- Albuferon(R) for hepatitis C and LymphoStat-B(R) for lupus on track for
potential launch in 2010 -
- ABthrax(TM) for inhalation anthrax on track to begin delivery fall 2008 -
- Pipeline strengthened with investments in oncology portfolio and new
targets initiative -
- GSK to advance darapladib to Phase 3 for atherosclerosis -
ROCKVILLE, Md., May 28 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) today will report significant progress for its three
late-stage products and outline plans to drive future growth at a meeting
of financial analysts and investors in New York. (A webcast of today's HGS
Analyst and Investor Meeting may be accessed at http://www.hgsi.com, beginning at
12:00 P.M. Eastern time.)
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"Our Phase 3 products are making substantial progress toward
commercialization," said H. Thomas Watkins, President and Chief Executive
Officer, HGS. "Both Albuferon and LymphoStat-B are on track for potential
launch in 2010, and we expect our first product sales after we begin
delivery of ABthrax to the Strategic National Stockpile in fall 2008. At
the same time, we are building our pipeline through several new
initiatives, including investing in the expansion of our oncology
portfolio. In addition, GSK plans to advance darapladib to Phase 3
development for the treatment of atherosclerosis."
During today's Analyst and Investor Meeting, HGS executives will
highlight the following key areas:
LATE-STAGE PRODUCTS: ON TRACK TO COMMERCIALIZATION
Albuferon(R) (albumin-interferon alpha 2b), a novel long-acting form of
interferon alpha for the treatment of chronic hepatitis C
At the 900-mcg dose now being studied in Phase 3, Albuferon requires
half as many injections as Pegasys (peginterferon alfa-2a). Final Phase 2b
results in treatment-naive patients, presented in November 2007 at the
Annual Meeting of the American Association for the Study of Liver Diseases,
demonstrated that the 900-mcg dose of Albuferon every two weeks provided
efficacy comparable to Pegasys, with comparable safety, the potential for
less impairment of health-related quality of life on treatment, and
significantly fewer working patients reporting missed days of work.
Albuferon is being developed by HGS and Novartis under an exclusive
worldwide co-development and commercialization agreement entered into in
June 2006.
Recent progress: In April 2008, HGS completed the treatment phase of
ACHIEVE 2/3, one of two Phase 3 trials of Albuferon (albinterferon alfa-2b)
in combination with ribavirin in treatment-naive patients with chronic
hepatitis C. The Company expects to complete the treatment phase of ACHIEVE
1 in July 2008. Data were presented in April 2008 at the Annual Meeting of
the European Association for the Study of the Liver, which showed that
Albuferon's pharmacodynamic characteristics and ability to maintain
effective blood levels for a longer period of time than is seen with other
long-acting interferons may make it an effective component of future
combination treatment with novel antivirals for the treatment of chronic
hepatitis C.
Key milestones leading to a potential launch of Albuferon in 2010:
-- Complete the treatment phase of ACHIEVE 1, the Phase 3 trial in
genotype 1 chronic hepatitis C, in July 2008.
-- First Phase 3 data available before the end of 2008 (from ACHIEVE 2/3,
the trial in genotypes 2 and 3 chronic hepatitis C).
-- All Phase 3 data available by spring 2009.
-- Planned filing of global marketing authorization applications by fall
2009.
Also in 2008, Novartis plans to initiate a Phase 2 trial to evaluate
monthly dosing of Albuferon in treatment-naïve patients with genotypes 2
and 3 chronic hepatitis C.
LymphoStat-B(R) (belimumab), a human monoclonal antibody that
neutralizes BLyS(TM) (B-lymphocyte stimulator), for the treatment of
systemic lupus erythematosus SLE
In November 2007, Phase 2 results were presented at the Annual
Scientific Meeting of the American College of Rheumatology, which
demonstrated that LymphoStat-B achieved a sustained improvement in disease
activity across multiple clinical measures, decreased the frequency of
disease flares over time, and was generally well tolerated through 2.5
years on treatment in combination with standard of care in patients with
active SLE. The results through 2.5 years confirm and extend the data
presented at previous scientific meetings at earlier time points, including
a significant reduction in SLE disease activity as measured by the response
rate chosen as the primary efficacy endpoint of the Phase 3 trials.
LymphoStat-B is being developed by HGS and GSK under a co-development and
commercialization agreement entered into in August 2006.
Recent progress: In April 2008, HGS completed enrollment and initial
dosing in BLISS-52, one of two pivotal Phase 3 clinical trials of
LymphoStat-B in patients with active SLE. Completion of enrollment for the
other pivotal Phase 3 trial, BLISS-76, is expected by the end of summer
2008. The LymphoStat-B BLISS program is the only Phase 3 program in SLE
with a protocol design informed by prior randomized data.
Today's therapy for SLE patients involves a variety of
immunosuppressive and cytotoxic agents, with prednisone as the mainstay.
These existing treatments are generally considered inadequate because of
their significant side effects and their inability to adequately control
disease symptoms and progression. HGS market research suggests that
LymphoStat-B, assuming Phase 3 trials are successful, could play a major
role in the treatment of SLE, with a differentiated profile for use in
chronic therapy.
