Human Genome Sciences, Inc (HGSI) announced that it is sharpening its focus in preparation for the commercialization of the company's most promising drug candidates. As part of this strategy, the company plans to reduce the number of drugs in early development and to focus resources on its drugs that address the greatest unmet medical needs with substantial growth potential.
The company will also embark on a cost reduction programme to include streamlining of operations, reduction of its staff, and consolidation of its facilities, which will substantially reduce projected future expenses. In addition, the company will look at business options for maximizing the value of its remaining early stage pipeline.
William A. Haseltine, Ph.D., chairman and chief executive officer of Human Genome Sciences, said, "It is only by bringing the benefits of genomics research to the market that patients will benefit. Successful late-stage development and marketing require an intense concentration and commitment to specific products. The changes announced today allow us to focus our efforts on bringing our most promising drug candidates to market. We are fortunate that genomics has provided our company with a wealth of exciting drug candidates. It is now up to us to bring these drugs to the patient. "
In a separate announcement, Dr. Haseltine announced that he plans to retire as chairman and CEO in 2004, but said that he will lead the company in implementing the refocused strategy and has asked the Board to work with him to identify a successor.
In 2004 and 2005, the company's primary focus will be clinical trials of its core pipeline, comprised of five products in two main therapeutic areas: immunology/infectious disease and oncology. These include: LymphoStat-B for the treatment of systemic lupus erythematosus and rheumatoid arthritis in Phase 2 trials; anti-TRAIL Receptor 1 and TRAIL Receptor 2 monoclonal antibodies for the treatment of cancer in Phase 1 trials; Albuferon for the treatment of chronic hepatitis C in Phase 1/2 trials; and an anti-CCR5 monoclonal antibody for the treatment of HIV/AIDS for which the company plans to file an Investigational New Drug application later this year.
The Company also holds significant royalty and co-promotion rights to several drugs in clinical trials by its partner, GlaxoSmithKline, including an inhibitor of the enzyme Lp-PLA2 for treatment of cardiovascular disease, which is scheduled to enter Phase 3 trials this year, and an inhibitor of a cathepsin enzyme for the treatment of osteoporosis.
Human Genome Sciences may also enter partnership or outlicensing agreements with other companies for the development of its clinical and preclinical drug candidates outside its current focus.
Human Genome Sciences also announced that it will reduce its workforce by approximately 200 positions, or about 20 per cent of the total staff. Employees who are affected will be eligible to receive severance pay, continuation of health benefits, and outplacement services. The company also expects to consolidate its facilities to achieve greater effectiveness. Human Genome Sciences plans to take a one-time charge to first quarter 2004 as a consequence of its refocusing activities.
Craig A. Rosen, Ph.D., president, research and development, said, "While the decision to reduce our staff is difficult, the streamlining of our operations and reduction of our expenditures will make it possible for us to concentrate our efforts and financial resources on those drugs that have the greatest potential and address significant unmet medical need. The sharpened focus on our most promising products, reduction in staff, and consolidation of facilities will substantially reduce our future expenses and help to ensure that our most promising drugs reach patients as soon as possible."
Among Human Genome Sciences' novel drugs in clinical development for immunology/infectious disease are:
LymphoStat-B, a human monoclonal antibody for the treatment of autoimmune diseases such as lupus and rheumatoid arthritis. The results of a Phase 1 clinical trial demonstrate that LymphoStat-B is safe, well tolerated and biologically active in patients with systemic lupus erythematosus. LymphoStat-B has received a Fast Track Product designation from the U.S. Food and Drug Administration (FDA) for the treatment of systemic lupus erythematosus, and was recently selected for inclusion in the FDA's new Continuous Marketing Application Pilot 2 Program. The Pilot 2 Program provides for more frequent scientific feedback and interactions between the FDA and participating companies. Human Genome Sciences currently is conducting Phase 2 clinical trials of LymphoStat-B in patients with systemic lupus erythematosus and in patients with rheumatoid arthritis. The Company expects to complete the enrollment of both Phase 2 trials of LymphoStat-B in 2004.
Albuferon, a novel long-acting form of interferon alpha for the treatment of chronic hepatitis C. Human Genome Sciences currently is conducting a Phase 1/2 clinical trial of Albuferon in adults with chronic hepatitis C who have failed previous interferon alpha treatments. Interim results reported to date demonstrate that Albuferon is well tolerated, has a prolonged half-life, and is biologically active. The company is continuing to evaluate Albuferon at higher doses, in single-dose and repeat-dose cohorts, under an amended protocol designed to seek the maximum biological response that can be achieved at a tolerable dose. In 2004, the Company expects to complete the ongoing Phase 1/2 trial, and to complete enrollment for a Phase 2 clinical trial of Albuferon in patients with chronic hepatitis C who are naove to treatment with interferon alpha.
Among Human Genome Sciences' novel drugs in clinical development for oncology are:
TRAIL Receptor 1 agonistic human monoclonal antibody (HGS-ETR1). HGS- ETR1 is a novel anticancer drug that specifically recognizes and binds to the TRAIL (tumour necrosis factor-related apoptosis-inducing ligand) Receptor 1 protein. Preclinical studies demonstrate that solid tumours and tumours of hematopoietic origin are sensitive to killing by apoptosis, or programmed cell death, induced by binding to HGS-ETR1. Because HGS-ETR1 mimics the activity of native TRAIL when it binds to TRAIL Receptor 1, it is considered an agonistic antibody. Human Genome Sciences currently is conducting Phase 1 clinical trials to evaluate the safety and pharmacology of HGS-ETR1 in patients with advanced solid tumours or hematological malignancies. The company expects to advance HGS-ETR1 to Phase 2 clinical trials in 2004.
TRAIL Receptor 2 agonistic human monoclonal antibody (HGS-ETR2). HGS- ETR2 specifically recognizes and binds to the TRAIL Receptor 2 protein, which is found on the surface of solid tumour and hematopoietic cancer cells. Human Genome Sciences currently is enrolling patients with advanced tumours into Phase 1 open-label, dose-escalating clinical trials of HGS-ETR2. The trials will evaluate HGS-ETR2's safety and pharmacology, and are being conducted in the United Kingdom and the United States. The Company plans to complete the enrollment of both Phase 1 trials of HGS-ETR2 in 2004.
In addition, Human Genome Sciences announced that it intends later this year to file an Investigational New Drug application for a human monoclonal antibody to the CCR5 receptor for the treatment of HIV/AIDS infection. The CCR5 receptor has been shown to be important for HIV entry into human cells. The Company's CCR5 antibody is intended to block entry of the HIV virus and its subsequent replication.