Menarini Secures European Rights to Gan & Lee Obesity Drug in Deal Worth Up to $771 Million

Italian pharmaceutical company Menarini Group has signed a deal worth up to $771 million (approximately 1.064 trillion won) to bring Chinese insulin manufacturer Gan & Lee’s obesity and diabetes drug bofanglutide to the European market.

According to Fierce Biotech, a U.S. biotechnology and pharmaceutical news outlet, on the 5th local time, Menarini agreed to pay Gan & Lee an upfront payment of 62 million euros (approximately $72 million) for registration and commercialization collaboration for bofanglutide.

Gan & Lee may also receive up to 664 million euros (approximately $771 million) in milestone payments, as well as sales royalties in the double-digit percentage range.

Menarini will be responsible for regulatory submissions and commercialization in a total of 39 countries, including the 27 European Union (EU) member states, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and the Balkan countries.

Bofanglutide is a glucagon-like peptide-1 (GLP-1) drug administered by subcutaneous injection once every 2 weeks. It is administered half as often as existing GLP-1 drugs, which are given once weekly.

The drug has completed phase 3 trials in China and phase 2 trials in the United States in patients with overweight or obesity or type 2 diabetes. Both studies met their primary endpoints and showed weight-loss effects and tolerability similar to those of other GLP-1 drugs.

Gan & Lee plans to begin global phase 3 trials to support registration in highly regulated markets, including Europe.

The deal comes 2 years after Gan & Lee announced that bofanglutide outperformed Novo Nordisk’s Ozempic (generic name semaglutide) in terms of glycated hemoglobin (HbA1c) and weight loss in a phase 2 trial involving patients with type 2 diabetes.

Gan & Lee Chairman and Chief Executive Officer (CEO) Wei Chen said in a statement on the 3rd, "This partnership establishes a significant pathway for bofanglutide’s entry into the European market and marks another milestone in Gan & Lee’s transformation from a leading insulin company into a global innovator in metabolic diseases."

Through the collaboration, Menarini aims to expand its position in metabolic diseases and innovative primary and specialty care.

Elcin Barker Ergun, CEO of Menarini Group, said, "The clinical results for bofanglutide demonstrated weight loss, secondary metabolic benefits and a safety profile at the level expected of drugs in this class," adding, "The once-every-2-weeks regimen provides an opportunity for differentiation."