Zydus Lifesciences Ltd on Wednesday said it has signed an exclusive development, licensing, supply and commercialisation pact with Synthon BV of the Netherlands for a novel oncology product for an undisclosed target. The novel 505(B)(2) oncology product is likely to be filed in 2026 and will offer additional strengths that are intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance, the company said in a statement.
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 commercialisation of the product in the US, it added.
Zydus Lifesciences Managing Director Sharvil Patel said the partnership with Synthon is for the commercialisation of the 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,” he added.
Synthon BV CEO Anish Mehta said, “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.” Zydus will bring this critical medicine to the market to provide patients with important treatment alternatives for this extremely challenging condition, he added.
Citing IQVIA MAT December 2024 data, the company said the addressable market size of reference product is approximately USD 1.5 billion.
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