MARTINSRIED/MUNICH, Germany, June 2 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in Waltham/Boston, Mass. and Princeton,
N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30;
Nasdaq: GPCB) today announced that the Committee for Orphan Medicinal Products
(COMP) of the European Medicines Agency (EMEA) has recommended the granting of
orphan medicinal product designation for the anticancer monoclonal antibody
1D09C3 for the treatment of Hodgkin's lymphoma. The orphan drug status becomes
effective when the European Commission has approved this recommendation.
1D09C3 is currently in a Phase 1 clinical trial that is evaluating the
antibody in patients with relapsed or refractory B-cell lymphomas, including
Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard therapy.
The EMEA's orphan drug program is designed to promote the development of
drugs to treat rare life-threatening or very serious conditions that affect no
more than five in every 10,000 people in the European Union (EU). The
designation provides EU market exclusivity for up to ten years in the given
indication. Other potential benefits include: a reduction in fees associated
with various aspects of the regulatory process, including the application for
marketing approval, and EMEA guidance in preparing protocols concerning
studies relevant for approval.
About 1D09C3
1D09C3 is an anti-MHC (major histocompatibility complex) class II
monoclonal antibody. 1D09C3 binds to certain cell surface receptors,
selectively killing activated, proliferating MHC class II-positive tumor
cells, which include those in B-cell and T-cell lymphomas. 1D09C3 has been
shown to induce programmed cell death and does not require a functioning
immune system for its cell-killing effect. A Phase 1 clinical study
evaluating 1D09C3 in patients with relapsed or refractory B-cell lymphomas,
such as Hodgkin's and non-Hodgkin's lymphomas, who have failed prior standard
therapy is currently underway. Additional information on 1D09C3 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 biopharmaceutical company discovering and developing
new anticancer drugs. The Company's lead product candidate -- satraplatin --
is currently in a Phase 3 registrational trial as a second-line chemotherapy
treatment in hormone-refractory prostate cancer following successful
completion of a Special Protocol Assessment by the U.S. FDA and receipt of a
Scientific Advice letter from the European central regulatory authority, EMEA.
The FDA has also granted fast track designation to satraplatin for this
indication. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc.
Other anticancer programs include: a monoclonal antibody with a novel
mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1
clinical development, and a small molecule broad-spectrum cell cycle
inhibitor, currently in pre-clinical development. The Company is leveraging
its drug discovery technologies to elucidate the mechanisms-of-action of drug
candidates and to support the growth of its drug pipeline. GPC Biotech also
has a multi-year alliance with ALTANA Pharma AG working with the ALTANA
Research Institute in the U.S., which provides GPC Biotech with revenues
through mid-2007. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany). The Company's wholly owned U.S. subsidiary has research and
development sites in Waltham, Massachusetts and Princeton, New Jersey. For
additional information, please visit the Company's Web site at http://www.gpc-
biotech.com .
This press release may contain projections or estimates relating to plans
and objectives relating to our future operations, products, or services;
future financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject to
risks and uncertainties, many of which are beyond our control. Actual results
could differ materially depending on a number of factors, including the timing
and effects of regulatory actions, the results of clinical trials, the
Company's relative success developing and gaining market acceptance for any
new products, and the effectiveness of patent protection. There can be no
guarantee that the satraplatin SPARC trial or the trial with 1D09C3 will be
completed nor that these drugs will be approved for marketing in a timely
manner, if at all. We direct you to the Company's Annual Report on Form 20-F,
as amended, for the fiscal year ended December 31, 2004 and other reports
filed with the U.S. Securities and Exchange Commission for additional details
on the important factors that may affect the Company's future results,
performance and achievements. The Company disclaims any intent or obligation
to update these forward-looking statements or the factors that may affect the
Company's future results, performance or achievements, even if new information
becomes available in the future.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
Phone/Fax: +49 (0)89 8565-2600/-2610
Martin Braendle
Associate Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.:
Laurie Doyle
Associate Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contact for Europe:
Maitland Noonan Russo
In London: Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Associate Director, Investor
Relations & Corporate Communications, +49-89-8565-2600 ext. 2693,
ir@gpc-biotech.com, or In the U.S.: Laurie Doyle, Associate
Director, Investor Relations & Corporate Communications,
+1-781-890-9007 ext. 267, usinvestors@gpc-biotech.com, both of
all of GPC Biotech; or Additional Media Contact for Europe: Brian
Hudspith of Maitland Noonan Russo, +44-20-7379-5151,
bhudspith@maitland.co.uk
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