Green Cross receives approval for Peramivir in South Korea

http://www.businesswire.com/news/home/20100816005534/en/BioCryst%E2%80%99s-Partner-Green-Cross-Receives-Marketing-Manufacturing

Peramivir has now received regulatory approval in both Japan and South Korea. In the US, Peramivir is in phase III clinical trials

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.

Is the swine flu scare over?

Apparently not, as the World Health Organization (WHO) is contemplating raising the pandemic alert from phase 5 to phase 6, the highest level. The Influenza A(H1N1) virus is rapidly spreading throughout multiple countries, and is now mutating to the point where there is human-to-human transmission. Roche's Tamiflu and GSK's Relenza are stockpiled in the US, but Tamiflu is potentially ineffective against new mutations, and Relenza may only be marginally effective in combating the virus.

Hence, I invested in another clinical company which has developed a vaccine which has been proven effective in Phase III and Phase II trials in Japan and the US, respectively. They already have existing contracts with government agencies, and negotiations are underway to roll out doses for hospital use and for stockpiling. Unfortunately, this swine flu pandemic is not going away any time soon.