* 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
* 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
* 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
MARTINSRIED/MUNICH, Germany, Dec. 20 /PRNewswire-FirstCall/ -- Waltham,
Mass., Princeton, N.J. and Boulder, Colo. -- GPC Biotech AG (Frankfurt Stock
Exchange: GPC; TecDAX index; Nasdaq: GPCB) and Pharmion Corporation
(Nasdaq: PHRM) 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.
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."
"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."
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 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
http://www.pharmion.com, http://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 http://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 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 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.
For further information, please contact:
For GPC Biotech:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
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 ext. 267
usinvestors@gpc-biotech.com
Additional Media Contacts for GPC Biotech:
In the U.S.:
Euro RSCG Life NRP
Emily Poe
Phone: +1 212 845 4266
emily.poe@eurorscg.com
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
For Pharmion Corporation:
Breanna Burkart or Anna Sussman
Directors, Investor Relations and Corporate Communications
Phone: +1 720 564 9150
ir@pharmion.com
Additional Media Contacts for Pharmion Corporation:
In the U.S.: Heather Pierce
Phone: +1 415 278 3312
Email: heather.pierce@mslpr.com
In Europe: Anne Hyder
Phone: +44 (0)20 7878 3123
Email: anne.hyder@mslpr.co.uk
SOURCE GPC Biotech AG; Pharmion Corporation
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Related links:
http://www.gpc-biotech.com
http://www.pharmion.com
CONTACT:
Martin Braendle, Associate Director, Investor
Relations & Corporate Communications, +49(0)89-8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Associate Director, Investor
Relations & Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or 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; or Breanna Burkart or Anna Sussman, Directors,
Investor Relations and Corporate Communications of Pharmion
Corporation, +1-720-564-9150, ir@pharmion.com; 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
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