Indian pharmaceutical major Zydus Lifesciences has announced an exclusive development, licensing, supply and commercialization agreement with Netherlands-based Synthon BV for a novel 505(B)(2) oncology product targeting an undisclosed indication. The partnership positions Zydus to enter a significant cancer treatment market estimated at $1.5 billion.
Strategic Partnership Structure
Under the terms of the agreement, Synthon will be responsible for the development, manufacturing and supply of the finished product, while Zydus will handle the New Drug Application (NDA) submission and commercialization activities in the United States. The filing for this product is expected in 2026.
The novel cancer drug is designed to offer additional strengths that are intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance. This approach addresses key challenges in cancer treatment adherence and patient management.
Market Opportunity and Clinical Impact
According to IQVIA MAT data for December 2024, the reference product's addressable market size is approximately $1.5 billion. The partnership targets what both companies describe as a high unmet medical need therapy area.
"We are pleased to partner with Synthon for the commercialization of this complex drug product in the US market," said Dr Sharvil Patel, Managing Director of Zydus Lifesciences. "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."
Complex Product Development Capabilities
Anish Mehta, CEO of Synthon BV, emphasized the strategic significance of the collaboration, stating: "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."
Mehta further noted that "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."
Regulatory Pathway and Timeline
The 505(B)(2) regulatory pathway allows for the development of new formulations or combinations of existing approved drugs, potentially reducing development timelines while maintaining safety and efficacy standards. The expected 2026 filing timeline positions the partnership to bring this oncology treatment to market within the next few years, addressing the identified unmet medical needs in cancer care.
