CIBA-GEIGY HAS URSODEOXYCHOLIC ACID IN EARLY U.S. CLINICALS

CIBA-GEIGY HAS URSODEOXYCHOLIC ACID IN EARLY U.S. CLINICALS as a sallstone dissolving agent. under a licensing agreement with the Italian firm Gipharmex, announced March 9, Ciba-Geigy will have exclusive U.S. marketing rights. "Ciba-Geigy Pharmaceuticals holds a patent on the use of ursodeoxycholic acid in the dissolution of gallstones," the release states. "This drug has been approved and is marketed in most European countries and Japan." Ciba-Geigy's interest in ursodeoxycholic acid follows the decision by Reid-Rowell to discontinue the development of a similar product. At one point, Reid-Rowell had planned a 1986 NDA filing for ursodeoxycholic acid but later decided to stop development work. Originally, Reid-Rowell viewed the compound as a second generation product with fewer side effects than its oral gallstone dissolving agent Chenix (chenodiol). Chenix was approved as an orphan drug in 1983 for a subgroup of patients suffering from gallstones. According to Ciba-Geigy, chenodiol is an epimer of ursodeoxycholic acid, a naturally occurring bile acid found in small amounts in human bile. A recent review, published in a December 1986 issue of Gastroenterology Journal, of studies of nonoperative treatments of silent gallstones stated that ursodeoxycholic acid, and a combination therapy of ursodeoxycholic acid and chenodeoxycholic acid have been shown to be effective and safe in dissolving cholesterol-composed gallstones. The review noted that a drawback to bile acid dissolution therapy is a significant recurrence of gallstones after treatment is ended.