BioCryst data makes it more of a threat to Roche, Glaxo

July 17, 2009 · Filed Under General 

BioCryst Pharmaceuticals Inc. (BCRX) shares surged after a Phase III study from one of its partners helped raise investor confidence into the company’s Peramavir anti-flu candidate.

A study sponsored by BioCryst partner Shionogi & Co Ltd. in Japan showed that Peramavir was not inferior in terms of efficacy and safety to the anti-flu standard, Roche’s Tamiflu. The study involved a total of 1,099 patients at 146 centers.

BioCryst now says it is planning late-stage studies of Peramivir, in hopes of winning an FDA approval.

Peramivir is not really BioCryst’s lead drug candidate is Fodosine, a treatment of cutaneous T-cell lymphoma. But ever since the FDA gave fast-track status to Peramivir in 2006, BioCryst has been considered an anti-flu play.

And that’s likely the way that traders will continue to see it, especially since the World Health Organization says swine flu a pandemic — the first time it has declared a flu pandemic in four decades.

More data is likely required before the FDA approves Peramivir. Even with an ongoing pandemic, there seem to be enough U.S. stockpiles of Tamiflu and GlaxoSmithKline’s (NYSE: GSK) Relenza to treat patients with the virus.

Regardless of whether Peramivir is expedited, more data that shows it’s at least on par with Tamiflu may help improve its approval chances, especially since trial data has showed Peramivir might be able to treat Tamiflu-resistant flu strains — Mike Tarsala

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