Saudi Arabia’s leading pharmaceutical firm Tabuk Pharmaceuticals and Singapore’s Prestige BioPharma, have signed an exclusive licensing and distribution agreement for the commercialisation of Prestige BioPharma's Trastuzumab biosimilar (HD201; Tuznue) in the Middle East and North Africa (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 commercialise 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.

The contract will also mark Prestige BioPharma’s -- a publicly-listed company focusing on a late-stage clinical development of new antibody therapeutics and biosimilars-- foray into the Mena market.

Under the terms of the licensing agreement, Tabuk will be responsible for the registration and commercialisation 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 specialised 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 commercialising 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 commercialise 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.”

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.

Established in 1994, 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.

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, Tabuk Pharmaceuticals has a strong regional presence serving patients across 17 countries in the Mena region.