Exhibit 99.1
Pharmion Corporation and GPC Biotech Announce Partnering Agreement for
Satraplatin
o Pharmion Obtains Commercial Rights for Satraplatin in Europe, Turkey,
the Middle East, Australia and New Zealand; GPC Biotech Retains Rights
in North America and all other Territories
o Pharmion to make an upfront payment of $37.1 million to GPC Biotech;
GPC Biotech may receive up to $270 million in total based upon the
achievement of regulatory and sales milestones
o Target Enrollment Achieved in Pivotal Phase 3 Study for Second-Line
Chemotherapy in Hormone-Refractory Prostate Cancer; Pharmion Expects
to Submit for European Marketing Authorization in 2007 pending
concurrence with the EMEA
BOULDER, Colo., MARTINSRIED/MUNICH, Germany, WALTHAM, Mass. and PRINCETON, N.J.,
Dec. 20 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and GPC
Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today
announced that the companies have entered into a co-development and license
agreement for satraplatin, the only oral platinum-based compound in advanced
clinical development. Satraplatin has shown promising safety and efficacy as
demonstrated by significant improvement in progression-free survival (PFS) in a
randomized study of first-line treatment of patients with hormone-refractory
prostate cancer (HRPC) and is currently the subject of a Phase 3 registrational
trial as second-line chemotherapy treatment for patients with HRPC. Data from
the pivotal Phase 3 trial are expected to form the basis of a Marketing
Authorization Application (MAA) in Europe and a New Drug Application (NDA) in
the U.S. for this indication. Based on data from this trial, Pharmion expects to
file the MAA in Europe in 2007, pending concurrence with the EMEA.
Under the terms of the agreement, Pharmion gains exclusive commercialization
rights for Europe, Turkey, the Middle East, Australia and New Zealand, while GPC
Biotech retains rights to the North American market and all other territories.
Pharmion is to provide an upfront payment of $37.1 million to GPC Biotech,
including an $18 million reimbursement for past satraplatin clinical development
costs and $19.1 million for funding of ongoing and certain future clinical
development to be conducted jointly by Pharmion and GPC Biotech. The companies
will pursue a joint development plan to evaluate development activities for
satraplatin in a variety of tumor types and will share global development costs,
for which Pharmion has made an additional commitment of $22.2 million, in
addition to the $37.1 million in initial payments. Pharmion will also pay GPC
Biotech $30.5 million based on the achievement of certain regulatory filing and
approval milestones, and up to an additional $75 million for up to five
subsequent EMEA approvals for additional indications. GPC Biotech will also
receive royalties on sales of satraplatin in Pharmion's territories at rates of
26 to 30 percent on annual sales up to $500 million, and 34 percent on annual
sales over $500 million. Finally, Pharmion will pay GPC Biotech sales milestones
totaling up to $105 million, based on the achievement of significant annual
sales levels in the Pharmion territories. Pharmion and GPC Biotech will lead
regulatory and commercial activities in their respective territories.
"We believe that satraplatin has the potential to provide significant additional
benefits in the well-characterized platinum treatment class, and we will work
closely with GPC Biotech to get this vital therapy to physicians and patients as
quickly as possible," said Patrick J. Mahaffy, Pharmion's president and chief
executive officer. "Satraplatin represents an important addition to our product
portfolio, complementing our existing products as well as the global regulatory,
clinical development and commercial organizations that support them."
Bernd R. Seizinger, M.D., Ph.D., chief executive officer of GPC Biotech, said:
"We were very pleased with the significant interest in satraplatin shown by a
large number of pharmaceutical and biotech firms in the U.S. and Europe. We have
selected Pharmion as a partner because we believe they are ideally suited to
help us fully exploit the potential of satraplatin in Europe and are strongly
committed to continued development of this important compound for a variety of
cancers. The deal structure provides us with significant funding but still
allows GPC Biotech to retain the full commercialization rights to the U.S.
market and other key pharmaceutical markets." Dr. Seizinger continued:
"Pharmion's expertise and its strong oncology focused commercial infrastructure
in Europe and other licensed territories will be critical in bringing
satraplatin to patients in those countries. With the complementary expertise and
the great respect that our teams have developed for one another, we look forward
to a very productive relationship."
About Satraplatin and its Clinical Development
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. An oral
platinum drug could offer key advantages, including ease of administration and
patient convenience, in a variety of applications.
The results of a clinical study conducted by the European Organization for
Research and Treatment of Cancer (EORTC) evaluating satraplatin in HRPC were
presented at the 2003 Annual Meeting of the American Society for Clinical
Oncology. Fifty patients were randomized to evaluate the use of satraplatin plus
prednisone (n=27) versus prednisone alone (n=23) for use as a first-line
chemotherapy treatment in HRPC. The study showed that treatment with satraplatin
significantly lengthened progression-free survival (PFS) (p=0.023); the median
PFS was 5.2 months for satraplatin compared to 2.5 months for the control arm.
Additionally, at six months, 41 percent of patients treated in the satraplatin
arm were progression-free compared to 22 percent of patients in the control arm.
