- 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 -
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 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 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
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.
