May 23: Mumbai-based drug maker Sun Pharmaceutical Industries Ltd and Churchill Pharmaceuticals, LLC (Churchill), a clinical-stage biopharmaceutical company based in US, on Wednesday announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the US Food and Drug Administration (USFDA) 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,” said Sun Pharma in a filing with the BSE.
Commenting on the development, Abhay Gandhi, CEO – North America, Sun Pharma, said, “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.”
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, according to the company.
Sun Pharma shares were trading at Rs 457.50, up 0.99% from the previous closing of Rs 453, on BSE at 12.06 pm today.