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* Internal oncology development efforts focused on satraplatin and
cell cycle inhibitors
* Restructuring to reduce costs and extend cash reserves
* Management Board reduced to reflect smaller company size
* Year-end 2007 cash position of approximately ? 65 million (~$ 95
million), higher than previous guidance
Martinsried/Munich (Germany) and Princeton, N.J., February 25, 2008 -
GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today
announced a corporate restructuring to sharpen the Company's focus on
oncology clinical development efforts and to further reduce costs to
extend its cash reserves to cover approximately three years of
operating expenses. The restructuring is mainly focused on the
Company's early-stage research activities in Munich and will result
in a reduction in the total workforce of approximately 38% (or 38
employees). The remaining work force will be 14 in Munich and 49 in
Princeton.
In addition, the Company announced that, by mutual consent, Elmar
Maier, Ph.D., Chief Operating Officer/Martinsried and Senior Vice
President, Business Development, and Sebastian Meier-Ewert, Ph.D.,
Senior Vice President and Chief Scientific Officer, two co-founders
of GPC Biotech, are retiring from their positions on the Management
Board of the Company, effective immediately, to allow for an
appropriate resizing of the Board, given the reduced size of the
Company. However, both Dr. Maier and Dr. Meier-Ewert will remain
dedicated to the Company as advisors. This includes their continued
support of the Company's internal pre-clinical and development
programs, as well as licensing and mergers and acquisitions
activities.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: "We
have implemented a comprehensive strategic plan which includes a
sharper focus on what we believe are our most promising oncology
development programs and a further reduction of the Company's cost
structure, so that we have approximately three years of operating
cash on hand. This will give us additional flexibility, even under
challenging market conditions. These goals for the long-term
viability of GPC Biotech have sadly necessitated a staff reduction.
I would like to express my sincere appreciation to our affected
employees for their many contributions to the Company."
Dr. Seizinger continued: "I would also like to express my heartfelt
gratitude to Dr. Maier and Dr. Meier-Ewert, who
co-founded our Company over ten years ago, for their vision and
tireless efforts in building GPC Biotech. I am very pleased they
will continue to serve the Company in an advisory capacity that will
include assisting us with our internal programs as well as potential
licensing and M&A opportunities."
Oncology development pipeline - focus sharpened
The Company also provided an update on its oncology development
pipeline, with its efforts being focused on satraplatin and the
cell-cycle inhibitors program. Internal development of the 1D09C3
monoclonal antibody is being discontinued.
Moving satraplatin forward
As previously communicated, GPC Biotech has revised its development
plan for satraplatin and decided to continue certain clinical trials,
stop other studies and selectively initiate new trials. The Company
continues to analyze overall survival data from the Phase 3 SPARC
trial in second-line hormone-refractory prostate cancer.
Pre-specified analyses show that subgroups of satraplatin-treated
patients who received Taxotere® (docetaxel) as first-line
chemotherapy or who had pain at baseline (Present Pain Intensity 2-5)
had a trend toward better survival. The Company is also evaluating
potential registrational paths for satraplatin, including beyond
second-line hormone-refractory prostate cancer. A Marketing
Authorization Application for satraplatin in Europe was submitted by
partner Pharmion in 2007, and a decision on this application is
expected in the second half of 2008.
1D09C3 monoclonal antibody internal development discontinued
The Company has decided to discontinue internal development of
1D09C3, a monoclonal antibody in Phase 1 clinical testing for
relapsed/refractory B-cell lymphomas. Initial clinical testing with
1D09C3 has not raised any unexpected or unacceptable safety concerns
and the maximum tolerated dose has not yet been reached. However,
newly published data have raised general concerns about the family of
IgG4 antibodies, to which 1D09C3 belongs. These data indicate that
an IgG4 antibody may swap one half of its Y-shaped structure with the
half of a different antibody, resulting in a new molecule whose
properties are unknown. GPC Biotech has recently conducted testing
and determined that 1D09C3 has this "swapping" characteristic. While
these results are not definitive, GPC Biotech has decided to not put
further internal resources into developing 1D09C3. However, the
Company will seek a partner for the intellectual property relating to
this program.
RGB-286638 broad-spectrum cell cycle kinase inhibitor expected to
enter clinic within the next six months
The Company reported that RGB-286638, a broad-spectrum cell cycle
kinase inhibitor, is expected to enter Phase 1 clinical testing
within the next six months. In a range of pre-clinical models in
both solid and liquid tumors, RGB-286638 resulted in tumor regression
and increased survival. A starting dose and intravenous schedule for
the compound for Phase 1 clinical testing has been determined, and
clinical trials are being designed in both solid and hematological
tumors.
A second drug candidate, RGB-344064, has been shown to selectively
inhibit all key cyclin-dependent kinase inhibitors - proteins that
control major parts of the cell cycle - but it exhibits
comparatively little interference with other kinases. The
pre-clinical testing required to move this compound into the clinic
is currently underway.
Financial guidance updated
The Company today also provided an update on its year-end 2007 cash
position. At the end of 2007, the Company had approximately ? 65
million (~$95 million) in cash, cash equivalents and
available-for-sale securities. This figure is higher than the
previous guidance of approximately ? 60 million. With the
anticipated savings from the restructuring announced today, GPC
Biotech now expects the cash position at December 31, 2007 will be
sufficient to fund operations for approximately three years.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company with a
mission to discover, develop and commercialize new anticancer drugs.
GPC Biotech's lead product candidate is satraplatin, an oral platinum
compound. The Company has various anti-cancer programs in research
and development 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
www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC
Biotech. 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 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.
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: 1-609-524-5884
usinvestors@gpc-biotech.com
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GPC Biotech AG
Fraunhoferstr. 20 Martinsried
WKN: 585150; ISIN:
DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX, HDAX,
TECH All Share;
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Börse Berlin,
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Düsseldorf,
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