Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FOREST LABS WILL MARKET KABIVITRUM's MICTUROL (TERODILINE)

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID1128360

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel