Zydus, Synthon enter licensing, supply agreement for multiple sclerosis drug Ozanimod for US market
As one of the first filers, Synthon has received tentative approval within 30 months from USFDA.
Ahmedabad: Zydus Lifesciences Ltd., a global healthcare company, has 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.
Speaking on the development, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., Punit Patel said, "This collaboration with Synthon enables us to bring this important treatment to the U.S. market. This collaboration reinforces our strategic focus on advancing care in therapeutic areas and reflects our commitment to making essential medicines more accessible to patients.”
Anish Mehta, Chief Executive Officer, Synthon BV, commented, “This collaboration with Zydus for Ozanimod capsules continues to underscore our proven expertise in developing first-tomarket, complex generic products. We are pleased to strengthen our partnership with Zydus as we continue advancing our strategic commitment to expanding access to essential medicines.”
