TUESDAY, SEPTEMBER 27, 2016

BioCryst Pharmaceuticals receives preliminary comment letter from U.S. FDA

BioCryst Pharmaceuticals, Inc., announced on Monday that it received a preliminary comment letter from the Food and Drug Administration outlining a pathway for the submission of a new drug application for intravenous peramivir.

The Durham, N.C.-based pharmaceutical company received the letter in response to questions BioCryst sent the FDA in advance of a type C regulatory meeting regarding i.v. peramivir. Additionally, the FDA suggested BioCryst request a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in the letter.

Peramivir is an intravenously administered investigational anti-viral agent that rapidly delivers high concentrations of plasma to sites of infection. In tests, peramivir demonstrated activity against multiple influenza strains, including pandemic H1N1 swine flu. The agent is being developed under a $231.8 million contract with the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.

BioCryst also received a stop-work order from the HHS directing the company to stop working on peramivir under its U.S. government contract. The order permits certain activities related to the upcoming type C meeting. The order confirms that BARDA will keep supporting and funding activities needed to achieve immediate milestones and essential activities for FDA compliance or requests.

BioCryst anticipates an in-process review meeting in the second quarter. After the meeting, BARDA and the HHS are expected to come up with the path forward for the contract.

"We are encouraged by these recent communications, and we look forward to advancing our peramivir discussions with the FDA and BARDA/HHS," Jon Stonehouse, the president and CEO of BioCryst. "Our ultimate objective is the approval of peramivir as an intravenous treatment option that could benefit patients in the United States. The stop-work 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 designs, optimizes and develops novel small molecule drugs to stop important enzymes related to inflammatory and infectious diseases.