HONG KONG – Prestige Biopharma Pte. Ltd., a Singapore-headquartered pharmaceutical company under the Prestige Group, has agreed to grant exclusive license to U.K.-based multinational company Mundipharma International Ltd. for distribution and sale of its trastuzumab biosimilar, Tuznue, in western European markets, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.

Tuznue (HD-201) is HER2-targeting monoclonal antibody that copies Herceptin, originally developed by Swiss pharmaceutical company Roche Holding AG. Herceptin, used to treat patients with HER2-overexpressing breast and metastatic gastric cancers and gastroesophageal junction adenocarcinoma, is Roche's biggest-selling blockbuster, at about $7 billion in 2018 sales.

In May, the EMA accepted Prestige's Tuznue marketing authorization application for review. In June, Prestige announced positive top-line results from a phase III trial in terms of clinical response, pharmacokinetics and safety.

The Prestige Group originated from a Singapore government-invested research institution including Prestige Biopharma Singapore, Prestige Bioresearch Singapore and the GMP facilities in Korea. The manufacturing facilities for global commercial supply are in Osong Bio Valley in South Korea.

"As a partner of Prestige Biopharma in Singapore, we are going to manufacture Tuznue and receive part of the profits from the sale of the medicine in Europe," a spokesman from Prestige Biopharmaceutical Co. Ltd. in Korea, told BioWorld.

The value of the deal has not been disclosed, according to the spokesman.

The current manufacturing facility, built in May 2018, can produce 1.5 million 150-mg vials a year. Prestige Biopharma is expanding the facility to produce up to an expected 10 million vials per year.

The company focuses on developing biosimilars and new antibody therapeutics. Its next products in the pipeline include a bevacizumab (Avastin, Roche Holding AG) biosimilar (HD-204) to treat solid tumors. It is in phase III testing, and the results of the phase I trials were published in the American Society of Clinical Oncology's Journal of Clinical Oncology on May 26.

The company also has an adalimumab (Humira, Abbvie Inc.) biosimilar (PBP-1502) for treatment of arthritis, as well as a first-in-class anti-PAUF (pancreatic adenocarcinoma up-regulated factor) monoclonal antibody (PBP-1510), both of which are ready for clinical development. Two drugs in the preclinical stage are a denosumab (Amgen Inc.) biosimilar (PBP-1601) for treatment of bone loss and osteoporosis and an aflibercept (Regeneron Pharmaceuticals Inc./Sanofi SA) biosimilar (PBP-1602) for macular edema, metastatic colorectal cancer and retinopathy.

In addition, there are three candidates in the discovery stage: an eculizumab (Alexion Pharmaceuticals Inc.) biosimilar (PBP-1603) for atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria; an ipilimumab (Bristol-Myers Squibb Co.) biosimilar (PBP-1701) for metastatic melanoma and unresectable melanoma; and a first-in-class antibody (PBP-1710) for solid tumors.

The company also develops various technologies such as cell biology, bioanalysis, nonclinical study technology and quality assurance platforms while maintaining OECD and FDA good laboratory practice (GLP) compliance for in-house and outsourced GLP studies.

The company also is expanding its biosimilar business overseas. "Prestige Biopharma's recent three global licensing-out deals have been successful," Seogwon Choi, analyst at Ebest Invest & Securities Co. Ltd. in Korea, told BioWorld.

On July 5, Prestige said it had entered an exclusive agreement with Russian drugmaker Pharmapark LLC to supply and market Tuznue in the Russian Federation. Prestige will take responsibility for product supply at the manufacturing facilities in Korea. Pharmapark will focus on local registration, sales and marketing in Russia, with the option to manufacture the product in the Russian Federation.

In addition, on June 28, Prestige signed a licensing agreement with American pharmaceutical company Alvogen Group Inc. to provide and commercialize its trastuzumab biosimilar HD-201, under name of Hervelous, in central and eastern Europe, giving exclusive rights for Alvogen in 20 markets.

If Tuznue is authorized by the EMA, the market of biosimilars following Herceptin is expected to be more competitive. Herceptin biosimilars include Herzuma from Korea's Celltrion Inc., Kanjinti from Amgen Inc., Ontruzant from Samsung Bioepis Co. Ltd., of Korea, and Trazimera from Pfizer Inc. The competition among biosimilars in Europe caused Roche's European sales of Herceptin, at CHF300 million (US$304 million) in the first quarter of this year, to be down 44% from the same period last year.

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