biospectrumasiaJuly 27, 2017
STA Pharmaceutical Co., Ltd. (STA) which is a WuXi AppTec subsidiary recently announced that it has signed a supply agreement with the oncology-focused biopharmaceutical company, TESARO, Inc. (TESARO) for certain starting and intermediate materials for ZEJULA™ (Niraparib).
ZEJULATM is an oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Under the five-year agreement, STA will provide supplies of certain starting and intermediate materials for the recently launched ZEJULA.
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 the FDA.
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 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."
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