Just in: Peramivir receives competition

http://www.nytimes.com/2009/11/06/business/06drug.html?_r=1

But peramivir will soon have competition. The federal government said late Thursday that it had also ordered 10,000 treatment courses each of intravenous versions of Tamiflu and Relenza, with options to buy 30,000 more courses of each.

Those drugs could not be used, however, until they received emergency use authorizations from the F.D.A.

The government is paying an average of only $450 a course for those other drugs — only one-fifth of what it is paying for peramivir.

Right now, Dr. Lurie said, peramivir is the only drug that can be used intravenously so the government had to pay a high price. “I would say that one of the things that happens in the market when you have competition is that the price drops.”

It looks like the government wants to create competition and reduce the price of intravenous (IV) anti-virals. The problem is that Tamiflu IV and Relenza IV, have not even gone through Phase 1 or Phase 2 clinical trials yet, much less Phase 3. Receiving Emergency Use Approval (EUA) will prove to be a challenge, as BCRX receiving EUA for Peramivir has been challenging enough--even after years of clinical trials.

This is a case of two big foreign pharmaceutical companies fighting back to regain market share they've lost to an upstart US biopharmaceutical company. Tamiflu and Relenza are still effective in many cases against the novel H1N1 virus in their present form, oral and inhalant, respectively. But the seasonal flu is almost 100% resistant to Tamiflu, and starting to show resistance against Relenza.

IV Peramivir has shown to have 90% efficacy in saving lives of complicated cases of the H1N1 virus--when all other measures have failed. If and when Tamiflu IV and Relenza IV receive EUA, it remains to be seen whether they can show similar capability in saving lives.

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).

Tamiflu-resistant swine flu

The US has a huge stockpile of Tamiflu and Relenza as anti-virals. Anti-virals are treatments for patients who have contracted the various flus already--they are not vaccines and hence, are not used as prophylaxis in prevention of said influenza viruses.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5816a6.htm

Read the editorial note, not just the article. Down at the bottom, you will see this:

Compared with M2 blockers, NAIs previously exhibited lower frequency of antiviral resistance during therapeutic use (16,19). However, during the 2007--08 influenza season, emergence and transmission of oseltamivir-resistant A (H1N1) viruses, with a H274Y mutation in the neuraminidase protein, was simultaneously detected in several countries in the Northern Hemisphere (4,20--22) and spread globally (7,9,23). As of April 2009, similar trends have been observed in the 2008--09 influenza season, with many countries reporting up to 100% oseltamivir resistance in A (H1N1) viruses

.

In case you were wondering, oseltamivir = Roche's Tamiflu, currently the anti-viral of choice for the nation's stock pile. It no longer works for avian or swine flus! So if you're sick from the swine flu enough to get admitted into a hospital, they will probably administer Tamiflu orally, as it is a pill. I have seen government data that up to half of admitted swine flu patients in ICU end up dead. One other possible reason for resistance (besides prevalence of Tamiflu in our sewage and water system) is oral consumption decreases and delays absorption of the compound. One of the members in this email thread used to work at Roche, perhaps he can add some color to this assessment.

The 2nd drug of choice is GlaxoSmithKline's Relenza, or zanamivir. It has maintained efficacy for treating various strains of flu, and is in the form of powder. If a patient is seriously ill enough to be intubated, that option is ruled out because Relenza can only be inhaled.

Which only leaves us with BCRX's Peramivir intravenous application as the only option. The share price has gapped up recently, despite only completion of Phase II clinical trials in the US. It is already approved for E-IND use, which basically allows individual doctors to administer it for individual patients as an emergency. But due to its efficacy, investors are waiting for Emergency Use Authorization, which allows national stockpiling, despite lack of FDA approval. This will translate to millions of doses, not just a few thousand.

Many investors feel this action is not just pending, but imminent. Vaccine manufacturers are scrambling to meet exploding demand--and they will still fall short, as best-case scenarios call for delivery in October. Unfortunately, school starts in August/Septemer, so we will unquestionably see a soaring number of cases this fall--rendering vaccines useless. Fortunately, most cases will be mild, and won't require hospitalization. But due to the high infectious rates, and sheer numbers of cases, hospitalization and death rates will be higher than seasonal flu cases by orders or magnitude.

http://news.yahoo.com/s/ap/20090724/ap_on_he_me/us_med_swine_flu

http://www.cbsnews.com/stories/2009/07/21/earlyshow/health/main5177452.shtml

Government health officials aren't in business to create unnecessary hype--quite the contrary--they aim to act quickly and decisively while attempting to not cause undue panic. They usually fail in both. However, they are on the hook to prepare for a worst-case scenario, and they will look awfully foolish if they don't take emergency measures as part of their contingency plans. In Japan and the rest of Asia, where sensitivity and awareness to infectious disease is high due to close living quarters, their FDA equivalent health agency has already completed Phase III trials, and results for Peramivir were positive. Approval in Japan will precede US FDA approval, and they will surely order millions of doses of Peramivir.

While FDA approval for Peramivir is further down the road, they will have to act soon in order to secure enough Peramivir inventory to prepare for a worst-case scenario. Because the public will not appreciate it if they find out their own US government is forced to stand in line--behind other countries because they didn't act quickly enough to protect their citizens.

I bought BCRX in the 2's and 3's in May and June, and it's currently bumping up against $10. I'm praying for a pullback to accumulate more shares, but I'm afraid the world is waking up to the severity and depth of the swine flu. It may keep increasing, as the big boys on Wall St. become more cozy with the investment thesis. However, with market makers, you never know, and they can force one more bear raid to help the shorts cover, and to help their friends at Goldman Sachs buy in at lower prices. Wall St. analysts usually don't get it right, so when they guess wrong, they have friends who come to their rescue to drive share prices down. Instead of complaining about it, we can use it to our advantage, buying at lower prices when the opportunity presents itself. But it can easily gap up into the teens upon arrival of the EUA. Let's hope all the fear-mongering ends up being a false alarm. On the other hand, I'm not betting on it. Good luck to all longs,

Disclaimer: This is not a recommendation. Do your own due diligence.

Disclosure: Long BCRX shares.

Why Tamiflu may not help

The season, avian and swine flu strains are developing a resistance to Roche's anti-viral Tamiflu. Here are the possible reasons why:

http://www.sciencedaily.com/releases/2007/10/071002213442.htm

GSK's Relenza has to be inhaled, so cannot be administered to intubated, critically severe cases.

Hence, BCRX's Peramivir may play a leading role, as late-stage clinical trials in Japan and the US show positive results when administered intravenously.

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.