Riyadh:Tabuk Pharmaceuticals a leading Saudi pharmaceuticals company and Prestige BioPharma a publicly listed company based in Singapore focusing on a late-stage clinical development of new antibody therapeutics and biosimilars today announced an exclusive licensing and distribution agreement with for the commercialization of Prestige BioPharma's Trastuzumab biosimilar (HD201; Tuznue™) in the MENA region.
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™ for review that was based on positive top-line results from global clinical trials.
The licensing agreement provides Tabuk with exclusive rights to commercialize and distribute Tuznue™ in the MENA region leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing key pharmaceutical products to market.
Under the terms of the licensing agreement, Tabuk will be responsible for the registration and commercialization of Tuznue™ in the MENA markets and Prestige BioPharma will be responsible for product supply. This agreement augments our biotech-immunology strategy in MENA and adds a specialized biosimilar product to our portfolio.
Basel Ziyadeh, CEO of Tabuk Pharmaceuticals, commented: “At Tabuk Pharmaceuticals, we are excited to form this partnership with Prestige BioPharma which builds on our market-leading position and advances our strategic objective of growing our specialty business in KSA and the MENA region. This is another important step forward for Tabuk in commercializing complex and specialty medicines that will benefit patients in critical disease areas and position our business for continued long-term growth.”
Lisa S. Park, CEO of Prestige BioPharma, commented: “We are very pleased to establish a partnership with Tabuk Pharmaceuticals for selected MENA markets. As the largest private Saudi Pharmaceutical company, Tabuk is an ideal partner to commercialize our lead biosimilar in the MENA markets. With this partnership, we look forward to further strengthening the value of our biosimilar programs in global markets.”
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 and will also be filed with the US FDA in 2021. Prestige BioPharma´s next products in line include Bevacizumab biosimilar (HD204) in Phase III, Adalimumab biosimilar (PBP1502) ready for Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer ready for Phase I/IIa stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea.
About Tabuk Pharmaceuticals:
Established in 1994, Tabuk Pharmaceuticals is a leading Saudi pharmaceuticals company with a strong regional presence in the Middle East and North Africa (MENA). Tabuk Pharmaceuticals develops, manufactures, markets and distributes branded and generic pharmaceutical products. The company also manufactures high-quality pharmaceutical products for renowned international brands and partners at its plants in Saudi Arabia. Tabuk Pharmaceuticals is a major player in the industry in the Kingdom of Saudi Arabia and the MENA region. With more than 2,400 employees and four state-of-the-art plants in Tabuk and Dammam in Saudi Arabia, in addition to sites in Sudan and Algeria, to serve the patients across 17 countries in MENA.
© Press Release 2021