BioCryst Pharmaceuticals stock fell 14 percent after the company reported another potential setback for its intravenous flu treatment peramivir.
The Durham drug developer said Thursday that a Food and Drug Administration inspection raised a “number of concerns” about the contract manufacturer that was to produce the treatment. The company did not indicate whether the FDA’s warning will delay a long-anticipated new drug application for peramivir.
The agency concerns, raised in a Form 483 and issued to BioCryst’s U.S.-based contract manufacturer, mean that FDA inspectors observed conditions or practices indicating “that any food, drug, device or cosmetic has been adulterated or ... may become adulterated or rendered injurious to health,” according to FDA’s website.
The 38-employee company also said it is making progress on developing several other treatments, most notably enrolling 24 patients for a Phase 2 human trial of an oral treatment for hereditary angioedema, a rare blood disorder that causes painful and dangerous swelling. BioCryst also said it plans to begin human trials on other hereditary angioedema treatments in 2015.
Peramivir has been under development with $235 million in federal funding since 2007 and is slated for introduction in the United States for the 2014-15 flu season. It was withdrawn from federal review last year after inconclusive tests, sinking the company’s stock and tanking a planned merger.
Peramivir delivers high plasma doses to infected areas, and, if approved, would be the first IV antiviral approved in this country. The company has said peramivir is effective against multiple flu strains, including the H1N1 swine flu.
BioCryst CEO Jon Stonehouse offered few details on the newly surfaced peramivir complications, telling analysts the problems are “pretty recent stuff” and that it’s still unclear what it means for peramivir’s prospects. BioCryst did not identify the contract manufacturer; the production and packaging facility was not making peramivir at the time the FDA discovered problems, but the facility was expected to begin initial production of peramivir later this year.
“It is unclear how these findings may impact the peramivir NDA or supply of peramivir drug product,” BioCryst said in its release. “BioCryst and its contract manufacturer are working with the FDA to meet the requirements for approval of the peramivir NDA.”
BioCryst has no products on the U.S. market; peramivir is approved in Japan and Korea.
BioCryst also reported that first-quarter revenue was $3.5 million, compared with $3.6 million a year earlier. The revenue included federal research grants, including funding from the National Institute of Allergy and Infectious Disesases to fund development of a treatment for Marburg virus disease, also known as a viral hemorrhagic fever.
Net loss for the first quarter was $10.1 million, or 17 cents a share, compared with $4.5 million, or 9 cents a share, a year earlier.
BioCryst shares closed Thursday at $7.37, down $1.18. The stock is down 3 percent this year.