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

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

See disclaimers in side bar.

Disclosure: long BCRX shares.

Michael Murphy still bullish on BCRX

http://www.investorplace.com/experts/michael_murphy/articles/biocryst-bcrx-biotech-health-care-stocks-flu.html

BioCryst revisited

Shares of BioCryst Pharmaceuticals (BCRX) have declined over 40% from its peak as fears of the complicated H1N1 pandemic flu virus have waned, but recent developments may be bullish for the investigational drug company.

According to this article, the CDC is receiving a request for the antiviral Peramivir at a rate of one per minute, under the FDA's Emergency Use Authorization (EUA). It's a convoluted way of ordering Peramivir, but for now, it's the only method for doctors to obtain the life-saving drug for critically ill patients.
http://www.minnpost.com/craigbowron/2009/12/09/14111/the_fury_of_h1n1_meeting_the_virus_in_its_most_virulent_form_face_to_face

Green Cross, a marketing partner for BCRX's Peramivir, recently received an EUA for South Korea.
http://seekingalpha.com/article/177249-biocryst-s-korean-partner-receives-emergency-use-authorization

Former CEO and Chairman of Glaxo and former Vice Chairman of Squibb Charles Sanders was elected to BCRX's Board of Directors. This could signal a buyout from a big pharmaceutical company.
http://www.google.com/hostednews/ap/article/ALeqM5iJXedGlOvEnPut4_IJ9UgVWBgZIwD9CFQKQ80

BCRX partner Shionogi has received fast-track review designation in their quest for regulatory approval in Japan. This gives Peramivir at least a year head start in Japan, as Peramivir is still undergoing Phase III clinical trials in the US. Approval in Japan for Peramivir should occur in the first half of 2010.
http://seekingalpha.com/article/177446-biocryst-h1n1-antiviral-partner-gets-fast-tracked-for-japanese-review

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.

Finally...

Biocryst Pharmaceuticals finally receives Emergency Use Authorization from the FDA for Peramivir, the intravenously-applied anti-viral for the novel H1N1 flu virus.

http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=417887

Now doctors can get down to the business of saving lives for patients with severe cases of the swine flu.

Expect orders domestically and abroad.

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

Two ships arrive overnight...

BDSI's cancer drug pain-killer finally gained approval yesterday, after an almost year-long delay regarding labeling issues against misuse and abuse. With a novel drug delivery system, along with a strong pipeline, and a low float of shares, this investment in BioDelivery Sciences is a winner.

http://www.reuters.com/article/marketsNews/idINN1643063420090716?rpc=44

BCRX shares shot up overnight, after partner Shionogi announced positive results in Peramivir Phase III trials in Japan and Korea. Peramivir is an anti-viral which competes against existing stockpiles of Roche's Tamiflu and GSK's Relenza. Due to mutation, viral strains are starting to show resistance to Tamiflu and possibly Relenza. Hence, the race to develop a new anti-viral.

We've known of this partnership for a while and the stock has more than tripled since we bought in May, but the shares should soar higher if and when the US assigns Emergency Use Authorization for stockpiling against a pandemic flu.

http://finance.yahoo.com/news/BioCryst-Pharmaceuticals-prnews-4103594572.html?x=0&.v=1