Prestige BioPharma and Alvogen 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; Hervelous™) in Central and Eastern Europe.
Hervelous™ is a mAb biosimilar to Roche’s Herceptin® (trastuzumab), which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Hervelous™ is in Phase-3 clinical development for filing with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2019.
The partnership arrangement includes the exclusive rights for Alvogen to commercialize Hervelous™ (trastuzumab) in all of its CEE markets, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for full development, product registration with EMA, and commercial supply of Hervelous™, out of its manufacturing facilities in Osong, Korea.
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on development of biosimilars and new antibody therapeutics. Its lead program, Hervelous™, is under Phase 3 clinical development. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase 1, and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, Korea.
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen’s single largest market and other key markets include: South Korea, Russia, Romania, Hungary, Ukraine, Taiwan, Japan and China.