Samsung Biologics Renews Manufacturing Deal to Expand Production of TG Therapeutics’ Cancer Drug

For the fourth time since February 2018, Korea’s Samsung Biologics renewed a large-scale contract manufacturing deal with TG Therapeutics to produce the latter’s blood cancer drug ublituximab (TG-1101). The expanded collaboration saw the deal leap from $21.7 million (24.1 billion won) to $48.5 million (54.1 billion won) in value.

“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” said John Rim, CEO of Samsung Biologics. “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.”

Combo Therapy Against Chronic Lymphocytic Leukemia

Ublituximab is an investigational monoclonal antibody that can target a specific epitope on CD20-expressing B cells. It elicits immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), and causes cell destruction.

Ublituximab is in development for treating patients with Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL). The drug registered a strong showing in the Phase 3 UNITY-CLL trial where it was evaluated along with UKONIQTM (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon. Based on the positive results, TG Therapeutics submitted a Biologics License Application to the FDA for the combination therapy.

“This is an important next step in our long-standing relationship with Samsung,” said Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics.

“With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab.”

Besides CLL, ublituximab also impressed in two other Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS). TG Therapeutics is currently preparing a BLA for this indication as well.

Related Article: Korea Made Humira Biosimilar Begins Sales in Australia, Marks its Presence in Third Overseas Market

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Tyler Chen

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