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GEN News Highlights : Nov 15, 2012

TG Enters mAb Therapeutic Agreement for South Korea, SE Asia

TG Therapeutics entered into an exclusive licensing agreement with Ildong Pharmaceutical Co., for the development and commercialization of the company's anti-CD20 antibody, Ublituximab (TGTX-1101) in South Korea and Southeast Asia. Based in Seoul, Korea, Ildong is a Korean company focused on the development, manufacturing, and marketing of pharmaceuticals and OTC products.

TG Therapeutics will receive an upfront payment of $2 million in addition to sales-based milestone and royalty payments in exchange for exclusive rights to develop and commercialize Ublituximab for all therapeutic indications in the territory.

Ublituximab is a third-generation chimeric monoclonal antibody targeting an epitope on the CD20 antigen found on B lymphocytes. The compound has reportedly been bioengineered for enhanced biological activity with an increased ability to trigger an immune response, delivering ADCC effects to aid in B-cell depletion. Ublituximab is under development for hematologic malignancies and other B-cell lymphoproliferative disorders, and is currently being evaluated in a North American Phase I/II clinical trial in patients with relapsed or refractory non-Hodgkin's lymphoma. The compound has been granted orphan status in Europe and in the U.S. for B-cell chronic lymphocytic leukemia.

"We are delighted to have added Ublituximab to our pipeline in biologics and it is a strategic fit for Ildong," said Jung-Chi Lee, chairman & CEO of Ildong. "We believe Ublituximab . . . will strengthen our presence in oncology and autoimmune areas and look forward to working with TG Therapeutics in developing Ublituximab in South Korea and Southeast Asia."

In March of this year, TG Therapeutics inked a license agreement with LFB Biotechnologies and GTC Biotherapeutics for worldwide, commercial rights to Ublituximab. TG Therapeutics was formed as a spinout from LFB Biotechnologies (minority stake) to focus on Ublituximab for the treatment of various B-cell proliferative disorders.