A greater than 50 percent decline in prostate-specific antigen (PSA) was
experienced by 33 percent of patients (9/27) in the satraplatin arm versus 9
percent of patients (2/23) in the control arm (p=0.046). The median overall
survival time was 15 months for patients treated in the satraplatin arm versus
12 months for patients in the control arm (p value not statistically
significant). To date, satraplatin is the only platinum compound that has
demonstrated efficacy in a randomized trial in HRPC.
In the second half of 2003, GPC Biotech launched its phase 3 Satraplatin and
Prednisone Against
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Refractory Cancer (SPARC) registrational trial. The SPARC trial, which assesses
the safety and efficacy of satraplatin in combination with prednisone as
second-line chemotherapy in patients with HRPC, compares satraplatin plus
prednisone to placebo plus prednisone. This trial is powered to show
improvements in both endpoints of PFS and overall survival. Target enrollment of
912 patients in this multicenter, multinational, double-blind, randomized study
was achieved earlier this month. GPC Biotech has initiated the rolling
submission of an NDA with the U.S. Food and Drug Administration (FDA) for
satraplatin in combination with prednisone as a second-line chemotherapy
treatment for patients with HRPC. Assuming continued progress, GPC Biotech
expects to complete the NDA filing in the second half of 2006. Data from the
SPARC trial are also expected to form the basis of an MAA in Europe for this
indication, and, pending concurrence with the EMEA, Pharmion expects to submit
that application in 2007.
In addition, satraplatin has been studied in a range of tumors, and Phase 2
trials have been completed in HRPC, ovarian cancer and small cell lung cancer.
In other trials, satraplatin appeared to augment the antitumor effects of
radiation therapy, a clinical application in which satraplatin's oral
bioavailability could be particularly advantageous. A Phase 1/2 study evaluating
this combination in patients with non-small cell lung cancer has been initiated.
Several other Phase 1 and 2 studies evaluating satraplatin in combination with
other therapies and in various cancers are underway or planned.
Conference Call Scheduled
Separate conference calls are planned for Pharmion Corporation at 8:30 a.m. and
GPC Biotech at 9:30 a.m. (both times Eastern) to which participants may listen
via live webcast, accessible through each company's Web site at
www.pharmion.com, www.gpc-biotech.com, or via telephone. Details, including
dial-in numbers, will be provided in separate announcements.
About Pharmion Corporation
Pharmion is a pharmaceutical company focused on acquiring, developing and
commercializing innovative products for the treatment of hematology and oncology
patients in the U.S., Europe and additional international markets. For
additional information about Pharmion, please visit the company's website at
www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and developing new
anticancer drugs. The Company's lead product candidate -- satraplatin -- has
achieved target enrolment 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 GPC
Biotech has begun the rolling NDA submission process for this compound.
Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc. 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). The Company's wholly owned U.S. subsidiary has sites in
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Waltham, Massachusetts and Princeton, New Jersey. For additional information,
please visit the Company's Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express the
current beliefs and expectations of management. 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, including the
timing and effects of regulatory actions, the results of clinical trials,
Pharmion's and GPC Biotech's relative success developing and gaining market
acceptance for any new products, and the effectiveness of patent protection.
There can be no guarantee that GPC Biotech will receive all of the payments and
royalties outlined in this press release. There can be no guarantee that the
SPARC trial will be completed nor that satraplatin will be approved for
marketing in a timely manner, if at all, nor that, if marketed, satraplatin will
be successful. We direct you to GPC Biotech's Annual Report on Form 20-F, as
amended, for the fiscal year ended December 31, 2004, Pharmion's most recent
filings on Form 10-Q and 10-K, 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 either Pharmion or
GPC Biotech. Forward-looking statements speak only as of the date on which they
are made and neither Pharmion nor GPC Biotech undertakes any obligation to
update these forward-looking statements, even if new information becomes
available in the future.
CONTACT:
Breanna Burkart or Anna Sussman, Directors, Investor Relations and Corporate
Communications, +1-720-564-9150, ir@pharmion.com, both of Pharmion Corporation;
or media, in the U.S., Heather Pierce, +1-415-278-3312,
heather.pierce@mslpr.com, or in Europe, Anne Hyder, +44 (0)20 7878 3123,
anne.hyder@mslpr.co.uk, both for Pharmion Corporation;
or Martin Braendle, Associate Director, Investor Relations & Corporate
Communications, +49 (0)89 8565-2693, 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 GPC Biotech;
or media, in the U.S., Emily Poe of Euro RSCG Life NRP, +1-212-845-4266
emily.poe@eurorscg.com, or in Europe, Brian Hudspith of Maitland Noonan Russo,
+44 (0)20 7379 5151, bhudspith@maitland.co.uk, both for GPC Biotech/ /
Web site: http://www.gpc-biotech.com Web site: http://www.pharmion.com /
(PHRM GPCB) CO: Pharmion Corporation; GPC Biotech AG ST: Colorado,
Massachusetts, New Jersey, Germany
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