DURHAM, NC (
(BCRX - Get Report)
shares are trading higher because another bird flu outbreak has hit China, leading the China State Food and Drug Administration to approve the company's injectable flu drug peramivir.
But here's the rub: BioCryst has nothing to do with peramivir's approval in China and isn't likely to see a dime from any drug sold there.
Spokesman Rob Bennett confirms BioCryst owns no peramivir patents in China and doesn't have a partner or any in-country operations. BioCryst still hasn't spoken to anyone in China to determine who is developing peramivir there or what steps were taken, specifically, to get the drug approved. Whether or not peramivir is effective against the current H7N9 version of bird flu affecting people in China is also unknown.
"We never looked at China as an opportunity for us," said Bennett, adding BioCryst remains focused on trying to get peramivir approved in the U.S.
The company is trying to convince FDA to accept a peramivir approval filing based on clinical studies conducted by partners in Japan and Taiwan. Last November, a registration study of peramivir conducted by BioCryst was shut down early based on a determination of futility from an independent data monitoring committee.
BioCryst does have some peramivir stockpiled from the H1N1 flu outbreak four years which could conceivably be shipped to China if requested, But such shipments would require coordination with the U.S. health officials and the FDA because peramivir is still considered an experimental therapy here. China is not on the list of countries that can accept delivery of unapproved drugs from the U.S. at this time, Bennett said.
BioCryst shares are up 15% to $1.96 in late Monday trading. Four years ago during the H1N1 bird flu epidemic, BioCryst topped $12 per share as investors pinned great hopes on blockbuster sales of peramivir to help combat the global H1N1 flu epidemic. Those sales never materialized and BioCryst's stock price crashed.
To its credit, BioCryst isn't hyping the peramivir bird flu opportunity this time around. The same cannot be said for
(CVM - Get Report)
, which issued a press release Monday touting the submission of a bird flu study paper to a scientific journal. The paper is focused on the old H1N1 virus and not the current H7N9 strain.
-- Reported by Adam Feuerstein in Boston.