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[Europak]

Die Aktien von Biopure sind seit vielen Monaten stark gebeutelt worden, zuletzt durch Aktien-Splitt.

Gestern ging der Kurs in USA um 19 % nach oben.
In Frankfurt heute trotz geringer Umsätze entsprechend.
Ich denke die Biopure hat wieder eine gute Storie und
wird in den nächsten Wochen zulegen.
Als Anhang die New´s vom 13.06.2005 leider nur in Englisch.
Biopure Corporation (ticker: BPUR, exchange: NASDAQ Stock Exchange (.O)) News Release - 6/13/2005


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U.S. Navy Seeks FDA Okay to Start Trauma Trial of Hemopure(R)

Naval Medical Research Center Submits IND Application for Proposed "RESUS" Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
CAMBRIDGE, Mass., June 13 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPURD; BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a two-stage clinical trial of the company`s oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the out-of-hospital treatment of trauma patients. Under a research agreement with Biopure, the NMRC has primary responsibility for designing, seeking FDA acceptance of and directing the trial, entitled "Restore Effective Survival in Shock (RESUS)".

RESUS is designed as a single-blinded, multicenter, randomized, controlled, Phase IIb/III study. The objective is to assess the safety and efficacy of Hemopure, as compared to standard treatment, in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock (acute blood loss) in the out-of-hospital setting, where blood is not available for transfusion. Patients would be randomized to receive either Hemopure or standard therapy at the scene of the injury and during transport to the hospital. The trial would require an exception from informed consent and would include a community consultation and disclosure program, as defined in federal regulations 21 CFR 50.24-25. Before the trial can proceed, the FDA and the participating hospitals` internal review boards must review and accept the study protocol.

RESUS represents a unique collaboration between scientists and clinicians from the military, academic hospitals, a nonprofit organization and Biopure under the direction and main funding of the NMRC. To date, Congress has appropriated a total of $18.5 million to the Navy and Army* for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for RESUS and for preclinical studies of Hemopure in animal models of hemorrhagic shock, including those that mimic military trauma scenarios.

Out-of-Hospital Trauma

Traumatic injuries may cause massive bleeding resulting in rapid loss of oxygen-carrying capacity. Due to logistical issues, red blood cells are not typically administered in emergency situations outside of the hospital; emergency caregivers administer intravenous fluids (Ringer`s lactate, saline) that restore blood volume but do not carry oxygen. If safety and effectiveness can be demonstrated and regulatory approval obtained, the company believes that the room- and elevated-temperature stability (3 years at 2 to 30 degrees Celsius, 18 months at 40 C), universal compatibility and other properties of Hemopure could allow it to be stockpiled, positioned abroad, and carried or stored in remote locations. These attributes may make it well suited for use on the battlefield, in ambulances, and in the Strategic National Stockpile.

Biopure Corporation

Biopure Corporation develops and manufactures intravenously administered pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body`s tissues. The company is developing Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia and, in collaboration with the U.S. Naval Medical Research Center, for an out- of-hospital trauma indication. The product is approved in South Africa for treating surgery patients who are acutely anemic and for eliminating, delaying or reducing allogeneic red blood cell transfusions in these patients. Hemopure has not been approved for sale in any other jurisdictions, including the United States or the European Union. 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.

Statements in this press release that are not strictly historical, including those about the FDA and the hospital internal review boards allowing the RESUS trial to proceed, are forward-looking statements. Actual results may differ materially from those projected in these forward-looking statements due to risks and uncertainties regarding the company`s operations and business environment. These risks include, without limitation, uncertainties regarding the company`s ability to generate revenues, cash requirements, unexpected costs and expenses, insurance coverage, and possible delays and unforeseen costs related to clinical trials, regulatory approvals and marketing and distribution of the company`s products. 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, and specific factors that could cause the company`s actual performance to differ from current expectations, can be found in the company`s filings with the U.S. Securities and Exchange Commission, including the Form 10-Q filed on June 9, 2005, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov, or through the Investor Relations section of Biopure`s website, http://www.biopure.com.

The content of this press release 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. Completion of the proposed RESUS clinical trial of Hemopure in trauma may be contingent upon further funding.


* $5,102,306 of the $6,500,000 appropriated to the Army is from Grant
DAMD17-02-1-0697. The U.S. Army Medical Research Acquisition Activity, 820
Chandler Street, Fort Detrick MD 21702-5014, is the awarding and administering
acquisition office.

Contact:
Douglas Sayles
Biopure Corporation
[phone]
[e-mail]

SOURCE Biopure Corporation
06/13/2005


CONTACT: Douglas Sayles of Biopure Corporation, [phone], [e-mail]

Web site: http://www.biopure.com
(BPUR BPURD)




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[lyta [VIP]]

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