BioCryst announces upbeat first quarter

http://www.marketwatch.com/story/biocryst-reports-first-quarter-2010-financial-results-and-provides-corporate-update-2010-04-28?reflink=MW_news_stmp

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Disclosure: long BCRX shares.

BCRX announces initial HHS order

BioCryst Pharmaceuticals (symbol "BCRX") announced shipment of an initial order from the Department of Health and Human Services (HHS). The order for 10,000 courses was for the amount of $22.5 million, setting a price of $2,250 per course for Peramivir, the intravenous anti-viral treatment for the novel H1N1 pandemic influenza virus. The order was shipped under the Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on October 23, 2009. The HHS may order up to 30,000 more courses at the same unit price.

BCRX is manufacturing up to 130,000 courses total to be shipped by the end of the year, as they expect additional orders from other countries.

http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=422102

In a related press release, "BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. has filed a New Drug Application (NDA) in Japan to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza. As a consequence of this filing, BioCryst will receive a regulatory milestone payment of $7 million under its agreement with Shionogi."
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=421714

Disclosure: long BCRX shares.

BioCryst sponsors a symposium at ICAAC

BioCryst Pharmaceuticals (BCRX) sponsored a symposium at the ICAAC conference last night on emerging therapies for novel strains of the flu:

http://www.icaac.org/index.php?option=com_content&view=article&id=57&Itemid=54

Intravenous Peramivir, BCRX's anti-viral against the flu, made news headlines as well:

http://abcnews.go.com/Health/wireStory?id=8562221

Now that President Obama and Congress have made appropriations for funding of vaccines and anti-virals to combat the pandemic flu, it is now in HHS Secretary Kathleen Sebellius' court to sign off on an order for the strategic national stockpile. The FDA will also have to issue an Emergency Use Authorization since Peramivir is not an approved treatment.

Currently, medical practitioners can order Peramivir for individual hospitalized patients through an emergency use investigational new drug (EIND) process. But an EUA needs to be issued so millions with complicated and severe cases can gain access to Peramivir. Peramivir saves lives--especially with novel strains becoming resistant to Tamiflu (Oseltamivir).

BCRX potential

According to Health and Human Services (HHS) Dr. Robin Robinson:

http://www.reuters.com/article/healthNews/idUSTRE56669020090709

The federal government has 52 million treatment courses of Tamiflu and Relenza in its strategic national stockpile. Tamiflu, or oseltamivir, is made by Roche under license from Gilead Sciences while Relenza, or zanamivir, is made by Glaxo under license from Australia's Biota Inc.

Dr. Robin Robinson of HHS said the department is also considering buying another tranche of drugs, including zanamivir and pediatric doses of Tamiflu.

A third drug, Biocryst Inc's peramivir, is nearing final trials before approval, Robinson said. "That would be used for severely ill individuals in hospitals," he said.

Having three different drugs would help address the issue of resistance. Some cases of the new H1N1 swine flu have been resistant to Tamiflu and that drug is now generally ineffective against the seasonal version of H1N1, a distant cousin of the pandemic strain.

Also, start reading on page 74 of the following National Biodefense Science Board report during a recent emergency meeting at the HHS regarding H1N1 countermeasures. The fact that BioCryst was at the meeting is a portent:

http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf