drugset / Press release

Sun Pharma Announces USFDA Approval of YONSA

2018-05-23 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

FOR IMMEDIATE RELEASE Sun Pharma Announces USFDA Approval of YONSA® (abiraterone acetate) To Treat Metastatic Castration- Resistant Prostate Cancer In Combination With Methylprednisolone 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. Mumbai India, Princeton NJ, and King of Prussia, May 23, 2018 – 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. About YONSA® (abiraterone acetate) tablets YONSA® is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology™ to create a micronized (smaller partic le size) formulation of abiraterone acetate tablets - for the treatment of metastatic castration-resista nt prostate cancer, in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis. Please see Full Prescribing Information for YONSA® at www.YonsaRx.com/Yonsa-pi Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable secu rities laws and regulati ons. Actual results, performance or achievements could differ materially from those expressed or implied. About Sun Pharmaceutical Industries Ltd. (CIN-L24230GJ1993PLC019050) 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 tr usted by customers and p a t i e n t s i n o v e r 1 5 0 countries across the world. Sun Pharma's glob al presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 13 different classes of doctors with 32 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence th rough innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. About Sun Oncology 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). About Churchill Pharmaceuticals, LLC Churchill is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profil es. Our commitment to responsibly deliver these products to the patients, payers and healthcare communities we serve is at the core of our business. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology™, a proprietary manufacturing process that may unlock the potential of certain oral drugs by changing how well they dissolve and how efficiently they are absorbed. For more information, please visit https://www.churchillpharma.com and http://www.iceutica.com Contacts: Sun Pharma Investors: Nimish Desai Media: Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 4324, Xtn 5373 Tel Direct +91 22 4324 2778 Tel Direct +91 22 4324 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail [email protected] E mail [email protected] US Media: Reba Auslander Tel Direct +1 917-836-9308 Email [email protected] Contacts: Churchill Pharmaceuticals Tel +1 610-382-5610 Email [email protected]

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