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CDC: Two influenza drugs don't work - Jan 14, 2006

2006-01-15T08:17:00.000-08:00

CDC: Two influenza drugs don't work
Doctors asked to stop prescribing amantadine and rimantadine

CDC Director Julie Gerberding said the flu virus's resistance wasn't expected to be "quite as dramatic."
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How did the strain become resistant? (2:44)
SPECIAL REPORT

• Season tempered by bird flu fears
• The animal connection
• Interactive: Flu 101
• Interactive: Superflu creation
• Gallery: The cold facts
• Special ReportATLANTA, Georgia (CNN) -- With flu season reaching its peak, two drugs typically prescribed to fight the virus will be ineffective this season and should not be prescribed, the Centers for Disease Control and Prevention announced Saturday.

The CDC found in tests that the antiviral drugs amantadine and rimantadine were ineffective 91 percent of the time against H3N2 influenza, the dominant strain this season.

However, two other antiviral drugs, Tamiflu and Relenza are still effective, said CDC Director Dr. Julie Gerberding. Amantadine and rimantadine are older, less-expensive and less commonly prescribed drugs.

There has been a global trend toward drug resistance, but Gerberding said health officials didn't expect the resistance "to be quite as dramatic so soon." (Watch Dr. Marc Siegel explain how the strain became resistant to some drugs -- 2:44)

"We don't know exactly why resistance has risen to these drugs," Gerberding said, adding that the flu virus may have mutated, but there is no evidence to support that. "Flu constantly evolves, and we are always one mutation away from drug resistance."

There is no "magic bullet" to prevent drugs from becoming ineffective against certain flu strains, she said.

There is plenty of Tamiflu and Relenza for this flu season because the CDC stockpiled the drugs in case of an influenza pandemic, Gerberding said.

The flu is widespread in Arizona, Texas, New Mexico, Nevada, California, Oregon and Colorado.

The season, which can begin as early as October and stretch into May, typically is most widespread in December, January and February.

News: U.S. Tamiflu shipments increase - myDNA

2006-01-08T00:06:00.000-08:00

Roche Pharmaceuticals, maker of the influenza drug Tamiflu, has stepped up shipments to U.S. cities with high incidences of the flu.

States that have been particularly hard hit this season include California, Arizona, New Mexico, Utah, Texas, Oregon, Nevada and Kansas.

Tamiflu targets the most common influenza strains, types A and B. Roche temporarily halted some Tamiflu shipments to the United States during the fall, when consumers fearful of a bird flu pandemic hoarded the drug. Tamiflu has shown some promise for treating people infected with the H5N1 bird flu strain, but it has not been approved for that use.

"When demand for Tamiflu rose last year, Roche took appropriate precautions to ensure adequate supplies would be available for the treatment and prevention of seasonal influenza," said George Abercrombie, president and CEO of Hoffmann-La Roche Inc. in a company statement.

"Because of those precautionary measures, Tamiflu is readily and widely available to patients who need it for flu treatment and prevention, while we continue to work with governments to supply stockpiles for pandemic preparedness."

Beware when buying Tamiflu online: Health Canada

2005-12-23T10:27:00.000-08:00

Consumers should be cautious about buying the prescription drug Tamiflu over the internet and avoid products claiming to be a generic version, Health Canada warned Friday.

Tamiflu, also known as oseltamivir, is considered the best early defence against a pandemic that could be triggered if H5N1 avian flu mutates into a form that spreads easily between people. The drug is also prescribed during the regular flu season.

Real versions of Tamiflu have a drug identification number on the box.
Regulators in Canada, the United States and Britain are concerned fears of a pandemic and shortages of the drug for the public could be fuelling internet sales of fake Tamiflu.

There are no authorized generic versions of the antiviral on the market, Health Canada said. It's made by the Swiss drug manufacturer Hoffman-La Roche.

The advisory comes as British regulators investigate internet sales of products purporting to be flu-fighting drug.

Reports from the U.K. suggest several internet sites, including two Canadian ones, have been selling illegal Tamiflu to British customers, Health Canada said.

U.S. border patrol agents have also stopped more than 50 shipments of bogus Tamiflu.

"As with any medication purchased online, consumers should only buy Tamiflu with a prescription from a doctor they know, using a pharmacy where they have an established relationship," Health Canada advises.

Consumers should look for the drug information number, or DIN, on the product, and buy from internet pharmacies that provide a street address and telephone number in case there is a problem.

British regulators are testing to determine if drugs purchased online are really Tamiflu.

Consumers who suspect they have received counterfeit drugs should check with Hoffman-La Roche, which may advise them to call the RCMP. The company can confirm if it manufacturered the product.

