- HGS reacquires GSK rights to TRAIL receptor antibodies in return for
reduction in Syncria(R) royalties -
- HGS-ETR1 Phase 2 development program expands -
ROCKVILLE, Md., April 16 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) today announced that it has reacquired rights
to the TRAIL receptor antibodies HGS-ETR1 (mapatumumab) and HGS-ETR2
(lexatumumab) from GlaxoSmithKline (GSK), in return for a reduction in
royalties due to HGS if Syncria(R) (albiglutide) is commercialized. HGS is
developing its TRAIL receptor antibodies for the treatment of a broad range
of cancers, and announced today that it plans to initiate its third
randomized Phase 2 chemotherapy combination trial of HGS-ETR1 by mid-2008
in patients with hepatocellular cancer.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"As our Phase 3 products near commercialization, we are investing
strategically to bring our next products forward," said H. Thomas Watkins,
President and Chief Executive Officer, HGS. "We are building our oncology
portfolio around our leading expertise in the apoptosis pathway. We have
added IAP inhibitors, which are highly complementary to our TRAIL receptor
antibodies. We have initiated new chemotherapy combination trials of
HGS-ETR1, and we have now reacquired the rights to our TRAIL receptor
antibodies."
The GSK rights to the TRAIL receptor antibodies resulted from a June
1996 agreement under which HGS granted a 50/50 co-development and
co-promotion option to GSK for certain human therapeutic products that
complete Phase 2a clinical trials. In exchange for reacquiring the rights
to its TRAIL receptor antibodies, HGS has agreed to a reduction in the
royalties to which it is entitled from GSK if Syncria is commercialized.
The fees and milestone payments due to HGS under the original Syncria
agreement, some of which have already been received, could amount to as
much as $183 million and remain unchanged in the amended agreement.
Syncria, a novel long-acting form of GLP-1 (glucagon-like peptide-1), was
created by HGS using its proprietary albumin-fusion technology. GSK has
exclusive rights to develop and commercialize Syncria, and is developing it
for use in the treatment of type 2 diabetes. HGS believes it is possible
that GSK will reach a decision in 2008 regarding whether to advance Syncria
to Phase 3 development.
"We view our oncology portfolio as the cornerstone of our mid-stage
pipeline, and as a key driver of future growth beyond the launch of our
late- stage products," said Barry A. Labinger, Executive Vice President and
Chief Commercial Officer, HGS. "Reacquiring the rights to our TRAIL
antibodies gives us the opportunity to drive and advance this growing
program. We will continue to explore the possibility of bringing in
additional new products, as well as forming new partnerships to add
expertise and near-term financial resources in support of our pipeline."
HGS reported that a 2002 agreement with the Pharmaceutical Division of
Kirin Brewery Company, Ltd. for joint development of antibodies to TRAIL
receptor 2 has also been terminated.
About the HGS-ETR1 Proof-of-Concept Program
HGS-ETR1 is the most advanced of any product in development that
targets the TRAIL apoptosis pathway. HGS has advanced HGS-ETR1 to a
proof-of-concept phase consisting of three randomized Phase 2 chemotherapy
combination trials to evaluate its potential in the treatment of specific
cancers:
-- HGS has completed the enrollment and initial dosing of 105 patients in
a randomized Phase 2 trial of HGS-ETR1 in combination with Velcade
(bortezomib) in advanced multiple myeloma, and expects to have data
available in the third quarter of 2008.
-- In December 2007, HGS initiated dosing of approximately 105 patients in
a randomized Phase 2 trial of HGS-ETR1 in combination with paclitaxel
and carboplatin as first-line therapy in advanced non-small cell lung
cancer, and expects to have data available in 2009.
-- Today, HGS announced that it plans by mid-2008 to initiate a randomized
Phase 2 trial of HGS-ETR1 in combination with Nexavar (sorafenib) in
hepatocellular cancer. The study in hepatocellular cancer will begin
with a safety lead-in to assure the safety of this combination therapy
in patients with hepatocellular cancer who are infected with hepatitis
C.
