[e-drug] generic Tamiflu?

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: generic Tamiflu?
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[Roche announces in the NYT (copied below as fair use) that it is talking to Teva Pharmaceutical Industries, Barr Pharmaceuticals, Mylan Laboratories and Ranbaxy Laboratories. Apparently it is not (yet) talking to Cipla and GPO Thailand, which earlier announced that they were also developing generic versions. Question remains, whether the world will be able to produce, buy, distribute and dispense enough to stop a human H5N1 influenza pandemic. More people could die of influenza than of AIDS? WB]

http://www.nytimes.com/2005/10/21/business/21roche.html 

Roche Agrees to Talks With Generic Rivals on Flu Drug 
By ANDREW POLLACK
Published: October 21, 2005

Roche has agreed to meet with four generic drug companies to discuss
allowing them to manufacture the anti-influenza drug Tamiflu, which is
in short supply as countries stockpile it to prepare for a possible flu
pandemic. 

The agreement was announced yesterday by Senators Charles Schumer,
Democrat of New York, and Lindsey Graham, a South Carolina Republican,
after a meeting with George Abercrombie, who runs Roche's operations in
the United States. 

"They will give full cooperation with these four companies and others
like them to get as much of the drug out as quickly as possible," Mr.
Schumer said. 

The four companies are Teva Pharmaceutical Industries, Barr
Pharmaceuticals, Mylan Laboratories and Ranbaxy Laboratories. 

Whether deals will be reached with the companies is unclear, as is how
much help Roche would provide and how quickly production could start. 

Roche, which is based in Switzerland, issued a statement yesterday
suggesting that its willingness to meet with the companies did not go
beyond its announcement on Tuesday that it would consider allowing
others to make the drug. 

Neither Roche nor the generic companies would provide details of what is
envisioned. But Mr. Schumer said Roche had indicated that the generic
manufacturers would be able to sell the drug not only to the government
stockpile but to others. But the companies might be allowed to make the
drug only for a limited period of time. 

He said that Roche would be paid for the patent rights and that the
generic companies would not be likely to sell the drug for much more or
less than Roche does. "The problem here is not the cost of the drug but
the supply," he said. 

Mr. Schumer said the generic companies could make Tamiflu in one month
with Roche's cooperation or in three months without. 

Roche has said it would take another company two to three years to bring
production online and that even Roche takes at least eight months to
make a batch of the drug. Regulatory approval alone for a drug or for a
manufacturing process usually takes longer than three months. 

Mylan Laboratories issued a statement that it was ready to produce
"significant volumes" of Tamiflu. 

Carol A. Cox, a Barr spokeswoman, said that "we don't have any
particular plans at this time" to produce Tamiflu but that Barr had told
legislators it would help if needed. 

William M. Burns, chief executive of Roche's pharmaceutical division,
said that some generic companies merely buy a drug's ingredient and put
it into tablets or capsules. But, he said, what is needed are companies
that can participate in the entire manufacturing process. 

He said Roche would consider companies that could produce the drug in
large enough quantities and with adequate quality. "Our responsibility
is not just to say first come first served, it's a free-for-all," he
said.