Geron Corp (GERN) Announces Receipt of FDA Orphan Drug Designation for Imetelstat as Myelofibrosis Treatment
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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.
The information contained in this Item 7.01 to this Current Report shall be deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01 to this Current Report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission under the Securities Act or the Exchange Act made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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