Geron Corp (GERN) Announces Receipt of FDA Orphan Drug Designation for Imetelstat as Myelofibrosis Treatment

June 15, 2015 7:14 AM EDT

On June 11, 2015, the United States Food and Drug Administration (the “FDA”) granted orphan-drug designation to imetelstat for the treatment of myelofibrosis. Imetelstat is a telomerase inhibitor discovered by Geron Corp (NASDAQ: GERN) that has been exclusively licensed to Janssen Biotech, Inc. (“Janssen”) on a worldwide basis for development and commercialization in oncology indications, including hematologic myeloid malignancies, and all other human therapeutic uses. Janssen sponsored the application to the FDA for orphan designation.

For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the Orphan Drug Act (the “ODA”) and FDA’s implementing regulations at 21 CFR Part 316. Orphan status is granted by the FDA’s Office of Orphan Drug Products in order to support development of medicines for underserved or rare diseases and patient populations that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including, if regulatory approval is received, market exclusivity, exemption from FDA application fees, and certain tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

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