- HGS acquires exclusive rights to develop and commercialize small-molecule
IAP inhibitors in oncology -
- Lead compound AEG40826 works synergistically with HGS TRAIL receptor
antibodies to enhance anticancer activity of both drugs -
- IAP inhibitors also show promise alone and in combination with other
anti- cancer agents across broad range of cancers -
ROCKVILLE, Md. and MONTREAL, Quebec, Dec. 20 /PRNewswire-FirstCall/ --
Human Genome Sciences, Inc. (Nasdaq: HGSI) and Aegera Therapeutics Inc.
today announced an agreement under which HGS has acquired exclusive
worldwide rights (excluding Japan) to develop and commercialize AEG40826
and related backup compounds to be chosen during a three-year research
collaboration. AEG40826 is a potent small-molecule inhibitor of multiple
IAP (inhibitor of apoptosis) protein family members that is expected to
begin oncology clinical trials in early 2008.
"Today's announcement underscores HGS's commitment to develop novel
targeted therapies for the treatment of cancer," said H. Thomas Watkins,
President and Chief Executive Officer, HGS. "Our company has pioneered
development of antibody therapies based on the TRAIL receptor apoptotic
pathway, and we will now have the opportunity to work collaboratively with
Aegera Therapeutics to develop and commercialize exciting small-molecule
drugs that also enhance apoptosis in cancer cells. We look forward to
developing our TRAIL receptor antibodies and IAP inhibitors in combination
with one another and in combination with other therapeutic agents. We
believe this agreement substantially enhances the value of our promising
oncology franchise."
Under the agreement, HGS has paid Aegera an upfront license fee of $15
million and has made an equity investment of C$5 million. Aegera will be
entitled to receive up to $295 million in future development and commercial
milestone payments, including a $5 million milestone payment upon FDA
clearance of an IND. Aegera will receive double-digit royalties on net
sales in the HGS territory. In North America, Aegera will have the option
to co- promote, under which it will share certain expenses and profits
(30%) in lieu of its royalties. Aegera retains the non-oncology rights to
its IAP inhibitors that are not selected for development under this
agreement.
"We carefully evaluated potential partners for our small molecule IAP
oncology franchise and are very excited to announce our collaboration with
Human Genome Sciences today," said Dr. Michael Berendt, President and Chief
Executive Officer, Aegera Therapeutics. "We believe that the combination of
our extensive knowledge of the control of apoptotic pathways with HGS's
unparalleled understanding of the development of targeted therapeutics,
their strong research and development teams and their leadership in the
clinical development of TRAIL receptor human monoclonal antibodies will
significantly enhance the potential for the rapid and successful
development of AEG40826 and follow-on compounds for multiple oncology
indications."
Preclinical studies of AEG40826 in combination with the HGS TRAIL
receptor antibodies have demonstrated dramatic synergistic activity against
a number of cancer types, including prostate, breast, esophageal,
colorectal and non-small cell lung cancer. Preclinical studies also show
that AEG40826 has significant anti-tumor activity alone and in combination
with other anti-cancer agents in a broad range of cancers.
About AEG40826, a Small Molecule IAP Inhibitor
Activation of apoptosis (programmed cell death) in cancer cells is a
key goal of cancer treatment. The proteins in the IAP (inhibitor of
apoptosis) family are important regulators of apoptosis in cancer cells. A
growing body of evidence indicates that cancer cells may avoid apoptosis by
the sustained over-expression of one or more members of the IAP family.
Decreased IAP expression has been shown to sensitize a number of tumor
types to a wide variety of treatment modalities.
AEG40826 is a member of a new class of designed small molecules that
directly, or in combination with other anti-cancer treatments, cause the
death of tumor cells through antagonism of IAP function. Preclinical
studies clearly demonstrate that AEG40826 potently stimulates apoptosis of
human tumor cells in vitro and in vivo. Consistent with its mechanism of
action, AEG40826 causes a rapid loss of IAP proteins in human tumor
xenografts.
Conference Call
HGS management will hold a conference call to discuss this announcement
today at 11 AM Eastern time. Participants may listen to the call by dialing
888-233-8128 or 913-312-0734, passcode 2718784, 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 2718784.
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 Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical-stage biotechnology company focused
on developing drugs that control apoptosis to address major unmet medical
needs. In addition to AEG40826, Aegera has three clinical stage/IND track
programs in development for oncology and neuropathic pain:
-- AEG35156 targets a key anti-apoptotic protein XIAP, and is currently in
four Phase II clinical trials for the treatment of solid tumors and
leukemia;
-- AEG41174 is a novel, non-ATP competitive, small molecule tyrosine
kinase inhibitor targeting therapeutically significant kinases
including JAK2 and Bcr-Abl, and is currently in a Phase 1 clinical
trial;
-- AEG33773 is a novel, orally active small molecule developed to treat
painful diabetic neuropathy; definitive IND-enabling preclinical
toxicology testing has been completed.
For more information about Aegera, please visit the website:
http://www.aegera.com.
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, anthrax disease, 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) (albinterferon
alfa- 2b) 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 anthrax disease, and the Company is on track to begin the
delivery in 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 cancers.
For more information about Human Genome Sciences, please visit the
Company's web site at http://www.hgsi.com. Health professionals interested in
information about clinical trials involving HGS products are encouraged to
inquire via the Contact Us section of the Human Genome Sciences web site,
http://www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension
3550.
ABthrax, Albuferon, LymphoStat-B, HGS and Human Genome Sciences are
trademarks of Human Genome Sciences, Inc.
HGS 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
http://www.hgsi.com/products/request.html
http://www.aegera.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.; or Donald Olds, Chief Operating Officer & Chief
Financial Officer, +1-514-288-5532, x. 295,
donald.olds@aegera.com, of Aegera Therapeutics Inc.
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