Zydus Lifesciences and Synthon have inked an exclusive agreement to create and market a new cancer treatment; Zydus will handle US marketing and NDA filing by 2026, while Synthon will handle production.

On Wednesday, Zydus Lifesciences said that it and Dutch pharmaceutical company Synthon had signed an exclusive research, license, supply, and commercialization deal for a new 505(B) (2) cancer medication that targets an unknown indication.

As per the deal, Synthon will be in charge of the final product's development, production, and distribution. Zydus will be in charge of submitting the New Drug Application (NDA) and bringing the product to market in the US. This product is anticipated to be filed in 2026. In order to promote patient compliance, allow flexibility for dosage modifications, and lessen pill load, the product is developed to offer additional strengths.

Zydus's MD, Dr. Sharvil Patel, stated that the company is happy to collaborate with Synthon on the marketing of this intricate medication solution in the US market. Access to a severely unmet need therapeutic area will be made possible by the agreement.

According to Synthon CEO Anish Mehta, this 505(B)(2) product is a strategic step toward more complicated and therapeutically distinct treatments and is another illustration of Synthon's exceptional complex product development capabilities.

The addressable market size for the reference product is estimated to be around $1.5 billion based on IQVIA MAT data as of December 2024.