April 30th 2009

H1N1 (Swine Flu) Pandemic and the Imminent Expiration of Millions of Courses of Tamiflu

The Chugai 2008 annual report to shareholders and investors included the

following information specific to the sales of Tamiflu:

FY 2008 Results Record-High Sales Excluding Tamiflu Foundation for Growth Established In FY2008, Chugai reported a decline in both revenues and operating income, with revenues down 5.2% to ¥326.9 billion, and operating income down 22.6% to ¥51.6 billion. The steady expansion of our new product lineup, however, made FY2008 a year in which we solidified our base for the next stage of growth. The biggest factor for the decline in revenues was the fall in sales of the anti-influenza agent Tamiflu (down ¥30.3 billion, a decrease of 78.3%). FY 2009 Outlook Increased Sales and Income Expected in FY 2009 Due to Higher Sales of Growth Drivers In FY2009, we expect revenues of ¥400 billion, up 22.4% year-on-year, driven by further growth of our major products. We project a 7.6% increase in product sales excluding Tamiflu to ¥337.3 billion. For the year, we forecast sales of Tamiflu to reach ¥53.0 billion, up 531.0%, due to expected resumption of government stockpiling in FY2009 and the ongoing recovery of the prescription rate for seasonal influenza. Link: http://www.chugai-pharm.co.jp/pdf/annual_report/2009/eAR2009_12_04.pdf

These excerpts show that Chugai’s 2008 revenue was severely impacted

by a decline in the sale of the anti-viral, Tamiflu. But all is not lost as

they expect a 531% increase in sales due to the expected resumption of

government stockpiling in FY2009. Does that mean the expected

resumption of government stockpiling because they are expecting a

pandemic? Or does it just mean the replacement of the stockpiles that

are about to expire? Either way, it demonstrates prior knowledge of the

stockpiling habits of the countries of the world.

How many courses of Tamiflu are about to expire? We know that the U.S. has 50 million courses of Tamiflu in a federal

stockpile. This was confirmed by Director of Homeland Security Janet

Napolitano in a conference on April 30 2009. We also know that 20

million of those courses were procured in 2006 and 24 million were

procured in 2008, as confirmed by the US Chamber of Commerce.

th

Link: http://www.uschamber.com/issues/index/defense/pandemic/tamiflu_stockpiles.htm

This Fox News article suggests that there were initially 5 million courses

Link: http://www.foxnews.com/story/0,2933,183379,00.html

The initial five million courses in the federal stockpile, and an untold

number stockpiled at the state level, would have been manufactured

prior to the date of that article, which was January 2006.

We also know that the shelf life for Tamiflu is now five years. When it

was first introduced in 1999, the shelf life was just two years. Then in

2002, the manufacturer, Roche, extended the shelf life to three years, as

can be seen in this excerpt from one of Roche’s pdf document:

Link: http://www.rocheusa.com/programs/TamifluChain2002.pdf

In November 2008, Japan extended its shelf life of Tamiflu to seven

years, but was contingent on the storage conditions of the product.

Link: http://www.biospectrumasia.com/content/121108JPN7643.asp

Knowing that the expiration date for Tamiflu in the US is five years and

also knowing that there are at least five million courses of Tamiflu that

were procured pre-January 2006, we also know that those five million

courses of Tamiflu are about to expire, if they have not expired already.

This is just at the federal level and does not take into account the

individual states’ stockpiles, pharmacies or individuals.

Online pharmacies are trying to get rid of their surplus of Tamiflu that is

soon to expire in 2009 or 2010 by putting it on sale. 2009 expiration

stock is cheaper than 2010 expiration stock:

Link: http://www.drugshoponline.com/Buy-Bird-Flu-Products-TAMiFLU-(OSELTAMiViR)-(ROCHE)-75mg-

100-caps-expires-10_2010.html

Link: http://www.drugdelivery.ca/s4632-s-TAMIFLU.aspx

Note the disclaimer at the end of the last advertisement. Due to the

pandemic there is a sudden increase in demand. It must be a relief to

get rid of stock that is close to expiration.

Link: http://www.bbonlinepharmacy.com/product/966/tamiflu-oseltamivir-roche/

In 2007, New Zealand reported how the “unwanted bird flu drugs clogs

shelves”, and state that most capsules expire in 2010.

Link: http://www.stuff.co.nz/dominion-post/archive/national-news/20430

This overwhelming evidence that there are many millions of courses of

Tamiflu around the world that are about to expire in 2009 and 2010 has

to make one wonder about the incidence of the current H1N1 (Swine Flu)

pandemic, that appears to be even less virulent than the seasonal flu

strains, which kills multiple thousands every year.

What Incentive Does the Government Have for Using Up

Tamiflu Stocks and Procuring More?

It is well know that Donald Rumsfeld owns stock in Gilead Sciences, the

California biotech company that owns the rights to Tamiflu. From the

article that follows:

“"I don't know of any biotech company that's so politically well-

connected," says analyst Andrew McDonald of Think Equity Partners in

San Francisco.”

Link: http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld/?cnn=yes

Document addition:

The FDA have now released information admitting that some of the Tamiflu

stockpiles are expiring.

“Stockpiled Antivirals at or Nearing Expiration

During this public health emergency, the FDA has issued Emergency Use Authorizations that expand access to medical products that may become necessary.

Two antiviral treatments covered by Emergency Use Authorizations, Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included in many emergency stockpiles.

All companies, U.S. states and localities, and other organizations with Tamiflu and Relenza that are approaching, or past, the labeled expiration date, are urged to consider keeping it while the U.S. Department of Health and Human Services evaluates options, including those that may allow for their use if needed during this 2009 H1N1 flu virus outbreak.

These organizations are also urged to contact the FDA’s Emergency Operations Center with information on how much Tamiflu and Relenza in their stockpiles is at or approaching expiration.”

Link: http://www.fda.gov/oc/opacom/hottopics/H1N1Flu/stockpile.html

The request for information on how much Tamiflu in the stockpiles has or

is about to expire will verify the re-order quantity from Chugai, which

will give them their 531% increase in sales for FY2009, as predicted in

their 2008 annual report cited at the start of this document.

Interesting that this information was released today – April 30th – the

same day that people on the ‘net started getting suspicious about the

expiration dates…