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Executive Summary

CIBA-GEIGY ACTIGALL DETAILING FEATURES LAPTOP COMPUTERS to present the cost effectiveness of the drug (ursodiol) compared to gallstone surgery. The sales reps' electronic cost effectiveness presentations, which use Lotus software, will be targeted at administrators of HMOs and other managed health care programs, Ciba-Geigy said. The cost effectiveness analysis was conducted by Milton Weinstein, PhD, Harvard University School of Public Health. Ciba-Geigy said it expects Weinstein's complete analysis to be published in a future issue of the Journal of the American Medical Association. Ciba-Geigy announced the launch of Actigall on Oct. 4. Marketed by Gipharmex in Europe as Deursil, ursodiol was approved on Dec. 31. as a 1B drug, a new molecular entity representing a modest therapeutic gain. The price to wholesalers for Actigall is $ 145 for 100, 300 mg capsules. According to the company, the daily cost to the consume for Actigall therapy will be approximately $ 4, or roughly $ 1,500 for a 12-month supply, Ciga-Geigy said. Most patients on Actigall therapy experience dissolution of their gallstones within 12 months of starting treatment, the company noted. Ciba-Geigy estimated the cost of gallbladder surgery at roughly $ 10,000. The launch of Actigall was delayed, Ciba-Geigy explained, in order to ship sufficient supplies from the manufacturer, Gipharmex, and to prepare sales reps for the launch. The company may also have delayed the Actigall launch in expectation of the approval and subsequent launch of its nonsteroidal anti-inflammatory Voltaren (diclofenac). Voltaren was approved on July 28 ("The Pink Sheet" Aug. 8, p. 4). Ciba-Geigy announced in March 1987 that it had set up a licensing agreement covering the U.S. with the Milan-based Gipharmex. Actigall is indicated for patients with radiolucent, noncalcified, gallbladder stones who are at high surgical risk or who refuse surgery. The company noted that out of the 525,000 patients that under gallbladder removal surgery, 350,000 are potential candidates for Actigall therapy. Reid-Rowell discontinued the development of a similar ursodeoxycholic acid product. The firm, which planned a 1986 NDA filing, viewed its compound as a second generation product with fewer side effects than its oral gallstone dissolving agent Chenix (chenodiol). Chenix was approved as an orphan in 1983 for a subgroup of patients with gallstones. Ascot Hospital Pharmaceuticals markets an orphan gallstone solvent Moctanin (monooctanoin), which was approved in October 1985. Print ads for Actigall should begin to appear in medical journals starting this month, Ciba-Geigy said. Those journals include the New England Journal of Medicine, Gastroenterology, and the Annals of Internal Medicine. A direct mailing to physicians announcing the availability of Actigall has been targeted at 25,000 physicians specializing in areas such as gastroenterology and internal medicine.

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