Oxygen Biotherapeutics Inc has filed an application with the US Food and Drug Administration (FDA) to obtain orphan drug designation for Oxycyte 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 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."
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.
Oxygen Biotherapeutics is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring.