Zydus Lifesciences has entered into an exclusive development, licensing, supply, and commercialisation agreement with Synthon BV for a novel 505(B)(2) oncology product targeting an undisclosed indication.
Under the agreement, Synthon BV will oversee the development, manufacturing, and supply of the finished product. Zydus will be responsible for the New Drug Application (NDA) submission and commercialisation in the United States. The filing for this product is expected in 2026. The product is designed to offer additional strengths intended to reduce pill burden, provide flexibility for dose adjustments, and improve patient compliance.
Dr Sharvil Patel, Managing Director of Zydus Lifesciences, said, “We are pleased to partner with Synthon for the commercialisation 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.”
According to IQVIA MAT data for December 2024, the reference product’s addressable market size is approximately US$1.5 billion.