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

STIEPEL LABS/ROCHE WILL CO-MARKET TOPICAL ACCUTANE IN THE U.S

Executive Summary

STIEPEL LABS/ROCHE WILL CO-MARKET TOPICAL ACCUTANE IN THE U.S under the trade name Isotrex. An NDA for the .05% isotretinoin gel is currently pending at FDA for the treatment of acne vulgaris and milder forms of severe recalcitrant acne based on pre-clinical and clinical work conducted by Stiefel. The two companies are currently working on additional studies requested by FDA and are anticipating approval in "late 1987-early 1988." Roche's agreement with Stiefel fits a pattern of licensing/comarketing arrangements Roche has used to broaden its product base, including agreements with DuPont for Versed and with Glaxo for Zantac. Roche recently announced a comarketing agreement covering Miles' calcium channel blocker Baypress (nitrendipine) ("The Pink Sheet" Aug. 25, T&G-1). Steifel will market Isotrex through its 37-person U.S. detail force. Founded in 1847, Stiefel is a closely-held dermatological drug manufacturer based in Coral Gables, Florida. The company's product line includes the top selling Rx wart product, Duofilm, and the Scabene line of pediculucide Rx products. Steifel has wholly owned subsidiaries in 18 foreign countries and Puerto Rico, which generate most of the company's sales.

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