Human Genome Sciences Completes Financing for Process Development and Manufacturing Expansion

Human Genome Sciences, Inc. (HGS; Rockville, MD) has completed financing for an expansion to its Process Development and Manufacturing facility. The expansion is being constructed by the Maryland Economic Development Corp. – essentially the state of Maryland – which will lease the Facility to HGS under a long-term arrangement. Financing was provided by Allfirst Bank and First Union National Bank, with continued support from the State of Maryland. Allfirst was involved in financing the first phase of the facility with the State of Maryland.

HGS dedicated the first phase of its 80,000 square foot, $42 million Process Development and Manufacturing Facility in April 1999. The expansion, totaling 43,000 square feet of additional space at a cost of $17.5 million, is expected to be completed next winter. The facility will house a mammalian cell cGMP production line to manufacture human gene-, protein-, and antibody- based drugs for use in human clinical trials and initial sales launch. The facility's configuration permits the simultaneous production of multiple products and is designed to provide HGS with broadened capability for the production of novel drugs.

With the capacity to support initial, late-stage clinical trial requirements and initial launch quantities of biotech drugs, the expansion serves HGS's immediate manufacturing needs. HGS will address requirements for more manufacturing capacity when and if their drugs are approved.

Whatever happens between now and possible product approvals, it's a good bet that HGS will continue to expand their existing facilities rather than farm manufacturing work out to contractors. That makes perfect sense for a small company which intends to become a fully integrated pharmaceutical company. The biotech landscape is strewn with defunct companies that had this same vision but HGS has approached the challenge of full vertical integration differently than most biotech startups of the past. Even before they went public and long before they needed such expertise, HGS made sure it employed a core of professionals with experience in biopharmaceutical manufacturing. In its journey towards full integration, therefore, HGS has decided to keep tight control over quality and production schedules.

Construction of the first phase of HGS' Process Development and Manufacturing Facility began in late 1997 and was completed in January 1999. It is located on a 10-acre site on the Johns Hopkins Belward Research Campus, a 138-acre tract to be developed by Johns Hopkins University in Montgomery County. Adjacent to the Shady Grove Life Sciences Center, the Facility is just minutes from HGS' 180,000 square feet of headquarters and laboratory facilities, which house the rest of HGS' nearly 500 employees. The Facility is designed to manufacture novel human gene-, protein- and antibody-based drugs, all of which are based on novel genes discovered by HGS.

Technology and Development
Part of HGS's roadmap for success is its highly focused genomics technology base which offers a number of exciting product opportunities. On February 15 the company announced it had received a patent for the gene coding for the CCR5 receptor, which serves as the entry point on cells for invading human immunodeficiency virus. Scientists learned years ago that individuals lacking the CCR5 receptor were astonishingly resistant to HIV infection. Blocking the receptor would prevent infection of new cells, perhaps opening a window of opportunity for eliminating the virus completely in infected individuals.

In addition to CCR5, HGS has an active pipeline of early-stage drugs and three drugs undergoing four clinical trials:

Myeloid Progenitor Inhibitory Factor-1 (for cancer) is believed to protect hematopoietic progenitor cells in the bone marrow from the effects of cancer chemotherapy. Depletion of the body's ability to form new red and white cells and platelets is a common side effect of chemotherapy and ultimately limits the number of cancer treatments that may be administered to a patient. Pre-clinical study results suggest that MPIF-1's protective effect is achieved by inhibiting proliferation and/or differentiation of these cells. MPIF-1 may allow oncologists to treat cancer patients with fewer interruptions and delays, and perhaps with more potent doses of chemotherapy.

Keratinocyte Growth Factor-2 (wound healing): Healing of chronic wounds to the skin is a major unmet medical need. Currently available treatments for wounds, such as venous, diabetic and pressure ulcers, have limited effectiveness. The patient populations for these indications are significant, totaling almost 3,000,000 patients in the U.S. and 6,000,000 patients in the US and Europe combined.

Keratinocyte Growth Factor-2 (mucositis/cancer): A second serious side effect of cancer treatment is damage to the body's mucosal tissues that line the mouth, intestine, colon, bladder, and lung. This damage results in painful lesions of the mucosal tissue, which prevents patients from eating and often results in a suspension of cancer treatments. At present there is no effective drug to treat chemotherapy-induced mucositis. Pre-clinical studies show that when administered by injection, KGF-2 lessens the severity of injury and speeds healing of injured mucosal tissues. Later this year, HGS plans to initiate Phase II human clinical trials to examine the effectiveness of KGF-2 in healing damage to mucosal tissues induced by cancer treatment.

Vascular Endothelial Growth Factor-2 (vascular disease): Vascular diseases of the heart and limbs pose a major unsolved medical challenge. Coronary artery disease afflicts more than 6,000,000 patients in the U.S. per year. Many of these patients have progressive disease, which may lead to angina. Some 482,000 patients require angioplasty and another 367,000 undergo coronary artery bypass surgery each year. Peripheral arterial disease of the limbs is relatively common, causing symptoms in about 1,800,000 patients in the U.S. each year and hospitalization of approximately 225,000 of these patients. Between 75,000 to 150,000 patients per year suffer from critical limb ischemia, a progressive disease that may cause intense pain at rest. Its current treatment often concludes with amputation. Pre-clinical studies showed that a DNA drug, based on the Vascular Endothelial Growth Factor-2 gene (VEGF-2), is active in the formation of new blood and lymph vessels (angiogenesis) when injected directly into both skeletal and cardiac muscle tissues.

Phase I/II human clinical trials of VEGF-2 for the treatment of critical limb ischemia were announced in December 1998. Another series of Phase I/II trials of VEGF-2 are anticipated to begin in 1999 to test its safety and efficacy as a treatment of chronic angina. The VEGF-2 clinical program is being conducted in collaboration with Vascular Genetics Inc., a joint-venture company in which HGS has a significant ownership interest and was founded to develop DNA drugs for the treatment of vascular disease.

For more information: Kate DeSantis, Human Genome Sciences, 9410 Key West Ave., Rockville, MD 20850-3338. Tel: 301-309-8504. Fax: 301-309-8512.

By Angelo DePalma