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Executive Summary

IMCLONE/CHUGAI PACT PROVIDES UP TO $35 MIL. IN R&D FUNDING for Imclone System's totipotent stem cell factor research (T-SCF) program, the two firms announced Jan. 26. In exchange for bankrolling Imclone's efforts to develop a blood cell growth factor, Chugai will have the exclusive right to manufacture and market any resulting therapeutics in Japan and several other Far East countries; the two companies will have co-marketing rights in China. The roughly three-year collaboration does not involve any equity stake in Imclone. The potential $35 mil. investment by Chugai includes research support and milestone payments up to and including product approval in Japan. The goal is to develop blood cell growth factors for use as an adjunct to chemotherapy, radiation therapy and bone marrow transplants. The T-SCF program is being conducted in collaboration with Princeton and Johns Hopkins universities. A patent covering FLK-2, the receptor which binds the candidate totipotent stem cell factor, has been assigned to Princeton and licensed exclusively to ImClone. The company is currently characterizing the growth factor that binds to the FLK-2 receptor; there is no projected date for clinical trials. ImClone's lead product candidate, MelVax anti-idotypic antibody vaccine for malignant melanoma, has been in Phase I trials since November 1991; Phase II clinicals may begin sometime in 1994, the company said. A second anti-idiotype vaccine, LuVax for small cell lung carcinoma, is expected to enter the clinic by the end of the current quarter. In addition to Chugai, New York City-based ImClone's corporate partners include E. Merck, Erbamont, American Cyanamid and a recently-announced alliance with Abbott Labs. Abbott is providing an unspecified amount of research and milestone payments for rights to ImClone's diagnostics products, including the Repair Chain Reaction target amplification technology and AmpliProbe DNA/RNA probe system; a separate five-year R&D agreement gives Abbott rights to all diagnostic products and ImClone rights to all therapeutic products that are developed. ImClone went public in November 1991, raising approximately $32 mil. in net proceeds ("The Pink Sheet" Nov. 4, 1991, T&G-3). At the end of the FY 1993 second quarter (ended Sept. 30), the firm had cash and short-term investments of $17 mil. Recent developments include the appointment in early January of Kenneth Krantz, MD/PhD, to VP-clinical and regulatory affairs. Krantz, 46, was most recently executive director of clinical research in the biotechnology division of Johnson & Johnson's R. W. Johnson Pharmaceutical Research Institute. ImClone is in the process of completing a 54,000 sq. ft. manufacturing plant in Branchburg, N.J.

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