Press release
Geron Receives Positive Opinion from the EMA Committee for Orphan Medicinal Products for Orphan Drug Designation in the European Union for Imetelstat to Treat Myelodysplastic Syndromes
Designation would provide 10-year period of marketing exclusivity in the European Union after product approvalPatients are currently enrolling in a
About this update from Geron Corporation
[{"type":"text","content":"Designation would provide 10-year period of marketing exclusivity in the European Union after product approvalPatients are currently enrolling in a Geron-sponsored Phase 3 clinical trial in lower risk myelodysplastic syndromes MENLO PARK, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company’s application for orphan drug designation of its first-in-class telomerase inhibitor, imetelstat, as a potential treatment for myelodysplastic syndromes (MDS). The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS.\n “The positive opinion from the COMP acknowledges the compelling clinical data from our Phase 2 clinical trial that imetelstat has the potential to provide a clinically relevant advantage to lower risk MDS patients who are transfusion dependent and have failed to respond to treatment with erythropoiesis stimulating agents,” said John A. Scarlett, Chairman and Chief Executive Officer. “Our ongoing IMerge Phase 3 clinical trial in lower risk MDS is being conducted at multiple sites around the world, and data from this trial are intended to support global regulatory filings.” To qualify for orphan drug designation in the EU, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and ten years of market exclusivity. Ongoing IMerge Phase 3 Clinical Trial The IMerge Phase 3 clin...