Cytokinetics (CYTK) Gets EMA Orphan Designation for CK-2017357
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Cytokinetics, Incorporated (Nasdaq: CYTK) reports that the European Medicines Agency (EMA) has granted the company's fast skeletal muscle troponin activator CK-2017357 orphan medicinal product designation for the treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease. CK-2017357 is the lead drug candidate that has emerged from the Cytokinetics' skeletal sarcomere activator program. CK-2017357 is currently the subject of an ongoing Phase II clinical development program in patients with ALS.
Orphan medicinal product designation is adopted by the European Commission based on an opinion that is rendered by the EMA's Committee for Orphan Medicinal Products. Orphan medicinal product designation is granted by the EMA to novel drugs or biologics that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the European Union (EU), or for which there is no reasonable expectation that the cost of development and distribution of the drug will be recovered by the expected sales under normal market conditions without the incentives provided through this designation. The designation offers a number of potential incentives, which may include a ten-year period of EU marketing exclusivity from the date of marketing authorization, EU-funded research, protocol assistance and fee reductions.
Orphan medicinal product designation is adopted by the European Commission based on an opinion that is rendered by the EMA's Committee for Orphan Medicinal Products. Orphan medicinal product designation is granted by the EMA to novel drugs or biologics that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the European Union (EU), or for which there is no reasonable expectation that the cost of development and distribution of the drug will be recovered by the expected sales under normal market conditions without the incentives provided through this designation. The designation offers a number of potential incentives, which may include a ten-year period of EU marketing exclusivity from the date of marketing authorization, EU-funded research, protocol assistance and fee reductions.
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