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Executive Summary

FOREST LABS WILL MARKET KABIVITRUM's MICTUROL (TERODILINE) in the U.S. Under the terms of the agreement, Forest will license the incontinence treatment from KabiVitrum and retain the right to acquire the U.S. license to future incontinence products developed by the Swedish company. Micturol is presently marketed in the United Kingdom and Scandinavia and will be introduced in Japan and other European countries in 1988. Launched in the U.K. by KabiVitrum in June 1986, Micturol "is now selling at an annual rate of $7 mil. and increasing monthly," a KabiVitrum backgrounder points out. Forest said it plans to file an NDA for Micturol in 1988. The company also anticipates that Micturol "could be approved and available for marketing by 1990 [and] could have far greater sales than any of the other products presently marketed by Forest." KabiVitrum estimates the U.S. market for prescription drugs for the control of incontinence at $26 mil. per year. The U.S. market leader is Marion Labs' Ditropan (oxybutynin), which has over $14 mil. in annual sales based on KabiVitrum's projections. KabiVitrum has assessed Micturol in 15 clinical trials. In the studies, Micturol "has consistently shown benefits" against both placebo and active controls such as Cetiprin and meladrazine, according to a KabiVitrum clinical and technical review of the drug. "Micturol is also effective when incontinence has been demonstrated to be refractory to other treatments." Forest said it will submit some or all of KabiVitrum's clinical data to FDA. Forest indicated that it may rely on KabiVitrum's foreign studies in putting together the Micturol NDA. Micturol has four mechanisms of action: "anticholinergic, antispasmodic, local anesthetic, and calcium channel blocker properties," KabiVitrum said. Highlighting Micturol's calcium channel blocker action, KabiVitrum maintains that the calcium antagonist effect of oxybutynin and propantheline (Searle's Pro-Banthine) is about 1% of those drugs' anticholinergic activity. The calcium antagonist action of terodiline, Forest says, accounts for 20-30% of its cholinergic action. This difference may be the reason why "terodiline does seem better tolerated than anticholinergic drugs such as oxybutynin," KabiVitrum said. Micturol also has a dosing advantage. The KabiVirtum drug is given twice a day, unlike oxybutynin and propantheline, which are given three to four times a day.

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