The drug received NDA approval in December of 2012 and is expected to be launched shortly. Aptuit established the chemistry for lomitapide, developed and validated its analytical methods, delivered solid state form control and crystallization R&D, and supplied registration batches of material. Aptuit will continue to supply commercial quantities of lomitapide to Aegerion.
Stuart Needleman, president and chief operating officer of Aptuit, said, “Because of the drug’s orphan status and the high unmet medical need of patients, on-time and in-full delivery of the API is crucial. Collaboration across several Aptuit sites in the U.S. and Europe has made this possible. By accessing the vast drug development expertise of our organization, we have been able to accelerate the delivery of materials, methods, solid state chemistry and regulatory documentation and help the client win prompt NDA approval.”