YONSA® was shown in clinical studies to be an effective form of abiraterone acetate, and can be taken with or without food, in combination with methylprednisolone
Sun Pharma had acquired YONSA® from Churchill Pharmaceuticals and will commercialize YONSA® in the U.S.
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. 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 U.S.
“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 U.S.
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