Shares of Zydus Lifesciences Ltd were trading 2% higher on 5 September after the company announced that its wholly-owned subsidiary, Zydus Lifesciences Global FZE, signed an exclusive licensing and supply deal with Synthon BV of the Netherlands for Ozanimod Capsules for the US market.
Synthon, as one of the earliest filers, earned provisional clearance from the US Food and Drug Administration (FDA) within 30 months, allowing the product to enter the market with a shared 180-day exclusivity period.
Synthon has an abbreviated new drug application filed in the United States for Ozanimod Capsules, which is indicated for relapsing forms of multiple sclerosis.
Synthon will be responsible for securing final regulatory approval for its Ozanimod Capsules product, as well as manufacturing and supplying the product, according to the conditions of this agreement.
Zydus will be responsible for the product’s commercialisation in the United States.
Punit Patel, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., said, “This collaboration with Synthon enables us to bring this important treatment to the US 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.”
Earlier this month, the business announced the launch of its trivalent influenza (Flu) vaccine VaxiFluTM, which was released in India for the first time in accordance with WHO global recommendations.
In August, Zydus Therapeutics, a wholly owned subsidiary, revealed promising topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial.
At 12:01 pm, the shares of Zydus Lifesciences were trading 0.30% higher at Rs 1,015 on NSE.
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