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Executive Summary

CORTICOTROPIN-RELEASING HORMONE COULD BE A $400,000 A YEAR DRUG for a company willing to develop the hormone as an orphan product for diagnosing Cushing's Syndrome, Pharmaceutical Mfrs. Assn. VP-Professional Relations Lawrence Weaver, PhD, stated at a meeting of the PMA Commission on Drugs for Rare Diseases May 12. Responding to a request by Natl. Institutes of Health Clinical Director Lynn Loriaux, PhD, that the commission solicit a company to manufacture the material at no charge for researchers outside NIH, Weaver suggested that a pharmaceutical firm might be able to develop and market the hormone profitably. NIH purchases corticotropin-releasing hormone (CRH) from a commercial company in California and then prepares the ovine-derived hormone for human use in its pharmacy. Loriaux explained that because of budget constraints and the amount of money needed for NIH research, the institute, under its IND, can meet only about 10% of requests for the hormone from outside researchers. "We use it and distribute it to as many people as we can" for diagnosing Cushing's Syndrome, Loriaux said. "It's working out okay, except it's breaking the bank." NIH pays $100,000 a gram for CRH. Loriaux estimated that two grams of the hormone would be enough to test the approximately 20,000 people examined for Cushing's Syndrome in the U.S. each year. Loriaux told the commission that NIH's success rate in diagnosing ectopic v. pituitary secretions of adrenocorticotropic hormone in Cushing's Syndrome "has climbed from 50% to 100%" using CRH. He also noted that use of the hormone is "incredibly cost saving" because of the speed and accuracy of the CRH test. "What you do in one morning with [CRH] evaluations requires a week or two to do [when] piling up the other tests that are required to give the same evaluation," Loriaux said. Discussing various approaches to the CRH supply problem, the commission said it could notify PMA member firms that NIH is seeking a corporate partner to manufacture the hormone for distribution to researchers through NIH's IND. As an alternative, Weaver suggested that "some small company might want to make it for the small profit that can be made." If you "double the price" to $200,000 a gram, he said, "it's still pretty cheap" compared to the hospital costs involved with other diagnostic procedures for Cushing's Syndrome. With a market need for 2 grams per year, at $200,000 a gram, the hormone could bring in $400,000 a year. At the meeting, the commission noted that 10 drugs/biologics had been designated as orphans between January and March 1986. The products include: anti pan T lymphocyte/monoclonal antibody H65-ricin A chain confugate, to eliminate mature T cells from potential bone marrow grafts ex vivo and in vivo treatment of bone marrow recipients to prevent graft rejection, under sponsorship by Xoma; antithrombin III, to prevent thrombosis in patients with antithrombin III deficiency, being sponsored by the American Natl. Red Cross; alpha-mercaptopropionylglycine (Thiola), for use in the prevention of cystine nephrolithiasis, being sponsored by Charles Pak, MD, University of Texas Health Science Center. The remaining 1986 orphan designations are: benzoate phenylacetate (Ucephan) for adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy, being sponsored by Kendall McGaw; etidronate disodium I.V. (Didronel), for treatment of hypercalcemia of a malignancy inadquately managed, sponsored by Norwich Eaton; flunarizine (Sibelium), for treatment of alternating hemiplegia, being sponsored by Janssen; guanethidine monosulfate (Ismelin IV), for treatment of moderate to severe reflex sympathetic dystrophy and causalgia, being sponsored by Ciba-Geigy; potassium citrate and citric acid (Polycitra-K), for dissolution and control of uric acid and cystine calculi in the urinary tract, under sponsorship by Willen Drug; recombinant human erythopoietin, for treatment of anemia associated with end stage renal disease, sponsored by Amgen; surfactant TA, for prevention and treatment of neonatal respiratory distress syndrome, being sponsored by Abbott's Ross Labs div.; and terlipressin (Glypressin), for the treatment of bleeding esophageal varices, sponsored by Swedish firm Ferring AB.

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