This excerpt taken from the NPSP 8-K filed Nov 5, 2008.
· NPS has finalized its protocol for a Phase 3-confirmatory study of GATTEX (teduglutide, recombinant GLP-2) in patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition (PN). The institutional review board (IRB) approval process for the proposed study is underway with patient enrollment expected to begin soon thereafter. The company believes positive results from this study will enable it to seek marketing approvals for GATTEX for patients with PN-dependent SBS.
· NPS and its partner Nycomed have agreed in principle to support the Phase 3-confirmatory study of GATTEX in SBS on a collaborative basis and share external clinical trial costs.
· Investigators presented additional positive Phase 3 data on GATTEX in SBS at the following medical meetings: the 30th European Society for Clinical Nutrition and Metabolism Congress, the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course, and the 16th United European Gastroenterology Week.
· Preclinical studies evaluating teduglutide in pediatric indications and in chemotherapy-induced gastrointestinal mucositis continue to advance in support of investigational new drug applications in 2009.
· NPS has finalized its protocol for a Phase 3 registration study of NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection or PTH 1-84) for the treatment of adults with hypoparathyroidism. The IRB approval process for this study is underway with patient enrollment expected to begin shortly thereafter. The company believes positive results from this study will enable it to seek marketing approvals for NPSP558 for patients with hypoparathyroidism.
· Positive interim data from an investigator-initiated Phase 2 proof-of-concept study of NPSP558 in hypoparathyroidism were presented at the 30th Annual Meeting of the American Society for Bone and Mineral Research.
· NPS has entered into a memorandum of understanding (MOU) to settle the previously disclosed consolidated securities class action pending against it and certain of its current and former officers and directors. Under the MOU, the companys insurance carriers will pay $15 million to settle all claims against NPS and the other defendants. The MOU provides that the action will be dismissed with prejudice, with no admission or finding of
wrongdoing on the part of any defendant. The company also reached an agreement in principle to settle the previously disclosed state and federal consolidated shareholder derivative actions. The agreement in principle provides that actions will be dismissed with prejudice, with no admission or finding of wrongdoing on the part of any defendant. The company shall institute certain corporate governance measures and the defendants insurers shall pay $1 million toward plaintiffs legal fees. Both proposed settlements are subject to negotiation of definitive settlement documents and final court approvals.
This excerpt taken from the NPSP 8-K filed Aug 7, 2007.
Debt Reduction/Refinancing and Balance Sheet Strength:
NPS has entered into the following three transactions, the proceeds of which will be used to retire all of the Companys 2008 convertible debt.
If results of the Phase 3 study are positive, NPS intends to submit a new drug application (NDA) in mid-2008 seeking approval to market teduglutide for the treatment of short bowel syndrome. Once the company has completed its analysis of data from the SBS study, it expects to pursue a pre-NDA meeting with the FDA to discuss its plan for submitting the NDA. The company anticipates submitting marketing applications in Europe and Canada shortly thereafter.
NPS is also conducting preclinical studies with teduglutide as a potential treatment for chemotherapy-induced gastrointestinal mucositis in cancer patients and necrotizing enterocolitis in preterm infants.