CAMBRIDGE, Mass., July 25 /PRNewswire-FirstCall/ -- Biopure Corporation today announced through a letter to stockholders its most recent progress in the clinical development of its lead oxygen therapeutic, Hemopure(R). The letter to stockholders was filed on Form 8-K with the Securities and Exchange Commission today. A summary of the progress reported on includes the following:
Biopure has submitted a final study report to the FDA for the first trial in its cardiovascular ischemia program (COR-001). COR-001 was a phase 2 safety and feasibility study trial that evaluated 45 patients with coronary artery disease who were undergoing percutaneous coronary intervention, or PCI. Investigators have started a COR-002 trial, also a phase 2 trial, which is currently enrolling patients in the Netherlands. This study is intended to enroll up to 10 patients and could be completed in the near future.
In addition to re-starting a compassionate use program in January, the company has submitted a study protocol to the FDA for the use of Hemopure in the United States in certain life-threatening situations where red blood cell transfusion is not an option. This is the first step towards formalizing the compassionate use of Hemopure without requiring an IND for each new case. To date, the FDA has approved all requests and granted single-patient INDs to Biopure for the treatment of individual patients with life-threatening anemia when red blood cell transfusion was not an option. The company continues to receive requests for Hemopure use in life-threatening situations on a weekly basis.
The U.S Navy Medical Research Center (NMRC) submitted a revised study protocol for RESUS, a proposed clinical trial to study the use of Hemopure to “Restore Effective SUrvival in Shock” that the FDA has on clinical hold. The revised protocol is based on commentary in an FDA Blood Products Advisory Committee meeting held in December 2006 and subsequent communications with the FDA. The general objective of this Phase 2 study is to test the NMRC hypothesis that HBOC-201 could be safe and tolerable and decrease morbidity and mortality in trauma patients before they arrive at the hospital.
Biopure has met with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to discuss comments received from the MHRA in a December 2006 letter relating to an application for market authorization. The company expects to submit its response to the MHRA letter by the end of this summer.
Biopure’s Cambridge manufacturing facility was recently inspected by representatives of the MHRA who undertook an inspection on behalf of the EMEA (European Agency for the Evaluation of Medicinal Products) relating to the veterinary product, Oxyglobin. As a result of the inspection, Biopure has received a GMP (“good manufacturing practices”) certificate for its plant.
With respect to business development activities, the company is considering a possible licensing opportunity to manufacture and sell Hemopure in certain Asian countries yet to be finalized. In this regard, the company is in discussions with individuals from the Malaysia Technology Development Corporation (the venture capital arm of the Malaysian Ministry of Science, Technology and Innovation) and private investors. A proposed transaction would likely involve an investment in Biopure class A common stock at a premium and the establishment of a production facility for Hemopure in Malaysia to supply the selected Asian territories. Biopure cannot give assurance that a transaction will occur, as any license remains subject to negotiation and required approvals.
Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body’s tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular 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 Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 182,000 units of Oxyglobin, which have been used to treat an estimated 100,000 animals.
Statements in this letter that are not strictly historical are forward- looking statements, including those that might imply that the Navy’s proposed RESUS clinical trial will be allowed to proceed or that Hemopure may receive marketing approval in additional jurisdictions or for additional indications, and those that might imply the timing of regulatory submissions and regulatory actions. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company’s financial position, unexpected costs and expenses, delays and adverse determinations by regulatory authorities, unanticipated problems with the product’s commercial use, whether or not product related, and with product distributors, sales agents or other third parties, and delays in or unpredictable outcomes of clinical trials, and the factors identified under the heading “Risk Factors” in the company’s quarterly report on Form 10-Q filed on June 14, 2007, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission’s (SEC) website, http://www.sec.gov. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company’s operations and financial condition can be found in the company’s filings with the SEC.
The content of this letter does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred.
Contact: Todd Wood Biopure Corporation (617) 234-6576 IR@biopure.com Herb Lanzet (Investors) H.L. Lanzet Inc. (212) 888-4570 lanzet@aol.com
Biopure Corporation
CONTACT: Todd Wood of Biopure Corporation, +1-617-234-6576,IR@biopure.com; or Investors, Herb Lanzet of H.L. Lanzet Inc.,+1-212-888-4570, lanzet@aol.com
Web site: http://www.biopure.com//
Company News On-Call: http://www.prnewswire.com/comp/131224.html /
