Menarini Group has entered an exclusive agreement with Gan & Lee Pharmaceuticals to develop, register and commercialize the investigational obesity medicine bofanglutide across 39 European countries, in a deal valued at up to about $849 million excluding royalties.
Gan & Lee is eligible for an upfront payment of €62 million, or about $73 million, and up to €664 million, or roughly $776 million, in development, regulatory and commercial milestones. The company is also eligible for double-digit royalties on net sales in the licensed territory.
The agreement covers the 27 European Union member states, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein and Balkan countries. Menarini will be responsible for regulatory filings and commercialization in those markets.
Bofanglutide, also known as GZR18, is a long-acting glucagon-like peptide-1 receptor agonist, or GLP-1 RA, being developed for weight management in adults with obesity or overweight. The drug is administered by subcutaneous injection once every two weeks.
Gan & Lee said the dosing schedule would reduce administration frequency by 50% compared with weekly GLP-1 therapies. The company said its pivotal Phase III trial in China and a Phase II U.S. study both met their primary endpoints in adults with obesity or overweight, demonstrating weight-loss efficacy and a tolerability profile consistent with other drugs in the GLP-1 class.
Bofanglutide remains investigational. Its safety and effectiveness have not been established by the European Medicines Agency or other health authorities, and it is not approved for commercial distribution.
Gan & Lee plans to begin a global Phase III clinical development program intended to support potential registration in Europe and other highly regulated markets. The company will handle clinical development, manufacturing and supply under the partnership.
Menarini said the agreement expands its presence in metabolic diseases. Gan & Lee said the transaction provides a route for bofanglutide to enter European markets and advances its strategy to expand its innovation pipeline internationally.
Menarini, based in Florence, Italy, operates in 140 countries and reported €4.88 billion in consolidated turnover. Gan & Lee is a Chinese biopharmaceutical company with insulin, metabolic-disease and broader biologics development programs.
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