Last fall BioCryst ($BCRX) took a careful look at the interim data from a late-stage study of its flu drug peramivir i.v. and prepared to read the last rites for the program after years of federally-funded research work. The company gave up on enrolling more patients and said any further development with an eye to filing for an approval in the U.S. was "unlikely."
For any other company, that would have been the end of the story. The bankers at the Biomedical Advanced Research and Development Authority (BARDA), though, appear to be more bullish about the failed therapy. The biotech announced today that BARDA had released funds under their $235 million development contract to finance an NDA. The funding follows an announcement three months ago that officials at the FDA had laid out as a possible pathway to an approval. And investors helped push the company's battered shares up on that report. Shares were up again this morning about 9%, trading around $1.77 on the new lease on life.
"It would have obviously been a Hail Mary to file on the Phase III data," company spokesperson Robert Bennett tells FierceBiotech. That late-stage study had been based on a program focused on severely ill patients hospitalized with influenza. But the interim analysis closed that avenue.
Nevertheless, he says, Japan's Shionogi, a partner of BioCryst's, was able to get an approval in Japan on positive Phase II data for uncomplicated flu. BioCryst believes it can add its own supporting data for uncomplicated flu and get an approval for an indication very similar to Tamiflu and Relenza, adds Bennett. With no i.v. treatment option available, he says, the biotech believes that an FDA approval would still pave the way for its use in hospitals.
And Durham, NC-based BioCryst is quite confident that it can succeed.
"We thank BARDA/HHS for its continued support of this program. This remaining funding is what we need to get peramivir to the finish line," said BioCryst CEO Jon P. Stonehouse. "We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States."
- here's the press release