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dievini Hopp BioTech holding to invest €15 million in merged
company
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Pipeline to include novel oncology therapy, talactoferrin, which
recently entered Phase 3 clinical testing
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Conference call scheduled for February 18, 2009, 15:00 CET/9:00
AM ET
GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) and
Agennix, Incorporated today announced that the two oncology-focused
biotechnology companies have signed a Business Combination Agreement
under which they propose to merge their businesses. In the transaction,
GPC Biotech is to be merged onto a new German company, which will hold
all of the shares of Agennix and a €15 million cash contribution by
dievini Hopp BioTech holding GmbH & Co KG, an investment company of
Dietmar Hopp, co-founder of SAP, and one of the largest shareholders of
GPC Biotech. The merger combines GPC Biotech’s and Agennix’s oncology
pipelines, including Agennix’s Phase 3 novel oncology therapy,
talactoferrin, with the clinical development and financial resources of
GPC Biotech and dievini Hopp BioTech holding.
The Management Board and Supervisory Board of GPC Biotech, as well as
the Board of Directors of Agennix, have voted unanimously to support the
proposed merger, which is subject to the approval of the shareholders'
meetings of both GPC Biotech and the new company. GPC Biotech plans to
submit the merger agreement to its shareholders for voting at a
shareholders’ meeting in the first half of 2009. The merger agreement
between GPC Biotech and the new company will be subject to further
closing conditions, including any necessary anti-trust clearances. The
merger is expected to be completed by the end of 2009.
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech,
said: “We are truly excited to join forces with Agennix to develop their
novel approach to cancer therapy, talactoferrin, which is currently in
Phase 3 clinical development in non-small cell lung cancer, an area of
major unmet need and the most frequent cause of cancer death. The skill
set and programs that the Agennix team brings to the combined
organization is highly complementary to our own group and pipeline.
Together we will be able to build a new and vital company that is
focused on developing important new treatments for cancer.”
Dr. Seizinger continued: “I am also very pleased with the ongoing
support that Mr. Hopp through dievini Hopp BioTech holding is showing
through his commitment to invest in the new company. Dievini focuses its
investments on creating and building entrepreneurial and sustainable
biotech organizations to foster the development of innovative new
treatments for patients. This philosophy fits well with our goals for
the new company. I firmly believe that this transaction is a win-win
scenario for both companies that will build value for all of our
shareholders.”
Rick G. Barsky, Chief Executive Officer of Agennix, said: “GPC Biotech’s
years of oncology development expertise, along with their public company
profile and solid financial position, make this merger an excellent fit
for us. We are excited about the clinical anti-tumor activity and safety
profile we have seen to date with talactoferrin and are pleased to have
recently started Phase 3 trials for this promising compound in non-small
cell lung cancer. This transaction brings us the critical human and
financial resources to accelerate the development of this important
anti-cancer therapy in an area in great need of new treatments. We look
forward to joining forces with the GPC Biotech team in an exciting new
company.”
About the transaction
The Business Combination Agreement provides that GPC Biotech will merge
onto a new German company which will hold all Agennix shares and a cash
contribution by dievini Hopp BioTech holding of approximately € 15
million. The agreement assumes a merger ratio resulting in an economic
ownership in the new company as follows: Agennix shareholders
(approximately 48.0%), GPC Biotech shareholders (approximately 39.3%),
and approximately 12.7% being attributed to the capital increase by
dievini Hopp BioTech holding. As part of the merger process, this ratio
is subject to review by an independent, court-appointed merger auditor
in Germany. The merger ratio translates into a value of €1.26 per share
of GPC Biotech. Upon registration of the merger, the new company will be
a publicly listed German stock corporation (AG). The new company
initially will have three sites: GPC Biotech’s offices in Munich,
Germany and in Princeton, New Jersey, and Agennix’s site in Houston,
Texas.
In connection with the business combination agreement, GPC Biotech has
made a $20 million (approximately €15 million) loan to Agennix in the
form of a senior secured convertible promissory note, bearing an
interest rate of 12% per annum, to support the funding of the clinical
development of talactoferrin. Additionally, during the period prior to
closing, GPC Biotech will provide clinical and regulatory support to
Agennix under a separate arrangement between the companies.
Rothschild Inc. served as a financial advisor to GPC Biotech in
connection with the transaction, and Lazard served as financial advisor
to Agennix.
