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Communication from Roche regarding Tamiflu
 
 
  Distributed by Roche Nov 9, 2005
 
Dear Colleague:
 
Recently, there has been a great deal of news media coverage regarding the possibility of an avian flu pandemic in Asia and in other parts of the world, including the U.S. This includes the recent release of the U.S. Government's flu pandemic preparation plan. Some of this coverage has focused on the role of Roche's drug, Tamiflu (oseltamivir phosphate) in preventing infection and treating individuals infected with a pandemic strain of the influenza virus.
 
Unfortunately, some media outlets have provided information-which, in some cases, has proven to be confusing or incomplete-regarding Roche's efforts to work with the World Health Organization (WHO), the U.S. government and other national governments, organizations and drug manufacturers across the globe to prepare for a potential flu pandemic.
 
We consider you and your organization to be invaluable partners on many critical health education, advocacy and policy initiatives. Therefore, we wanted to provide you, directly, with a snapshot of some of the activities we have undertaken to collaboratively prepare for a possible flu pandemic here and abroad:
 
Why So Much Focus on Tamiflu?
 
The WHO has recommended that governments develop flu pandemic preparedness plans, recognizing the essential and central role that national, regional and local governments should play in pandemic planning. So, while Tamiflu stockpiling may play an important role in the management of a flu pandemic, it is only one piece of a comprehensive public health strategy. That is why, in the U.S., Roche has been working so closely with the Department of Health and Human Services (HHS) on this issue for the past few years. In terms of Tamiflu's specific role in flu pandemic planning, both the Infectious Diseases Society of America (IDSA) and the WHO have acknowledged that Tamiflu is especially suited to pandemic stockpiling because:
 
- It is efficacious against influenza types A and B
- It is useful in both prophylaxis and treatment
- There is minimal Tamiflu-resistant virus transmissible in humans - Tamiflu capsules have a five-year shelf-life
 
Increasing Roche's Tamiflu Production Capacity
 
Roche began increasing its Tamiflu production capacity in 2003, when the threat of avian flu began to escalate. Roche doubled its global production capacity for Tamiflu in 2004, compared to 2003, and then doubled it again in 2005. We expect an eight to ten-fold increase in production capacity (over 2003) by mid-2006. At the same time, Roche has identified additional manufacturing partners to accelerate and increase our capacity to supply Tamiflu. For example, recently, the FDA approved a new U.S.-based capsule manufacturing site for the final steps in the production of Tamiflu.
 
Negotiating for Tamiflu Production with Other Companies and Governments
 
Since there have been conflicting reports in the media regarding this issue, we want to assure you that Roche is committed and prepared to discuss all available options, including granting sub-licenses where appropriate, with any government or private company who approaches us to manufacture Tamiflu or collaborate with us in expanding manufacturing capacity. In the interest of public health, Roche also wants to ensure that interested companies and governments can realistically produce substantial amounts of Tamiflu for pandemic use in accordance with necessary quality standards.
 
Donation of Tamiflu Capsules
 
Roche recently donated three million treatment courses of Tamiflu to the WHO for use in a possible influenza pandemic. This stockpile could be used to contain or delay the spread of the influenza virus at the source of an epidemic. Roche continues to work closely with global health experts, governments and the WHO to ensure Tamiflu availability for pandemic stockpiling needs.
 
Tamiflu "Hoarding"
 
Some media reports indicate that corporations and institutions are attempting to create their own stockpiles of Tamiflu to prepare for a possible pandemic. Many state health departments in the U.S. have recommended against the stockpiling of Tamiflu and other antivirals, as they want to ensure an adequate supply of the drug for the most vulnerable populations who may need it for seasonal flu. Roche supports the stance of public health experts in this regard, and is working with HHS and others to ensure an adequate supply of Tamiflu for the coming flu season.
 
We hope that this communication has answered some of your questions regarding Roche's role in the U.S. and global flu pandemic planning effort. We plan to provide you with periodic updates, since we know this issue is a significant concern for many of our community partners. In the meantime, please call if you have additional questions. For Tamiflu product information, please visit www.tamiflu.com. In addition, we have provided a few links below where you may obtain current information on the flu pandemic planning process.
 
www.who.int/csr/disease/influenza/en/(WHO Global Influenza Program)
 
www.who.int/mediacentre/factsheets/avian_influenza/en/ (WHO Avian Flu Information)
 
www.cdc.gov/flu/avian (Centers for Disease Control and Prevention Flu Information)
 
www.idsociety.org (Infectious Diseases Society of America)
 
www.pandemicflu.gov (U.S. Government's Official Flu Pandemic Site)
 
Arnie Doyle
Director, Public Policy
(973) 562-3207
arnold.doyle@roche.com
 
Bob Madison
Director, Public Affairs
(973) 562-2231
bob.madison@roche.com
 
Mike Nelson
Director, Patient Relations
(973) 562-2409
mike.nelson@roche.com
 
 
 
 
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