ARTICLE | Company News

Biopure hematology news

September 19, 2005 7:00 AM UTC

BPUR said the SEC filed a lawsuit against the company, two former officers and a current officer related to disclosures about Hemopure hemoglobin glutamer. BPUR said the commission claims that BPUR should have disclosed in April 2003 that FDA put a hold on a proposed trial of Hemopure hemoglobin glutamer to treat trauma patients in a hospital setting. The company disagrees that it was required to disclose the hold status of a proposed trial in a new indication. At that time, a BLA was under review for Hemopure to treat acute anemia associated with orthopedic surgery and to reduce the need for red blood cell transfusions.

According to BPUR, SEC also claims the company was "too positive in tone" in its disclosure of a July 2003 FDA letter about the BLA. BPUR's press release at that time said FDA asked for clarification on data and labeling but did not ask for additional trials ...