Lomitapide, an orphan drug designed for the treatment of a rare disease caused by a genetic disorder, is expected to be launched in January 2013.
Previously, scientists of Aptuit have established the chemistry for lomitapide, developed and validated its analytical methods, delivered solid state form control and crystallization R&D as well as supplied registration batches of material.
Aptuit, which provides integrated early to mid-phase development services said, after the launch, it will continue to supply commercial quantities of lomitapide to Aegerion.
Aptuit president and chief operating officer Stuart Needleman said because of the drug’s orphan status and high unmet medical need of the patients, on time and in full delivery of the API is crucial.
"Collaboration across several Aptuit sites in the US and Europe has made this possible," Needleman added.
"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."