July 23, 2017
STA today announces it signed a supply agreement with the oncology-focused biopharmaceutical company, TESARO, Inc. (TESARO) for certain starting and intermediate materials for ZEJULA™ (niraparib).
Under the five-year agreement, STA will provide supply of certain starting and intermediate materials for the recently launched ZEJULA – an orally active and potent poly(ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer. ZEJULA was approved for epithelial ovarian, fallopian tube or primary peritoneal cancer by the U.S. Food and Drug Administration (FDA) on March 27th 2017, and is now available to patients in the USA. This agreement follows a successful multiple-year development and clinical manufacturing arrangement with TESARO, and assisting TESARO with the expedited New Drug Application submission and final approval by FDA.
ZEJULA 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 3 clinical trial.
STA is committed to helping our partners develop and commercialize innovative breakthrough drugs like ZEJULA via our state-of-the-art enabling platform. It has been an extremely successful partnership and we look forward to working alongside the TESARO team to expedite their development and commercial timelines.