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Oxygen Biotherapeutics, Inc. Submits Orphan Drug Application for Oxycyte

Posted on: Thursday, 7 May 2009, 07:30 CDT

COSTA MESA, Calif., May 7 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has filed an application with the U.S. Food and Drug Administration (FDA) to obtain orphan drug designation for Oxycyte(R) for the treatment of patients with severe, closed-head traumatic brain injury (TBI). Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.

If granted, orphan drug status would entitle Oxycyte to key regulatory and tax benefits, and seven years of marketing exclusivity for the orphan TBI indication after FDA approval.

"The exclusive marketing rights for an indication are the key benefit of an orphan drug designation," said company chairman and CEO Chris Stern. "This would complement our expansive patent protection and allow us to build an exclusive beach-head in the market. With the U.S. orphan drug application filed and plans moving forward for a timely start to our dose escalation clinical trials in Switzerland and Israel, we are continuing to make progress on the critical path leading to bringing Oxycyte to market for multiple indications."

The orphan drug designation in cases of severe, closed-head TBI would be in addition to Oxycyte use in other clinical interventions, including treatment of other types of TBI (estimated at about five million annually in the United States and Europe), decompression sickness, sickle cell crisis pain, and topical indications.

About Oxygen Biotherapeutics, Inc.

Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The company has under development a perfluorocarbon therapeutic oxygen carrier and liquid ventilation product (Oxycyte(R)) and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including traumatic brain injury, sickle cell crisis pain, trauma, wound care, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, diabetes and cosmetic applications. More information is available at www.oxybiomed.com.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include those referring to expected benefits from receiving orphan drug designation for Oxycyte in severe, closed-head traumatic brain injury and the start of dose escalation clinical trials. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the FDA will approve orphan drug designation for Oxycyte or that dose escalation clinical trials in traumatic brain injury will be allowed to begin in Switzerland or Israel, that such trials will be successful or that Oxycyte will be approved for market for traumatic brain injury or any other indication. Additional information concerning these and other risk factors affecting Oxygen Biotherapeutics, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via www.oxybiomed.com. Oxygen Biotherapeutics, Inc. disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Oxygen Biotherapeutics, Inc.

Source: PR Newswire

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