NPS Pharmaceuticals 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.”
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