Zydus Lifesciences Ltd., a global healthcare company, announced that its fully owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing and supply agreement with Synthon BV, a pharmaceutical company based in the Netherlands. This agreement will help bring Ozanimod Capsules to the U.S. market. Ozanimod Capsules are a generic version of ZEPOSIA, which is currently being reviewed by the U.S. Food and Drug Administration (FDA) for treating different types of multiple sclerosis that involve relapses. Synthon has already submitted an abbreviated new drug application in the U.S. and is working to get approval for this treatment.
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Under the agreement, Synthon will be responsible for getting the final FDA approval for Ozanimod and will manage the production and distribution of the drug. Zydus will handle the marketing and selling of the medicine in the U.S. Since Synthon was one of the first to apply, they have received a tentative approval from the FDA within 30 months and will have a 180-day period where they are the only company allowed to sell the product once it is on the market.
ZEPOSIA (Ozanimod) is a medicine that works by affecting a certain type of receptor in the body. It is used to treat different kinds of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is also approved for moderate to severe ulcerative colitis in adults. The trademark for ZEPOSIA is owned by Receptos, LLC, which is a part of Bristol Myers Squibb.
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Punit Patel, the President and CEO of Zydus Pharmaceuticals (USA) Inc., said he is hopeful about this deal. He said that by working with Synthon, Zydus can offer this important treatment to patients in the U.S. He added that this agreement supports Zydus’s mission to provide better care for patients by making essential medicines more accessible.
Anish Mehta, the CEO of Synthon BV, also commented on the partnership. He said that working with Zydus shows Synthon’s ability to create complex, first-to-market generic medicines. Mehta mentioned that this partnership helps them continue their work to make important medicines available and achieve their goals in the pharmaceutical industry.
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