Aptuit & Aegerion Sign Long-Term API Agreement
Stuart Needleman, President and Chief Operating Officer, Aptuit LLC, recently announced that Aptuit and Aegerion Pharmaceuticals, Cambridge, MA, have signed a long-term supply agreement for commercial quantities of the active pharmaceutical ingredient (API) lomitapide.
Lomitapide is Aegerion’s orphan drug that is targeted to the treatment of a rare disease caused by a genetic disorder. The drug received NDA approval in December 2012 and is expected to be launched commercially in January 2013. Previously, Aptuit scientists had 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. Post-launch, Aptuit will continue to supply commercial quantities of lomitapide to Aegerion.
“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,” said Mr. Needleman. “Collaboration across several Aptuit sites in the US 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.”
Although the exact terms of the agreement were not disclosed, Mr. Needleman added, “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 LLC provides the most complete set of integrated early to mid-phase development services in the pharmaceutical industry. Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Drug Product Formulation Development & Manufacture, Sterile Fill Finish, Clinical Sciences, Consulting and Aptuit INDiGO (a program that accelerates drug development) are offered as stand-alone or integrated services. Fully integrated drug discovery and development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. For more information, visit www.aptuit.com.
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