About the new company
The new company will focus on the development of new anti-cancer
therapies. The lead compound will be Agennix’s talactoferrin, a novel
oral agent being developed for lung, kidney and other cancers, as well
as for severe sepsis. Talactoferrin has recently entered Phase 3
clinical testing for non-small cell lung cancer (NSCLC). In addition to
orally administered talactoferrin, other programs the new company will
focus on include: topical talactoferrin in clinical development for the
treatment of diabetic foot ulcers; and RGB-286638 from GPC Biotech, a
novel multi-targeted kinase inhibitor currently in Phase 1 testing for
advanced solid tumors. Furthermore, GPC Biotech is currently talking
with Yakult Honsha Co. Ltd., its partner in Japan for the oral platinum
compound, satraplatin, regarding further development and registrational
efforts for this program.
The parties are committed to building the new company by advancing the
current anti-cancer programs that GPC Biotech and Agennix bring, as well
as by pursuing additional oncology opportunities to fully utilize the
significant expertise and transatlantic operations of the combined
entity.
The new company’s Management Board will consist of three members. A
search will be conducted for a new Chief Executive Officer for the
combined entity. Friedrich von Bohlen, Ph.D., Managing Director of
dievini Hopp BioTech holding GmbH & Co KG, will serve as Interim CEO
until a new CEO is on board. Torsten Hombeck, Ph.D., currently Chief
Financial Officer of GPC Biotech and Atul Varadhachary, M.D., Ph.D.,
currently President & Chief Operating Officer of Agennix, will also
serve on the new company’s Management Board. Dr. Bernd Seizinger and Mr.
Rick Barsky will serve on the Supervisory Board of the new company.
The Supervisory Board of the new company will consist of six members.
The proposed slate is as follows:
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Prof. Dr. Christof Hettich (Chairman), Managing Director of dievini
Hopp BioTech holding GmbH & Co KG and managing partner of RITTERSHAUS
law firm in Mannheim, Germany
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Dr. Frank Young (Vice Chairman), Chairman of the Board of Directors of
Agennix and former Commissioner of the U.S. Food and Drug
Administration
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Dr. Bernd Seizinger, Chief Executive Officer of GPC Biotech
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Mr. Rick Barsky, Chief Executive Officer of Agennix
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Mr. James Weaver, Chairman of the Board of the Gordon Cain Foundation,
a leading Texas philanthropic organization, and member of the Agennix
Board of Directors
A sixth member of the Supervisory Board will be named at a later date.
Drug development portfolio
Talactoferrin: Talactoferrin, a novel dendritic cell recruiter
and activator (DCRA), is a unique recombinant form of human lactoferrin,
a protein important in modulating the immune system. A first-in-class
molecule, oral talactoferrin is being developed to treat various
cancers, including lung and kidney cancers. Compelling clinical activity
and safety data from two randomized, placebo-controlled Phase 2 clinical
trials in non-small cell lung cancer and an open label Phase 2 trial in
renal cell carcinoma have been presented. Two Phase 3 clinical trials in
NSCLC have recently been initiated. The first involves NSCLC patients
whose disease has progressed following two or more prior anti-cancer
drug regimens. The second Phase 3 clinical trial in NSCLC is evaluating
talactoferrin in combination with first-line chemotherapy. A Phase 2b
trial in combination with first-line therapy in renal cell carcinoma is
being planned, as well as other clinical trials in various cancer
indications. A Phase 2 clinical trial, sponsored by the U.S. National
Institutes of Health (NIH), to evaluate talactoferrin in patients with
severe sepsis is currently underway, and a topical formulation of
talactoferrin is in clinical development for the treatment of diabetic
foot ulcers. To date, talactoferrin has been administered in various
clinical studies to over 600 patients and appears to be well tolerated.
Satraplatin: Satraplatin is an oral platinum compound being
developed to treat a variety of cancers. GPC Biotech is currently
talking with its partner for satraplatin in Japan, Yakult Honsha Co.
Ltd., regarding further development and registrational efforts for
satraplatin.
RGB-286638: RGB-286638 is a multi-targeted protein kinase
inhibitor being developed by GPC Biotech. In a range of pre-clinical
models of solid and hematological tumors, RGB-286638 treatment results
in tumor regression and increased survival. This compound has recently
entered Phase 1 clinical testing and will continue to be developed.
All other development programs are currently under evaluation.
