China’s outbreak of a rare bird flu strain has given a fresh look for the prospects of a BioCryst Pharmaceuticals (Nasdaq: BCRX) influenza drug that just a few months ago looked like it was dead in the water.

Regulators in China reportedly approved BioCryst’s experimental treatment Peramivir, even though the Durham company has not tested the drug in China, sought Chinese approval or even talked with Chinese officials.

Rob Bennett, BioCryst’s executive director of investor relations and communications, told WRAL Tech Wire that the company has reached out to Chinese officials to offer help with the H7N9 flu outbreak but the company has yet to hear a response.

Chinese news agency Xinua reported on April 6 that the China Food and Drug Administration approved Peramivir after injections of the treatment diluted in sodium chloride was “proven by preliminary tests.” BioCryst knows nothing about these tests and Bennett concedes that it’s not even clear whether Peramivir would work on the H7N9 strain, which has resulted in a total of 28 confirmed cases and nine deaths so far, according to the World Health Organization.

“We haven’t supplied product for them to do that (testing),” Bennett said. “They could have in theory done testing. But we haven’t seen any clinical testing data.”

Yet on Monday, BioCryst stock traded as high as $2.12, its highest price since the company’s stock price plunged in December after the company announced a corporate restructuring. It’s not the first time a regulator’s decision to allow patients access to Peramivir in the face of a flu outbreak has led to a boost in BioCryst’s stock price. In October 2009 the Food and Drug Administration granted emergency authorization to the still experimental Peramivir to address the H1N1 swine flu outbreak. BioCryst stock reached as high as $12.30 per share on Nov. 9 of that year.

Shares closed Thursday at $1.66, down 10 cents from its opening price for the day.

Partners in Asia

Peramivir is an antiviral that combats influenza by blocking an enzyme critical for the spread of the virus in the host patient. Peramivir, which was discovered and developed in BioCryst’s labs, is intended to be administered intravenously to hospitalized patients though it is also available as an injectable drug. So far, it is approved in only Japan and South Korea, where Peramivir is sold by companies that have licensed the antiviral from BioCryst. Shionogi holds the rights for Japan, where it is sold as Rapiacta. Green Cross Corporation markets Peramivir under the name Peramiflu.

If China plans to use Peramivir, it’s not clear how it would do so. Shionogi and Green Cross do not have rights to the China market and their clinical tests were limited to their respective markets. BioCryst has not made more Peramivir since production was completed for the emergency authorization of the drug. That stockpile was manufactured in the United States and China has no access to it.

“We know where our inventory is,” Bennett said, “And we haven’t provided them any.”

Until this month, Peramivir’s prospects beyond Japan and Korea looked questionable. BioCryst, which has been focused on getting U.S. approval, stopped phase III trials on Peramivir in November. An interim analysis found little difference between the Peramivir group and the control group. An independent board recommended terminating the trial.

FDA meeting

But on April 1, BioCryst announced a Food and Drug Administration a letter outlining a possible pathway for Peramivir approval. BioCryst has an upcoming meeting with the FDA to discuss Peramivir. Bennett says the company will see if it needs to resize the sample size of the study but it does not plan on resurrecting the phase III trial that was stopped. Peramivir has already been approved in Korea and Japan and clinical data from those countries could be part of a Peramivir drug filing with the FDA, Bennett said. Details still need to be worked out in future discussions with the agency.

The reality is that Peramivir’s status now is not much different than it has been in recent months. Chinese health officials apparently want Peramivir but they can’t get it and it’s not clear it would even work on the H7N9 strain. And while BioCryst does plan to sit down with the FDA to discuss Peramivir, it’s also not yet clear what the FDA will say and approval is never a given. That’s probably why BioCryst stock has settled back down to around $1.66 per share, close to the same price it trading before Peramivir resurfaced in the news.