• The U.K. Government will buy 60 million doses of the A (H1N1) adjuvanted influenza vaccine from GlaxoSmithKline PLC and 30 million from Baxter
• The French Government will buy 50 million doses of the A (H1N1) influenza vaccine from GlaxoSmithKline PLC
• The Government of Belgium will buy 12.6 million doses of the A (H1N1) influenza vaccine from GlaxoSmithKline PLC
• The Government of Finland will buy 5.3 million doses of H1N1 antigen from GlaxoSmithKline PLC
• Glaxo will provide 128 million doses of the A (H1N1) adjuvanted influenza vaccine to European countries. The European orders could contribute about $1 billlion to Glaxo sales in 2009.
• The WHO estimates that the pharmaceutical industry can produce from 1 billion to 2 billion doses of H1N1 pandemic vaccine a year.
• The Australian Government ordered 10-million doses of influenza vaccine from Commonwealth Serum Laboratories (CSL).
• HHS Sets Aside $1 Billion Toward Development of Vaccine for the Novel Influenza A (H1N1).
• The U.S. Government will have 60 million vaccine doses by the end of October, 100 million more doses by the end of November and 80 million more doses each month thereafter through March 2010.

Success with adjuvanted vaccines could have implications for the use of resources devoted to development of the next generation of vaccines and for the mechanisms the government uses to accomplish its objectives. Specifically, if adjuvanted vaccines reduced the near-term risk posed by pandemic influenza because they stretched available and planned production capacity, more resources might be made available to support the development of next generation vaccines.

European countries and US took different approaches. European countries are entering into advance supply agreements with manufacturers to provide vaccines in the event of a pandemic; those governments agree to make advance payments to guarantee the supply of vaccine in the event of an influenza pandemic. The current U.S. approach is directly subsidizing vaccine development and additional production capacity.

MedImmune Vaccines Inc. of Gaithersburg, MD received a $32 million firm-fixed-price sole source contract. Sanofi Pasteur received a $12 million firm-fixed-price contract. Both Sanofi Pasteur and MedImmune will benefit from HHS funding of about $1 billion for clinical studies that will take place over the next few months and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.

Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater, Pa. and Val de Reuil, France. Production of the new A(H1N1) vaccine for HHS will initially occur in Sanofi Pasteur’s recently licensed influenza vaccine production facility in Swiftwater, Pa. Once ongoing seasonal influenza production concludes in the second facility in Swiftwater, A(H1N1) production can occur in both Swiftwater facilities.

In Swiftwater, Sanofi Pasteur has two licensed influenza production facilities. On May 6, 2009, the FDA licensed Sanofi Pasteur’s new influenza vaccine manufacturing facility in Swiftwater. When operating at full capacity, the new facility will have a capacity of approximately 100 million doses of seasonal influenza vaccine per year. An existing facility in Swiftwater is capable of producing 50 million doses per year and currently is producing vaccine for the 2009/2010 season. In total, the company will have a capacity equivalent to approximately 150 million doses of trivalent seasonal influenza vaccine per year in the United States when both facilities are operating at full capacity.

In Val De Reuil, Sanofi Pasteur is currently producing the trivalent seasonal influenza vaccine for the 2009/2010 season, with the capacity of 120 million doses per year. Sanofi Pasteur’s production facility in Val De Reuil is also capable of producing the new A(H1N1) vaccine.

MedImmune is producing the vaccine against the H1N1 influenza strain known as swine flu, using reverse genetics technology at its facility in the San Francisco area.

The U.S. government is setting aside $1 billion to launch development of an H1N1 swine flu vaccine to immunize 20 million people in key positions in health care, national security and emergency services.

“Preparation and planning are critical to keep Americans safe in the face of a potential pandemic,” Secretary Sebelius said. “Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.”

The following companies will receive funding to produce H1N1 vaccine ingredients:

• Novartis AG – $289 million,
• Sanofi Aventis SA – $191 million,
• GlaxoSmithKline PLC – $181 million,
• Another $150 million will be directed to produce pilot lots of vaccine and to fund the clinical studies.

HHS is also in negotiations with other manufacturers to find more capacity.

