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Gattex

Generic name: teduglutide
Treatment for: Short Bowel Syndrome

Update: Gattex (teduglutide) Now FDA Approved - December 21, 2012

NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)

BEDMINSTER, N.J.--(BUSINESS WIRE)--Dec 1, 2011 - NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Gattex (teduglutide). NPS has also asked the FDA to designate the application for Priority Review, which is given to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair, which NPS has been developing for the treatment of adults with short bowel syndrome or SBS, a highly disabling and potentially life-threatening chronic disorder.

“The submission of this NDA is an important milestone for NPS as it brings us one step closer to bringing Gattex to market and to making a clinically-meaningful impact on the lives of SBS patients who are suffering from this debilitating disorder,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “SBS patients are typically tethered to parenteral nutrition many days per week, which has been linked to life-threatening complications, a shortened life span, and reduced quality of life. Gattex could represent the first FDA-approved therapy indicated for the long-term treatment of this condition, potentially reducing or even eliminating a patient's dependence on intravenous nutrition and fluid.”

The company's SBS clinical development program represents the largest and most comprehensive to date. The information in the NDA is derived from 14 completed and one ongoing clinical study. A total of 566 subjects have been treated with teduglutide. Of the 566 subjects treated with teduglutide, 299 subjects were treated in the clinical pharmacology studies, 94 subjects in Crohn's Disease studies, and 173 subjects in the SBS efficacy and safety studies. Seventy-five SBS subjects have more than 12 months of exposure to Gattex.

About Short Bowel Syndrome

Short bowel syndrome, or SBS, is a highly disabling condition that can lead to serious life-threatening complications and impair a patient's quality-of-life. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions.

SBS is associated with intestinal failure and the inability to absorb sufficient nutrients and/or fluids through the gastrointestinal tract. Patients with SBS are highly prone to malnutrition, diarrhea, dehydration, and an inability to maintain weight due to the reduced intestinal capacity to absorb macronutrients, water, and electrolytes. As a result, many patients require the chronic use of parenteral nutrition (PN) and intravenous (IV) fluids to supplement their nutritional needs and stabilize their hydration. PN/IV fluids bypass the digestive tract and are delivered directly into the bloodstream through a central venous catheter. Although PN/IV can meet basic nutrition and fluid requirements, it does not improve the body's ability to absorb nutrients.

The long-term use of PN/IV fluids is associated with shortened life span and life-threatening complications such as blood clots and liver damage. The development of PN-associated liver disease predisposes patients to an increased incidence of sepsis, increased mortality rates, and the potential to develop irreversible liver damage. Patients on parenteral support often experience a poor quality of life with difficulty sleeping, frequent urination, and loss of independence.

There are an estimated 10,000 to 15,000 SBS patients in the U.S. who are dependent on parenteral nutrition and intravenous fluids.

About Gattex (teduglutide)

Gattex (teduglutide) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. The lead indication for Gattex is treatment of adults with short bowel syndrome. NPS has reported findings from completed studies in which Gattex was well tolerated and effectively reduced parenteral nutrition and intravenous fluid volume requirements in subjects with adult short bowel syndrome.

Teduglutide has received orphan drug designation for the treatment of SBS from the U.S. Food and Drug Administration and the European Medicines Agency.

In March 2011, Nycomed, a Takeda Company since end of September 2011, submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for clearance to market teduglutide (Revestive(R)) as a once-daily subcutaneous treatment for short bowel syndrome. 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 North America.

About NPS Pharmaceuticals

NPS Pharmaceuticals is a biopharmaceutical company focused on bringing orphan products to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, Gattex® (teduglutide) in adult short bowel syndrome (SBS) and NATPARA™ (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. NPS' earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.

“NPS”, “NPS Pharmaceuticals”, and “Gattex” are the company's registered trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to the company's business include, but are not limited to, the risks associated with any failure by the company to successfully complete its preclinical and clinical studies within the projected time frames or not at all, the risk of not gaining marketing approvals for Gattex and NPSP558, the risks associated with the company's strategy, as well as other risk factors described in the company's periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information.

Contact: NPS Pharmaceuticals, Inc.
Susan M. Mesco, +1 908-450-5516
smesco@npsp.com

Posted: December 2011

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