Zydus Lifesciences today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with Synthon BV of the Netherlands for Ozanimod Capsules (a generic version of ZEPOSIA®) for the U.S. market. Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules indicated for relapsing forms of multiple sclerosis.
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product, and thereafter, for the manufacture and supply of the product. Zydus will be responsible for the commercialization of the product in the USA. As one of the first filers, Synthon has received tentative approval within 30 months from U.S. Food and Drug Administration (FDA), making the product eligible for a shared 180-day exclusivity upon market entry.
ZEPOSIA® (Ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is also approved for moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA® is a trademark of Receptos, LLC, a Bristol Myers Squibb company.