Rapid response stockpile of Tamiflu now ready and available to the World Health Organisation (WHO)

3 million treatment courses ready to be shipped to site of influenza pandemic outbreak

Basel, 19 April 2006, Roche announced today that the “Rapid Response Stockpile” of Tamiflu is now assembled and available to the WHO upon request. A symbolic “handover” event has taken place today between Franz B. Humer, Chairman and CEO of Roche, and Lee Jong-Wook, Director General, WHO. The agreement in which Roche committed to reserve for donation to the WHO a “Rapid Response Stockpile” of 3 million treatment courses (30 million capsules) of the influenza antiviral Tamiflu (oseltamivir) for the use by the WHO was signed on August 22nd 2005. The aim is to contain an emerging outbreak of a novel and potentially pandemic strain of influenza and to slow or prevent its national and international spread. Roche will deliver the required stockpile to an international airport of the WHO’s choosing.

As of 2.30pm CET, pictures / downloads of the event will be available at (link inactive until then): http://www.roche.com/pages/downloads/photosel/060419/

Roche has been in discussions with governments as early as 1997 regarding pandemic preparedness and in the last few years, has supplied Tamiflu to over 65 governments around the world for pandemic stockpiling. Clearly, anti-viral medicines like Tamiflu are an important component of any pandemic preparedness plan. To meet this demand, by working with third parties, Roche has substantially increased the production of Tamiflu and are in a position to produce 400 million treatments annually by the end of this year. In addition, sub-licensing agreements have been granted to companies in China and India for production of oseltamivir.

During discussions with governments, it became clear that developing nations were the least prepared in terms of antiviral stockpiling. Subsequent discussions between Roche and WHO led to the concept of a rapid response stockpile of 3 million treatments, 1.5 million treatments being stored in Kaiseraugst and 1.5 million treatments stored in Nutley, US. The idea of such stock is to use the medicine as a fire blanket, to contain a pandemic where it starts.
Under a separate agreement, Roche has also donated a further two million treatment courses to WHO for use in those developing countries which are most likely to be affected by avian influenza in humans and are unable to afford the drug. These treatment courses can be used by WHO according to its assessment of the situation, and will be available for delivery at the end of the year.

About Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically relevant influenza viruses and works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.

Roche and Gilead
Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996. Roche and Gilead partnered on clinical development, with Roche leading efforts to produce, register and bring the product to the markets. Under the terms of the companies’ agreement, amended in November 2005, Gilead participates with Roche in the consideration of sub-licenses for the pandemic supply of oseltamivir. To ensure broader access to Tamiflu for all patients in need, Gilead has agreed to waive its right to full royalty payments for product sold under these sub-licenses.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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References
1. Govorkova E.A and Webster R.G. Evaluation of oseltamivir in lethal H5N1 in vivo model. Presented 20 January, 2006 at The First Pandemic of the 21st century – a central role for antivirals conference, London.
2. Yen et al. Duration and Dosage of Oseltamivir Treatment of H5N1 (A/Vietnam/1203/04) influenza virus infection in mice. Journal of Infectious Diseases, 2005.
3. Treanor JJ et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized, controlled trial. JAMA 2000;283: 1016–24.
4. Kaiser et al. Impact of Oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalisations. Arch Intern Med. 163:1667-1672 (2003).
5. Nicholson KG et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet 2000; 355:1845–1850.
6. Welliver R. W. et al. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA, 2001 Feb 14; 285(6): 748-754.
7. Whitely RJ, Hayden FG et al; Oral oseltamivir treatment of influenza in children, Pediatr Infect Dis J 2000; 20: 122-133.
8. Roche data on file, 2003.

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Alexander Klauser

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Roche

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