Prestige BioPharma Ltd. and Abic Marketing Ltd., a subsidiary of Teva Pharmaceutical Industries Ltd. announced 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. ParkLi, 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.”