Aptuit says that collaboration amongst its global facilities was a key factor in bringing Lomitapide to market.
Working with Aegerion Pharmaceuticals’ orphan drug since 2007, Aptuit has overseen the process of developing and producing the API, bringing it to market in a relative short time. The cholesterol-lowering drug Lomitapide received approval by the US Food and Drug Administration (FDA) in late December last year.
Senior Manager for Marketing and Communications, Jennifer Demaree, told Outsourcing-Pharma.com that Aptuit’s worldwide facilities each played their part in the swiftness of Lomitapide’s lifespan:
“The API chemistry development and manufacturing activities were centered at the Harrisonville, Missouri site. Aptuit Verona, Italy supported with method development and chemical R&D, as did the site in Oxford, UK. Aptuit West Lafayette, Indiana conducted extensive solid state and crystallization control R&D in support of the overall process.”
Aptuit agree supply deal with Aegerion
Following FDA approval, Aptuit and Aegerion announced a long-term commercial supply agreement for the API in Lomitapide.
The two companies continue to collaborate under a deal which will see quantities of less than 1MT per year being manufactured at Aptuit’s Missouri plant.
Demaree said that the deal will help Aptuit “demonstrate that the company can fully support clinical programs, but also has the regulatory compliance and manufacturing systems to take orphan or HPAPI’s all the way to market.”