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STA will provide supplies of certain starting and intermediate materials for Tesaro’s recently launched Zejula (niraparib), an orally active and potent poly(ADP-ribose) polymerase inhibitor approved by FDA for the treatment of ovarian cancer.
STA Pharmaceutical, a WuXi AppTec subsidiary, announced on July 24, 2017 that it has signed a supply agreement with oncology-focused biopharmaceutical company Tesaro for certain starting and intermediate materials for Zejula (niraparib).
Under the five-year agreement, STA will provide supplies of certain starting and intermediate materials for the recently launched Zejula. This agreement follows a successful multiple-year development and clinical manufacturing arrangement with Tesaro and STA’s assistance with the expedited new drug application submission and final approval by FDA.
Zejula is an orally active and potent poly(ADP-ribose) polymerase (PARP) inhibitor approved by FDA on March 27, 2017 for the treatment of epithelial ovarian, fallopian tube, and primary peritoneal cancer. It is now available to patients in the United States. It is the only PARP inhibitor that has demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase III clinical trial.
Source: WuXi AppTec