ROCKVILLE, Md., Jan. 23 /PRNewswire-FirstCall/ -- Human Genome Sciences
Inc. (Nasdaq: HGSI) announced today that it will modify the dosing in one
arm of each of its ACHIEVE clinical trials of Albuferon(R) (albinterferon
alfa-2b) for chronic hepatitis C. Patients in the Phase 3 trials who have
been receiving the 1200-mcg dose will now receive a 900-mcg dose. The
change is based on recommendations made by the studies' independent Data
Monitoring Committee (DMC). HGS continues to expect to have all Phase 3
data available by spring 2009 to support the filing of global marketing
authorization applications by fall 2009.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"For some time we have viewed the 900-mcg dose administered every two
weeks as the most likely marketed dose of Albuferon," said H. Thomas
Watkins, President and Chief Executive Officer, HGS. "The 900-mcg dose
demonstrated comparable efficacy and safety to Pegasys in Phase 2 - with
half the injections, improvements in quality of life and fewer missed days
of work during treatment. We continue to believe that Albuferon could
become the market-leading interferon for the treatment of hepatitis C if
Phase 2 900-mcg results are confirmed in Phase 3."
Consistent with its charter, the DMC routinely reviews all adverse
events for each treatment group. Serious pulmonary adverse events, while
expected and rare during interferon therapy, were higher in the treatment
group receiving 1200-mcg Albuferon administered every two weeks. The DMC
did not express any safety concerns about the 900-mcg dose of Albuferon.
Based on the DMC's review and conclusions, the patients receiving a
1200-mcg dose of Albuferon will be moved to the 900-mcg dose.
"The independent Data Monitoring Committee for these trials assessed
risk/benefit based on review of unblinded safety and efficacy data for all
doses, to which HGS remains blinded, and concluded that dosing should be
modified for patients receiving the 1200-mcg dose of Albuferon every two
weeks," said David C. Stump, M.D., Executive Vice President, Research and
Development, HGS. "HGS and Novartis have chosen to accept the Data
Monitoring Committee's recommendation to modify dosing in the 1200-mcg arms
in these studies. We are pleased that after careful review by the Data
Monitoring Committee, the safety and continued dosing of 900-mcg Albuferon
was affirmed. Thus, all Albuferon patients will now receive 900-mcg every
two weeks."
About Albuferon
Albuferon is a novel, longer-acting form of interferon alpha that was
created using the proprietary HGS albumin-fusion technology. Recombinant
interferon alpha is approved for the treatment of hepatitis C, hepatitis B
and a broad range of cancers. HGS is currently conducting two pivotal Phase
3 clinical trials of Albuferon in combination with ribavirin: ACHIEVE 1 in
treatment-naive patients with genotype 1 chronic hepatitis C, and ACHIEVE
2/3 in treatment-naive patients with genotype 2 or 3 chronic hepatitis C.
Albuferon requires half as many injections as Pegasys, and Phase 2
clinical results suggest that Albuferon could offer efficacy and safety
comparable to Pegasys, in addition to the potential for improved quality of
life and fewer lost days of work on treatment. Based on these data, HGS
believes that Albuferon could become the market-leading interferon for the
treatment of hepatitis C if Phase 2 results are confirmed in Phase 3
trials.
Albuferon is being developed by HGS and Novartis under a worldwide co-
development and commercialization agreement entered into in June 2006.
ACHIEVE 1 and ACHIEVE 2/3, assuming that they are successful, will provide
the pivotal data to support global marketing authorization applications for
Albuferon, which HGS and Novartis expect to file by fall 2009.
Conference Call
HGS management will hold a conference call to discuss this announcement
today at 10 AM Eastern time. Participants may listen to the call by dialing
888-690-2876 or 913-981-5550, passcode 8463866, 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 8463866.
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, 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 cancer. AEG40826, a small-molecule
antagonist of IAP (inhibitor of apoptosis) proteins, is expected to enter
Phase 1 clinical trials for the treatment of cancer in early 2008.
For more information about HGS, please visit the Company's web site at
http://www.hgsi.com. 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
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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