- Payment to be received in September 2007 for successful completion of
Phase 2b clinical trial -
ROCKVILLE, Md., Aug. 28 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc., (Nasdaq: HGSI) today announced that it will receive a $40
million payment from Novartis in September 2007 for the previously reported
successful completion of a Phase 2b trial of Albuferon(R) (albinterferon
alfa-2b) in treatment-naive patients with chronic hepatitis C.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"This $40 million payment will bring the total milestone payments
received from Novartis under our Albuferon co-development and
commercialization agreement to $132.5 million," said H. Thomas Watkins,
President and Chief Executive Officer, HGS. "Novartis and HGS are also
sharing clinical development costs equally. From a strategic perspective,
our collaboration with Novartis is proceeding very well. Our companies are
jointly committed to the highest quality of clinical development, and we
are working closely together to bring Albuferon to market as rapidly as
possible."
HGS also reported in a separate press release issued earlier today that
it has completed enrollment ahead of schedule in the first of two pivotal
Phase 3 trials of Albuferon in chronic hepatitis C, and now expects to have
Phase 3 data available by the spring of 2009, with filing of global
marketing authorization applications anticipated by the fall of 2009.
Under a co-development and commercialization agreement entered into in
June 2006, HGS and Novartis will co-commercialize Albuferon in the United
States and will share clinical development costs, U.S. commercialization
costs and U.S. profits equally. Novartis will be responsible for
commercialization in the rest of the world and will pay HGS a royalty on
those sales. Clinical development, commercial milestone and other payments
to HGS could total as much as $507.5 million, including $92.5 million
received to date and the $40 million payment expected in September 2007.
About Albuferon
Albuferon is a novel long-acting form of interferon alpha created by
HGS using its proprietary albumin fusion technology. Albuferon results from
the genetic fusion of human albumin and interferon alpha. Human albumin is
the most prevalent naturally occurring blood protein in the human
circulatory system, persisting in circulation in the body for more than 20
days. Research shows that genetic fusion of therapeutic proteins to human
albumin decreases clearance and prolongs the half-life of the proteins.
Recombinant interferon alpha is approved for the treatment of hepatitis C,
hepatitis B and a number of cancers.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C
virus. An estimated 170 million people worldwide are infected with the
virus, including nearly 4 million people in the United States. When
detectable levels of the hepatitis C virus persist in the blood for at
least six months, a person is diagnosed as having chronic hepatitis C. The
hepatitis C virus can cause serious liver disease in a significant
proportion of people who are infected, leading to cirrhosis, primary liver
cancer and even death.
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 for hepatitis C and
LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both
drugs are under way.
In June 2006, HGS announced that the U.S. government exercised its
option under an existing contract to purchase 20,000 doses of ABthrax(TM)
(raxibacumab) for the treatment of anthrax disease. Other HGS drugs in
clinical development include two TRAIL receptor antibodies for the
treatment of hematologic and solid malignancies.
For more information about HGS, please visit the Company's web site at
http://www.hgsi.com. For more information about Albuferon, please visit
http://www.hgsi.com/products/albuferon.html. Health professionals or patients
interested in Albuferon clinical trials or other studies involving HGS
products may inquire via the "Contact Us" section of the Company's web
site, http://www.hgsi.com/products/request.html, or by calling (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
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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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