Zydus Lifesciences Inks Pact With Synthon For US Launch of Generic Zeposia

Zydus Lifesciences Ltd. on Thursday said its wholly-owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing agreement with Netherlands-based Synthon BV for the US launch of Ozanimod capsules, the generic version of Bristol Myers Squibb’s Zeposia.

Synthon has filed an abbreviated new drug application in the US for Ozanimod, which is indicated for relapsing forms of multiple sclerosis. The company has already received tentative approval from the US Food and Drug Administration as one of the first filers, making it eligible for a shared 180-day exclusivity on launch.

Under the agreement, Synthon will handle regulatory approval, manufacturing, and supply of the drug, while Zydus will be responsible for commercialisation in the US, the company said in an exchange filing.