With these orders, the pharmaceutical manufacturers will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

Having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.

With these funds the pharmaceutical manufacturers will also prepare pilot lots of potential vaccine for use in clinical studies to determine the proper dose for a vaccine, determine if adjuvants are appropriate and ensure a vaccine is safe and effective. The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness.

Update July12, 2009: “There’ll be another $1 billion worth of orders placed to get the bulk ingredients for an H1N1 vaccination.” U.S. Health and Human Services Secretary Kathleen Sebelius announced on July 12.

Global Pandemic Influenza Preparedness Market Forecast 2010-2015 covers market trends and opportunities in addressing pandemic influenza threat.

• Finland and Thailand on May 12 each reported two cases of swine flu in patients recently visiting Mexico.
• Cuba reported its first case on May 11.
• Mexico has reported two more deaths from the A (H1N1) virus, totaling fatalities to 58.
• Three H1N1-related deaths were reported in the United States, one in Costa Rica and one in Canada.
• More swine flu cases have been reported in Europe (Italy, Switzerland, Spain, Portugal, France, Ireland, Britain, the Netherlands, Denmark, Norway, Sweden, Poland, Germany, Austria), Latin America (Guatemala, El Salvador, Panama, Colombia, Argentina, Brazil), Middle East (Israel) and Pacific Rim (Japan, South Korea, China, Australia and New Zealand)

A (H1N1) Influenza Status Report as of May13, 2009

Relenza: GlaxoSmithKline is planning to produce 5 million Relenza treatments a month. Current annual production capacity of GlaxoSmithKline is estimated at 60 million treatments of Relenza.

Tamiflu: Swiss drugmaker Roche is planning to produce 20 million Tamiflu treatments a month. Current annual production capacity of Roche is estimated at 400 million Tamiflu treatments.

Relenza vs. Tamiflu Annual Production Capacity 2009

In 2008 Relenza’s sales were US$103 million comparing to US$525 million of Tamiflu sales.

Relenza vs. Tamiflu Sales 2008

A recent report Global Pandemic Influenza Preparedness Market Forecast 2010-2015 of Market Research Media suggests that government investments in fighting pandemic flu will grow at rather moderate rate, despite raising public fears. Take the following poll to help us understand whether the current influenza crisis is an Epidemic, Pandemic or Infodemic. What do you think?

• Epidemic: a temporary prevalence of a disease in a community or geographic region.
• Pandemic: a widespread epidemic occurring throughout a region or even throughout the world
• Infodemic: widespread media coverage about an epidemic or pandemic that may create unwarranted fear

H1N1 statistics as of May 10, 2009

The results of this study found that since outbreaks of bird flu in 2005 and swine flu in 2009, the governments had recognized antiviral pandemic stockpiling as their preferred strategy for disease containment and mitigation. Since that time, the role of antiviral pandemic stockpiling has migrated across all branches of the healthcare systems and sub systems. Not surprisingly, the size of antiviral pandemic stockpiling spending has grown faster than the market overall.

Market Research Media has found that over the past five years, government spending worldwide on Pandemic Influenza Preparedness has more than tripled from $2.2 billion in 2004 to $7 billion in 2009, at a 17% CAGR. Market Research Media forecasts that worldwide government spending on Pandemic Influenza Preparedness will continue to grow, though at more moderate rate of a 5% CAGR, reaching almost $10 billion by 2015.

The study also identifies issues and challenges for both the government as well as drug makers in addressing this market.

Table of Contents

1. Executive Summary
1.1. Key Report Findings

2. Market Report Scope, Methodology and Assumptions
2.1. Scope
2.2. Research Methodology
2.3. Assumptions

3. Pandemic Influenza Preparedness Market: Products, Technologies, Services and Infrastructure
3.1. Vaccine
3.2. Pre‐Pandemic Vaccines
3.3. Egg‐Based Vaccine
3.4. Cell‐Based Vaccine
3.5. Antigen‐Sparing Technologies
3.6. Antiviral Drugs
3.7. Medical Supplies
3.8. National Preparedness

