Sun Pharmaceutical Industries Ltd.  and Churchill Pharmaceuticals, LLC. (Churchill) announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the US Food and Drug Administration (FDA) for Yonsa (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize Yonsa in the US

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO - North America, Sun Pharma.

Yonsa in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the US.

Yonsa is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology to create a micronised (smaller particle size) formulation of abiraterone acetate tablets - for the treatment of metastatic castration-resistant prostate cancer, in combination with methylprednisolone.  The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 á-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis.

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world.

Sun Oncology is the branded oncology division of a wholly owned subsidiary of Sun Pharma with focus on enhancing patient access to innovative cancer therapies. Sun Oncology is comprised of branded cancer products like Odomzo (sonidegib) and Yonsa (abiraterone acetate).

Churchill is focused on providing value to cancer care by developing quality orally delivered oncology products with optimised clinical profiles. The company's commitment to responsibly deliver these products to the patients, payers and healthcare communities we serve is at the core of our business.