In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|August 14, 2013
Amgen and Servier Complete Product Collaboration Transaction
Author(s)Melanie Sena
Amgen, Servier collaborate ivabraline and other cardiovascular products.
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Under the agreement, Amgen has obtained commercial rights in the United States to Servier's oral drug, approved in the European Union as Procoralan (ivabradine), for chronic heart failure and stable angina in patients with elevated heart rates. Amgen has also received an option to develop and commercialize Servier's investigational molecule, S38844, for cardiovascular diseases in the United States. Currently, S38844 is in Phase II studies for the treatment of heart failure. Through the collaboration, Servier has obtained an option to commercialize omecamtiv mecarbil in Europe. Omecamtiv mecarbil is a small-molecule activator of cardiac myosin and is currently being tested for potential applications in the treatment of heart failure in patients with systolic dysfunction.
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