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Will support development and manufacture of drug candidates for neurological disorders
January 19, 2015
By: Kristin Brooks
Managing Editor, Contract Pharma
AMRI has received a 10-year federal contract from the National Institutes of Health (NIH) for drug development and manufacturing services to support NIH’s Drug Manufacturing and Formulation Program (DMFP), a component of the Blueprint Neurotherapeutics Network (BPN). AMRI has supported the NIH BPN since 2011, providing chemistry services and discovery technologies and since 2005, AMRI has collaborated with NINDS in the area of medicinal chemistry on treatments for spinal muscular atrophy, a degenerative neuromuscular disease. The goal of the DMFP is to support Neurological Disorders and Stroke (NINDS) in the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical and clinical studies of neurological disease/disorders. This contract provides AMRI with funding of as much as $37.3 million to advance BPN projects having positive results in early stage drug discovery into clinical trials. Services to be provided include the manufacture of API; drug product formulation; analytical testing; and clinical trial supply chain management, including packaging, labeling, storage, and distribution of the completed drug product. AMRI will be responsible for completing manufacturing, documentation, formulation, fill and finish, packaging, and labeling. “AMRI was selected for this contract award because of our proven track record on projects with NIH and our demonstrated expertise in drug manufacture and formulation, which is enriched by our integrated pharmaceutical services platform,” said AMRI’s president and chief executive officer, William S. Marth. “Since our initial NIH BPN award in 2011, AMRI has provided discovery chemistry services to NINDS and its private sector BPN members on 15 drug candidate programs, and two of these programs have advanced to the stage where a pre-clinical candidate has been declared, with a third candidate pending.
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