- HGS expects to have all Phase 3 data available by spring 2009 to support
the filing of global marketing authorization applications by fall 2009 -
ROCKVILLE, Md., Nov. 1 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) today announced that it has completed enrollment and
initial dosing ahead of schedule in ACHIEVE 2/3, the second of two pivotal
global Phase 3 trials of Albuferon(R) (albinterferon alfa-2b) in
combination with ribavirin in treatment-naive patients with chronic
hepatitis C. ACHIEVE 2/3 is being conducted in patients with genotypes 2
and 3 chronic hepatitis C.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"We are ahead of our original schedule with both Phase 3 trials of
Albuferon and we expect the filing of global marketing applications by fall
2009," said H. Thomas Watkins, President and Chief Executive Officer, HGS.
"If the results of our Phase 2 trials are confirmed in Phase 3, we believe
Albuferon could become the interferon of choice for the treatment of
chronic hepatitis C.
ACHIEVE 2/3 enrolled 933 treatment-naive patients with genotypes 2 and
3 chronic hepatitis C. ACHIEVE 1, the first of the two Phase 3 trials,
completed enrollment of 1331 treatment-naive patients with genotype 1
chronic hepatitis C in August 2007. HGS originally projected enrollment of
the Phase 3 trials by the end of 2007. Albuferon is being developed by HGS
and Novartis under an exclusive worldwide co-development and
commercialization agreement entered into in 2006.
"Albuferon requires half as many injections as the long-acting
interferons that are currently in use," said David Nelson, M.D., lead
investigator of the ACHIEVE 2/3 trial, and Associate Professor of Medicine,
Medical Director of Liver Transplantation, and Chief of the Hepatobiliary
Disease Section, University of Florida. "In previous studies, Albuferon
showed efficacy at least comparable to the pegylated interferons, with
comparable safety and significant potential for improving quality of life
on treatment. Albuferon could play an important role in the treatment of
chronic hepatitis C, and we look forward to completing the Phase 3
studies."
About the Albuferon Phase 3 Development Program
The Albuferon Phase 3 clinical development program includes two
randomized, open-label, active-controlled, multi-center, non-inferiority
trials -- ACHIEVE 1 and ACHIEVE 2/3 -- to evaluate the efficacy, safety and
impact on health-related quality of life of Albuferon in combination with
ribavirin versus Pegasys (peginterferon alfa-2a) in combination with
ribavirin.
"We are pleased with the rapid progress of enrollment in both Phase 3
trials of Albuferon, and consider it evidence of the high level of interest
among those who treat hepatitis C," said Mani Subramanian, M.D., Ph.D.,
Senior Director of Clinical Research, Infectious Diseases, HGS.
Higher doses of Albuferon administered monthly, in combination with
ribavirin, will be explored in a separate Phase 2b trial conducted by
Novartis, which is expected to begin by year-end 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.
Under the worldwide 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
$132.5 million received to date.
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 with chronic hepatitis C. The
hepatitis C virus can cause serious liver disease, 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 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 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
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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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