Nycomed submits teduglutide MAA to EMA for SBS treatment

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported that Nycomed, a global pharmaceutical company, headquartered in Switzerland, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for clearance to market teduglutide (Revestive®) as a once-daily subcutaneous treatment for short bowel syndrome (SBS). The submission triggers a mid-seven digit milestone payment to NPS.

Teduglutide is a novel, recombinant analog of human glucagon-like peptide 2, a naturally occurring peptide involved in the repair and maintenance of normal intestinal structure and function. NPS is developing teduglutide in the United States for adult short bowel syndrome under the brand name GATTEX® and has licensed Nycomed the rights to develop and commercialize the drug in ex-North American regions. NPS expects to submit a marketing application to the U.S. Food and Drug Administration later this year.

SBS is a rare and debilitating condition in which the body is unable to absorb enough nutrients and/or fluids through the gastrointestinal tract. SBS typically arises after surgical removal of a significant portion of the small bowel due to Crohn's disease, ischemia or other conditions. There are an estimated 15,000 patients with SBS in the U.S. who rely on chronic parenteral support to survive. Parenteral support does not improve the body's own ability to absorb nutrients as it only meets basic nutrition and fluid requirements by delivering them intravenously. Parenteral support is expensive and often associated with serious complications such as infections, blood clots or liver damage, and diminished quality-of-life due to difficulty sleeping, frequent bowel movements and urination, and loss of independence.

"We congratulate our partner on this important milestone," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "Teduglutide has the potential to become a new standard of care for patients with SBS who have limited gut function. NPS and Nycomed are committed to making teduglutide available for the tens of thousands adults who suffer from this debilitating condition."

Teduglutide has been designated an orphan drug for the treatment of SBS by the U.S. 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 countries. The agreement provides for NPS to earn double-digit royalties on teduglutide sales in the Nycomed territories and payments related to the attainment of certain defined milestones. Pursuant to a previously existing third-party patent licensing agreement for GLP-2, the company is required to pay the licensor a percentage of sub-licensing revenue received.