Zydus Lifesciences, Synthon ink pact for new oncology product

Ahmedabad: Zydus Lifesciences Ltd., a global innovation-driven healthcare
company announced that it has signed an exclusive development, licensing, supply and
commercialization agreement with Synthon BV of the Netherlands for a novel 505(B)(2) Oncology
product for an undisclosed target.

This 505(B)(2) Oncology product will likely be filed in 2026 and will be offering
additional strengths that is intended to provide reduced pill burden, flexibility for dose adjustment and
enhanced patient compliance.

Speaking on the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “We
are pleased to partner with Synthon for the commercialization of this complex drug product in the US
market. The partnership will bring access to a high unmet need therapy area. We are certain that by
pooling our resources and knowledge, we will meet critical needs of patients and stakeholders.”

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. We are excited to strengthen our partnership with Zydus, who will
bring this critical medicine to market to provide patients with important treatment alternatives for this
extremely challenging condition.”

The addressable market size of Reference Product is approximately US$1.5 billion as per IQVIA MAT
Dec 2024.

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. 

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