Roche Donates 'Rapid Response Stockpile' of Tamiflu to WHO

PharmaManufacturing.com
08/24/2005

Roche announced August 24 that it will donate 3 million treatments, or 30 million doses, of the antiviral Tamiflu (oseltamivir) to the World Health Organization (WHO). This "Rapid Response Stockpile" can be used by the WHO at the site of a new and potentially pandemic outbreak of human influenza, in order to reduce morbidity and mortality and to contain or delay the spread of this outbreak. Should such an outbreak occur, the WHO will work in partnership with the country concerned to co-ordinate the distribution of the antiviral and to promote the most effective use of the product.

"We realize how important it is for governments to have stockpiles of Tamiflu in place when an influenza pandemic hits, as the production lead time is about 12 months," remarked William M. Burns, CEO of Roche's Pharma Division. "In order to increase the availability of the drug, we have taken steps to increase our manufacturing capacity, doubling manufacturing capacity both in 2004 and again in 2005, with further increase planned in 2006. In addition, manufacturing facilities producing Tamiflu have increased from one to three, with a fourth facility available later in 2005. We believe that with these forward-looking actions we are well placed in our collaboration with world governments on their plans to manage a potential health crisis.”

Lee Jong-wook, the WHO's Director-General, said, "This donation is a critical early step designed to directly address an influenza pandemic at the place of origin, thereby potentially slowing the initial national and international spread of the virus. An influenza pandemic would be a serious threat to public health, and it is therefore critical that all countries take steps now to follow the WHO guidance and ensure that local pandemic plans are in place."

Roche and the WHO underscore that the "Rapid Response Stockpile" is not a replacement for national antiviral stockpiles which should be considered as one of a number of measures of national pandemic preparedness consistent with the national priorities of each country.

Influenza pandemics occur approximately every 40 years, and experts caution that it is a case of when, not if, the next pandemic will strike.

The H5N1 avian influenza strain originating in Asia is considered by experts to be the most likely source of the next pandemic. Tamiflu is designed to be active against all clinically relevant influenza viruses, including H5N1, and data suggest it could be effective against any mutating strain of the virus – the key to a pandemic. An orally administered treatment, Tamiflu is systemically active, and can protect against the virus at all sites in the body, whilst currently, other neuraminidase inhibitors can only provide protection from influenza within the lungs.

Roche has been working with many governments over the last few months to discuss their needs for stockpiling of Tamiflu and has received and fulfilled orders from around 30 countries. The magnitude of these orders varies from country to country. For instance, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland, and the UK are stockpiling or intending to stockpile adequate Tamiflu supplies to cover 20-40 percent of their respective populations.