CIBA CONSUMER ENTERING OTC LAXATIVE MARKET WITH ACQUISITION OF RYDELLE LAB'S FIBERALL; FIRM HAS EXPERTISE FOR ANTI-CHOLESTEROL NDA, IF NECESSARY

Ciba Consumer Pharmaceutical is entering the OTC laxative market through the acquisition of Fiberall bulk laxative from S.C. Johnson subsidiary Rydelle Labs. The sale, currently at the definitive agreement stage, is expected to be finalized before the end of August. In an Aug. 10 release announcing the acquisition, Ciba said the agreement would give he firm "distribution, patent and trademark rights, including the registered trademark 'Fiberall.'" The deal gives Ciba Consumer's parent, Ciba-Geigy Limited, rights to Fiberall "in the rest of the world." With the development expertise of Ciba-Geigy behind it, Fiberall, a psyllium-based product that is currently Category I as a laxative, could also have potential as a cholesterol reduction product. FDA told Rydelle and Metamucil maker Procter & Gamble on July 29 that current data were not sufficient to support the indication, but that data "provide some evidence" of the efficacy (see preceding story). In the letter to the companies, FDA has outlined those efficacy and safety issues, such as long-term effects and high-density lipoprotein cholesterol measurements, that it would like to see addressed in future studies. With the apparent necessity for additional trials, Ciba Consumer may choose to go the NDA route, rather than the monograph, with the aim of gaining exclusivity. The firm said it has not decided whether it will conduct additional cholesterol reduction studies with the agent. Ciba said it is looking at the available data and evaluating the options. Fiberall expands to nearly 10 product lines Ciba's current consumer product business, which centers on Accutrim diet tablets and Doan's Backache Pills (acquired from Jeffrey Martin in March 1987). The six-year old consumer products unit also markets Q-Vel muscle relaxant, Otrivin and Privine nasal sprays, Nupercainal hemorrhoidal and anesthetic ointment/cream, PBZ antihistamine cream, Slow-Fe iron tabs, and Sunkist vitamins. The sale of Fiberall is part of a strategic restructuring of S.C. Johnson's consumer products business. In early June, the firm said it decided to look for a buyer for Fiberall. Rydelle described the pending sale as part of a strategic marketing shift to its area of expertise - dermatologists. With the exception of Fiberall, Rydelle's current product mix consists of oral health and skin care products. The S.C. Johnson subsidiary markets: the Aveeno skin care line and Rhuli anti-itch line, which were both acquired from Cooper Labs in 1984; the Cramer sports analgesic line; Checkup toothpaste, acquired from Minnetonka in early 1987; and Zact smokers toothpaste, the firm's first oral health care product, which was introduced under a joint venture agreement with the Lion Corp. of Tokyo in 1984. Reportedly, the firm has been considering moving the Rydelle products under the personal care group of S.C. Johnson to further concentrate on dermatologists. S.C Johnson's existing product line in the personal care area consists primarily of skin and hair products. S.C. Johnson entered the skin care market in 1981 with Soft Sense lotion and added Curel lotion in 1985. Products in the hair care line include Halsa, Agree and L'Envie shampoos and conditioners. S.C. Johnson also markets Edge shaving gel.