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Executive Summary

HOUSTON BIOTECH ANTI-CATARACT IND FOR IMMUNOTOXIN HB-1001 was submitted to FDA on July 31 for the 30-day waiting period/protocol review prior to the initiation of clinical trials. HB-1001, a surgical biopharmaceutical product, will be Houston Biotechnology's first product to enter human clinicals. The product is designed for use during initial cataract surgery to prevent the formation of secondary cataracts. The immunotoxin HB-1001 is "designed to selectively destroy any residual lens epithelial cells," which could grow, cloud the vision and later require laser surgery to destroy, the firm explained. In initial cataract surgery, the membrane surrounding the lens is not completely removed and frequently becomes clouded over from the residual epithelial cell growth. The resulting secondary cataracts are most commonly treated with laser surgery. Development and clinical trial costs are being supported by $26.1 mil. from a limited partnership, Houston Biotech Partners. Santen Pharmaceutical Co. Ltd. (Osaka) is paying $3 mil. for HB-1001 marketing rights in Japan. The HBP limited partnership is the largest investor in privately held Houston Biotechnology. In addition, five venture capitalists, including The Woodlands Venture Capital Company and Allstate Insurance of Chicago, have invested a total of $2.8 mil. in the company. The firm also raised $500,000 through a private placement. In addition to Santen, Houston Biotechnology has licensing agreements with Baylor College of Medicine, Sanofi S.A. and Stanford University. Houston Biotechnology holds an equity position in GES Pharmaceuticals in the neurological products R&D area. The company has R&D and collaborative agreements with: Baylor College of Medicine, Beijing General Pharmaceutical Corp., Los Angeles-based Doheny Eye Institute, Hong Kong Institute of Biotechnology, Houston Advanced Research Center, Luc Tissot Development d'Enterprise, and the Chinese University of Hong Kong. Further back in Houston Biotech's pipeline are "immunotoxin/immunoconjugates for proliferative vitreoretinopathy and glaucoma filtering surgery" and therapeutic products for glaucoma and "retinal and optic nerve disorders." The company also has projects underway on autoimmune disease therapies and "antiviral compounds composed of naturally occurring substances." The company was founded in 1984 by Dominic Man-Kit Lam, PhD, and Jared Emery, MD, both professors at the Baylor College of Medicine. They licensed the technology for HB-1001 from Baylor. David Leech has been president and CEO since November 1988. Before joining Houston Biotech, Leech spent 10 years with American Cyanamid in its Warner-Lambert Pharmaceutical, Cyanamid Americas Far East, Cyanamid Nordiska, and Davis & Geck Medical Device divisions; Leech served as VP of Davis & Geck. Houston Biotech recorded losses of $700,000 in 1989, $1.2 mil. in 1988 and $1.7 mil. in 1987. Revenues were $3.9 mil., $3.1 mil. and $1.5 mil. respectively. Houston Biotech (headquartered in The Woodlands, Tex.) has research facilities of approximately 20,000 square feet.

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