NPSP » Topics » First Quarter Highlights

This excerpt taken from the NPSP 8-K filed May 7, 2008.

First Quarter Highlights

 

   

NPS completed the implementation of its new business strategy, which focused its development programs on specialty indications for gastrointestinal and endocrine disorders and consolidated operations into one facility in New Jersey.

 

   

NPS appointed Francois Nader, M.D., as president, chief executive officer and director. Dr. Nader previously served as executive vice president and chief operating officer of NPS and played a key role in the development and implementation of the company’s new business strategy.

 

   

NPS appointed Alan G. Harris, M.D., Ph.D., as senior vice president and chief medical officer. Dr. Harris brings more than 20 years of pharmaceutical industry experience to NPS with an emphasis on gastrointestinal and endocrine disorders.

 

   

NPS reported positive top-line results from a blinded Phase 3-extension study of GATTEX™ for patients with short bowel syndrome (SBS) who are dependent upon parenteral nutrition (PN). Data from this study demonstrated a favorable safety profile and a number of positive efficacy measures. Sixty-eight percent (68%) of the 25 patients who had received low-dose GATTEX therapy and 52% of the 27 patients who had received high-dose GATTEX therapy achieved a 20% or greater reduction in PN after a total of 52 weeks of therapy.

 

   

Three GATTEX-related abstracts were accepted for presentation at the 2008 Digestive Disease Week (DDW) conference, including two oral presentations of data from the Phase 3 study of GATTEX for PN-dependent SBS patients.


 

 

Kirin launched REGPARA® (cinacalcet HCl) in Japan for secondary hyperparathyroidism during maintenance dialysis.

Francois Nader, M.D., president and chief executive officer, stated: “The first quarter was marked by the continued advancement of our proprietary and partnered pipeline. We reported positive top-line results from our Phase 3-extension study of GATTEX for SBS and our partner Kirin launched REGPARA in Japan. We are finalizing our protocol for a Phase 3 confirmatory study for GATTEX and we remain on track to launch the study in the third quarter of this year. Our second late-stage program, NPSP558, for hypoparathyroidism continues to progress with the initiation of a pivotal study on target for the second half of this year. Equally important, we continue to manage our expenses in line with our 2008 cash burn guidance.”

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