Samsung Biologics expands drug manufacturing with TG Therapeutics

Samsung Biologics' plant in Incheon, west of Seoul / Courtesy of Samsung Biologics

By Baek Byung-yeul

Samsung Biologics CEO John Rim

Samsung Biologics has renewed its contract-based drug manufacturing deal to produce more drugs for U.S.-based biopharmaceutical company TG Therapeutics, the Samsung Group affiliate said Monday.

The Korean biopharmaceutical development and manufacturing company said the two sides agreed to expand their deal for the supply of the drug Ublituximab for a contract price of $50.3 million, up from the previous $22.4 million. This contract manufacturing organization (CMO) deal is their fourth collaboration since the two companies first signed one in February 2018.

TG Therapeutics has been developing Ublituximab, a monoclonal antibody drug to treat multiple sclerosis. The drug firm has submitted a biologics license application to the U.S. Food and Drug Administration (FDA) requesting approval for use of Ublituximab, which is in Phase 3 testing.

Samsung Biologics said the minimum guaranteed contract amount for the company will be $278.1 million, if the drug development is successful, and the figure could increase to up to $345.6 million if TG Therapeutics wants to produce more drugs.

“We are very glad to be able to flexibly accommodate our client's expanded needs through our facilities," Samsung Biologics CEO John Rim said. "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."

TG Therapeutics CEO Michael S. Weiss also said the company is pleased to secure a stable supply of the drug.

“Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of Ublituximab across both oncology and autoimmune indications,” he said. “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. This is an important next step in our long-standing relationship with Samsung.”

Samsung Biologics provides contract manufacturing, development and testing services from a single location, offering end-to-end services for its clients. To meet the growing demand for contract-based manufacturing, it has been constructing its fourth and largest bio-manufacturing facility in Incheon, west of Seoul.

Currently the company runs three plants there capable of producing 362,000 liters, which is the world's largest production volume. Upon completion of the new facility in 2023, Samsung Biologics will be able to produce 620,000 liters, making it the largest CMO facility at a single location. The company said the production volume from its four plants will account for about 30 percent of the global CMO market.

The company is also expanding into the contract development organization (CDO) business, an end-to-end biopharmaceutical project running drug development procedures from laboratory research to clinical trials.

During last month's Korea Times Bio Webinar, company Vice President and head of CDO business Ahn Yong-ho said, “Our specialty is providing a super-fast drug development process for customers. Our CDO business is able to provide a full scope of drug development services from the gene level to investigational new drug filing, which takes seven months.”