BioCryst (NASDAQ:BCRX) is reviving efforts to win regulatory approval for a flu treatment that could become part of U.S. preparations against pandemic influenza.
The Durham-based drug developer said announced Thursday that the Biomedical Advanced Research and Development Authority, or BARDA, has released funding for the drug candidate and BioCryst expects to file a new drug application, or NDA, with the Food and Drug Administration by the end of the year.
BioCryst had developed peramivir through phase III clinical trials financed by a $235.8 million contract awarded by BARDA. The phase III studies were suspended last November after an interim analysis showed little difference between the peramivir group and the control group. Stopping the study suspended its federal funding.
BioCryst said Thursday that BARDA’s release of the funding under the peramivir contract enables BioCryst to complete its new drug application for intravenous peramivir. But the company won’t be revising the phase III trial. BioCryst is not getting the full remaining funding of the contract, just $12.8 million, according to securities filings. BioCryst said BARDA decided to release funding for peramivir after a second quarter “In-process review” meeting, or IPR, to review the drug candidate.
“Based on the results of the IPR, and considering first and foremost what it viewed as in the best interest of the U.S. Government and the nation’s preparedness for pandemic influenza, BARDA/HHS decided to modify the existing stop-work order relating to the contract to support only those activities directly associated with the NDA and to allow no more than $12.8M of funding already obligated on the contract to be used for that purpose.”
Because the BARDA funds can only be applied toward the new drug application, BioCryst said it believes it will incur “some modest costs associated with the NDA filing.”
Peramivir has already been approved in Korea and Japan. The company has previously said that it did not expect to conduct new phase III studies on peramivir but clinical data from the drug’s studies in Korea and Japan could be part of the drug application with the FDA. BioCryst said it has already had a pre-NDA meeting regarding peramivir during which the company reached agreement with the FDA about all the requirements needed for a complete NDA submission.
