South Korea’s Samsung Biologics said on Monday it has agreed to expand its contract manufacturing deal for the supply of ublituximab, an investigational monoclonal antibody, from U.S.-based biotech firm TG Therapeutics. Samsung Biologics renewed its contract value from the previous $22.4 million to $50.3 million in the latest regulatory filing.
This marks the fourth CMO contract between Samsung Biologics and TG Therapeutics. The two have expanded their contract volume three times, including the latest one, after signing the first CMO deal for ublituximab in February 2018.
If ublituximab is successfully developed by TG Therapeutics, the minimum guaranteed contract amount for Samsung Biologics will be adjusted to $278.1 million and could increase to up to $345.6 million when demand for the drug increases.
Ublituximab is being evaluated in phase 3 clinical trials for patients with relapsing forms of multiple sclerosis after receiving orphan drug designation from the U.S. Food and Drug Administration (FDA).
“With the recent positive 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,” said Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics.
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