4. Pandemic Influenza
4.2. Pandemic Timeline

5. Global Pandemic Influenza Preparedness Market Forecast 2010-2015
5.1. Global Pandemic Influenza Preparedness Market Segmentation
5.2. US Pandemic Influenza Preparedness Market Forecast 2010-2015
5.2.1. US Market Developments
5.3. Japanese Pandemic Influenza Preparedness Market Forecast 2010-2015
5.3.1. Japanese Market Developments
5.4. French Pandemic Influenza Preparedness Market Forecast 2010-2015
5.4.1. French Market Developments
5.5. UK Pandemic Influenza Preparedness Market Forecast 2010-2015
5.5.1. UK Market Developments
5.6. German Pandemic Influenza Preparedness Market Forecast 2010-2015
5.6.1. German Market Developments
5.7. Spanish Pandemic Influenza Preparedness Market Forecast 2010-2015
5.7.1. Spanish Market Developments
5.8. Canadian Pandemic Influenza Preparedness Market Forecast 2010-2015
5.8.1. Canadian Market Developments
5.9. Italian Pandemic Influenza Preparedness Market Forecast 2010-2015
5.9.1. Italian Market Developments
5.10. South Korean Pandemic Influenza Preparedness Market Forecast 2010-2015
5.10.1. South Korean Market Developments
5.11. Australian Pandemic Influenza Preparedness Market Forecast 2010-2015
5.11.1. Australian Market Developments
5.12. Dutch Pandemic Influenza Preparedness Market Forecast 2010-2015
5.12.1. Dutch Market Developments
5.13. Belgian Pandemic Influenza Preparedness Market Forecast 2010-2015
5.13.1. Belgian Market Developments
5.14. Swedish Pandemic Influenza Preparedness Market Forecast 2010-2015
5.14.1. Swedish Market Developments
5.15. Austrian Pandemic Influenza Preparedness Market Forecast 2010-2015
5.15.1. Austrian Market Developments
5.16. Swiss Pandemic Influenza Preparedness Market Forecast 2010-2015
5.16.1. Swiss Market Developments
5.17. Portuguese Pandemic Influenza Preparedness Market Forecast 2010-2015
5.17.1. Portuguese Market Developments
5.18. Finnish Pandemic Influenza Preparedness Market Forecast 2010-2015
5.18.1. Finnish Market Developments
5.19. Norwegian Pandemic Influenza Preparedness Market Forecast 2010‐2015
5.19.1. Norwegian Market Developments
5.20. Danish Pandemic Influenza Preparedness Market Forecast 2010-2015
5.20.1. Danish Market Developments
5.21. Rest of the World: Influenza Preparedness Market Intelligence

Appendix
Vendor Profiles

List of Figures
Fig. 1 Pandemic Vaccine Production Timeline
Fig. 2 Pandemic Influenza Phases
Fig. 3 Top Five Pandemic Influenza Preparedness Markets 2010-2015, $ Mln
Fig. 4 Global Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 5 Global Pandemic Influenza Preparedness Market Segmentation
Fig. 6 US Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 7 Japanese Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 8 French Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 9 UK Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 10 German Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 11 Spanish Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 12 Canadian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 13 Italian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 14 South Korean Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 15 Australian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 16 Dutch Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 17 Belgian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 18 Swedish Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 19 Austrian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 20 Swiss Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 21 Portuguese Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 22 Finnish Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 23 Norwegian Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln
Fig. 24 Danish Pandemic Influenza Preparedness Market Forecast 2010-2015, $Mln

List of Tables
Table 1 – Influenza Vaccine Types
Table 2 – Global Pandemic Influenza Preparedness Market Forecast 2010‐2015, By Country, $Mln
Table 3 – US Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 4 – Pandemic Influenza Funding Allocation as of December 31, 2008
Table 5 – Japanese Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 6 – French Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 7 – UK Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 8 – German Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 9 – Spanish Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 10 – Canadian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 11 – Italian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 12 – South Korean Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 13 – Australian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 14 – Dutch Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 15 – Belgian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 16 – Swedish Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 17 – Austrian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 18 – Swiss Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 19 – Portuguese Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 20 – Norwegian Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln
Table 21 – Danish Pandemic Influenza Preparedness Market Forecast 2010‐2015, $Mln