STA Pharmaceutical Co., Ltd. (STA) – a WuXi AppTec subsidiary and the leading open-access capability and technology platform for small molecule pharmaceutical development and manufacturing – 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 supplies 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.
“We have been working with TESARO for a number of years, and we are honored to be selected as a TESARO global supplies partner for this critical life-saving drug,” said Dr. Minzhang Chen, CEO of STA Pharmaceutical. “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.”
STA Pharmaceutical Co., Ltd. (STA), a WuXi AppTec company, is a leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.