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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 30th 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.
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…