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Tamiflu readily available for 2006/2007 influenza season


Production expansion ensures supply for both seasonal use and pandemic stockpiling

Basel, 2 October 2006 - Roche announces that its antiviral medication Tamiflu (oseltamivir) is readily available for the forthcoming 2006-2007 influenza season for the treatment and prevention of influenza. Seasonal influenza is a debilitating and disruptive illness that affects millions of people each year and can lead to complications and death if not treated. Roche can also confirm that any government and corporate orders for stockpiling for an influenza pandemic are being progressed.

“During the past year, Roche has been gearing up its production capacity and we will be in a position to produce 400 million treatment courses by the end of this year”, said William M. Burns, CEO Division Roche Pharma. “Physicians can be confident that Tamiflu will be readily and widely available to patients who need it this season for flu treatment and post-exposure prevention. The measures taken also enable us to schedule any additional orders from governments and corporations who are stockpiling Tamiflu in preparation for an influenza pandemic. Of course, the rate at which this capacity is utilized will depend in large part on the future order flow and the severity of this year’s influenza season”.

During the 2005 -2006 season Roche had to restrict distribution of Tamiflu to wholesalers in many markets to ensure availability during an influenza outbreak, whilst the production capacity was being expanded. This led to the perception that Tamiflu was in short supply. Based on the available manufacturing capacities, the supply shortage no longer exits.

Manufacturing Capacity
The broad availability of Tamiflu for both seasonal and pandemic use is due to expanded global production capacity, which will reach the rate of 400 million treatment courses annually by the end of 2006, a more than 10-fold increase since 2004. Roche’s global network for the manufacture of Tamiflu includes several Roche sites and more than 15 external contractors located in 10 different countries around the world. The expansion includes a fully functioning European supply chain and a North American supply chain for Tamiflu with an annual capacity of 80 million treatment courses. In addition, Roche has further extended global availability by offering sublicenses to Hetero Pharmaceuticals and the HEC Group in India and Shanghai Pharmaceuticals in China. Roche has also finalised an agreement on sharing technical know-how with the South African company Aspen, allowing them to supply for pandemic use in the African continent.

About influenza
Influenza, commonly called the ‘flu’, is a serious disease and annual outbreaks and epidemics are caused by influenza A and B viruses. Influenza is a highly contagious viral illness and is characterised by a sudden onset of debilitating clinical symptoms which affect the entire body. Up to 500 million people are infected by influenza and up to 500,000 deaths are attributed to influenza each year. Influenza complications occur in all patient groups and include bronchitis, sinusitis, otitis media, and pneumonia.

About Tamiflu
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.
It is licensed for the treatment and prophylaxis of influenza in children aged one year and above and in adults.

Roche’s efforts to support government pandemic stockpiling
The World Health Organization (WHO) advises that stockpiling antivirals in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received and fulfilled pandemic orders for Tamiflu from more than 75 countries worldwide. The magnitude of these orders varies with some countries, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland and UK stockpiling or intending to stockpile adequate Tamiflu to cover 20-40% of their population. Roche has also donated 5.125 million courses of Tamiflu treatment to the WHO for international rapid response and regional response to a pandemic influenza strain.

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 (

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