STA Pharmaceutical, a subsidiary of China-based company WuXi AppTec with facilities in China and the US, has signed a new supply agreement with oncology-focused biopharmaceutical company Tesaro for certain starting and intermediate materials for zejula (niraparib).
STA offers an open-access capability and technology platform for the development and manufacturing of small molecule pharmaceutical products.
Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor indicated in the US 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.
The STA treatment is the only PARP inhibitor that has shown 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 III clinical study.
STA Pharmaceutical chief executive officer Dr Minzhang Chen said: “We have been working with Tesaro for a number of years, and we are honoured to be selected as a Tesaro global supply 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.”
Zejula is currently available to patients in the US after receiving approval from the Food and Drug Administration (FDA) on 27 March.
The new five-year deal follows the company’s multiple-year development and clinical manufacturing agreement with Tesaro, and assisting the oncology-focused company with the expedited New Drug Application (NDA) submission and final approval by the FDA.