API for orphan drug should be available commercially this month
Aptuit, a provider of drug discovery and development services, has signed a long-term agreement to supply Aegerion Pharmaceuticals, of Cambridge, Massachusetts, with commercial quantities of the active pharmaceutical ingredient (API) lomitapide.
Lomitapide is Aegerion’s orphan drug to treat a rare disease caused by a genetic disorder. The drug received NDA approval last December and should be launched commercially this month.
Aptuit scientists have established the chemistry for lomitapide, developed and validated its analytical methods, delivered solid state form control and crystallisation R&D, and supplied registration batches of material. Post-launch, Aptuit will continue to supply commercial quantities of the ingredient to Aegerion.
Although the exact terms of the agreement were not disclosed, Stuart Needleman, president and COO of Aptuit, said: ‘The collaboration represents another good example of how Aptuit’s integrated, global drug development capabilities can have a direct, positive impact on the pharmaceutical industry.’
Aptuit offers drug design and discovery, preclinical biosciences, API development and manufacture, solid state chemistry, drug product formulation development and manufacture, sterile fill finish, clinical sciences, consultation and Aptuit INDiGO, a programme that accelerates drug development services from a single site at The Aptuit Centre for Drug Discovery & Development in Verona, Italy.