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Executive Summary

AMGEN INVESTING $26 MIL. IN REGENERON NEUROTROPHIC DRUG R&D in a pact to develop and commercialize Brain-Derived Neurotrophic Factor (BDNF) and Neurotrophin-3 (NT-3). Under a multiyear collaborative agreement announced Sept. 4, Amgen has acquired slightly more than 7% of Tarrytown, N.Y.-based Regeneron Pharmaceuticals for $15 mil. and paid the firm $1 mil. in licensing fees. The equity stake is convertible to preferred stock. Over the next two years, Amgen will fund $10 mil. in BDNF and NT-3 research and development. Additional payments are dependent upon the attainment of certain milestones. "Neurotrophic factors are believed to be crucial to the survival and maintenance of nerve tissues," Amgen said in the release on the agreement. Neurotrophic factors may be useful in treating "neurodegenerative diseases of the central nervous system, nerve injury or trauma." Amgen indicated that it is focusing on BDNF and NT-3 as therapies for peripheral neuropathies, such as those associated with chemotherapy, diabetes and AIDS. The neurotrophic factors also are active on the same types of nerve tissues involved in CNS disorders such as Parkinson's and, potentially, Alzheimer's, Amgen said. The collaboration is split into two parts along world markets. In the U.S., the project will be run as a joint venture partnership, Amgen-Regeneron Partners, once the products have reached IND status. Amgen has obtained the license to market all therapeutics derived from the agreement outside the U.S., with the exception of Japan and certain other Asian countries, where Regeneron investor Sumitomo Chemical has first rights of refusal. Regeneron will receive profits from U.S. sales and royalties from any non-U.S. sales. Privately held Regeneron was established in January 1988 and operates out of a 12,000 sq. ft. facility, soon to be expanded to 40,000-50,000 sq. ft. In addition to private financing by Sumitomo Chemical, Regeneron backers include Merrill Lynch Venture Capital. Beyond BDNF and NT-3, the company is also in preclinicals with ciliary neurotrophic factor (CNTF) and neurite growth regulatory factors for neurodegenerative diseases and CNS trauma. Amgen has first rights of negotiation to CNTF. The company was co-founded by President and CEO Leonard Schleifer, MD/PhD, a neurologist and pharmacologist formerly with Cornell University Medical Center. Regeneron's chief financial officer is Fred Middleton, who held the same position at Genentech from 1978-84. Regeneron's science advisory board includes Eric Shooter, PhD, chairman emeritus of Stanford University's neurobiology department. The company's three program directors are: Mark Furth, PhD, molecular biology, formerly with Oncogene Sciences; Ronald Lindsay, PhD, neurobiology program, formerly with Sandoz; and, Jesse Cedarbaum, MD, clinical program, formerly director of Cornell's Parkinson's and Movement Disorder and Burke Rehabilitation Clinics. The Regeneron agreement, reached after a 15-month search for a neurobiology drug development project, marks Amgen's first venture into the CNS drug R&D area and its first major in-licensing effort. The company joins a growing number of biotech and pharmaceutical firms making investments in smaller neurobiology start-ups with potential therapies for Alzheimer's, Parkinson's and other CNS and trauma-related disease states. For example, in February, Syntex put up $15 mil. and agreed to fund up to $50 mil. to support Synergen's efforts in nerve cell regeneration factors ("The Pink Sheet" Feb. 12, T&G-4). In June, Schering-Plough put $20 mil. behind Cephalon's R&D effort focusing on Alzheimer's drugs and the prevention of amyloid plaques ("The Pink Sheet" June 11, T&G-7).



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