About the HGS IAP Inhibitor Program
In December 2007, the HGS oncology portfolio was further strengthened
by a licensing and collaboration agreement between HGS and Aegera
Therapeutics Inc. This agreement provides HGS with exclusive worldwide
rights (excluding Japan) to develop and commercialize HGS1029 (formerly
AEG40826) and other small- molecule inhibitors of IAP (inhibitor of
apoptosis) proteins in oncology. Preclinical studies of HGS1029 in
combination with the Company's TRAIL receptor antibodies demonstrated
dramatic synergistic activity against a number of cancer types. HGS1029 has
also shown significant anti-tumor activity alone and in combination with
other agents in a broad range of cancers. HGS expects to initiate a Phase 1
clinical trial of HGS1029 by mid-2008 and plans to develop its TRAIL
receptor antibodies and IAP inhibitors in combination with one another and
in combination with other therapeutic agents.
About HGS-ETR1 and HGS-ETR2
HGS-ETR1 and HGS-ETR2 are agonistic human monoclonal antibodies that
directly induce cancer-cell death by specifically binding to and activating
the proteins known as TRAIL receptors 1 and 2, respectively. Using genomic
techniques, HGS originally identified the TRAIL receptor 1 and 2 proteins.
HGS is developing its TRAIL receptor antibodies as potential treatments for
a broad range of cancers.
Conference Call
HGS management will hold a conference call to discuss this announcement
today at 5 PM Eastern time. Participants may listen to the call by dialing
800-930-1344 or 913-312-1416, passcode 8678241, five to 10 minutes before
the start of the call. A replay of the conference call will be available
for several days by dialing 888-203-1112 or 719-457-0820, passcode 8678241.
This conference call also will be webcast. Interested parties who wish to
listen to the webcast should visit the Human Genome Sciences website at
http://www.hgsi.com. The archive of the conference call will be made
available within a few hours after the call and will remain available for
several days.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to
bring innovative drugs to patients with unmet medical needs.
The HGS clinical development pipeline includes novel drugs to treat
hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated
diseases. The Company's primary focus is rapid progress toward the
commercialization of its two key lead drugs, Albuferon(R) for hepatitis C
and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both
drugs are ongoing.
ABthrax(TM) (raxibacumab) is in late-stage development for the
treatment of inhalation anthrax, and the Company is on track to begin the
delivery in fall 2008 of 20,000 doses of ABthrax to the Strategic National
Stockpile under a contract entered into with the U.S. Government in June
2006. Other HGS drugs in clinical development include two TRAIL receptor
antibodies for the treatment of cancer. HGS1029, a small-molecule
antagonist of IAP (inhibitor of apoptosis) proteins, is expected to enter
Phase 1 clinical trials for the treatment of cancer by mid-2008. In
addition, HGS has substantial financial rights to certain products in the
GlaxoSmithKline clinical development pipeline.
For more information about HGS, please visit the Company's web site at
http://www.hgsi.com. Health professionals and patients interested in
clinical trials of HGS-ETR1, HGS-ETR2 or other HGS products may inquire via
e-mail to clinical_trials@hgsi.com or by calling HGS at (301) 610-5790,
extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are
trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on Human Genome Sciences' current
intent, belief and expectations. These statements are not guarantees of
future performance and are subject to certain risks and uncertainties that
are difficult to predict. Actual results may differ materially from these
forward-looking statements because of the Company's unproven business
model, its dependence on new technologies, the uncertainty and timing of
clinical trials, the Company's ability to develop and commercialize
products, its dependence on collaborators for services and revenue, its
substantial indebtedness and lease obligations, its changing requirements
and costs associated with facilities, intense competition, the uncertainty
of patent and intellectual property protection, the Company's dependence on
key management and key suppliers, the uncertainty of regulation of
products, the impact of future alliances or transactions and other risks
described in the Company's filings with the Securities and Exchange
Commission. In addition, the Company will continue to face risks related to
animal and human testing, to the manufacture of ABthrax and to FDA
concurrence that ABthrax meets the requirements of the ABthrax contract. If
the Company is unable to meet the product requirements associated with the
ABthrax contract, the U.S. government will not be required to reimburse the
Company for the costs incurred or to purchase any ABthrax doses. Existing
and prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of today's date.
Human Genome Sciences undertakes no obligation to update or revise the
information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.
SOURCE Human Genome Sciences, Inc.
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Related links:
http://www.hgsi.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/121115.html/
CONTACT:
Jerry Parrott, Vice President, Corporate
Communications, +1-301-315-2777, or Kate de Santis, Director,
Investor Relations, +1-301-251-6003, both of Human Genome
Sciences, Inc.
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