Aptuit and Aegerion Sign Commercial API Supply Agreement
GREENWICH, Connecticut, Jan. 8, 2013
GREENWICH, Connecticut, Jan. 8, 2013 /PRNewswire/ -- Stuart Needleman,
President and Chief Operating Officer, Aptuit LLC, announced that Aptuit and
Aegerion Pharmaceuticals, Cambridge, Massachusetts, have signed a long-term
supply agreement for commercial quantities of the active pharmaceutical
ingredient (API) lomitapide.
(Logo: http://photos.prnewswire.com/prnh/20120217/NY55633LOGO )
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 of 2012 and is expected to be launched commercially in January of
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.
Mr. Needleman explained, "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. 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."
Press Contact: Maria Garvey, Media Manager, Delfino Marketing, 914-747-1400
Aptuit Contact: Jennifer Demaree, Senior Manager, Marketing & Communications,
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 & development services are available
from a single site at The Aptuit Center for Drug Discovery & Development in
The company maintains five global facilities with approximately 800 employees
in Europe and the United States, and has a strategic relationship with Laurus
Labs in India. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe,
one of the world's leading private equity investors.
For more information about Aptuit, visit www.aptuit.com
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