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Tamiflu supplies prioritised for flu season, govt

News release

Tamiflu® (oseltamivir) supplies prioritised for influenza season and government pandemic stockpiling

Tamiflu unavailable in New Zealand until May 2006

Auckland, 25 November 2005 – Heightened interest in avian influenza has resulted in an unprecedented increase in demand for Tamiflu worldwide. Roche is therefore taking the step of prioritising its global production capacity of Tamiflu to ensure it is available where it is needed most. That is, for patients experiencing seasonal influenza and, for the fulfilment of government pandemic orders. This will help health teams in affected regions manage the spread of the H5N1 avian influenza virus and the risk of it mixing into a form easily transmittable by humans. As a result, Tamiflu will not be commercially available in New Zealand pharmacies until May 2006, when the southern hemisphere influenza season starts.

Roche Products (New Zealand) Ltd Managing Director Svend Petersen said that although the company was rapidly increasing international production of Tamiflu, interim measures were being put in place to ensure that the drug was being directed to where it is needed most.

“With this unique situation it is important to concentrate the limited resources on targeting the events most likely to cause a pandemic and to assist governments around the world with antiviral stockpiles, rather than focus on individual pandemic preparedness. The company will make every effort to bring additional supplies to New Zealand earlier if possible but at present, existing local demand for Tamiflu will remain unmet. But from May 2006, Tamiflu will be made available for the fulfilment of prescriptions including the treatment of seasonal influenza as a back-up to primary vaccination programmes."

“We appreciate that members of the New Zealand public wanting Tamiflu will be disappointed. But temporarily delaying private non-treatment related purchases is necessary to ensure that pandemic prevention strategies are targeted and coordinated globally. Within the context of limited resources, it makes sense to assist stopping a pandemic potentially arising at the source”. Mr Petersen said. Roche has made similar announcements so far in the USA, Canada and China.

Roche Products (New Zealand) Ltd has this month completed delivery of the New Zealand Government order of 835,000 individual Tamiflu courses. Roche has also provided several large orders in response to public demand thereby giving New Zealand one of the highest per capita stocks in the world. “The decision by Roche to delay further supplies is independent of the quantity of Tamiflu New Zealand has already received.” Mr Petersen said.

Roche has doubled its worldwide Tamiflu production capabilities this year and will be able to produce 300 million packs a year by 2007. This is more than a ten-fold increase over the capacity in 2004. It is presently in discussion with additional manufacturing partners to further upscale global production.

New Zealand virologist and bird flu expert Dr Lance Jennings said with limited supplies available worldwide it was vital that global production of Tamiflu should be deployed in a way that minimised the chances of a pandemic starting and spreading around the world.

Dr Jennings said there were three likely ways a global flu pandemic could start. One would be for the bird flu virus to adapt to efficient human-to-human transmission, similar to the evolution of the 1918 Spanish Flu virus. Alternatively, the virus could cross the species barrier to pigs and combine with a pig influenza virus, or the bird flu virus could combine with a normal seasonal human flu virus.

Roche sincerely thanks the New Zealand public for its patience and understanding and apologises for the inconvenience this delay may cause.

Further information for the public relating to the influenza virus and its management can be found on the Ministry of Health website at: www.moh.govt.nz/pandemicinfluenza and at free phone 0800 AVN FLU (0800 286 358)

ENDS

Tamiflu® (oseltamivir 75mg capsules and 12mg/ml oral suspension) is a Prescription Medicine indicated for the treatment of influenza in adults and children ≥ 1 year of age and for the prophylaxis of influenza in adults and adolescents ≥ 13 years of age.

Precautions: Renal impairment. Undesirable effects: Common; nausea, vomiting, diarrhoea, abdominal pain, headache. In children, also otitis media, epitaxis, ear disorder, conjunctivitis.

Rare; anaphylactic reactions, elevated liver enzymes and hepatitis.

Tamiflu is an unfunded medicine. A prescription charge will apply. Further information is available on request. For detailed prescribing information consult the Tamiflu Data Sheet available at www.medsafe.govt.nz Pharmaceuticals.

Summary:

- New production of Tamiflu is concentrated on the Northern Hemisphere winter flu season and filling Government orders to minimise risk of a global pandemic.

- Tamiflu supplies to New Zealand unlikely before May 2006.

- New Zealand Government order of 835,000 packs of Tamiflu has been filled. Significant additional private sales demand has been met.

- New Zealand has one of highest stocks of Tamiflu in the world per capita.

- Roche is working with New Zealand health providers to ensure flu patients can access Tamiflu this winter as a back-up to vaccination.

- Pandemic likely to start in one of three ways:
o Bird flu virus adapts for efficient human-to-human transmission
o Bird flu virus crossing species barrier to pigs and then to humans
o Bird flu virus combining with seasonal human flu in a human.

- Flu experts say that during period of up scaling production, Tamiflu deployment must be focused on prevention of a pandemic.

- Roche is increasing Tamiflu production as fast as possible. Production has doubled this year and it will have the capacity to produce over 300 million packs annually by 2007.

- Ministry of Health website and free phone are a useful source of further information.

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