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| |  Halofuginone Receives FDA Orphan Drug Status For Scleroderma WABAN, MA and TEL AVIV, ISRAEL -- March 10, 2000 -- Collgard Biopharmaceuticals Ltd., today announced that it received orphan drug designation from the U.S. Food and Drug Administration (FDA) for halofuginone in the treatment of scleroderma. Halofuginone is a specific inhibitor of collagen type I synthesis and is the most advanced in a portfolio of products Collgard is developing to treat disorders, including cancer, restenosis and fibrosis, where tissue trauma and collagen turnover play an important role in the disease process. A topical formulation for the treatment of scleroderma is currently undergoing multicenter Phase II clinical trials in the United Kingdom. U.S. studies are planned to begin during 2000. "Orphan drug designation for halofuginone in the treatment of scleroderma affords Collgard the opportunity to help accelerate our efforts as part of our strategy to develop clinical opportunities for our products so they can be commercialized rapidly," said Dr. Neal Farber, Chief Executive Officer of Collgard Biopharmaceuticals. "This designation will allow us to expedite halofuginone's availability to the 150,000 people in the United States who suffer this debilitating disease. It is about four times more prevalent in women than men." Scleroderma is a chronic, autoimmune condition of the connective tissue. It can affect internal organs or be characterized by disfiguring skin damage as a consequence of excessive accumulation of collagen type I. The disease is serious, sometimes life threatening and there are no effective treatments. Collgard's clinical program is based in part on published animal models and human studies conducted by company researchers. Halofuginone is an orally bioavailable and extremely potent small molecule inhibitor of the synthesis of collagen type I and collagenase. Collagen I plays a critical role in a number of key cellular activities including: cell migration, cell proliferation and angiogenesis. Collgard scientists have mapped a broad array of diseases that are potentially amenable to treatment through the inhibition of collagen synthesis. In addition to Collgard's program for scleroderma, the company is conducting development programs with several systemic formulations of halofuginone for use in the prevention or The FDA's orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 U.S. residents. As a designated orphan drug, halofuginone is eligible for tax credits based upon its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. The designation provides the opportunity for halofuginone to obtain market exclusivity for seven years from the drug's approval date. Related links: Halofuginone, Collgard Biopharmaceuticals Ltd.
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