SFGate: Flu vaccine maker won't share patent/Roche rejects calls to allow production of generic versions

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Thursday, October 13, 2005 (SF Chronicle)

Flu vaccine maker won't share patent/Roche rejects calls to allow production

of generic versions

Sabin Russell, Chronicle Medical Writer

 

Tamiflu, a pricey antiviral pill invented in a Bay Area lab and made in

part from a spice used in Chinese cookery, has emerged as the world's first

line of defense against bird flu should the deadly strain begin its feared

spread among human beings.

As nations begin to stockpile the drug in anticipation of a flu pandemic,

calls are mounting for countries to sidestep patents on the drug -- as

Brazil first did for AIDS medications -- and make their own generic

versions.

But Swiss pharmaceuticals giant Roche, which acquired rights to the drug

from Gilead Sciences Inc. of Foster City in 1996, said Wednesday it had no

intention of letting others make it.

" Roche ... fully intends to remain the sole manufacturer of Tamiflu, "

said company spokesman Terry Hurley.

The immediate problem is not the cost of Tamiflu, which runs about $60

for a 10-pill course of treatment, but a staggering gap between the sudden

demand for it and the capacity of its sole manufacturer to produce it.

Although Roche has increased production of Tamiflu eightfold in the past

two years, it will take $16 billion and 10 years to make enough of the

drug for 20 percent of the world's population, said Klaus Stohr, director of

the World Health Organization's Global Influenza Program, in comments

to reporters in San Francisco last week.

" Something has to be done, " said Ira Longini, an Emory University

professor whose computer model of a potential avian flu pandemic shows that

an outbreak could be snuffed out within a month by rushing antiviral drugs

to the place where it started. " When you think of the potential damage a

pandemic flu could do, and how little drug we have, the situation is quite

absurd.

" It makes sense to do something along the lines of what was done with

AIDS drugs. "

James Love, director of the Consumer Project on Technology in Washington,

D.C., said that during the anthrax bioterrorism scare in 2001, both the

United States and Canada had threatened to bypass the patent of Bayer

Corp.'s antibiotic Cipro to assure a sufficient supply of the drug. The

Tamiflu problem is similar.

" The WHO should buy stockpiles from generic suppliers, " he said. " If

patents are in the way, the WHO should ask the manufacturing country to

issue the appropriate compulsory licenses. The patent owner will receive

royalties, but we will have the stockpiles. "

U.N. Secretary-General Kofi Annan has signaled a willingness to consider

generic production of flu drugs and vaccines. During remarks at the World

Health Organization headquarters in Geneva last week, he said drug companies

should be " helpful " by not letting their patent claims interfere with access

to medicines. " I wouldn't want to hear the kind of debate we got into when

it came to the HIV anti-retrovirals, " he said.

Roche will not release its Tamiflu production figures, deeming it

" commercially sensitive " information, said Hurley, the company spokesman.

However, he said the company produced " many hundreds of millions " of the

pills annually. In response to WHO concerns about bird flu this summer, the

company agreed to donate enough Tamiflu to treat 3 million people.

Although public awareness of the pandemic threat posed by the bird flu

has blossomed in recent weeks, scientists have been warning since 1997 that

the rogue influenza strain known as H5N1 could be the one that triggers a

pandemic rivaling the devastating Spanish flu of 1918 -- which killed 50

million.

Tests on laboratory mice strongly suggest that Tamiflu -- and a

lesser-known inhaled antiviral, Relenza -- are the only medications that can

treat infection with the H5N1 strain.

Tamiflu has not been effective in the treatment of the small number of

people who've contracted the H5N1 virus in Asia. Of 116 people infected

since 2003, half have died. However, most of those patients were admitted to

hospitals days or weeks after they became ill. Tamiflu is thought to work

best within 36 hours of symptoms.

" Late treatment is clearly ineffective, " said Dr. Frederick Hayden, a

University of Virginia expert on flu drugs.

As a treatment for ordinary flu, Tamiflu has been effective, but in a

Japanese study of children treated with the drug, about 1 in 6 patients

developed strains of flu resistant to the drug, though the new flu strains

were much weaker, causing less illness.

At WHO's urging, 40 nations last year began building stockpiles of

Tamiflu. The United Kingdom, for example, has ordered enough for 14.6

million people, a quarter of its population. The U.S. stockpile goal for

this year is 4.3 million 10-pill treatments, enough to cover less than 2

percent of the population.

Secretary of Health and Human Services Michael Leavitt has said the U.S.

government plans to buy 20 million courses of Tamiflu, although no timeframe

for the purchase has been revealed. To accommodate U.S. demand for the drug,

Roche is building Tamiflu production capacity in the United States, and

spokesman Hurley said the plant -- actually a series of facilities owned by

the company and subcontractors -- would be " up and running " by the end of

the year.

The U.S. appetite for Tamiflu, however, may quickly outstrip the capacity

of any one company to make it. A draft proposal by the National Vaccine

Advisory Committee, charged with developing a federal response plan to a

pandemic, envisions distribution of nearly 90 million courses of antiviral

drugs. The pills would be rationed according to need, with hospital patients

and health care workers who treat them at the top of the list.

WHO flu chief Stohr is not optimistic that generic producers would be

able to make Tamiflu. He told reporters in San Francisco that the drug takes

a full year to make and involves a potentially explosive process that would

drive out all but the most sophisticated manufacturers. It would take a

generic supplier at least " two years " to put a plant into action.

In addition, Stohr said, the starter ingredient for Tamiflu is a Chinese

spice called star anise, whose seeds are used in flavorings, medicines and

cooking oils. Most of the world production of star anise is located in four

provinces of China, and the supply of it has been back ordered, primarily

for drug production.

Meanwhile, the shortage of Tamiflu has begun to trickle down to American

hospitals, which normally keep small quantities of the drug to treat garden

variety influenza each winter.

Dr. Roger Baxter, director of Kaiser Permanente's flu surveillance

program in Northern California, said the health care giant had stopped

prescribing the drug to patients who wanted it for their own personal

stockpiles, or sought it for travel abroad.

" Kaiser has a very small supply, " he said. " We don't have a stockpile

that would cope with a major outbreak. "

Only patients with so-called B-strains of influenza -- which like H5N1 do

not respond to older line flu drugs -- and those who are hospitalized will

be considered for Tamiflu, he said.

" We can't get a large amount of oseltamivir for stockpiling, even if we

wanted to, " he said.

 

E-mail Sabin Russell at

srussell.

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Copyright 2005 SF Chronicle

 

 

 

 

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