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

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).

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