Oxygen Biotherapeutics wins orphan designation for brain injury drug

Oxygen Biotherapeutics, a company engaged in the business of developing biotechnology products with a focus on oxygen delivery to tissue, has filed an application with the FDA to obtain orphan drug designation for Oxycyte for the treatment of patients with severe, closed-head traumatic brain injury. Oxycyte is the company’s perfluorocarbon 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 traumatic brain injury (TBI) indication after FDA approval.

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, decompression sickness, sickle cell crisis pain, and topical indications.

Chris Stern, chairman and CEO of Oxygen Biotherapeutics, said: The exclusive marketing rights for an indication are the key benefit of an orphan drug designation. This would complement our expansive patent protection and allow us to build an exclusive beach-head in the market.

With the US 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.