European CHMP adopts positive opinion for teduglutide to treat short bowel syndrome

Jun 22 2012

• European CHMP adopts positive opinion for teduglutide (Revestive®) for patients with short bowel syndrome (SBS)
• 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product teduglutide (tradename in Europe: Revestive^®) as a once-daily  treatment for adult patients with short bowel syndrome (SBS). The marketing authorisation application was submitted in March 2011.

SBS is a rare and debilitating disease characterised by the body's severely impaired ability to absorb nutrients and fluids through the gastrointestinal tract in people who have had a significant portion of their small intestine removed. SBS typically arises after extensive surgical resection of the bowel due to Crohn's disease, ischemia or other conditions. Many patients with SBS depend on chronic parenteral nutrition (PN) and/or intravenous (IV) fluids to survive. There are currently no therapies approved for the treatment of SBS in Europe.

Teduglutide (Revestive^®) is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), a naturally occurring protein involved in the rehabilitation of the intestinal lining. 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).

"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.D, Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark. "Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium."

"We welcome the positive opinion from the CHMP for teduglutide. This is good news for patients with SBS," said Trevor Smith, Head of Commercial Operations, Europe & Canada, of Takeda.

"We are pleased with the Committee's recommendation, which brings us closer to our goal of making teduglutide available in Europe for patients with short bowel syndrome," said Francois Nader, MD, President and Chief Executive Officer of NPS Pharmaceuticals. "Teduglutide represents an important treatment advance that could significantly reduce or even eliminate parenteral nutrition support for patients with short bowel syndrome. We congratulate our partner Takeda on receiving this positive opinion and look forward to supporting their efforts to bring this much-needed therapy to patients."