BEDMINSTER, N.J., Dec. 21, 2012 /PRNewswire/ -- NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved Gattex ® (Teduglutide [rDNA origin]) for Injection, for subcutaneous use for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Gattex will be available in the first quarter of 2013. For full prescribing information, please visit www.Gattex.com.
To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/59518-nps-pharmaceuticals-fda-approval-gattex-adult-short-bowel-syndrome-sbs
"Gattex is a ground-breaking therapy that has been evaluated in the largest clinical program to date in short bowel syndrome," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "We are very excited about the opportunity to help SBS patients by offering this first-in-class therapy. The approval of Gattex is a crowning achievement for our company and the catalyst for our transformation into a premier orphan drug business. We are prepared for a successful launch based on productive interactions with payers, methodical patient identification, and the strategic development of our field-based commercial infrastructure. We have also launched NPS Advantage, our free support program that includes, care coordinators who will work closely with patients to help them understand the clinical characteristics of Gattex and navigate the reimbursement landscape."
SBS is a serious, complex disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal tract to sustain life. SBS patients are commonly infused with PN/IV five to seven nights per week for up to 10 to 12 hours at a time, and in extreme cases, some patients could receive PN/IV for 24 hours a day. Long-term use of PN/ IV fluids can be associated with life-threatening complications such as liver damage, serious bloodstream infections, and blood clots.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV