Galmed Pharmaceuticals, a clinical-stage biopharmaceutical company focussed on the development and commercialisation of a once-daily, oral medication for the treatment of liver diseases and cholesterol gallstones, has entered into a Manufacturing Services Agreement with Perrigo API, a subsidiary of Perrigo Company plc (Perrigo), for the large-scale production of the active pharmaceutical ingredient (API) of Galmed's product candidate, aramchol. 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.
According to the terms of the agreement, Perrigo will provide manufacturing process optimisation 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 optimisation 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, states, "we are delighted to partner with Perrigo, one of the world's leading pharmaceutical manufacturers, for large-scale API production." 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."