Ligand Pharmaceuticals Incorporated reports that Merck & Co. has received approval for Noxafil  (posaconazole) 300 mg Concentrate for Solution for Infusion from the European Medicines Agency (EMA). Ligand earns a $550,000 milestone payment as a result of the approval. Ligand will sell Captisol to Merck for the product marketed in Europe under an existing commercial supply agreement.

The EMA approval grants Merck centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

Noxafil is a novel triazole antifungal agent with demonstrated broad-spectrum activity, covering both yeast and molds responsible for serious invasive fungal infections Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This technology has enabled six FDA-approved products, including Onyx Pharmaceuticals' Kyprolis, Baxter International’s Nexterone and Merck's Noxafil IV. There are currently more than 50 Captisol-enabled products in development, including Lundbeck's Carbella, Spectrum Pharmaceuticals' Captisol-enabled Melphalan, and Melinta Therapeutics' delafloxacin IV program.

Source: Ligand Pharmaceuticals