Breaking News

Aptuit, Aegerion in Commercial API Supply Pact

January 9, 2013

Aptuit to supply lomitapide for product launch

Aptuit and Aegerion Pharmaceuticals have signed a long-term supply agreement for commercial quantities of the API lomitapide, Aegerion’s orphan drug targeted for the treatment of a rare disease caused by a genetic disorder.
 
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.”

Related Contract Manufacturing:

Related Packaging:

Related Compliance:

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus

  • Choosing Oral Formulations for First-in-man Clinical Trials

    Choosing Oral Formulations for First-in-man Clinical Trials

    Jon Sutch, Senior Manager of Formulation Development, Patheon||October 11, 2016
    Early formulations should be simple, but selecting a simple formulation isn’t as easy as it seems