Roche announces further progress in Tamiflu production expansion

November 7, 2005
Roche's current production network on track to produce 300 million treatments as of 2007
Over 150 requests received from third parties - first negotiations initiated

Roche announces today that it will have increased its own production capacity by the end of 2006 to then be in a position to produce 300 million treatments of Tamiflu annually. The expansion will be achieved by a further stepwise scale-up of Roche's production network. It means a ten fold increase over the capacity in 2004 when the decision was taken to increase production, without any firm pandemic orders in place, in order to meet government's needs for pandemic planning.

William M. Burns, CEO Division Roche Pharma, commented: "Patients' needs in case of a pandemic remain our top priority. We have continually increased our production capacities and are now putting in place the means to increase production of Tamiflu to 300 million treatments as of 2007. In addition, we have entered into discussions with a number of interested parties to expand world wide supply, so governments can be as prepared as possible for when the influenza pandemic happens."

More than 150 requests from third parties have been received to date and Roche production experts have already been in initial talks with 8 companies, amongst them large generic manufacturers and major pharmaceutical companies, as well as with a number of governments, including Taiwan and Vietnam. The goal is to be in a position to select potential partners for more detailed discussions by the end of November. Selection criteria are quality, technical ability, capacity and the speed of bringing that capacity on stream.

About pandemic planning

Roche has been working with many governments over the last few years to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 50 countries.

Roche has also pledged to donate 3 million treatments to the WHO for use where an influenza pandemic may start. This amount, according to experts, could contain or stop the spread of a potential pandemic at the source of the outbreak, if delivered rapidly.
Recently Roche has donated Tamiflu to Turkey and Romania, following the emergence of the avian influenza virus in these countries

About Tamiflu (oseltamivir)

Tamiflu is designed to be active against all clinically relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian H5N1 strain circulating in the Far East. (3)

It 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.

Tamiflu delivers:

- 38 percent reduction in the severity of symptoms (1)
- 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals (2)
- 37 percent reduction in the duration of influenza illness (5, 3)
- Tamiflu was shown to provide up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients (4)

In children, Tamiflu delivers:

- 36 percent reduction in the severity and duration of influenza symptoms (5)
- 44 percent reduced incidence of associated otitis media as compared to standard care (6)

As with any antiviral, a theoretical potential exists for an influenza virus to emerge with decreased sensitivity to a drug. Extensive monitoring, by Roche and the independently established Neuraminidase Inhibitor Susceptibility Network (NISN) measured the incidence of resistance to NAIs. From around 4000 patients treated with Tamiflu resistance was encountered in 0.4 per cent in adults and 4 per cent in children aged one to 12. This resistant virus was found to be less virulent than the wild type virus and did not affect the course of the illness.

The greatest use of Tamiflu today is in Japan. To illustrate this, there were an estimated 16 million influenza infections in Japan over the 2004/2005 influenza season. Roche estimates that around 6 million of those individuals infected with the influenza virus received Tamiflu. Even with this degree of usage, resistance appears very infrequent.

Avian Influenza and Pandemics

Most avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely new in composition, so vaccines developed and administered to date to protect humans during seasonal epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection. Experts believe the next influenza pandemic could result from such a mutation of virus strains.

Please see Tamiflu Purchase for more info on Tamiflu.