Key milestones leading to a potential U.S. launch of LymphoStat-B in 2010:
-- Complete enrollment and initial dosing in BLISS-76, one of two Phase 3
trials of LymphoStat-B in patients with active SLE, by the end of
summer 2008.
-- First Phase 3 data available by mid-2009 (from BLISS-52), the second
Phase 3 trial of LymphoStat-B in patients with active SLE.
-- All Phase 3 data available in fall 2009.
-- Planned filing of a Biologics License Application (BLA) in early 2010.
HGS today also announced that HGS and GSK have agreed to initiate a
Phase 2 trial of LymphoStat-B for use in the treatment of multiple
sclerosis (MS). Patients with MS continue to have unmet medical needs
despite the treatments currently available. The scientific rationale for
testing LymphoStat-B in MS is strong, since the drug acts by inhibiting the
activity of BLyS(TM), a protein discovered by HGS, which is found at
elevated levels in MS lesions and is associated with the MS disease
process. In addition, the results of a Phase 2 trial of rituximab provided
clinical validation for B-cell modulation in the treatment of
relapsing-remitting MS.
ABthrax(TM) (raxibacumab), a human monoclonal antibody that prevents
anthrax toxins from entering and killing cells, for the treatment of
anthrax disease
HGS reported in December 2007 that the results of two animal studies
demonstrated the life-saving potential of ABthrax in the treatment of
inhalation anthrax. The results show that a single dose of ABthrax,
administered without the use of antibiotics, improved survival rates by up
to 64 percent when administered after animals were already showing symptoms
of anthrax disease as a result of inhalation exposure to massively lethal
doses of anthrax spores. These dramatic and statistically significant
findings demonstrate a survival benefit in two animal species, which is the
requirement for establishing the efficacy of new drugs used to counter
bioterrorism. ABthrax is being developed under contract with the Biomedical
Advanced Research and Development Authority (BARDA) of the U.S. Department
of Health and Human Services (HHS).
Recent progress: In May 2008, HGS submitted the final data package to
BARDA and FDA, which is required to support authorization of delivery to
the Strategic National Stockpile. The Company is currently manufacturing
ABthrax on schedule to begin delivery of 20,000 doses to the Stockpile by
fall 2008. HGS has conducted multiple safety studies of ABthrax in more
than 400 adult human volunteers. Final safety follow-up and data collection
are underway to support a BLA submission in 2009. Neither the additional
safety data nor the BLA submission are required for delivery to the
Stockpile.
In June 2006, the U.S. Government exercised its option to purchase
20,000 doses of ABthrax for the Strategic National Stockpile. The purchase
award was made under the Project BioShield Act of 2004, which is designed
to accelerate the development, purchase and availability of medical
countermeasures for the Stockpile. HGS expects to receive $165 million in
revenue from the award. In addition, there is potential for future orders
for ABthrax from the U.S. Government or from other governments friendly to
the U.S.
Key milestones leading to the Company's first product sales:
-- Begin delivery of ABthrax to the Strategic National Stockpile in fall
2008.
-- Receive $100-120 million in revenues in late 2008.
INVESTMENT IN NEW INITIATIVES TO BUILD THE HGS PIPELINE
Oncology Portfolio: A Key Driver of Future Growth
As the Company's late-stage products are nearing commercialization, HGS
is investing strategically to expand and advance its oncology portfolio
around its leading expertise in the apoptosis, or controlled cell death,
pathway. This strategy involves a series of actions.
HGS advanced HGS-ETR1 (mapatumumab) to a proof-of-concept phase,
consisting of three randomized chemotherapy combination trials to evaluate
its potential in the treatment of specific cancers:
-- Advanced multiple myeloma. The enrollment and initial dosing of 105
patients has been completed in a randomized Phase 2 trial of HGS-ETR1
in combination with Velcade (bortezomib).
-- Advanced non-small cell lung cancer. 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.
-- Hepatocellular cancer. In April 2008, HGS announced plans to initiate
a randomized trial of HGS-ETR1 in combination with Nexavar (sorafenib)
in patients with advanced hepatocellular cancer.
HGS-ETR1 is the most advanced of any product in development that
targets the TRAIL apoptosis pathway.
HGS added the new opportunity to develop and commercialize HGS1029 and
other small-molecule IAP inhibitors for the treatment of cancer through a
strategic transaction entered into in December 2007 with Aegera
Therapeutics. The HGS TRAIL receptor antibodies and small-molecule IAP
inhibitors represent two different highly targeted approaches targeting
different points in the apoptosis pathway. Each is able to cause cancer
cells to die selectively. When IAP (inhibitor of apoptosis) proteins are
over-expressed in cancer cells, they can help cancer cells resist apoptosis
and resume growth and proliferation. The IAP inhibitors are a novel class
of compounds that block the activity of IAP proteins, thus allowing
apoptosis to proceed and causing the cancer cells to die.
