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Executive Summary

CHUGAI-UPJOHN MAROGEN (ERYTHROPOIETIN) PLA FOR ANEMIA associated with end-stage renal disease was filed with FDA Sept. 21. The Product License Application (PLA) is based on data from more than 500 patients treated in the U.S. and Japan. U.S. clinical trials were conducted by G.H. Besselaar Associates. Marogen, a sterile powder, is reconstituted into a liquid formulation and administered intravenously during dialysis. Studies of Marogen for the end-stage renal indication are ongoing in "hundreds" of patients in U.S. and Japan locations, Genetics Institute said. The product is also in clinicals for hematological and surgical indications. Marogen contains recombinant erythropoietin produced through techniques developed by Genetics Institute. Chugai-Upjohn is a joint venture of Chugai Pharmaceutical, Tokyo and Upjohn. The firm was formed in March to develop and market Chugai products in the U.S. Chugai Pharmaceutical manufactures Marogen and Upjohn will be its U.S. distributor. Chugai-Upjohn is currently headquartered in Kalamazoo, Mich.; the joint venture will more to Chicago in October. A regulatory filing for the recombinant EPO product in Europe was made by Genetics Institute licensee Boehringer Mannheim on August 11. Chugai is expected to seek approval in Japan by the end of 1988. The validity of patents covering Marogen and Epogen, manufactured by Amgen, is currently the subject of litigation and an International Trade Commission proceeding. Amgen has filed for summary judgment regarding its complaint that its patent for EPO is being infringed by Chugai. Oral arguments on Amgen's motion for summary determination on the economic phase of the trade dispute will be heard before ITC Administrative Law Judge Sidney Harris on Sept. 28. If the judge grants Amgen's motion, which is based on provisions favorable to Amgen in the recently enacted Omnibus Trade Bill, the economic phase of hearings scheduled to begin Oct. 3 will be eliminated from the proceedings ("The Pink Sheet" Aug. 8, T&G-3). Whether or not economic-phase hearings take place, a final decision on the case is expected by Nov. 10. Meanwhile, Chugai has filed a motion to compel discovery of certain confidential Amgen documents, in particular, correspondence between FDA and Amgen concerning the company's Product License Application for Epogen. In a June 21 letter, FDA requested that Amgen supply additional data in support of its PLA. The company subsequently met in July with FDA to discuss the Epogen PLA and submit data. Administrative Law Judge Harris raised the issue in a Sept. 7 phone conversation with the companies' attorneys: "I think it bears upon the question of domestic industry where a U.S. regulatory agency will not or may not give required approvals for marketing the product." Chugai has argued that Amgen is not a domestic industry because it does not have an FDA-approved product. Amgen filed a PLA for its recombinant EPO product in November 1987 for the treatment of anemia associated with kidney dialysis. Ortho, Amgen's licensee, is planning to file a separate PLA for pre-dialysis anemia this year.

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