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Executive Summary

MARION MERRELL DOW MOVING INTO DIABETES, AGING DRUG THERAPIES under a development and commercialization agreement with Geritech, Inc. Announced Dec. 19, the strategic alliance's initial efforts will focus on aminoguanidine for diabetic complications. The compound "eventually may yield treatments for some health effects of aging," Geritech says. Protocols for Phase II/III clinical trials in the areas of diabetic neuropathy and end-stage renal disease will be discussed with FDA in mid-January, the companies said. Phase I studies began in 1987. Under the agreement, MMD will provide funding to continue clinical development of aminoguanidine and "possibly other Geritech compounds." The companies will execute a strategy providing for joint marketing in North America and some European markets and giving MMD exclusive rights in some markets in western Europe, Latin American, Australia and New Zealand. In addition, Marion Merrell Dow has acquired an 8% equity position in privately held Geritech, along with the right of first negotiation for ancillary technologies developed by the firm. Aminoguanidine, Geritech's lead compound, is an outgrowth of research by Rockefeller University Professor Anthony Cerami, PhD, and colleagues. Cerami's team discovered that "certain diabetic complications appear to result from biochemical reactions between proteins and the blood sugar glucose," Geritech said. "These reactions lead to protein cross-linking and hardening of tissues, as in artherosclerosis and stiffening of joints." Geritech, founded in 1986 and headquartered in Northvale, New Jersey, has exclusive rights to aminoguanidine and Rockefeller provides its discovery research. Geritech's Chairman, President and CEO is former Squibb, Warner-Lambert and Monsanto veteran Charles Faden. Faden spent 16 of his 30 years in the pharmaceutical industry with Squibb, heading the company's European and Latin American operations and holding a variety of marketing and general manager jobs in the U.S. and Asia. He ended his Squibb career as president of E. R. Squibb & Sons, Inc. in 1978, when he left to join Warner-Lambert. In 1983 Faden moved to Monsanto and helped prepare for that company's entry into health care with the acquisition of Searle. Faden joined Geritech in 1987. The company entered into its first alliance in October 1989 with Yamanouchi Pharmaceutical of Tokyo. In return for an undisclosed sum of money upfront and funding commitments for preclinical R&D and long-term toxicology work, Yamanouchi has an exclusive license for Geritech's core technologies in Japan and other Asian markets. The agreement also conferred a nearly 8% stake in Geritech to Yamanouchi. Geritech's seed funding round in 1987 yielded $2 mil. In 1988, the company raised an additional $6 mil. in venture capital backing. With the addition of funding commitments from Yamanouchi and now MMD, the company has raised $33 mil. in cash. In addition to its lead compound aminoguanidine, Geritech is in preliminary development of a number of other projects, including macrophage activator compounds.

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