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. For more information, please visit http://www.STApharma.com
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi’s dream that “every drug can be made and every disease can be treated.” Please visit http://www.wuxiapptec.com
About ZEJULATM (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. The National Comprehensive Cancer Network (NCCN) recently added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017—April 12, 2017—as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of 2 or more lines of platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
SOURCE WuXi AppTec