Israel’s Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral medication for the treatment of liver diseases and cholesterol gallstones, announced that it has entered into a Manufacturing Services Agreement with Irelands’ Perrigo API Ltd., a subsidiary of Perrigo Company plc, for the large-scale production of the active pharmaceutical ingredient (“API”) of Galmed’s product candidate, aramchol.
The company says that the API produced pursuant to this agreement is expected to provide sufficient quantities of aramchol for Galmed’s potential future Phase III clinical trials of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.
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According to the terms of the agreement, Perrigo will provide manufacturing process optimization services for large-scale production of the aramchol API, manufacture the aramchol API pursuant to current good manufacturing processes, or cGMP, and perform additional development services regarding scale-up and manufacturing optimization for the aramchol API.
The agreement also provides Perrigo with the option to manufacture commercial supplies of the aramchol API in the future.
Galmed’s Chief Executive Officer, Allen Baharaff, stated, “we are delighted to partner with Perrigo, one of the world’s leading pharmaceutical manufacturers, for large-scale API production.” Mr. Baharaff continued, “we selected Perrigo as our API supplier because of its experience in cost-effective large-scale cGMP production of small molecule APIs. We believe that initiating the process of large-scale API production now may facilitate the commencement of our potential future Phase III clinical trials, assuming applicable regulatory approval to conduct the same, and provide preferential pricing, which we believe may ultimately provide a more affordable treatment option for NASH patients in the future.”
Perrigo develops, manufactures and distributes over-the-counter (“OTC”) and generic prescription pharmaceuticals, nutritional products and APIs, and receives royalties from the Multiple Sclerosis drug, Tysabri. It is the world’s largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo declares its mission is to offer uncompromised “Quality Affordable Healthcare Products” and it does so across a wide variety of product categories, primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America.