CAMBRIDGE, Mass., Sept. 6 Biopure Corporation(Nasdaq: BPUR) today announced that it had recently met with the FDA todiscuss the compassionate use protocol submitted by the company in July. Atthe FDA's suggestion, the company intends to submit a protocol for a Phase 2randomized trial for the treatment of autoimmune hemolytic anemia and otherforms of hemolytic anemia, including alloantibody anemia but excluding sicklecell anemia. Hemopure has been used previously, on a compassionate use basis,to treat patients with these conditions.
The proposed patient group was included in the compassionate use protocolpreviously proposed to the FDA. A study protocol for the treatment ofautoimmune hemolytic anemia and other forms of hemolytic anemia would be inplace of that compassionate use protocol. Biopure may continue to work withthe FDA on compassionate use cases through single patient INDs that arerequested from treating physicians.
Autoimmune hemolytic anemia is a group of disorders characterized by amalfunction of the immune system that produces antibodies to the patient's redblood cells attacking them as if they were substances foreign to the body.This group of disorders is uncommon, can occur at any age and affects womenmore often than men.
Biopure Corporation develops, manufactures and markets pharmaceuticals,called oxygen therapeutics, that are intravenously administered to deliveroxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250(bovine)], or HBOC-201, is approved for sale in South Africa for the treatmentof surgical patients who are acutely anemic. Biopure has applied in the UnitedKingdom for regulatory approval of a proposed orthopedic surgical anemiaindication. The company is developing Hemopure for a potential indication incardiovascular ischemia, in addition to supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication.Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 bovine)],or HBOC-301, the only oxygen therapeutic approved by the U.S. Food and DrugAdministration and the European Commission, is indicated for the treatment ofanemia in dogs. Biopure has sold approximately 186,000 units of Oxyglobin,which have been used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are forward-looking statements, including those statements implying that the FDA willapprove any study protocol for the use of Hemopure in the U.S., the patientseligible for such a study, and any statements that might imply that Hemopuremay receive marketing approval in additional jurisdictions or for additionalindications. Actual results and their timing may differ materially from thoseprojected in these forward-looking statements due to risks and uncertainties.These risks include, without limitation, uncertainties regarding the company'sfinancial position, unexpected costs and expenses, delays and adversedeterminations by regulatory authorities, unanticipated problems with theproduct's commercial use, whether or not product related, and with productdistributors, sales agents or other third parties, and delays in orunpredictable outcomes of clinical trials, and the factors identified underthe heading "Risk Factors" in the company's quarterly report on Form 10-Qfiled on June 14, 2007, which can be accessed in the EDGAR database at theU.S. Securities and Exchange Commission's (SEC) website, http://www.sec.gov.The company undertakes no obligation to release publicly the results of anyrevisions to these forward-looking statements to reflect events orcircumstances arising after the date hereof. A full discussion of thecompany's operations and financial condition can be found in the company'sfilings with the SEC.
The content of this release does not necessarily reflect the position orthe policy of the U