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RIKER WILL TAKE J&J's PLACE IN SPACE SHUTTLE

Executive Summary

RIKER WILL TAKE J&J's PLACE IN SPACE SHUTTLE program with McDonnell Douglas to produce the hormone erythropoietin. In a joint Nov. 18 press release, the two companies announced that they "have begun work on a definitive agreement to produce erythropoietin, a hormone used in the treatment of anemia. Production of pure erythropoietin will utilize the electrophoresis technology currently under development in the McDonnell Douglas Electrophoresis Operations in Space (EOS) program." Under the agreement, Riker will be responsible for testing and marketing the space-produced compound. Riker is replacing J&J subsidiary Ortho, which pulled out of its agreement with McDonnell in September. At that time, J&J indicated that it felt the pharmaceutical, which until now was unnamed, could be more easily produced on the ground. One month earlier, J&J announced an agreement with Amgen for the development and marketing of genetically engineered erythropoietin, interleukin-2, and hepatitis-B vaccine. McDonnell said that a "letter of intent" has been signed for erythropoietin and that "negotiations are under way for the joint development of space-processed pharmaceutical products" other than erythropoietin. Riker noted that it is "especially interested in exploring this project with McDonnell Douglas because it complements existing programs in biotechnology and therapeutic apheresis." If "negotiations and initial-stage investigations prove successful, this program would fit well with products in development at Riker Laboratories," the release continued. Specifically, Riker said erythropoietin, which cannot be orally ingested, is compatible with the company's drug delivery technology. Riker has technology for transvenous injection and inhaler delivery systems. The firm said it is also interested in microgravity research in general as it relates to pharmaceuticals. The EOS program involves a device, EOS-1,(END ITALICS) that uses continuous flow electrophoresis to separate materials in solution by subjecting them to an electrical field. McDonnell said its electrophoresis device will make its seventh flight aboard the space shuttle Atlantis Nov. 26. One of the objectives of the flight, according to the release, "is to purify sufficient quantities" of erythropoietin for Riker "to begin the animal and clinical testing program necessary" for FDA approval. McDonnell said it hopes to produce enough erythropoietin to complete clinical trials from a flight planned for July. The summer flight will utilize a larger electrophoresis device that will be located in the cargo bay. The larger unit, according to McDonnell, has 24 times the production capacity of the current device which is located in the mid-deck crew compartment of the shuttle. McDonnell said it envisions erythropoietin collection three to four times a year to meet market demand once the product is approved.

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