The initiation of dosing is imminent in a Phase 1 clinical trial of
HGS1029 in patients with advanced solid tumors. Preclinical studies of
HGS1029 in combination with the Company's TRAIL receptor antibodies
demonstrated 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 plans to develop its
TRAIL receptor antibodies and IAP inhibitors in combination with one
another and in combination with other therapeutic agents.
HGS reacquired the rights to its TRAIL receptor antibodies from GSK in
April 2008 in return for a reduction in royalties due to HGS if Syncria(R)
(albiglutide) 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.
HGS views the oncology portfolio as a key driver of future growth
beyond the launch of the Company's late-stage products. Reacquiring the
rights to HGS-ETR1 and HGS-ETR2 (lexatumumab) gives HGS the opportunity to
drive and advance this important program more aggressively by enabling the
exploration of new alliances with a more optimal structure that could bring
development expertise and resources, commercial leadership, near-term
milestone payments and cost-sharing. HGS is also capable financially and
organizationally of taking the TRAIL receptor antibodies forward on its
own, thus retaining 100% of the value.
Key milestones of advancement for the HGS oncology portfolio:
-- Potential new alliance(s) for TRAIL receptor antibodies.
-- Initiation of HGS1029 Phase 1 trial in solid tumors imminent.
-- Initiation of HGS-ETR1 randomized trial in hepatocellular cancer.
-- Data expected from HGS-ETR1 Phase 2 trial in multiple myeloma in the
third quarter of 2008.
-- Data expected from HGS-ETR1 Phase 2 trial in non-small cell lung cancer
in 2009.
New Targets Initiative to Feed Early-Stage Pipeline
HGS has a rich heritage of scientific discovery that has produced a
vast intellectual property estate and a library of thousands of therapeutic
and diagnostic targets. Over the past couple of years, HGS has conducted a
careful review and selected approximately 50 targets for further research
and potential development, with the goal of filing new IND's in 2010-2011.
HGS plans to develop the selected targets through co-development or
research collaborations, as well as through its own internal research,
including the application of antibody development technology from
collaborators such as Cambridge Antibody Technologies and Xencor.
DARAPLADIB ADVANCING TO PHASE 3 TRIALS FOR THE TREATMENT OF
ATHEROSCLEROSIS
Darapladib, a small-molecule inhibitor of Lp-PLA2, was discovered by
GSK based on HGS technology. HGS will receive a 10% royalty on worldwide
sales of darapladib if it is commercialized, and also has a 20%
co-promotion option in North America and Europe.
In April 2008, GSK announced that it intends to advance darapladib to
Phase 3 clinical trials as a potential treatment for atherosclerosis and
will shortly start discussions with regulators regarding the structure of
the darapladib Phase 3 program. Darapladib has the potential to be an
important treatment for atherosclerosis.
At the American College of Cardiology's 57th Annual Scientific Session
in March, GSK presented data from a randomized Phase 2 dose-ranging trial
of darapladib in patients with coronary heart disease (CHD). The study
showed that darapladib produced sustained, dose-dependent inhibition of
plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in
patients receiving intensive atorvastatin (cholesterol-lowering) therapy.
Lp-PLA2 is an enzyme associated with the formation of atherosclerotic
plaques and identified in clinical trials as an independent risk factor for
CHD and ischemic stroke. Changes in biomarkers suggested a possible
reduction in systemic inflammatory burden. In addition, GSK stated in
February 2008 that the results of its randomized Phase 2/3 imaging trial of
darapladib in coronary artery disease will be presented and published in
the second half of 2008.
SYNCRIA(R): POSSIBLE PHASE 3 DECISION IN 2008
Syncria (albiglutide) is a novel long-acting form of GLP-1
(glucagon-like peptide 1) created by HGS using its proprietary
albumin-fusion technology, and licensed to GSK in 2004. Syncria is
generated from the genetic fusion of human albumin and GLP-1, a peptide
hormone that acts throughout the body to help maintain normal blood-sugar
levels and to control appetite. GSK is developing Syncria as a treatment
for type 2 diabetes mellitus, and initiated a randomized Phase 2b
dose-ranging clinical trial of Syncria in May 2007 in patients with type 2
diabetes. As a comparison, one group of patients is receiving Byetta
(exenatide).
HGS is entitled to fees and milestone payments, some of which have
already been received, that could amount to as much as $183 million, in
addition to single-digit royalties on worldwide sales if Syncria is
commercialized. HGS believes it is possible that GSK will reach a decision
in 2008 regarding whether to advance Syncria to Phase 3 development.
HGS ANALYST DAY WEBCAST
HGS senior executives will provide an overview of the Company at its
Analyst and Investor Meeting today in New York, starting at 12 noon Eastern
time. The presentations will be webcast and may be accessed at
http://www.hgsi.com. Investors interested in listening to the live webcast should
log on before the presentations begin in order to download any software
required. The archive of the presentations will be available for several
days following the meeting.
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. The initiation of dosing is
imminent in a Phase 1 trial of HGS1029, a small-molecule antagonist of IAP
(inhibitor of apoptosis) proteins, in patients with advanced solid tumors.
In addition, HGS has substantial financial rights to three 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 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, and we
will not receive any of the expected revenues relative to ABthrax. 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/20080416/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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