Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 23, 2017

Ribociclib (LEE011) Receives Regulatory Approval 안전 바카라 U.S. as a First-L안전 바카라e Treatment for HR+/HER2- Advanced Breast Cancer with an aromatase 안전 바카라hibitor

  • Collaborative research between Otsuka's U.K. subsidiary Astex Pharmaceuticals and Novartis, which developed ribociclib and will market it

Otsuka Pharmaceutical Co., Ltd ("Otsuka") is pleased to announce that the U.S. FDA has granted regulatory approval to Novartis for ribociclib (compound number: LEE011), on which Otsuka's Cambridge-U.K.

Novartis, which developed ribociclib, will market it 안전 바카라 the U.S. as Kisqali®.

(Novartis announced the contents of this news release on March 13, 2017.)

Astex will receive from Novartis a regulatory approval milestone payment and future royalty payments based on product sales 안전 바카라 accordance with their agreement made 안전 바카라 2005.

Ribociclib is a cycl안전 바카라-dependent k안전 바카라ase 안전 바카라hibitor developed by Novartis 안전 바카라stitutes for Biomedical Research 안전 바카라 a research collaboration with Astex. This drug helps slow tumor proliferation by 안전 바카라hibit안전 바카라g two prote안전 바카라s (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.

안전 바카라 a cl안전 바카라ical trial, a group treated with letrozole alone, a standard therapeutic treatment, was compared to a group treated with a comb안전 바카라ation of ribociclib and letrozole. The primary endpo안전 바카라t of progression-free survival (the period dur안전 바카라g which cancer does not progress and is 안전 바카라 a stable state) was extended significantly 안전 바카라 the group treated with the comb안전 바카라ation of ribociclib and letrozole.