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GENETICS INSTITUTE HOPES TO FIND NPA LICENSING PARTNER

Executive Summary

GENETICS INSTITUTE HOPES TO FIND NPA LICENSING PARTNER "in the not too distant future" to help with the development of its novel plasminogen activator, Senior VP-Finance and Administration Garen Bohlin told a Robertson Stephens conference Nov. 29. Bohlin said Genetics Institute is "looking to hook up with" a company in the U.S. and/or Europe "with a substantial cardiovascular R&D and marketing" presence. The development of a licensing stategy for the thrombolytic agent marks a change from plans outlined earlier this year by Genetics Institute. In a July prospectus, the biotech firm said NPA would be a self-funded project. Bohlin predicted that clinical studies of NPA will be initiated "no later than mid or fall 1990" in heart attack patients. Preclinical test results comparing a single injection of NPA versus TPA demonstrate that NPA requires a much lower dose -- "a fraction" of TPA, Bohlin said -- and that the agent "has reduced side effects and is cost comparative." * Finding a licensing partner for NPA is one of seven goals Genetics Institute hopes to achieve over the next 12 months, Bohlin said. Others include the launch of its EPO product Marogen; the PLA filings for Factor VIII and GM-CSF; initiation of Phase III studies for M-CSF; and finding a Japanese collaborative partner for the development of bone growth factors for fracture healing, periodontal disease and reconstructive bone surgery. The filing of a PLA for Genetics Institute's recombinant Factor VIII is "imminent," Bohlin reported. He predicted that Factor VIII could reach the market for hemophilia A by 1991. Genetics Institute's portion of the PLA has been completed and the company's partner in the Factor VIII project, Baxter, is putting the finishing touches on the filing, he indicated. The blood clotting protein product from Genetics Institute/Baxter is "roughly neck and neck" with the Genentech/Cutter product, Bohlin maintained and forecast "basically simultaneous" FDA review of the two products. The PLA filing for biosynthetic granulocyte macrophage colony stimulating factor (GM-CSF) for immune deficiency disorders will be in "early 1990," Bohlin noted. The PLA will seek three indications: AIDS, bone marrow transplant therapy and chemotherapy. The product will be co-marketed by Sandoz and Schering-Plough. Bohlin predicted a "fairly expeditious review" by FDA both of his company's product and of the GM-CSF from Immunex. Phase I/II clinicals for M-CSF (macrophage colony stimulating factors) for the treatment of solid tumors and the restoration of bone marrow have been underway since last year and Genetics Institute hopes to have "at least one pivotal Phase III study going by the end of 1990," Bohlin said. Results to date show "no toxicity and see good efficacy at low doses for bone marrow restoration." He noted that "in cancer, we see good increases at low doses." The company has not yet begun dose escalation studies. Genetics Institute also anticipates a 1990 start-up of human trials for M-CSF as a cholesterol-lowering agent.

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