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NPS Pharma Expects to File Natpara BLA in Mid 2013


NPS Pharmaceuticals (NASDAQ: NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that it expects to submit its Biologic License Application (BLA) for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84])) in mid-2013. The change in the company's forecasted timeline is due to a request from the Medical Device Division of the U.S. Food and Drug Administration (FDA) to modify the company's instructions for using the injection pen device to deliver Natpara. The FDA has not requested any new clinical data or clinical studies of Natpara. The requested changes will require the company to repeat its Usability Testing of the injection pen device using the modified instructions before submitting its BLA.

“I have every confidence that we will complete the requested testing of the injection pen instructions and deliver our BLA submission in line with our mid-2013 guidance,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “We are continuing to prepare the remaining components of the Natpara BLA to ensure that we assemble a high-quality submission. In addition, we are making good progress toward resolving the previously disclosed manufacturing issue and we fully believe this matter will be resolved well in advance of our BLA submission.”

Posted-In: News FDA


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