Cynata Therapeutics (ASX:CYP) said the potential approval of its CYP-001 drug candidate will not be impeded by the orphan-drug exclusivity granted by the US Food and Drug Administration to Mesoblast's (ASX:MSB) Ryoncil, according to a Friday Australian bourse filing.
Ryoncil was granted the exclusivity period for the treatment of steroid-refractory acute graft versus host disease in paediatric patients aged two months of age and older.
CYP-001 is an off-the-shelf product for intravenous infusion based on a proprietary therapeutic stem cell platform technology. The FDA earlier granted orphan-drug designation to CYP-001 for the treatment of acute graft versus host disease, qualifying Cynata for incentives, including extended marketing exclusivity, tax credits, and fee waivers.
It emphasized that CYP-001 does not contain "the same drug" as Ryoncil, noting that the orphan-drug designation says that approval will not be given to a sponsor of the same drug for the same use or indication for seven years.
Its shares jumped 6% in recent trading on Friday.
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