Completion of enrollment of patients in two clinical trials of its diabetes drug candidate pramlintide, a chemical analog of human insulin, has been announced by USA-based Amylin Pharmaceuticals. These Phase III studies involve approximately 1,000 patients at more than 75 centers, and are testing whether pramlintide can reduce blood sugar in patients who use insulin.
Amylin is collaborating with Johnson & Johnson in developing pramlintide as a drug candidate for improving glucose control, thereby reducing the risk of diabetic complications, including blindness, kidney failure, nerve damage and amputation. Amylin's chairman and chief executive, Howard Green, told the recent US Goldman Sachs Healthcare conference that his company is responsible for managing the clinical studies and seeking worldwide marketing approval, and "we remain on schedule for filing regulatory applications in the USA and Europe during 1998."
Decisions On J&J Collaboration Scheduled For Third Quarter By end third-quarter 1996, Mr Greene noted, Amylin and J&J will conduct an administrative interim analysis of the first two studies in order to make business decisions related to their collaboration.
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