Key Developments For NPS Pharmaceuticals, Inc.
NPS Pharmaceuticals, Inc. (NPSP.O) (Consolidated Issue listed on NASDAQ Global Market)
Data Demonstrate NPS Pharmaceuticals, Inc.'s GATTEX Improves Lean Body Mass, Mineral Composition And Electrolyte Levels In Patients With Parenteral Nutrition Dependent Short Bowel Syndrome
NPS Pharmaceuticals, Inc. announced that it has reported additional data from a Phase 3 study supporting the efficacy of GATTEX (teduglutide) in patients with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). Data were presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting and Postgraduate Course taking place in San Diego, October 23-28. Data from the randomized, placebo-controlled, 24-week study showed that teduglutide significantly improved lean body mass and total bone mineral content in PN-dependent SBS patients (Abstract P272). A separate presentation showed that teduglutide improves intestinal electrolyte and wet weight absorption in SBS patients (Abstract P273). Previously reported results from the study showed that teduglutide was generally well-tolerated and effective in reducing the PN requirements of SBS patients. The 83 patients in the Phase 3 study all had SBS resulting from major intestinal resection and required PN infusions three or more times per week. Following a four-16 week optimization and stabilization period, patients were randomized to placebo or one of two dose levels of teduglutide (0.05 or 0.10 mg/kg/d sc) for 24 weeks. PN fluid volume was weaned according to an algorithm based on changes in urine production in relation to teduglutide treatment.
NPS Pharmaceuticals, Inc. Secures $40 Million Committed Equity Financing Facility
NPS Pharmaceuticals, Inc. announced that it has secured a committed equity financing facility under which it may sell up to $40 million of its registered common stock to Azimuth Opportunity, Ltd. over an 18 month period. NPS is not obligated to utilize the facility and remains free to enter into other financing transactions (other than another committed equity financing facility). NPS did not pay a commitment fee or issue any warrants to secure this facility. NPS will determine, at its sole discretion, the timing, the dollar amount, and the floor price per share of any draw under this facility, subject to certain defined limitations. When and if NPS elects to use the facility, it will issue shares to Azimuth at a small discount to the volume weighted average price of NPS common stock over a preceding period of trading days. Any shares sold under this facility will be sold pursuant to a shelf registration statement declared effective by the Securities and Exchange Commission on June 5, 2009.
NPS Pharmaceuticals, Inc. Announces New Findings Demonstrate Potential Benefits Of GATTEX (teduglutide) In Phase 3 Study Of Patients With Short Bowel Syndrome
NPS Pharmaceuticals, Inc. announced Clinical investigators presented new data from three sub-studies in patients with short bowel syndrome (SBS) who received GATTEX (teduglutide) during a 24-week, placebo-controlled Phase 3 clinical trial. Investigators reported that teduglutide achieved a significant increase in absolute intestinal absorption and a decrease in electrolyte losses in SBS patients dependent on parenteral nutrition (PN), with no significant changes observed from baseline for placebo. In addition, new findings demonstrated changes in citrulline, an endogenous non-protein amino acid, appear to be useful biomarkers of PN reduction response when teduglutide is used. Data also suggest that patients with an increase in citrulline at week eight are likely to achieve a significant response, as defined by a greater than 20% reduction in PN. In the third sub-study, investigators reported that with a constant dietary intake, 24 weeks of teduglutide treatment significantly increased energy absorption in PN-dependent SBS patients. GATTEX (teduglutide) is a novel investigational compound that may reduce dependence upon PN in patients with SBS, a rare disorder primarily caused by intestinal resection and the subsequent inability to maintain oral fluid, electrolyte, and nutrient balances.
NPS Pharmaceuticals, Inc. Says Teva Pharmaceutical Industries Ltd. Files Patent Infringement Suit Vs Amgen, Inc.-DJ
Dow Jones reported that NPS Pharmaceuticals Inc. disclosed that Teva Pharmaceutical Industries Ltd. has filed a lawsuit against Amgen Inc. alleging patent infringement on a Teva patent, according to a Securities and Exchange Commission filing. The alleged infringement relates Teva's U.S. Patent No. 7,449,603, but didn't provide further information on the patent. NPS Pharmaceuticals said under a license agreement between Amgen and NPS, Amgen may reserve up to 50% of the royalties otherwise payable by Amgen with respect to the affected compound in the country in question until the proceedings are concluded. The Company said if Teva's patent is found to be uninfringed, unenforceable or invalid, Amgen is required to promptly pay any reserved royalties to NPS. NPS Pharmaceuticals said if Teva's patent is found to be valid and infringed, or if Amgen enters into a settlement of Teva's infringement claim, then Amgen may deduct any damages or settlement amount regarding such claim from the reserved royalties prior to payment of any remaining amount.
NPS Pharmaceuticals, Inc. Initiates Phase 3 STEPS Study To Confirm GATTEX Reduces Parenteral Nutrition Dependence In Short Bowel Syndrome
NPS Pharmaceuticals, Inc. announced that patient enrollment has begun in a Phase 3 registrational study to confirm previously reported data that demonstrated GATTEX (teduglutide) was well tolerated and reduced parenteral nutrition (PN) dependence in short bowl syndrome (SBS) patients. The international, double blind, placebo controlled safety and efficacy study of GATTEX is known as STEPS (Study of TEduglutide in PN dependent Short bowel syndrome). STEPS will enroll approximately 86 PN-dependent SBS patients in North America and Europe. The trial includes an initial three to eight week PN optimization and stabilization period, after which patients will be randomized 1:1 to compare daily subcutaneous dosing of 0.05 mg/kg of GATTEX to placebo over a 24 week treatment period. The primary efficacy endpoint is the percentage of patients who achieve a 20% or greater reduction in weekly PN volume at week 20 and maintain that response at week 24, when compared to baseline. The study’s secondary objectives will evaluate efficacy variables based on reductions in PN volume or the direct effects of improved intestinal absorption of fluid.
