- 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.)
"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 COMMERCIALIly 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 firstname.lastname@example.org 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.ZATION
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
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
Also in 2008, Novartis plans to initiate a Phase 2 trial to evaluate monthly dosing of Albuferon in treatment-nave 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
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
-- 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
Key milestones leading to the Company's first product sales:
-- Begin delivery of ABthrax to the Strategic National Stockpile in fall
-- 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
-- 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
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 app
|SOURCE Human Genome Sciences, Inc.|
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