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GPC Biotech and Agennix Announce Proposed Merger |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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§ dievini Hopp BioTech holding to invest ¤15 million in
merged company
§ Pipeline to include novel oncology therapy, talactoferrin,
which recently entered Phase 3 clinical testing
§ Conference call scheduled for February 18, 2009, 15:00
CET/9:00 AM ET
Martinsried/Munich (Germany), Princeton, N.J. and Houston, TX,
February 18, 2009 - 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:
§ 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
§ Dr. Frank Young (Vice Chairman), Chairman of the Board of
Directors of Agennix and former Commissioner of the U.S. Food and
Drug Administration
§ Dr. Bernd Seizinger, Chief Executive Officer of GPC Biotech
§ Mr. Rick Barsky, Chief Executive Officer of Agennix
§ 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:
Participants from Europe: 0049(0) 89 9982 99911
0044(0) 20 7806
1956
Participants from the U.S.: 1-718 354 1389
Please dial in 10 minutes before the beginning of the call.
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 further information, please contact:
For GPC Biotech
GPC Biotech AG
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 or +1 (609) 524-1025
usinvestors@gpc-biotech.com
Additional media contacts for GPC Biotech for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda Juhasz
hilda.juhasz@mc-services.eu
Additional investor contact for GPC Biotech for Europe:
Trout International LLC
Lauren Rigg, Vice President
Phone: +44 207 936 9325
lrigg@troutgroup.com
For Agennix
Rick Barsky
Chief Executive Officer
Agennix, Inc.
+1 (713) 552-1091
Dr. Atul Varadhachary
President & COO
Agennix, Inc.
+1 (713) 552-1091
Daniel Budwick - Media
BMC Communications Group
+1 (973) 271-6085
For dievini Hopp BioTech holding
Prof. Dr. Christof Hettich
dievini Hopp BioTech holding GmbH & Co KG
RITTERSHAUS Rechtsanwälte
+49 (0) 621 4256 208
Prof. Dr. Friedrich von Bohlen
dievini Hopp BioTech holding GmbH & Co KG
+49 (0) 6202 204 89 45
--- End of Message ---
GPC Biotech AG
Fraunhoferstr. 20 Martinsried Germany
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,
Freiverkehr in Bayerische Börse München, Freiverkehr in Börse
Düsseldorf,
Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische
Wertpapierbörse zu Hamburg,
Regulierter Markt in Frankfurter Wertpapierbörse; Copyright © Hugin AS 2009. All rights reserved.
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