SINGAPORE--(BUSINESS WIRE)--Prestige BioPharma Ltd. and Abic Marketing Ltd. (operates under the brand of Teva Israel, hereinafter "Teva Israel"), a subsidiary of Teva Pharmaceutical Industries Ltd. announced today that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma's Trastuzumab biosimilar (HD201; Tuznue™) in Israel.
Tuznue™ is a mAb biosimilar to Roche’s Herceptin® (trastuzumab), which is used to treat patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The European Medicines Agency (EMA) has accepted a Marketing Authorisation Application for Tuznue™ that was based on positive top-line results from global clinical trials of Tuznue™ which confirmed that it is a biosimilar to Herceptin® in terms of clinical response and pharmacokinetics, in addition to having a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.
The partnership includes the exclusive rights for Teva Israel to commercialize Tuznue™ (trastuzumab) in Israel, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing pharmaceutical products to market. Prestige BioPharma will assume responsibility for product registration with the EMA and commercial supply of Tuznue™ from its manufacturing facilities in Osong, Korea and Teva Israel will be responsible for local registration, sales, and marketing in Israel.
Lisa S. Park, CEO of Prestige BioPharma, commented: “We are very pleased to partner with Teva to commercialize our lead biosimilar program in Israel. Israel is an important market for us, and Teva Israel is the best possible marketeer to bring our high-quality product to patients in Israel.”
Yossi Ofek, General Manager of Teva Israel and Cluster Head – Israel, Ukraine and S. Africa elaborated “This partnership with Prestige further demonstrates our focus on biopharmaceuticals and it aims to bolster our leadership as a pharma company in Israel. Patients are at the center of everything we do and this agreement continues to position us to provide quality, affordable and accessible biosimilars medicines around the world and in Israel in particular.”
About Prestige BioPharma
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed with the EMA in 2019 and will also be filed with the USFDA in 2021. Prestige BioPharma's next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) IND-ready for Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer also IND-ready for Phase I/IIa. Manufacturing facilities for global commercial supply are located in Osong, South Korea.
About Teva Israel:
Teva Pharmaceutical Industries Ltd. is the world leader in generic medicines, developing and producing medicines to improve people’s lives for more than a century. Teva Israel – the commercial arm of Teva in the Israeli market – is responsible for marketing numerous products and medications, in a broad portfolio that includes specialty and generic medicines as well as biosimilars and OTC. Teva Israel is committed to constant innovation, and collaborates with healthcare partners in the healthcare space, in Israel and internationally, to promote health in Israel.