New Launch12 Feb 2025, 09:34 pm
Zydus and Synthon Partner for Novel 505(B)(2) Oncology Product in US Market
AI Summary
Zydus Lifesciences Ltd. and Synthon BV have signed an exclusive development, licensing, supply and commercialization agreement for a novel 505(B)(2) Oncology product for an undisclosed target, aimed at providing reduced pill burden, flexibility for dose adjustment and enhanced patient compliance. The product is expected to be filed in 2026, targeting the US$1.5 billion addressable market of the Reference Product.
Key Highlights
- Zydus and Synthon have signed an exclusive agreement for a novel 505(B)(2) Oncology product for the US market.
- Synthon will be responsible for development, manufacturing and supply, while Zydus will handle NDA submission and commercialization.
- The product is expected to offer reduced pill burden, flexibility for dose adjustment and enhanced patient compliance.
- The product is likely to be filed in 2026, targeting the US$1.5 billion addressable market of the Reference Product.
- The partnership aims to meet critical needs of patients and stakeholders in the high unmet need therapy area.