Elbit Imaging Ltd. announced that it was informed by Gamida Cell Ltd., an indirect associate of the Company, that the orphan drug designation, which has been granted by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) regarding NiCord®, has been broadened and now includes any treatment which is based on blood system stem cells (haematopoetic stem cells) transplant.
The EMA grants an orphan drug designation to promote the development of products that demonstrate promise for the treatment of rare diseases. EMA Orphan drug designation provides 10 years of market exclusivity in the EU, as well as prospective grants receiving easement and assistance with developing and registration of drugs for marketing.
As of today, the development of NiCord® remains at the clinical stage of development, and there is no certainty that NiCord® will be marketed on a commercial basis.
The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.8% on a fully diluted basis) which, in turn, holds approximately 25% of the share capital in Gamida (22.5% on a fully diluted basis).