Under the 5 year agreement, STA Pharmaceutical (STA) will provide supplies of certain starting and intermediate materials for the recently launched ZEJULA (Niraparib) — 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 US Food and Drug Administration (FDA) on 27 March 2017 and is now available to patients in the US.
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 the 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 randomised prospectively designed Phase 3 clinical trial.
Dr Minzhang Chen, CEO of STA Pharmaceutical, said: “We have been working with TESARO for a number of years and we are honoured to be selected as a TESARO global supplies partner for this critical life saving drug.
"STA is committed to helping our partners develop and commercialise 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.”
STA Pharmaceutical is a WuXi AppTec subsidiary