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Roche offers companies plan to stockpile Tamiflu

Thu Jun 26, 2008 2:35pm EDT

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By Maggie Fox, Health and Science Editor

WASHINGTON, June 26 (Reuters) - Roche (ROG.VX) offered U.S. companies a plan on Thursday to reserve stockpiles of its flu capsule Tamiflu in case of a pandemic of influenza, and the U.S. Health and Human Services Department backed the plan.

"Under the new plan, businesses pay a nominal annual fee to 'reserve' their own stockpile of Tamiflu, which Roche will store and rotate to keep 'in date,'" the company said in a statement. The fee will be $6 a year per course of treatment reserved.

"The contract comes up for renewal annually, at which time companies will have the opportunity to re-evaluate their investment decision," the statement added.

"If and when a company decides to take possession of the medicine -- for example, if a novel strain of influenza virus begins human-to-human spread -- they can purchase their dedicated product from Roche at the prevailing wholesale price."

HHS, which has been encouraging companies to make their own plans for a pandemic, supported the plan and held an unusual joint briefing with Roche.

"I think it is unprecedented in that we are facing an unprecedented threat," Tevi Troy, an HHS deputy secretary, told reporters in the briefing.

"We said we are not subsidizing this effort by Roche in any way. We are encouraging it." Troy said the plan fits in with a U.S. government doctrine of shared responsibility.

"We are recognizing that, if in the worst case a pandemic were to break out, we would need help on all levels of society -- not just the federal government," Troy said.

"I have to commend Roche for coming up with this new plan. If other (makers of) drugs or vaccines were to come to us, we would consider them."

INEVITABLE PANDEMIC

Most experts agree that a pandemic of influenza is inevitable, although no one can predict when it might come or what strain might strike.

The current main suspect is H5N1 avian influenza, which has swept through flocks of birds in Asia, Europe, the Middle East and Africa and become entrenched in ways that experts say has never happened before.

It rarely infects people but has killed 243 out of 385 people infected so far globally, according to the World Health Organization.

Several experimental vaccines are being tested against H5N1, but if a pandemic were to start, it would likely be months before vaccine production could begin to be ramped up.

Tamiflu, known generically as oseltamivir, can treat seasonal influenza and has helped some people infected with H5N1. Roche licenses it from Gilead Sciences (GILD.O).

Tamiflu can also prevent infection if people take it in time.

"Once an outbreak occurs or a pandemic flu starts spreading, it will be impossible to meet immediate and widespread demand for Tamiflu," said Mike McGuire, vice president of anti-infectives at Hoffmann-La Roche Inc.

The company currently can make 400 million courses of therapy a year.

Another drug, Relenza or zanamivir, made by GlaxoSmithKline (GSK.L) under license from Australia's Biota (BTA.AX), can also treat and prevent flu. It is an inhaled formulation.

"To date, Roche U.S. has received inquiries from more than 800 U.S.-based companies, large and small in a variety of industries, with Tamiflu orders from more than 300 companies, in quantities ranging from a few hundred to hundreds of thousands of treatment courses," Roche said in a statement.

The U.S. government now has 50 million courses of antiviral drugs, with 10 pills in each course in the case of Tamiflu. States can buy 31 million more courses under a federal contract that subsidizes the cost, for a total of 81 million courses. (Editing by Maureen Bavdek)





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