BIOPURE RECEIVES RESPONSE FROM MHRA ON HEMOPURE FILING

Biopure announced it has received a provisional opinion letter from the UK Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application for Hemopure (hemoglobin glutamer 250 (bovine)) for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age. The letter provides Biopure the opportunity to respond to these issues before the commission gives its final advice to the Medicines and Healthcare products Regulatory Agency (MHRA).

The letter identifies "major" issues relating to toxicology, quality, clinical efficacy and safety, including the product's benefit-risk balance in the proposed indication when blood is readily available. It also includes several dozen other issues primarily relating to chemistry, manufacturing and controls. Unless these issues are satisfactorily addressed, the commission may be unable to recommend marketing authorization.

"Based on our initial review of the letter, we believe the issues are addressable," Biopure Chairman and CEO Zafiris Zafirelis said. "During the next several weeks, we expect to continue evaluating the issues and the time and resources required to fully respond to the commission's questions."

The FDA is currently maintaining a clinical hold on a Navy clinical trial of Hemopure after its Blood Products Advisory Committee voted 11-8 to recommend against proceeding with the trial.