GATTEX(R) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. A New Drug Application (NDA) is undergoing U.S. Food and Drug Administration (FDA) review for GATTEX in adult short bowel syndrome (SBS). NPS has reported findings from completed studies in which GATTEX significantly reduced parenteral nutrition (PN) and intravenous (IV) fluid volumes in adult subjects with SBS, with no significant difference in withdrawal rates due to adverse events as compared to placebo. Given GATTEX's mechanism of action, NPS believes it has the potential to treat gastrointestinal conditions associated with intestinal failure. GATTEX has received orphan drug designation for the treatment of SBS from the US Food and Drug Administration and the European Medicines Agency. In 2007, NPS granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico. NPS retains all rights to teduglutide in these three countries. In March 2011, Nycomed filed a marketing application for teduglutide (Revestive(R)) as a treatment for SBS. |