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Executive Summary

J&J/AMGEN R&D AND MARKETING AGREEMENT COVERS THREE DNA COMPOUNDS; erythropoietin, interleukin-2, and a hepatitis B vaccine. The agreement-in-principle, announced Aug. 19, covers the clinical development, manufacturing and marketing of the three genetically engineered pharmaceutical compounds. In addition, the joint venture agreement "calls for milestone payments to Amgen which are expected to exceed $6 mil. during its current fiscal year ]ending March 31,1986[, and substantial payments in future years," a joint release noted. The two firms added that the arrangement is "subject to negotiation of a definitive agreement." Under the agreement, J&J will have "certain marketing rights to erythropoietin in the U.S.," the release states. Amgen said it has retained some U.S. marketing rights. In addition, J&J and Kirin-Amgen, a 50-50 joint venture to develop and market erythropoietin, said in a separate release on Aug. 20 that they reached an agreement-in-principle providing J&J with worldwide marketing rights outside of China, Japan, and unspecified markets in the U.S. Amgen entered into the $24 mil. joint venture with the Japanese firm, Kirin, in May 1984 covering development and marketing of the drug for kidney dialysis- induced anemia. That earlier agreement had given Kirin exclusive marketing rights for Amgen's erythropoietin in Japan and the right to co-market the drug worldwide except in the U.S. The agreement with Amgen also gives J&J worldwide marketing rights for interleukin-2 as well as exclusive marketing rights to the hepatitis B vaccine in all countries except China, the release notes. Amgen said it expects all three products to reach clinical development by the end of calendar year 1985. "All three products will be marketed and sold by Ortho Pharmaceutical and other J&J companies," the release notes. "Amgen and J&J will share manufacturing and profits from sales." In addition to its ties with Kirin and J&J, Amgen also has product development agreements with Abbott covering DNA hybridization probes; with Upjohn covering bovine growth hormone; and with Texaco covering work in specialty chemicals. For J&J, the agreement with Amgen represents the firm's first public relationship with a biotech company aimed at the development and marketing of pharmaceutical compounds. Also in the biotech area, J&J has an active in-house immunobiology group at Ortho Pharmaceutical, which has developed a number of monoclonal antibody tests marketed by Ortho Diagnostics and is currently looking at therapeutic uses for its monoclonal antibodies. In addition, J&J has agreements with Enzo Biochem covering DNA probes; Cambridge Bioscience for work on a second generation AIDS test; and Scripps Institute.

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