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GYNEX' OXANDRIN RECEIVES TREATMENT IND APPROVAL OCT. 17

Executive Summary

GYNEX' OXANDRIN RECEIVES TREATMENT IND APPROVAL OCT. 17 for the treatment of "constitutional delay of growth and puberty [CDGP], a growth disorder in boys," Gynex Pharmaceuticals announced Oct. 23. Oral Oxandrin (the protein anabolic steroid oxandrolone), supplied in .25 mg tablets, will become available "in the coming weeks," Vernon Hill, Ill.-based Gynex said. Gynex said the Treatment IND allows the company to provide the testosterone analog to patients on a cost-recovery basis. The company said the annual charge per patient will be between $ 1,000 and $ 2,000. Gynex will be the fifth company to provide Treatment IND- approved drugs to patients on a cost-recovery basis. The others were Somerset for the anti-Parkinson's drug Eldepryl (selegilene); Lyphomed for NebuPent aerosolized pentamidine for AIDS-related pneumocystis carinii pneumonia; the Massachussets Department of Health for intravenous cytomegalovirus immune globulin for kidney transplant patients; and Genzyme with Ceredase for the treatment of Gaucher's disease. All four products eventually received approved NDAs. In addition to the open label study of oxandrolone under the Treatment IND, Gynex says it is currently enrolling patients for Phase III trials for CDGP treatment and that it plans to file an NDA for Oxandrin in the first quarter of 1993 for that indication. The patients in the Phase III placebo-controlled trial, which is being conducted by Darrell Wilson, MD, Stanford University Medical Center, will receive Oxandrin free of charge. Constitutional delay of growth and puberty affects approximately 80,000 boys and Oxandrin has received orphan drug status from FDA. Only about one-third of the patient population currently is being treated for the disorder, Gynex said. The company suggested that Oxandrin's price and oral dosage form will make it more attractive than the current therapies for delay of growth and puberty -- injectable testosterone and human growth hormone. Gynex licensed the U.S. rights to oxandrolone from Searle in October of 1990 and rights for 22 other countries in Europe and Asia on Aug. 8 this year. Searle previously had gained approval for oxandrolone for the treatment of weight loss in chronically ill and post-operative patients but discontinued sales of the product in May of 1989. Gynex plans to file an IND for the orphan indications of HIV-wasting syndrome and HIV-associated muscle weakness "by the end of 1991," the company said. Searle has agreed to manufacture the drug for Gynex until 2001. Oxandrin is also in Phase III to promote growth in patients with Turner syndrome, which affects 45,000 girls in the U.S. The condition occurs in girls who have only one healthy X chromosome and results in short stature, nonfunctioning ovaries and failure to develop secondary sexual characteristics. Gynex claims that oxandrolone "has been used for years by pediatric endocrinologists" to treat both Turner syndrome and CDGP. On May 13, Gynex received a $ 220,000 grant from FDA to conduct the Phase III trials, which are being directed by Jo Anne Brasel, MD, at the University of California at Los Angeles-Harbor Medical Center. Gynex, which does not yet have any drugs on the market, is also developing two other endocrinological products: Androtest-SL, a sublingual form of testosterone for CDGP as well as hypogonadism in men; and Estrafem, (low-dose ethinyl estradiol) designed to gradually stimulate the development of secondary sex characteristics in Turner syndrome patients. Androtest-SL is in Phase II clincials for CDGP in boys, and Estrafem is being studied in an FDA-funded Phase III multicenter trial under the direction of Ron Rosenfeld, MD, at Stanford. FDA is funding the trial under a clinical research grant of $ 100,000 per year for three years. Gynex also has a patented oral contraceptive dosing regimen for which it signed an option agreement in late 1990 with the Dutch firm Organon. The Akzo subsidiary is conducting studies to evaluate the regimen.
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