Abt Associates Manages Clinical Trials, Regulatory Process for Hemopure--an Oxygen Carrier; FDA Accepts Hemopure Biologic License Application.

Business Editors/Health/Medical Writers

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 10, 2002

Abt Associates Clinical Trials (AACT) today said it is conducting clinical trials on behalf of Biopure Corporation (Nasdaq: BPUR) on Hemopure(R), an oxygen carrier. AACT is also assisting in the regulatory process for Hemopure in the U.S. and international markets.

The U.S. Food and Drug Administration (FDA) recently accepted the electronic Biologic License Application (BLA) prepared by AACT seeking regulatory approval to market Hemopure in the United States for the treatment of acute anemia in adult patients undergoing elective orthopedic surgery. The submission, which included 21 clinical studies involving more than 1400 subjects, represented more than one million pages of data on chemistry, manufacturing and controls (CMC), toxicology, pre-clinical data, clinical data from individual trials, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and the annotated label.

AACT is also assisting Biopure in the filing of the Common Technical Document (CTD) for product registration in the European Union and Japan, as well as updated submission to regulatory authorities in South Africa, where Hemopure has been approved for use in humans.

Inder Kaul, M.D., M.P.H., Vice President and Executive Director of Clinical Operations and Medical Affairs for AACT, said, "Biopure has invested 17 years in the development of Hemopure. With our core competency in the planning, execution and management of clinical trials, we are assisting Biopure in managing the entire product development process pre-product introduction for Hemopure, including clinical trials and regulatory filings."

Hemopure is an intravenously administered pharmaceutical consisting of chemically stabilized bovine hemoglobin formulated in a balanced salt solution. This stabilized, acellular hemoglobin circulates directly in plasma when infused and has lower viscosity and releases oxygen to tissues more efficiently than red blood cells. Hemopure is compatible with all blood types, stable both refrigerated and at room temperature for up to three years, and is purified through patented and proprietary techniques that are validated to remove potential contaminants, including infectious agents such as bacteria, viruses and transmissible spongiform encephalopathy (TSE) agents.

AACT is a full service Contract Research Organization serving the pharmaceutical, biotechnology and medical device industries. AACT provides a broad array of pre-approval and post-marketing services, including clinical trial design, implementation and monitoring, data processing, analysis and reporting, registries, pharmacoeconomic studies, marketing research and strategy consulting.

Abt Associates (www.abtassociates.com) is a private, employee-owned company that applies rigorous research and consulting techniques, as well as technical assistance expertise, to a wide range of issues in social and economic policy, international development, business research and consulting, and clinical trials and registries. Since its founding in 1965, Abt Associates has provided services to U.S. federal, state and local governments; foreign governments; international organizations; foundations; and business and industry. Its staff of over 1,000 employees is located in offices in Cambridge, Lexington, and Amherst, Massachusetts; and offices in Bethesda, Maryland; Washington, D.C.; Old Greenwich, Connecticut; Chicago, Illinois; Cairo, Egypt; and Pretoria, South Africa.