- Deal includes $10 million upfront payment
- Yakult responsible for all development, marketing and sales costs for
Japan
MARTINSRIED/MUNICH, Germany /PRNewswire-FirstCall/ -- 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 yen (~$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 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 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.
SOURCE GPC Biotech
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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 U.S., Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609-524-5884,
usinvestors@gpc-biotech.com, both of GPC Biotech; Media, Europe,
Brian Hudspith of Maitland, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk; or U.S., or David Schull of Russo
Partners, LLC, +1-212-845-4271, david.schull@russopartnersllc.com
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