BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) designs, optimizes and develops novel small-molecule drugs that block key enzymes involved in infectious and inflammatory diseases.
BioCryst announced that it received a preliminary comment letter from the FDA that outlines a pathway by which BioCryst could file a New Drug Application (NDA) seeking regulatory approval of its drug candidate intravenous peramivir. Pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in intravenous peramivir’s preliminary comment letter has been suggested by the FDA to the Company.
Also BioCryst received written notification from the Department of Health and Human ServicesT confirmed that the Biomedical Advanced Research and Development Authority (BARDA/HHS) will continue to support and fund certain activities that are necessary to achieve immediate milestones, as well as activities deemed essential to maintain compliance with FDA regulations or to fulfill pending FDA requests.
Jon P. Stonehouse , President & Chief Executive Officer of BCRX, noted:
Our ultimate objective is the approval of peramivir as an intravenous treatment option that could benefit patients in the United States. The StopWork Order is understandable, as it focuses the scope of reimbursable activities to those that are essential and supportive to continuing regulatory communications, with the objective of preparing an NDA submission. If the conversations with the FDA and BARDA/HHS are successful, BioCryst stands ready to file an NDA for peramivir as soon as feasible.
BioCryst’s current pipeline consists of the following development programs:
- Oral inhibitors of plasma kallikrein for hereditary angioedema; BCX4161 and a 2nd generation candidate
- BCX4430 a broad spectrum antiviral for development as a medical countermeasure against hemorrhagic fevers.
- Peramivir, a viral neuraminidase inhibitor developed under a HHS/BARDA contract as an intravenous antiviral for influenza until November 8, 2012, when enrollment in the Phase 3 Trial was suspended.
- Ulodesine (BCX4208), a Phase 3 ready purine nucleoside phosphorylase (PNP) inhibitor, in development as an add-on therapy for gout