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 BUCINDOLOL SHOULD BE CONTINUED FOR CHF (congestive heart failure), University of Michigan Cardiology Director Bertram Pitt urged at a May 4 seminar on new drug development. Pointing out that the alpha beta blocker may face a long, and potentially "expensive" clinical development period, Pitt expressed concern that B-M is debating whether to halt further work on the drug. "It would be a shame," Pitt said, if work was not continued on the product. Pitt's primary interest in the product derives from its potential in the treatment of sudden death as well as signs of activity in congestive heart failure. The researcher made his comments at a conference sponsored by "The Pink Sheet" and International Business Communications. Pitt noted "clues" that beta blockers can help prevent sudden death in stabilized congestive heart failure patients. A NIH propranolol vs. placebo study, for example, resulted "in a dramatic almost fifty percent reduction in sudden death" in a subset of patients who had congestive heart failure. Pitt maintained that the prevalence of sudden death in the congestive heart failure mortality trials indicates a major potential for further drug development. "There may be a lot of potential for new research understanding the mechanism and drugs targeted for sudden death," Pitt commented. "I think that if we could do that we might even make some dent here. We certainly have to understand this before we begin major trials looking at mortality because this is going to confound any of the trials that we are going to undertake." Noting the immense popularity of the ACE (angiotensin converting enzyme) inhibitors, Pitt observed that about "45-50% of patients" in a recent ACE study did not show sustained benefit. "That's where there is great potential for pharmaceutical development . . . there is room for other agents in the vasodilator class that perhaps might have a broader spectrum," Pitt said. The Bristol-Myers compound has "alpha blocking properties or maybe some vasodilating properties," Pitt explained. He reported that bucindolol "has been shown [in recent studies] to be very well tolerated in long-term followup (about 21 months). Ejection fraction has been shown to be significantly improved." He acknowledged that the product faces a burden in approval because "so far is that it has not been able to be shown that exercise time has been improved." Patients "are beta blocked, the hemodynamics are improved, but exercise is not improved," Pitt commented.

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

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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