Ischemia Research & Education Foundation Wins $33 Million in Damages From Belgian Pharmaceutical Firm Following Federal Court Ruling.

SAN FRANCISCO--(BW HealthWire)--Dec. 15, 1999--

U.S. District Court Ruling Ends Five-Year Dispute Over Ownership

Rights To Intellectual Property From Major Clinical Studies and

Exonerates Foundation Chairman of All Scientific and Ethical

Misconduct Charges

In one of the largest judgments of its kind, a renowned nonprofit biomedical research organization - the Ischemia Research & Education Foundation - has won $33 million in damages from a Belgian pharmaceutical firm following a federal court ruling. The decision ends a closely watched, five-year dispute over ownership of major clinical studies to lower mortality among high-risk surgery patients.

U.S. District Court Judge William Orrick Jr.'s 28-page ruling which upheld an international arbitration panel's decision - also restores to the Foundation all "intellectual property" derived from clinical trials IREF conducted for Belgian firm UCB, a publicly-held firm, at more than 50 medical centers in the U.S. and in Europe in the early to mid-1990s. The trials sought to evaluate a novel therapy for prevention of heart attacks in surgery patients.

The ruling also exonerates the San Francisco-based Foundation (IREF) and its founder and chairman - internationally-acclaimed clinical researcher Dr. Dennis T. Mangano - of all allegations of scientific and ethical misconduct raised by UCB in the case which involved 22 witnesses and more than 100,000 pages of evidence.

Officials of IREF and an affiliated organization - the Multicenter Study of Perioperative Ischemia (McSPI) Research Group - hailed the ruling which also ordered UCB to pay IREF's and Mangano's legal costs.

"We are obviously very pleased with this decision, which validates the long-standing scientific integrity of IREF and ends what has been a very long and challenging personal ordeal," said Mangano. "This ruling will allow us to continue to focus on our real work - the prevention of serious diseases in high-risk surgery patients and the saving of lives."

IREF Chief Operating Officer Dr. William Spickler said, "This addition to the endowment will assist the foundation in carrying out further important research on prevention of heart attacks and stroke, particularly in patients undergoing surgery."

The legal dispute began when UCB decided to terminate its contract with IREF and refused to pay IREF for work performed in the groundbreaking studies. UCB's case focused on unsubstantiated allegations raised in an internal dispute between Mangano and administrators at the University of California San Francisco (UCSF) medical school, where Mangano served for more than two decades as a professor.

The dispute centered on UCB's and UCSF administrators' charges that Mangano inappropriately used UCSF resources without paying for them, and also fraudulently included the cost of those resources in the negotiation of the contract between UCB and IREF. But Mangano and IREF countered that UCSF bore little or no cost associated with the research, and that UCB deprived IREF of the rights to independently publish results of the clinical trials conducted on approximately 3,000 patients throughout the world. IREF filed an arbitration demand with the International Division of the American Arbitration Association and UCB subsequently filed a countersuit against IREF and Mangano.

The case was heard earlier this year by an international panel of three arbitration judges, who rejected all of UCB's allegations regarding scientific and ethical misconduct and fraud and ruled in favor of IREF and Mangano on all counts.

Several weeks into the arbitration, the judges challenged UCB's charges against Mangano regarding misrepresentation, fraud or any other suspect activity. But UCB refused to drop Mangano from the case. Subsequently, arbitration judges ruled against UCB on all points, and for the foundation and for Mangano on all points.

Yale Professor Paul Barash, the director of McSPI, the world's largest perioperative medicine research group, called IREF's and Dr. Mangano's victory "extraordinary."

"Dr. Mangano demonstrated extraordinary courage. This was really a case of `David' taking on `Goliath,'" said Barash. "Dr. Mangano protected not only IREF and McSPI, but also protected what he thought was right for science. This money will allow us to continue our research and concentrate on saving lives of surgery patients throughout the world."

Attorneys Gilbert Serota and Pam Fulmer of San Francisco-based Howard, Rice, Nemerovski, Canady, Falk & Rabkin, as well as attorney David Hoffmeister of Palo Alto-based Wilson-Sonsini, represented IREF. Attorney J. Alan Galbraith, senior partner at Williams & Connolly of Washington, D.C., represented Mangano.

Founded in 1987 by Dr. Dennis T. Mangano, the San Francisco-based Ischemia Research & Education Foundation is an independent non-profit biomedical research organization dedicated to saving lives and economic resources through unbiased scientific research that focuses on prevention of ischemic injury such as heart attack and stroke in high-risk patients undergoing surgery. IREF has a staff of 67 professionals, including clinicians, biometricians and engineers as well as professionals in the fields of health economics, quality of life and stroke.

The Multicenter Study of Perioperative Ischemia - also founded by Dr. Mangano in 1987 - is a consortium of more than 150 worldwide academic centers that have been responsible for large-scale studies addressing myocardial ischemia, infarction and stroke in high-risk patients undergoing cardiac and non-cardiac surgery. The research group represents the world's leading academic centers in surgery.

For more information about IREF, visit its website at www.iref.org.