Tesaro And Zai Lab Announce Collaboration, Development And License Agreement
• Collaboration enables the clinical development of niraparib in China by Zai Lab
• TESARO retains right to co-market in China and receives option to license up to two novel immuno-oncology programs outside China
WALTHAM, Mass., and SHANGHAI, China, Sept. 29, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, today announced a collaboration to support the development and commercialization of niraparib for patients in China and the potential to advance two immuno-oncology programs outside of China. This partnership reflects the commitment of both companies to develop novel therapeutic approaches for people living with cancer around the world.
Within this collaboration, TESARO has granted to Zai Lab an exclusive license for the development of niraparib specifically for the China market, which includes an option for TESARO to participate in the commercialization of niraparib in greater China. The companies will establish a joint steering committee to review and oversee all development and commercialization plans. In addition, TESARO has the option to license two novel, discovery-stage immuno-oncology programs from Zai Lab.
"TESARO is devoted to providing transformative therapies for people bravely facing cancer, and this partnership will enable us to globalize our mission," said Lonnie Moulder, CEO of TESARO. "The Zai Lab team has a track record of regulatory and development successes in China, and we are excited to work with them to quickly advance new treatment options for patients."
Samantha Du, Chairman and CEO of Zai Lab, added, "We are delighted to partner with TESARO, a leader in global oncology drug development. Ovarian and other cancer types that niraparib is being evaluated in are areas of large unmet medical need in China, with very limited treatment options. Our collaboration with TESARO will bring this exciting new product candidate quickly to the Chinese patients, and we look forward to working with TESARO."
In addition to an upfront payment, TESARO will be eligible to receive milestone payments contingent upon Zai Lab achieving certain specified development and commercial goals. Should TESARO elect not to participate in the commercialization of niraparib in China, TESARO will be eligible to receive tiered, double-digit royalty payments on annual net sales from Zai Lab. Additional financial details were not disclosed.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.
About Zai Lab
Zai Lab is a leading biopharmaceutical company based in China focused on discovering, developing and commercializing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients' lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success — having successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the U.S., and brought the first China discovered drug into global Phase 3 trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com and follow us on Twitter and LinkedIn.
• TESARO retains right to co-market in China and receives option to license up to two novel immuno-oncology programs outside China
WALTHAM, Mass., and SHANGHAI, China, Sept. 29, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, today announced a collaboration to support the development and commercialization of niraparib for patients in China and the potential to advance two immuno-oncology programs outside of China. This partnership reflects the commitment of both companies to develop novel therapeutic approaches for people living with cancer around the world.
Within this collaboration, TESARO has granted to Zai Lab an exclusive license for the development of niraparib specifically for the China market, which includes an option for TESARO to participate in the commercialization of niraparib in greater China. The companies will establish a joint steering committee to review and oversee all development and commercialization plans. In addition, TESARO has the option to license two novel, discovery-stage immuno-oncology programs from Zai Lab.
"TESARO is devoted to providing transformative therapies for people bravely facing cancer, and this partnership will enable us to globalize our mission," said Lonnie Moulder, CEO of TESARO. "The Zai Lab team has a track record of regulatory and development successes in China, and we are excited to work with them to quickly advance new treatment options for patients."
Samantha Du, Chairman and CEO of Zai Lab, added, "We are delighted to partner with TESARO, a leader in global oncology drug development. Ovarian and other cancer types that niraparib is being evaluated in are areas of large unmet medical need in China, with very limited treatment options. Our collaboration with TESARO will bring this exciting new product candidate quickly to the Chinese patients, and we look forward to working with TESARO."
In addition to an upfront payment, TESARO will be eligible to receive milestone payments contingent upon Zai Lab achieving certain specified development and commercial goals. Should TESARO elect not to participate in the commercialization of niraparib in China, TESARO will be eligible to receive tiered, double-digit royalty payments on annual net sales from Zai Lab. Additional financial details were not disclosed.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.
About Zai Lab
Zai Lab is a leading biopharmaceutical company based in China focused on discovering, developing and commercializing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients' lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success — having successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the U.S., and brought the first China discovered drug into global Phase 3 trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
About TESARO
TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com and follow us on Twitter and LinkedIn.