Revestive(R) (Teduglutide) Receives European Marketing Authorization for the Treatment of Adults With Short Bowel Syndrome (SBS)

Revestive(R) (Teduglutide) Receives European Marketing Authorization for the Treatment of Adults With Short Bowel Syndrome (SBS) PR Newswire OSAKA, Japan and BEDMINSTER, New Jersey, September 4, 2012 OSAKA, Japan and BEDMINSTER, New Jersey, September 4, 2012 /PRNewswire/ -- SBS is a rare and highly disabling condition that impacts patients' quality of life and can lead to serious life-threatening complications. Teduglutide has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda") and NPS Pharmaceuticals, Inc. (NASDAQ: NPSP, "NPS") jointly announced today that the European Commission (EC) has granted European market authorization for the medicinal product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the authorization, Takeda [1]intends to provide patient access to Revestive® within Europe initially through a Named Patient Program (NPP) . "Short Bowel Syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life," said Professor Palle Bekker Jeppesen, M.D., Ph.