Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



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.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts