GPC Biotech Announces Partnering Agreement for Satraplatin for Japan
with Yakult
* Deal includes $10 million upfront payment
* Yakult responsible for all development, marketing and sales
costs for Japan
Martinsried/Munich (Germany) and Princeton, N.J., June 25, 2007 - GPC
Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ:
GPCB) today announced that the Company has entered into a license
agreement with Yakult Honsha Co. Ltd. for satraplatin in Japan.
Under the terms of the agreement, Yakult gains exclusive
commercialization rights to satraplatin for Japan and will take the
lead in developing the drug in Japan. Yakult is to provide an
upfront payment of ¥1.2 billion (~$10 million) to GPC Biotech as
reimbursement for past satraplatin clinical development expenses.
Yakult will also make GPC Biotech additional payments based on the
achievement of certain regulatory filing and approval milestones.
GPC Biotech will also receive a minimum of 21% royalties on sales of
satraplatin in Japan.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC
Biotech, said: "We are delighted to have Yakult as our partner for
Japan. Yakult's pharmaceutical business specializes in cancer and
cancer-related ailments and has expanded its operations in this
area. They are the inventor of irinotecan, which is a global
standard drug for colorectal cancer, and have a solid track record of
successfully commercializing another platinum-based drug,
oxaliplatin, in Japan. They also share the development philosophy of
GPC Biotech and plan to develop satraplatin for additional cancer
indications for Japan. We look forward to a productive working
relationship with Yakult."
Teruo Yokokura, Ph.D., Head of Pharmaceutical Division of Yakult
Honsha Co., Ltd., said: "We are excited to have the opportunity to
develop and commercialize satraplatin for the Japanese market. We
look forward to building on the solid foundation of the Phase 3 data
from the satraplatin SPARC trial conducted by GPC Biotech in
second-line hormone-refractory prostate cancer to bring this product
through development, the regulatory process and onto the market in
Japan. We believe that, if shown to be effective and well-tolerated,
satraplatin, which is given as capsules that patients can take at
home, could be an important option for cancer patients in Japan."
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 showing a statistically
significant improvement in progression-free survival and data on
prostate specific antigen (PSA) have been presented at recent medical
conferences. The satraplatin NDA, filed on February 15 2007, is
currently under review by the U.S. FDA for hormone-refractory
prostate cancer patients whose prior chemotherapy has failed and will
be reviewed by the Oncologic Drugs Advisory Committee (ODAC) on July
24, 2007. The FDA has accepted for filing the Company's NDA and
granted the NDA priority review status. An action from the FDA on the
application is expected in August of this year.
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.
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
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.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
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
--- End of Message ---
GPC Biotech AG
Fraunhoferstr. 20 Martinsried
WKN: 585150; ISIN:
DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX, HDAX,
TECH All Share;
Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in
Börse Berlin Bremen,
Freiverkehr in Bayerische Börse München, Freiverkehr in Börse
Düsseldorf,
Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische
Wertpapierbörse zu Hamburg,
Geregelter Markt in Frankfurter Wertpapierbörse;