Roche Update on Tamiflu for Pandemic Influenza Preparedness- Further research to combat the H5N1 virus - Manufacturing capacity now significantly outstripping demand
BASEL, Switzerland, April 26, 2007-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. Roche is holding a media briefing today, the conference will start at 10.00am Basel time and is also available through live audio webcast.
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."
Based on current government orders Roche will start tailoring the Tamiflu production schedule while maintaining stock of intermediates and active pharmaceutical ingredient along the supply chain. Gearing up production to full capacity will be triggered by one of two events 1. Roche inventories of final active ingredient (oseltamivir) or key intermediates drop below target levels 2. WHO declares pandemic has evolved to phase 4 (human to human transmission) Roche has taken a number of additional steps to help prepare for a possible pandemic.
- Roche donated more than 5 million treatment courses to the World Health Organization for emergency use. - Roche sub-licensed the patent for oseltamivir to companies in India, China and Africa to provide oseltamivir in these regions. - Roche established a special price for government orders and implemented a further price reduction for low income countries.
Roche's efforts to support government pandemic stockpiling In the last week, the World Health Organization (WHO) reconfirmed the need for world governments to be vigilant in their plans to protect against a potential pandemic outbreak. WHO also reconfirmed that stockpiling antivirals - in particular oseltamivir- 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 80 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 quantities of Tamiflu to cover 20-40% of their population.
About Influenza and Tamiflu
Influenza is a serious, sometimes life-threatening disease and the infecting virus gives rise to a number of unpleasant symptoms including a high fever (40 degrees or more), tender joints/limbs, severe malaise, a racking cough and in some cases delirium, confusion and general disorientation. Influenza associated delirium and neuropsychiatric disorders are not uncommon
Tamiflu has now been used in over 50 million influenza patients worldwide and treatment with Tamiflu has proven successful in reducing the duration and severity of the disease. The most common side effects are mild to moderate nausea and vomiting. Rare but serious skin reactions and allergic reaction have been reported. Patients with influenza should be carefully watched for signs of confusion and unusual behaviour. Reports of neuropsychiatric events leading to death are extremely rare, occurring in around 1 out of every 5 million influenza patients treated. No causal link between such events and Tamiflu has been established. Indeed, study covering health insurance records in more than 300'000 patients showed that the incident of such reports is significantly lower in the Tamiflu treated patient group than in patients not treated for their influenza.
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.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide 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.
All trademarks used or mentioned in this release are legally protected.
Posted: April 2007
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