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BIO-TECHNOLOGY GENERAL's BIOTROPIN (hGH) AIDS PATIENT TRIALS

Executive Summary

BIO-TECHNOLOGY GENERAL's BIOTROPIN (hGH) AIDS PATIENT TRIALS will begin "within 30 days," BTG President Sim Fass told the Alex. Brown & Sons Health Care Seminar May 6. A protocol to test Bio- Technology General's human growth hormone to treat cachexia in persons with AIDS is currently under review at the New York Hospital Cornell Medical Center. BTG said a second center in California may also join the trial. The AIDS study will be conducted under an IND approved in April, BTG said. Phase I/II studies began April 23 at Memorial Sloan-Kettering Cancer Center in New York for treatment of cachexia in cancer patients. A third group of patients, elderly hip fracture victims, soon also could begin anti-muscle-wasting treatment with BioTropin. A protocol for that use is being reviewed by the New York Hospital for Special Surgery, BTG said. The three Phase I/II trials represent an effort by Bio- Technology General to establish a niche for its product in the U.S. where it is blocked from approval as a treatment for dwarfism by Lilly's Humatrope, which has orphan drug exclusivity until March 1994. FDA has indicated that the BTG product can be expected to clear the agency soon after the expiration of Lilly's exclusivity. Fass said the agency has told BTG that its product "will be approvable . . . essentially simultaneously" with the end of Lilly's exclusivity. The BioTropin trials also suggest possible future indications to be pursued by the other manufacturers of growth hormone, including Genentech; its Protropin hGH shares exclusivity with Humatrope. Lilly already has moved into early-stage research of hGH for anti-aging indications and last year supported a preliminary study at the Medical College of Wisconsin that found increased muscle mass in 21 healthy, elderly men ("The Pink Sheet" July 9, T&G-4). Genentech, on the other hand, has disavowed any open interest in anti-aging indications for hGH. BTG announced May 7 that it is is "finalizing" an agreement to reacquire U.S. rights to BioTropin for all indications from DuPont-Merck Pharmaceuticals. The reacquisition will cost BTG $ 1 mil. in shares issued to DuPont and a maximum of $ 5 mil. in royalties, BTG said, with $ 2 mil. of the total to be paid between 1993 and 1996. BTG has not "yet decided" whether to find a comarketer or to market the product in house, Fass said. SmithKline Beecham is BTG's European partner for BioTropin.

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