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BRISTOL-MYERS SQUIBB/SCHERING AG SWAPPING BETAPACE/PROHANCE RIGHTS

Executive Summary

BRISTOL-MYERS SQUIBB/SCHERING AG SWAPPING BETAPACE/PROHANCE RIGHTS under a deal announced Nov. 27. In return for licensing the U.S. marketing rights to its beta blocker Betapace (sotalol) to Schering AG, Bristol-Myers Squibb will receive "worldwide rights under Schering's existing patents and patent applications relating" to the Bristol-Myers Squibb gadolinium-based imaging agent ProHance (gadoteridol), BMS said. The licensing agreement for ProHance preempts the possibility of litigation over broad patents for gadolinium and gadolinium technology held by Schering. In return, Schering gets a U.S. product in the important cardiovascular category for its Berlex Labs subsidiary. The German firm Schering AG is the proprietary developer of gadolinium image-enhancer technology and markets the only currently-approved gadolinium agent, Magnevist (gadopentetate dimeglumine), through Berlex. Magnevist sales grew over 50% in 1990, exceeding $ 70 mil. in the U.S., Berlex said. ProHance, which will be marketed by the Squibb Diagnostics division, was favorably reviewed by FDA's Medical Imaging Drugs Advisory Committee Nov. 7-8 ("The Pink Sheet" Nov. 11, p. 9). The committee found that ProHance is safe and effective in enhancing tumor definition in MRI, and the FDA medical officer who reviewed the ProHance data found it was as effective as Magnevist. ProHance, like Sterling's Omniscan (gadodiamide), which was also given a favorable review at the same meeting, is a non-ionic agent, whereas Magnevist is ionic. It was suggested at the advisory committee meeting that the potential for added benefits to patients using non-ionic imaging agents should be examined. Berlex will market sotalol in the U.S. in exchange for an up- front licensing fee and royalties on product sales. Terms were not disclosed. Sotalol received a conditional approval recommendation from FDA's Cardio-Renal Drugs Advisory Committee on Dec. 13, 1990 and is awaiting approval as an orphan drug for prevention of life- threatening ventricular tachyarrhythmias ("The Pink Sheet" Dec. 17, 1990, p. 21). BMS is selling the U.S. rights to Betapace two months after the company announced it will begin withdrawal of its beta blocker Enkaid (encainide) on Dec. 16 due to evidence provided by the National Heart, Lung & Blood Institute's Cardiac Arrhythmia Suppression Trial that the drug's risks outweigh its benefits ("The Pink Sheet" Sept. 23, T&G-4). The sotalol deal and the Enkaid withdrawal leaves BMS with only one beta blocker on the U.S. market, Corgard (nadolol).

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