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Executive Summary

PFIZER WILL PROVIDE CAL BIO DIABETES R&D VENTURE WITH $ 30 MIL. FUNDING over the next five years, the two companies noted in a joint Sept. 14 announcement. The Cal Bio research venture, Metabolic Biosystems, will focus on the development of diabetes and obesity pharmaceutical products in four years: improved insulins; insulin-releasing agents; insulin mimickers; and adipsin. "Pfizer and Meta Bio will share manufacturing and marketing rights for certain therapeutics in the U.S. and Canada, while Pfizer will hold exclusive manufacturing and marketing rights for therapeutics throughout the rest of the world," the two companies noted. "Research is being conducted in the laboratories of Cal Bio, Pfizer and various leading universities," the release states. The agreement also brings three leading medical researchers from Harvard Medical School into the research venture as co-founders of Meta Bio -- Jeffrey Flier, MD, Ronald Kahn, MD, and Bruce Spiegelman, PhD. The three will hold a 20% stake in Meta Bio while Cal Bio will control 80%. "Potential Meta Bio diabetes products will address the needs for improved performance of injected insulin and for the more natural and enhanced secretion of insulin in adult-onset diabetes," the release explains. The research programs for improved insulins and insulin releasing agents are the furthest along and are scheduled to enter animal trials in 1989, a Cal Bio spokesperson said. The venture is looking to improve insulin proteins to allow for more consistent management of blood sugar levels. The insulin releasing agents will be targeted at stimulating insulin release from the pancreas. The third area of diabetes product research, insulin mimickers, are still in early research, the spokesperson said. The agents will be developed as potential insulin replacements for insul-resistant Type II diabetes patients. Cal Bio's work on adipsin, a protein produced by fat storage cells, is also in early research. Adipsin will be studied to determine its relationship to metabolic obesity, the spokesperson said. "it is believed that addressing the fat cell and its role in obesity and the body's system of energy balance at the molecular level may lead to development of new obesity therapeutics," the two companies noted in the release. Cal Bio and Pfizer both have active diabetes-related research programs that will not be covered by the agreement. Cal Bio is working with Lilly on a nasal delivery form of insulin, Nazlin, which makes use of Cal Bio's Nazdel delivery system. Nazlin is scheduled to enter clinical trials before the year is out. Pfizer has been doing work in the area of aldose reductase inhibitors for the treatment and prevention of diabetic neuropathy for at least a decade. The company's lead aldose reductase inhibitor compound is sorbinil. The clinical program in support of sorbinil has been pared back due to a high incidence of rash associated with the drug. However, a long term study with the National Eye Institute is still is progress. Although Pfizer has begun considering related compound for clinical development, a limited clinical hold is in effect that essentially prevents the start of new clinical studies with aldose reductase inhibitors ("The Pink Sheet" May 2, T&G 1).

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