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RHONE-POULENC RORER TO MARKET RECOMBINANT FACTOR VIII SUPPLIED BY BAXTER

Executive Summary

RHONE-POULENC RORER TO MARKET RECOMBINANT FACTOR VIII SUPPLIED BY BAXTER as part of the settlement of a longstanding patent dispute between the two companies. Baxter said May 12 that Rhone- Poulenc Rorer will sign long-term agreements to purchase recombinant Factor VIII (Recombinate), which will be packaged and labeled to RPR's specifications. RPR said it will probably sell recombinant Factor VIII in all the markets where the product is approved. On May 13, Baxter and its recombinant Factor VIII licensor Genetics Institute announced that Recombinate had been approved by the European Community's Committee for Proprietary Medicinal Products. Recombinate was approved previously in the U.S., Brazil and Sweden. RPR said that it has not decided whether it will market the recombinant product under the Recombinate name or a new brand. The company markets the monoclonally purified Factor VIII product Monoclate P. Baxter will make a $105 mil. payment to Rhone-Poulenc Rorer and pay royalties and processing fees on sales of its monoclonally purified antihemophilic Factor VIII:C concentrate (Hemofil M). Baxter will continue to market Hemofil M and Recombinate under a non-exclusive license from RPR. Rhone-Poulenc Rorer will renew a supply agreement for automated plasma-collection systems manufactured by Baxter. The settlement ends a six-year patent dispute started when Scripps Research Institute and its licensee Rhone-Poulenc Rorer filed suit against Baxter alleging infringement of a Factor VIII:C patent. The case was dismissed in 1989 and then reinstated upon appeal in 1991. RPR agreed to settle with KoGENate (recombinant Factor VIII) marketer Miles in January ("The Pink Sheet" Feb. 8, In Brief). A patent infringement suit against Chiron licensee Novo Nordisk is still pending. Baxter restated its sales and earnings for the first quarter ended March 31 to reflect the settlement. The company's adjusted net income was $138 mil. compared to a net loss of $37 mil. in the first quarter of 1992. Another biotech patent suit, between Amgen and Genetics Institute over erythropoietin, was settled during the week of May 10. Genetics Institute will pay Amgen $14 mil. and possibly an additional $2 mil. "contingent upon the outcome of certain future events." Genetics Institute's European licensee Boehringer Mannheim will pay a portion of the settlement costs. Genetics Institute took a charge of $11 mil. in March 1991 to cover anticipated damages when it lost its patent dispute with Amgen at the appellate level ("The Pink Sheet" March 11, 1991, p. 18). Consequently, Genetics Institute said that the settlement "will not have a significant effect on this fiscal year's results of operations." An infringement suit filed by Amgen U.S. licensee Ortho is pending an appellate decision as to whether the J&J subsidiary can be considered an injured party in the EPO litigation.

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