Business & Finance
US FDA Grants Approval to Sun Pharma Subsididary for Yonsa (abiraterone acetate) for Treatment of MCRPC in Combination with Methylprednisolone
25 May 2018 - - Mumbai, India-based specialty generic company Sun Pharmaceutical Industries Ltd. (NSE: SUNPHARMA, BSE: 524715) subsidiary, Princeton, New Jersey-based SPII, has received approval from the US Food and Drug Administration for Yonsa (abiraterone acetate), in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), Sun Pharma and King Of Prussia, Pennsylvania-based oral oncology products developer Churchill Pharmaceuticals, LLC said.
Sun Pharma acquired Yonsa from Churchill Pharmaceuticals and will commercialize Yonsa in the US. 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.
Yonsa is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology to create a micronized (smaller particle size) formulation of abiraterone acetate tablets for the treatment of mCRPC 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.
Sun Pharmaceutical Industries provides innovative, high-quality, affordable medicines in over 150 countries.
It fosters excellence through innovation, supported by strong R and D capabilities, with approximately 2,000 scientists on staff and R and D investments of approximately 8% of annual revenues.
SPII, a wholly owned subsidiary of Sun Pharma, is expanding its portfolio of products and technologies that offer unique formulations and novel delivery systems of common therapies, across various disease areas. Its oncology division portfolio includes Yonsa (abiraterone acetate) which is manufactured in the US, and Odomzo (sonidegib).
Churchill is focused on developing orally delivered oncology products with optimized clinical profiles.
The company 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.