Zydus Lifesciences announced that it has signed an exclusive development, licensing, supply and commercialization agreement with Synthon BV of the Netherlands for a novel oncology product for an undisclosed target, says a company statement. The drug will be marketed in the US.The addressable market size of reference product is approximately $1.5 billion as per IQVIA MAT Dec 2024.Under the terms of this agreement, Synthon will be responsible for the development, manufacturing and supply of the finished product. Zydus will be responsible for the NDA submission and commercialization of the product in the US. This product will likely be filed in 2026 and will be offering additional strengths that are intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance.Zydus Lifesciences MD Sharvil Patel said, “The partnership will bring access to a high unmet need therapy area.”Anish Mehta, CEO of Synthon BV, stated, “This 505(B)(2) product is another example of Synthon’s superior complex product development capabilities and represents a strategic move toward more complex and clinically differentiated products."
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