Influenza :: Roche update on Tamiflu for pandemic influenza preparedness

Roche announces several new research initiatives to further study the use of Tamiflu against the evolving H5N1 avian influenza virus and outlined the future production strategy for Tamiflu.

As one of the most important medicines currently available to fight both seasonal and pandemic influenza, Tamiflu is in the front line of national pandemic defense strategies.

Roche continues to research on the optimal use of Tamiflu in collaboration with Universities, Health Institutes and others.

These research initiatives include:

Pre-clinical virology studies, looking at different H5N1 strains to optimize the dose of Tamiflu.

Avian influenza registry study, to collect available clinical and virological data, to characterize the virus and the use of Tamiflu

Post-exposure prophylaxis case studies, collecting retrospective and prospective data on Tamiflu?s ability to prevent influenza illness

High dose (150mg twice daily) versus standard dose study (75mg twice daily) in collaboration with the National Institute of Health in the USA in both seasonal and pandemic influenza.

Long term prophylaxis (26 weeks) against H5N1 for workers in essential activities, e.g. hospitals. Monitoring for resistance of the influenza virus to Tamiflu.

Investigation on the feasibility of an intravenous formulation.

Registration activities for a lower dose capsule to facilitate storage and administration for young children.

This is in addition to continuing to study the role and established safety record in seasonal influenza outbreaks

Due to Roche?s efforts the global manufacturing network for Tamiflu can produce in excess of 400 million treatments annually and has been tested accordingly. This network includes eight Roche sites and 19 external manufacturing partners located in 9 different countries around the world. As supply significantly exceeds current Tamiflu orders, Roche is tailoring its production schedule to this current demand.

William M. Burns, CEO Division Roche Pharma, said: “The manufacturing expansion went to plan and Roche together with external partners now have the ability to produce more than 400 million courses of Tamiflu a year. To date we have had orders from governments amounting to about 215 million treatments in total. Today we can satisfy significant additional orders from governments and corporations and unless the demand picks up Roche will be tailoring its production schedule accordingly. These measures include maintaining a buffer stock at all times while remaining in close contact with our manufacturing partners to respond speedily to a surge in demand.?

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