US embassy cable - 05QUEBEC12

UNCLAS QUEBEC 000012 
 
SIPDIS 
 
STATE FOR WHA/CAN EWHEELER, EB/IPC SWILSON, OES/IHA HAROLD FOSTER 
EB/TPP/BTA/EWH DSHEEHAN 
FDA/CHARLES GAYLORD AND NAOMI KAWIN 
 
E.O. 12958: N/A 
TAGS: TBIO, ETRD, ECON, PGOV, CA, Health, Trade 
SUBJECT: ID BIOMEDICAL READIES TO SELL INFLUENZA VACCINE TO U.S. 
 
 
Sensitive But Unclassified 
 
1.  (SBU) Summary:  Late last year local and national media 
widely reported the possible sale of Canadian flu vaccine 
Flurival to the U.S. to offset shortages.  Here is the current 
state of play following our meeting with ID Biomedical, the 
biotech company which is now well positioned to provide 
influenza doses to the United States and whose manufacturing 
plant is based in Quebec City.   ID Biomedical officials 
recently told us they did not end up selling to the U.S. in 2004 
but were confident they would meet FDA requirements to supply 
vaccines for the 2006 cycle, or perhaps as early as 2005.  End 
Summary. 
 2. (SBU)  In November and December 2004 there was a flurry of 
media reports on the shortage of flu vaccines in the U.S. and 
the likelihood that Canadian ID Biomedical would sell its 
surpluses to the U.S.  On January 18, Consul General and 
Pol/Econ Assistant met with company officials in Quebec City who 
explained that they were unable to sell owing to required 
adjustments to their production system (which they have now 
made).  At lunch, CEO Anthony Holler told us he had just come 
back from Washington and had a very good meeting with FDA 
Commissioner Crawford.  He believed there was a strong 
commitment on the American side to make the process move more 
expeditiously and that the FDA understands the importance of 
having more products made available faster. 
 3. (SBU) ID Biomedical gave us a tour of their facility 
currently under construction so that they may double their 
capacity and create sufficient flu shots to supply both the 
Canadian and U.S. markets. The firm manufactures the influenza 
vaccine Flurival and is Canada's main source of the vaccine with 
approximately 75% of the public market. ID Biomedical calls 
itself a North American company in what is a fully integrated 
U.S.-Canada market.  It currently has 450 employees with three 
facilities in Canada (Quebec City, Vancouver and Montreal) and 
two in the U.S. (Northborough MA, Bothell WA). 
 
 4. (SBU)  At the beginning of the flu season last fall, the 
company had 1.2 million excess doses of vaccine and was well 
placed to sell its surpluses to the U.S., hustling to make up 
for a unexpected shortfall caused by one of its suppliers, 
Chiron Corp.  Ultimately, ID Biomedical announced last December 
that it would sell its remaining surplus doses of vaccine in 
Canada, not the United States. Dr. Holler said they realized 
selling the surplus to the U.S. would not help the company in 
its bid to get accelerated licensing approval in that market, 
and the decision was made to sell to Canadian purchasers.  The 
firm hopes to get an expedited FDA license early enough to sell 
Flurival in the U.S. for next flu season: 10-15 million doses 
that can be shipped as early as August of this year.  The FDA 
spent several weeks examining the company's clinical trials data 
and inspecting the manufacturing process last year and ID 
Biomedical officials believe their Quebec City plant now fully 
meets U.S. requirements on this level.  In late December 2004 
clinical testing began. 
5. (SBU)  ID Biomedical has the current capacity to produce 5 
million doses of flu vaccine and the expansion will allow them 
to produce 50 million doses by 2007, 38-40 million of which 
could go to the US. market.   Holler said he has signed a 
multi-year, multibillion-dollar contract with three U.S. vaccine 
distributors (Henry Schein, Amerisource Bergen, and McKesson) to 
deliver influenza vaccine stateside. 
6. (SBU) Separately, ID Biomedical said they are also working 
with the Canadian government on pandemic influenza vaccine that 
has a highly deadly virus strain.  It signed a ten-year mandate 
until 2011 to assure a state of readiness should an influenza 
pandemic breakout. The WHO is monitoring the global picture and 
at the moment they are looking at Vietnam, where the avian flu 
situation is highly unstable.  ID Biomedical representatives 
told us they are capable of stopping production to immediately 
go into pandemic mode should this ever be necessary. 
 
 
 
FRIEDMAN