CAMBRIDGE, Mass., Aug. 22 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today the status of discussions with Malaysia about a possible joint venture. The possibility of such a venture was described by a Malaysian government official to the Malaysian national news agency Bernama in early July.
As indicated in the July statements in Malaysia, Biopure and officials representing public and private interests in Malaysia have been in discussions related to a possible joint venture between the company and a Malaysian entity under the Malaysian Ministry of Science Technology and Innovation.
The Malaysian Ministry has expressed to Biopure its wish to pursue a Hemopure joint venture licensing agreement for Malaysia and certain other countries in Asia upon Biopure's receipt of marketing authorization for Hemopure in the United Kingdom. The investment as discussed, would be well over $100 million. The following broad terms have been discussed:
-- A direct investment in Biopure common stock-up to 19.9% of the company.
-- Licensing rights for Hemopure(R).
-- The funding by Malaysia of a joint venture company to be owned by
Biopure and a Malaysian entity.
-- A large-scale plant for manufacturing Hemopure in Malaysia, at an
estimated cost in excess of $100 million, with government financing.
Many details and final agreements must still be reached between Biopure and Malaysia should the company receive U.K. market approval for Hemopure. Malaysia has conducted business, medical and regulatory due diligence, including diligence in the United States and South Africa.
Biopure continues to believe there is a reasonable chance that Hemopure can be approved for a surgical patient population when blood is not available or an option in the United Kingdom. There is no prescribed time frame for a final decision from the U.K. licensing authority once Biopure makes its submission addressing pending MHRA questions, but four to six months is typical. Biopure expects to meet with the MHRA and make its response in September.
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 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 regarding possible future discussion of a transaction with involving Malaysia, the terms of any such transaction, and that Hemopure may receive marketing approval in the U.K.. 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, the company's ability to respond to requests for additional data, unanticipated problems with the product's commercial use, whether or not product related, 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 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.
Herb Lanzet (Investors)
H.L. Lanzet Inc.
|SOURCE Biopure Corporation|
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