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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Basel, Switzerland (Apr. 26)-Roche outlined advances it is production strategy for "Tamiflu" (oseltamivir) for treating the H5N1 avian influenza virus.
Basel, Switzerland (Apr. 26)-Roche (www.roche.com) outlined advances in its production strategy for "Tamiflu" (oseltamivir) for treating the H5N1 avian influenza virus.
Roche's manufacturing network for Tamiflu production includes eight Roche sites and 19 external manufacturing partners located in nine countries. William M. Burns, CEO, Division Roche Pharma, outlined the company's current production plan.
"The manufacturing expansion went according to plan and Roche, together with external partners, now has the ability to produce more than 400 million courses of Tamiflu a year," he said in a company release. "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 says it will start tailoring the Tamiflu production schedule while maintaining stock of intermediates and active pharmaceutical ingredients (APIs) along the supply chain. It said gearing production up to full capacity will be triggered by one of two events: (1) Roche inventories of oseltamivir, the API in Tamiflu drop below target levels or (2) the World Health Organization (WHO) declares the pandemic has evolved to phase 4 (human-to-human transmission).
Roche also took several additional steps to help prepare for a possible pandemic. These measures include:
• Roche donated more than 5 million treatment courses to WHO for emergency use.
• Roche sublicensed the patent for oseltamivir to companies in India, China, and Africa to provide oseltamivir to these regions.
• Roche established a special price for government orders and implemented a further price reduction for low-income countries.
Roche also pointed to recent information from the WHO that stresses the need for world governments to be vigilant in their plans to protect against a potential pandemic outbreak. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals such as oseltamivir 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. Some countries such as France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland, and the United Kingdom are stockpiling or intending to stockpile adequate quantities of Tamiflu to cover 20–40% of their population.