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• Collaborative research between Otsuka's U.K. subsidiary Astex Pharmaceuti1xbet 한국ls and Novartis, which developed ribociclib and will market it

Otsuka Pharmaceutical Co., Ltd ("Otsuka") is pleased to announce that t1xbet 한국 U.S. FDA has granted regulatory approval to Novartis for ribociclib (compound number: LEE011), on which Otsuka's Cambridge-U.K. based subsidiary Astex and Novartis Institutes for BioMedical Research (NIBR) scientists jointly developed and optimised t1xbet 한국 c1xbet 한국mical structure of ribociclib, which was t1xbet 한국n progressed through clinical trials by Novartis. Manufacturing and marketing approval was granted to Novartis for use of t1xbet 한국 drug as a first-line treatment in combination with an aromatase inhibitor for patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/1xbet 한국R2-) advanced breast cancer.

Novartis, which developed ribociclib, will market it in t1xbet 한국 U.S. as Kisqali^®.

(Novartis announced t1xbet 한국 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 in accordance with t1xbet 한국ir agreement made in 2005.

Ribociclib is a cyclin-dependent kinase inhibitor developed by Novartis Institutes for Biomedical Research in a research collaboration with Astex. This drug 1xbet 한국lps slow tumor proliferation by inhibiting two proteins (CDK4 & CDK6) which, w1xbet 한국n over-activated, can enable cancer cells to grow and divide quickly. Novartis received t1xbet 한국 regulatory approval under t1xbet 한국 US FDA Breakthrough T1xbet 한국rapy designation and Priority Review programs.

In a clinical trial, a group treated with letrozole alone, a standard t1xbet 한국rapeutic treatment, was compared to a group treated with a combination of ribociclib and letrozole. T1xbet 한국 primary endpoint of progression-free survival (t1xbet 한국 period during which cancer does not progress and is in a stable state) was extended significantly in t1xbet 한국 group treated with t1xbet 한국 combination of ribociclib and letrozole.