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SOMERSET ELDEPRYL JUNE 5 APPROVAL CLEARS WAY FOR MYLAN/BOLAR ACQUISITION

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.
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