NEW YORK, Sept. 9, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced that ublituximab (TG-1101), the Company's novel, glycoengineered anti-CD20 monoclonal antibody has received two Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma (Mucosa-Associated Lymphatic Tissue, MALT), both rare subtypes of non-Hodgkin's lymphoma (NHL) for which there are limited effective treatments.
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Marginal Zone LymphomaMarginal Zone Lymphomas are relatively rare subtype of non-Hodgkin's lymphoma (NHL), accounting for approximately 5-10% of all NHLs according to the American Cancer Society. The median age of diagnosis of this type of lymphoma is approximately 66. There are three types of Marginal Zone Lymphoma: (1) extranodal or mucosa associated lymphoid tissue (MALT), occurring outside the lymph nodes; (2) nodal, occurring within the lymph nodes; and (3) splenic, occurring mostly in the spleen and blood. Presently there are no agents approved specifically for the treatment of MZL.
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