USFDA Approval to Sun Pharma for Prostate Cancer Drug

USFDA Approval to Sun Pharma for Prostate Cancer Drug

NEW DELHI: US Food and Drug Administration (USFDA) has given its approval to a subsidiary of Sun Pharmaceuticals Industries for YONSA a drug used for the treatment of a form of prostate cancer. The drug major acquired it from Churchill Pharmaceuticals and the commercialization of the drug will be done in the US.

Both, Sun Pharma and Churchill Pharmaceuticals, LLC said in a regulatory filing that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the USFDA for YONSA.”

Sun Pharma also said that Churchill is eligible to receive upfront and sales-lined milestone payments as well as royalties on sales pursuant to an agreement between the two companies to commercialize YONSA in the US.

Further, it added that the drug is in combination with methylprednisolone was filed as a new drug application (NDA) and will be promoted as a branded product in the US.

In a statement filed by the company, it read that YONSA (abiraterone acetate) is a novel formulation in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Interestingly, the shares of Sun Pharma were trading 1.49 per cent higher at Rs 459.75 apiece on BSE.

About Sun Pharmaceuticals Industries Ltd.

Sun Pharmaceuticals Industries Ltd. was established in 1983 in Vapi, Gujarat by Dilip Sanghvi with five products to treat psychiatry ailments. The company introduced the cardiology products in 1987 after which the products for gastroenterology were introduced in 1989. In 2014 after it acquired Ranbaxy, the company became the largest pharma company in India, the largest Indian pharma company in the US and the 5th largest specialty generic company globally. Notably, around 72 per cent of Sun Pharma sales are from markets outside India, primarily in the US. Today the company boasts of being the largest chronic prescription company in India and market leader in psychiatry, neurology, cardiology, orthopedics, ophthalmology, gastroenterology and nephrology.