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



Executive Summary

SOMERSET ELDEPRYL JUNE 5 APPROVAL CLEARS WAY FOR MYLAN/BOLAR ACQUISITION of the Denville, New Jersey-based firm. The acquisition, which calls for Mylan and Bolar to jointly purchase the firm for $ 33.5 mil. in cash, was contingent upon Somerset Pharmaceuticals obtaining approval for the anti-Parkinsonian drug. Somerset projects that the acquisition will be completed in the next two weeks. An orphan drug, Eldepryl (selegilene) is indicated "as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa [Merck's Sinemet] who exhibit deterioration in the quality of their response to this therapy." In a June 7 press release announcing the approval, FDA estimated that the agent would be useful for "20,000 to 50,000 persons, mostly over 40, who have severe Parkinson's." Eldepryl has been available under a Treatment IND since June 1988 and reached approvable status at FDA in April ("The Pink Sheet" April 17, T&G-1). The drug marks the second Treatment IND to be approved by FDA; Bristol-Myers' Ifex/Mesnex (ifosfamide and mesna) was approved in December, also on the one year anniversary of its Treatment IND. Eldepryl also is being investigated as a first line Parkinson's therapy by the National Institutes of Health. The three-year NIH study, which began in 1987, is comparing the drug to vitamin E alone, a combination of Eldepryl and vitamin E and a placebo. The endpoint for the study is the necessity for patients to be treated with levodopa. Somerset plans to have Eldepryl out in trade channels by mid-September. The company, which will continue to operate as a separate R&D/marketing entity after the acquisition, will be marketing Eldepryl through a 40 person sales force. The 500-600 patients currently receiving the drug under Treatment IND will continue to receive drug through that mechanism until it is available through pharmacies. Under the Treatment IND, Somerset has been charging 30 cents per 5 mg tablet (the recommended dosage regimen is 5 mg twice a day). Somerset said a final marketing price has not yet been set, but indicated that the agent would be sold for at least several times the Treatment IND charge. Somerset licenses the U.S. rights to selegilene from the Hungarian firm Chinoin, which will be manufacturing the drug for the company. The company licenses rights to several other compounds from Chinoin and also has relationships with the Hungarian firm Gideon Richter and the Hungarian Institute of Pharmaceutical Research. Somerset indicated, however, that development work on other compounds is not currently active. Somerset was spun off from parent company S. C. Johnson in 1985.

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



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