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Pharma company prepared to supply Tamiflu for U.S. Government stockpile
(Vaccine Weekly)
2005 NOV 30 - (NewsRx.com) -- Roche announced that it is prepared to supply its antiviral medication Tamiflu (oseltamivir phosphate) for the U.S. Strategic National Stockpile, following President Bush's remarks at the U.S. National Institutes of Health (NIH).
The company said it will work with the U.S. Department of Health and Human Services (HHS) to coordinate a delivery schedule based on the number of treatments ordered.
Roche has an internal team in place that is dedicated to assessing the ability of other companies and partners to either produce or provide capabilities in Tamiflu production. Roche wants to be sure that potential partners can produce substantial incremental amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety and regulatory guidelines.
Following discussions with HHS in 2003, Roche began to expand its Tamiflu supply chain. The U.S. Food and Drug Administration (FDA) recently approved an additional manufacturing site in the U.S. for the production of Tamiflu. The newly registered site in the U.S. further expands Roche's already significantly increased worldwide production capacity.
This U.S. facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third-party manufacturers. By mid-2006, global production capacity for Tamiflu will have increased eight to ten-fold over 2003. Roche has already fulfilled an initial U.S. government request and delivered 2.3 million Tamiflu treatment courses in 2004 and is on schedule to deliver another two million treatments as ordered for 2005.
Roche began increasing its Tamiflu production capacity in 2003, when the threat of avian flu began to escalate. Since that time, Roche has taken the following steps, at its own investment, to prepare for and facilitate stockpiling needs:
-Doubled its production capacity for Tamiflu in 2004 and 2005;
-Committed to increase manufacturing capacity eight to ten-fold by mid-2006 (over 2003);
-Received U.S. Food and Drug Administration (FDA) approval for an additional manufacturing facility;
-Developed special U.S. Packaging for federal government for stockpiled Tamiflu in order to allow extension of expiration dating and ease distribution and administration in the event of a pandemic; and
-Developed a synthetic process for manufacturing the chemical used in the initial production step, which will ultimately greatly reduce reliance on natural sources;
-Committed to a single discounted global pandemic price for all industrialized nations.
Roche recently donated three million treatment courses of Tamiflu to the World Health Organization (WHO) for use in an influenza pandemic, primarily at the site of a potential outbreak of human influenza.
Roche is pharmaceutical and diagnostics company.
This article was prepared by Vaccine Weekly editors from staff and other reports. Copyright 2005, Vaccine Weekly via NewsRx.com.
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