HGS To Focus On "Core Pipeline" As Part Of Cost Reduction Plan; CEO Steps Down
This article was originally published in The Pink Sheet Daily
Executive Summary
Human Genome Sciences plans to reduce its headcount by 20% and limit the number of drugs in early development. In 2004 and 2005, the company will focus on five products in immunology/infectious disease and oncology.
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Human Genome Sciences is implementing a cost reduction program to focus its resources on the clinical development of its immunology/infectious disease and oncology drug candidates. The company announced March 25 that it would be reducing its headcount by approximately 200 positions, or 20% of the total staff. Rockville, Md.-based HGS also plans to consolidate its facilities to "achieve greater efficiency." The cost reduction plan includes efforts to "reduce the number of drugs in early development," the company said. HGS is considering partnerships or outlicensing agreements for drug candidates that fall outside its current focus on immunology/infectious disease and oncology. HGS will take a one-time charge during the first quarter related to the cost reduction plan. During 2004 and 2005, the company will allocate the savings from the cost reduction plan to fund the clinical development for five "core pipeline" products. HGS' lead candidate is the auto-immune disease therapy LymphoStat-B, which is in development for systemic lupus erythematosus and rheumatoid arthritis. Both indications are in Phase II; the company expects to complete enrollment in both trials during 2004. LymphoStat-B was selected for FDA's continuous marketing application pilot 2 program in March. The application is under review by the therapeutic biologics division (1 (Also see "FDA’s Second Continuous Marketing Application Pilot Program Nearly 50% Enrolled" - Pink Sheet, 9 Mar, 2004.)). HGS is conducting a Phase I/II trial evaluating albuferon, a long-acting form of interferon alpha, in patients with hepatitis C who have failed previous interferon alpha treatments. The company expects to complete the trial this year. HGS also hopes to complete enrollment for a Phase II trial evaluating albuferon in patients naïve to interferon alpha therapy in 2004. In oncology, HGS is developing two TRAIL (tumor necrosis factor-related apoptosis-inducing ligand) receptor agonists for the treatment of solid tumors and hematological malignancies. The company is evaluating HGS-ETR1 in Phase I trials and expects to advance the agent to Phase II trials in 2004. HGS also plans to complete enrollment in two Phase I trials for HGS-ETR2 this year. Finally, HGS expects to file an IND for a human monoclonal antibody to the CCR5 receptor in late 2004. The company intends to develop the compound for the treatment of HIV. The same day, HGS announced that founder and CEO William Haseltine, PhD, will step down either in late 2004 or when the board selects his successor. Haseltine's decision to retire was prompted by the company's need for a CEO with late-stage product development experience, he said. "First and foremost, I am a scientist dedicated to pushing back the boundaries of knowledge for the betterment of human health," Haseltine said. "Our company now has a mature pipeline, which requires additional late-stage product development and commercial expertise to ready it for the marketplace." The CEO search will target candidates with "demonstrated skills" in product development, manufacturing, and pharmaceutical sales and marketing, Haseltine said. - Steele Thomas |