OPK Biotech LLC – Regulatory Milestone Reached

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Hemopure Now Approved in Russia

OPK Biotech LLC is pleased to announce the first approval in Russia for a Hemoglobin-Based Oxygen Therapeutic. The Russian Ministry of Health has granted a certificate of registration for the Company’s drug Hemopure® [hemoglobin glutamer – 250 (bovine)], or HBOC-201, a first-in-class drug for use in the treatment of acute anemia in adults. Russia becomes the second country, after South Africa in 2001, to recognize the potential benefit of Hemopure in situations where the supply of blood may be insufficient or unsafe. A further regulatory milestone was reached recently when the South Africa’s Medicines Control Council upheld the Company’s appeal of the de-registration of Hemopure® approved for use in the treatment of acute surgical anemia.

OPK Biotech recently acquired the intellectual property through the bankruptcy of Northfield Laboratories, Inc. of Evanston, IL, the company that developed the drug, PolyHeme®, a human hemoglobin-based oxygen carrier. The purchase included drug product; worldwide patents relating to manufacturing, packaging, composition and use; PolyHeme’s development history, including clinical trial data; and communications with Regulatory Authorities. This acquisition will further consolidate the Company’s leadership position in the field.

OPK Biotech LLC, Cambridge, Massachusetts, USA, has developed and manufactures two first-in-class pharmaceuticals or oxygen therapeutics: Hemopure® and Oxyglobin® [hemoglobin glutamer – 200 (bovine)], or HBOC-301, for veterinary use., the only oxygen therapeutic approved for use by both the European Commission and the U.S. Food and Drug Administration, is indicated for the treatment of all-cause anemia in dogs. The Company’s research strategy focuses on the further development of Hemopure in indications that may be benefitted from use of an oxygen therapeutic, such as ischemia, anemia, and trauma.

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Tiana Gorham

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