpc-biotech.com, or In the U.S., Laurie Doyle, Director,
Investor Relations & Corporate Communications, +1-781-890-9007,
Ext. 267, or usinvestors@gpc-biotech.com, both of GPC Biotech AG;
or In Europe, Brian Hudspith of Maitland Noonan Russo, +44 (0)20
7379 5151, or bhudspith@maitland.co.uk; or In the U.S., David
Schull of Noonan Russo, +1-212-845-4271, or
david.schull@eurorscg.com
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