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GLAXO ORAL ANTI-MIGRAINE AGENT SUMATRIPTAN

Executive Summary

GLAXO ORAL ANTI-MIGRAINE AGENT SUMATRIPTAN has entered Phase II trials in the U.S. Glaxo recently started the early efficacy trials of sumatriptan (GR-43175) for both prevention and treatment of migraines in two clinical centers. The 5HT]1[-like receptor agonist is a follow-up oral compound to an injectable formulation currently in Phase III clinicals in the U.S. The company says that a total of 700 patients are enrolled at 40 sites in the injectable sumatriptan trials. Sumatriptan was derived from the company's research on the 5-hydroxytryptamine (5HT) serotonin receptors. The clinical progress on sumatriptan in the U.S. is important as a benchmark in the race for a new form of migraine treatment and as a sign of Glaxo's decision to conduct its major drug development programs in the U.S. through the Glaxo, Inc. subsidiary. Glaxo says it has decided to first pursue U.S. approval for its key development projects. That decision reflects the importance to Glaxo of a headstart in the U.S. market and is an implicit acknowledgement of the strength of U.S. clinical trials for regulatory registrations worldwide and reflects the parent company's confidence in the development skills of the U.S. subsidiary. The head of clinical development at Glaxo, Inc., is Peter Wise, MD, who directs a group of about 475. The research effort in North Carolina, under Pedro Cuatrecasas, is smaller (175) but growing. The firm has a 1 mil. sq. ft. lab and office facility for R&D under construction for occupancy in 1991. It is ironic that a U.K. firm is one of the first openly to take a U.S.-first position in drug development. For more than a decade, many companies have initially sought approval outside the U.S. as a way to avoid the perceived FDA approval delays. Glaxo is going in the face of that tradition, apparently betting on the status of U.S. clinicals and FDA's repeated assertions of renewed interest in breakthrough products to counter-balance its drug-lag reputation. Ondansetron (GR-38032F), another compound to emerge from Glaxo's work with 5HT receptors, is also in early clinicals. Schizophrenia trials with ondansetron are reportedly underway in the U.S. and abroad. The company says it is currently evaluating preliminary clinical results. Animal studies were said to show that ondansetron inhibits anxiety, is nonsedating and does not have the addictive properties associated with benzodiazepines. Glaxo's initial indication for ondansetron, however, will be as an anti-emetic in cancer treatment. The drug is in Phase III clinicals involving over 700 patients in more than 70 sites for the anti-emetic indication. Glaxo has maintained that the compound is more potent and longer-lasting than metoclopramide in the management of nausea and vomiting induced by chemotherapeutic agents. Beecham similarly has a 5HT product, designated BRL 43694, in clinical development as an anti-emetic.

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