GPC Biotech announces corporate changes
Further, GPC Biotech and Dr. Bernd Seizinger agreed that Dr. Seizinger
will step down as Chief Executive Officer to pursue other activities. He
will leave GPC Biotech after the shareholder meeting that votes on the
merger, but no later than June 30, 2009. Dr. Seizinger will, however,
actively support the new company as a member of its Supervisory Board.
GPC Biotech also announced that it plans to voluntarily delist its
American Depositary Shares (ADSs) from the NASDAQ stock exchange and
deregister its ADSs and ordinary shares under the U.S. Securities
Exchange Act of 1934, as amended. GPC Biotech intends to make the
necessary filing with the U.S. Securities and Exchange Commission (SEC)
on February 27, 2009 to effect the delisting of its ADSs from NASDAQ.
The delisting will become effective 10 days thereafter. Upon delisting,
GPC Biotech will make the necessary filing with the SEC to initiate the
deregistration process for its shares. Following delisting and
deregistration in the U.S., GPC Biotech’s ordinary shares will continue
to trade on the Frankfurt Stock Exchange (“FSE”) until the closing of
the merger. The new company’s shares will be listed on the FSE at the
time the merger becomes effective, replacing the listing of GPC
Biotech’s ordinary shares on the FSE.
Conference call scheduled
A conference call will be held on February 18, 2009 at 9:00 AM Eastern
time/15:00 CET to which participants may listen via live webcast,
accessible through the GPC Biotech Web site at www.gpc-biotech.com
or via telephone. Slides accompanying the call will be available on the
GPC Biotech Website. A replay will be available on the Web site
following the live event. The dial-in numbers for the call are as
follows:
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Participants from Europe:
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0049(0) 89 9982 99911
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0044(0) 20 7806 1956
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Participants from the U.S.:
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1-718 354 1389
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Please dial in 10 minutes before the beginning of the call.
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About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on
developing anti-cancer drugs. The Company currently has two programs in
clinical development: satraplatin, an oral platinum compound and
RGB-286638, a multi-targeted protein kinase inhibitor. GPC Biotech AG is
headquartered in Martinsried/Munich (Germany) and has a wholly owned
U.S. subsidiary in Princeton, New Jersey. For additional information,
please visit GPC Biotech's Web site at www.gpc-biotech.com.
About Agennix
Agennix, Inc. is a private biotechnology company developing a
first-in-class molecule with activity in several types of cancer and in
other indications with unmet medical needs. This molecule,
talactoferrin, is a targeted dendritic cell recruiter and activator with
a novel mechanism of action. Agennix has recently initiated Phase 3
development with oral talactoferrin in patients with non-small cell lung
cancer. Other clinical trials with talactoferrin are underway or
planned. Agennix retains all of the commercial and economic rights to
talactoferrin for all indications worldwide. More information about
Agennix is available on the Company's web site at www.agennix.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. There can be no guarantee that the merger with
Agennix will be completed. We direct you to GPC Biotech’s Annual Report
on Form 20-F for the fiscal year ended December 31, 2007 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 GPC Biotech
GPC
Biotech AG
Investor Relations & Corporate Communications
Phone:
+49 (0)89 8565-2693
ir@gpc-biotech.com
or
In
the U.S.:
Laurie Doyle, +1 (609) 524-5884 or +1 (609) 524-1025
Director,
Investor Relations & Corporate Communications
usinvestors@gpc-biotech.com
or
Additional
media contacts for GPC Biotech for Europe:
MC Services AG
Raimund
Gabriel, +49 (0) 89 210 228 0
raimund.gabriel@mc-services.eu
Hilda
Juhasz, +49 (0) 89 210 228 0
hilda.juhasz@mc-services.eu
or
Additional
investor contact for GPC Biotech for Europe:
Trout
International LLC
Lauren Rigg, +44 207 936 9325
Vice President
lrigg@troutgroup.com
or
For
Agennix
Agennix, Inc.
Rick Barsky, +1 (713) 552-1091
Chief
Executive Officer
or
Dr. Atul Varadhachary, +1 (713) 552-1091
President
& COO
or
BMC Communications Group
Daniel Budwick -
Media, +1 (973) 271-6085
or
For
dievini Hopp BioTech holding
dievini Hopp BioTech
holding GmbH & Co KG
Prof. Dr. Christof Hettich, +49 (0) 621
4256 208
RITTERSHAUS Rechtsanwälte
or
dievini Hopp
BioTech holding GmbH & Co KG
Prof. Dr. Friedrich von Bohlen,
+49 (0) 6202 204 89 45