Zydus Lifesciences in pact with Synthon for specialty oncology product in US

Zydus Lifesciences on Wednesday said it has entered into an exclusive development, licensing, supply, and commercialisation agreement with Dutch drugmaker Synthon for a novel 505(B)(2) oncology product targeting an undisclosed indication.

Under the agreement, Synthon 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.

“We are pleased to partner with Synthon for the commercialisation of this complex drug product in the US market,” said Dr Sharvil Patel, MD of Zydus.

“The partnership will bring access to a high unmet need therapy area,” he added.
“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,” said Anish Mehta, CEO of Synthon.