Showing posts with label resistance. Show all posts
Showing posts with label resistance. Show all posts
Monday, November 26, 2012
Thursday, November 5, 2009
Just in: Peramivir receives competition
http://www.nytimes.com/2009/11/06/business/06drug.html?_r=1
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.
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.
Thursday, September 17, 2009
Gold chart
http://www.the-privateer.com/chart/gold-pf.html
This point and figure chart shows support at $950/oz., with the next level of support at $850/oz, should the price of gold correct below $950. Expect retracement higher if we get a test of these support levels.
However, should we consolidate for a few weeks at current levels, expect another move higher, with little resistance, as we are in uncharted all-time highs, at least in terms of a a weakened dollar.
In fact, gold is inversely correlated to the US Dollar. As long as market complacency continues (as measured by a low Volatility Index), equities will continue to rise as investors are willing to take on more risk. This would be bearish for US Treasury bonds--and the US Dollar, which would be bullish for gold. However, if the VIX rises, money will flow back to the dollar as a safety haven, and that will precipitate gold's decline.
That correction in gold may be a good entry point for gold bugs, or for accumulation of more gold mining shares.
Disclosure: I am long gold mining shares.
This point and figure chart shows support at $950/oz., with the next level of support at $850/oz, should the price of gold correct below $950. Expect retracement higher if we get a test of these support levels.
However, should we consolidate for a few weeks at current levels, expect another move higher, with little resistance, as we are in uncharted all-time highs, at least in terms of a a weakened dollar.
In fact, gold is inversely correlated to the US Dollar. As long as market complacency continues (as measured by a low Volatility Index), equities will continue to rise as investors are willing to take on more risk. This would be bearish for US Treasury bonds--and the US Dollar, which would be bullish for gold. However, if the VIX rises, money will flow back to the dollar as a safety haven, and that will precipitate gold's decline.
That correction in gold may be a good entry point for gold bugs, or for accumulation of more gold mining shares.
Disclosure: I am long gold mining shares.
Monday, August 24, 2009
Swine flu portfolio rally
Shares of BCRX, NVAX, SVA, HEB, and APT all increased double-digit percentages today. I keep expecting the overall market to roll over and have protective puts in place--hence, the hedges keep eroding in value. But I am not complaining, given triple digit gains on the aforementioned stocks.
Exit strategies for longs need to be in place. But after polling several experts in the field, the swine flu will be worse than general public expectations. Also, very few understand the five vaccines and the anti-virals available, either approved or under Emergency Use Authorization review. Unless, of course, they've been reading these blogs for a few months (pardon the temporary lapse in modesty).
The most recent update is that egg-based vaccines won't be available until October, due to lower than expected yields. With a 21-day duration between doses, and one more week thereafter before immunogenicity kicks in, most students and young adults won't be immunized until November at the earliest. As noted before, with schools already in session, the swine flu will peak in October, rendering many vaccines useless among the targeted population.
Anti-virals will have to step in, even though Tamiflu has tolerability as well as efficacy issues due to resistance. Inhaled Relenza has limitations, so intravenously administered Peramivir has BCRX longs excited about an imminent EUA stockpiling order.
Good luck to all longs, and good luck to those who will become infected with the novel H1N1 virus.
Disclosure: Long shares in BCRX, NVAX, SVA, HEB, and APT.
Exit strategies for longs need to be in place. But after polling several experts in the field, the swine flu will be worse than general public expectations. Also, very few understand the five vaccines and the anti-virals available, either approved or under Emergency Use Authorization review. Unless, of course, they've been reading these blogs for a few months (pardon the temporary lapse in modesty).
The most recent update is that egg-based vaccines won't be available until October, due to lower than expected yields. With a 21-day duration between doses, and one more week thereafter before immunogenicity kicks in, most students and young adults won't be immunized until November at the earliest. As noted before, with schools already in session, the swine flu will peak in October, rendering many vaccines useless among the targeted population.
Anti-virals will have to step in, even though Tamiflu has tolerability as well as efficacy issues due to resistance. Inhaled Relenza has limitations, so intravenously administered Peramivir has BCRX longs excited about an imminent EUA stockpiling order.
Good luck to all longs, and good luck to those who will become infected with the novel H1N1 virus.
Disclosure: Long shares in BCRX, NVAX, SVA, HEB, and APT.
Monday, July 27, 2009
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:
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.
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.
Thursday, July 23, 2009
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.
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.
Tuesday, February 3, 2009
Gold pauses
As suspected, Gold corrected yesterday, as the mining shares did not move up friday, despite spot prices rising to resistance at $927. Corrections are healthy, so we'll see if gold prices hold their support levels. With further consolidation, the technicals favor another move up, with resistance at the $975 level.
More importantly, the fundamentals are still in price for a bullish case for gold. We'll see if gold trades in this range before testing last year's high.
More importantly, the fundamentals are still in price for a bullish case for gold. We'll see if gold trades in this range before testing last year's high.
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