NPS Announces Aggressive Plan to Restructure Operations and Cut Costs
NPS will focus its clinical development activities on teduglutide, its proprietary potential first-in-class drug candidate for gastrointestinal disorders, and will work to accelerate the drug's development for Crohn's disease and other indications. Patient enrollment for the Short Bowel Syndrome (SBS) trial continues and aggressive efforts will be made to file a new drug application for this indication by 2008.
Because of the delay in FDA approval of PREOS and the uncertainty regarding the time and expense needed to obtain U.S. approval, NPS is revising its U.S. strategy for PREOS. The company is discontinuing all current commercialization activities for the U.S. launch of PREOS, while evaluating the most appropriate regulatory, development and investment options for bringing PREOS to the market. The company has previously disclosed that the two options it is assessing are the filing of an amendment with data from existing and ongoing studies and the initiation of a new clinical trial to collect additional data to demonstrate the benefit/risk ratio of PREOS.
The NPS discovery team is currently working on a series of antiepileptic compounds from which it expects to select a lead candidate for preclinical development by the end of the year. Discovery scientists are also working on earlier-stage proprietary programs in obesity and schizophrenia.
Most read news
Topics
Organizations
Other news from the department business & finance
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.