On April 13, 2016 (TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TG-1101, the Company’s novel, glycoengineered monoclonal antibody (Press release, TG Therapeutics, APR 13, 2016, View Source [SID:1234510746]). The patent, U.S. Patent No. 9,234,045 specifically covers the composition of TG-1101, and its use for treating various forms of CD20 expressing leukemia and lymphoma, including chronic lymphocytic leukemia (CLL) and various types of non-Hodgkin’s lymphoma, including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).
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The patent was issued to LFB SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with LFB SA. The issuance affords patent protection for TG-1101 in the US through July of 2029, exclusive of additional patent term extensions also available. TG-1101 is currently being studied in two Phase 3 clinical trials in patients with CLL, with additional registration directed trials in NHL expected to commence in 2016.
"We are excited to announce the issuance of the first U.S. patent for TG-1101 which affords protection through 2029. With composition of matter patents now in place for both TG-1101 and TGR-1202, and an additional later-filed patent application on the combination of TG-1101 and TGR-1202, we believe we have established a very strong intellectual property position for the two components of our proprietary ‘TG-1303′ regimen that provides a very attractive exclusivity period without the risk of generic competition for many years to come," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We remain focused on continuing to strengthen our intellectual property position through the issuance of additional patents for both TG-1101 and TGR-1202 individually as well as in combination here in the US and abroad."