Roche Selects Potential Tamiflu Partners

2005-12-12T07:13:00.000-08:00

BASEL, Switzerland — Swiss drugmaker Roche Holding AG said Monday it has chosen 12 potential partners for the production of Tamiflu and granted one sublicense for the antiviral drug to Shanghai Pharmaceutical.

Roche said it compiled the shortlist of potential partners, which it did not identify, after evaluating around 200 applicants interested in helping with certain steps in the manufacture of Tamiflu. It didn't say how many it would finally choose.

Roche said it would mainly use the partners, which include major pharmaceutical makers, large generic manufacturers and specialty chemical producers, as backups, to meet specific regional needs and to prepare for any large additional government orders in the future.

"We are now also in the position to have a backup supply in case of an emergency," said David Reddy, who heads Roche's influenza pandemic task force.

Roche has come under international pressure to ease its monopoly grip on the manufacture of Tamiflu, which is considered the most efficient treatment in case of an outbreak of human influenza caused by a mutation of the bird flu virus.

The company has been pressed to step up production, cut prices and allow other companies to make copies of the drug.

Roche said it will now evaluate the potential partners' specific skills, the quality of their production and their delivery speed before making the final choice. "We will then choose among the companies to help us with certain steps in the production process such as fermentation or alcoholic granulation," said Roche spokesman Daniel Piller.

Roche has pledged to increase the production of Tamiflu by nearly six-fold by planning to make 300 million treatments annually by 2007 in order to meet government orders amid fears of a flu pandemic.

Separately, Roche said it will grant Shanghai Pharmaceutical rights for the overall production of Tamiflu, also known as oseltamivir, for use in China.

"They are allowed to and they will produce the drug from the beginning to the end," said Piller.

Roche said it could already produce the 300 million annual treatments with its existing partners such as Mylan Laboratories Inc. of Pittsburgh or Israeli drugmaker Teva Pharmaceutical Industries. The making of Tamiflu is considered very complicated.

Although some 50 companies around the world have bought or ordered supplies of Tamiflu for pandemic stockpiles, so far Roche has no firm orders for 2007. That leaves the company with a large degree of uncertainty over possible future needs.

For example, Roche has not yet received any large orders from the United States _ although President Bush has proposed stockpiling anti-flu drugs Tamiflu and GlaxoSmithKline PLC's Relenza for 81 million people. and U.S. Department of Health and Human Services Secretary Michael Leavitt has called for a Tamiflu stockpile to treat 20 million Americans. So far, the United States has only enough anti-flu drug doses in stock to treat 4.3 million people.

Roche said it has already brought forward delivery schedules for countries that have had large bird-flu outbreaks, or are near countries that have. Roche has also allowed Vietnamese companies to encapsulate Tamiflu locally.

Tamiflu is not patent-protected in Thailand, the Philippines and Indonesia. As a result, local governments can purchase and manufacture oseltamimivir at their discretion.

Bird Flu Threat Prompts Stockpiling of Roche's Tamiflu Pills

2005-12-06T07:14:00.000-08:00

Dec. 5 (Bloomberg) -- Susan Wolfson says her teenage daughter became frightened in September by a TV news program highlighting the threat that avian flu will mutate into a pandemic capable of killing millions of humans.

Wolfson responded by getting a doctor's prescription for Tamiflu, the antiviral drug that has shown some benefit against the flu in lab tests. She then hid 30 capsules behind other items in a medicine chest to reduce chances that anybody visiting her home might swipe them.

``I know it sounds really crazy, but this drug seemed more precious than other things that I own,'' says Wolfson, 52, the president of Sensei, a New York public relations firm. ``It's the best available defense that I know of to protect my kid and myself.''

Now Wolfson -- and thousands of other Americans who have stocked up on the drug -- must face the reality that guarding against the looming threat of a flu pandemic with Roche Holding AG's Tamiflu may not be as surefire or simple as many consumers think, according to infectious-disease specialists.

``It's a difficult drug to use properly,'' says John Treanor, a 51-year-old professor of medicine at University of Rochester in Rochester, New York. ``People who hoard the drug might use it improperly or store it improperly, so it won't work. Hoarding is a panic thing.''

Misuse would waste drugs -- needed if a pandemic does occur -- and squander the money spent on Tamiflu, Treanor says. Ten capsules, or enough drugs to treat one person for five days at Roche's recommended dose, cost $78.99 on Drugstore.com, an Internet seller.

Hoarding

``There's no reason to hoard Tamiflu,'' Treanor says. ``The likelihood of a pandemic is extremely small.''

Tamiflu sales are jumping nonetheless. U.S. drug stores filled almost 422,000 prescriptions for Tamiflu during the 14 weeks ended Nov. 18, more than four times the total in the year- earlier period, according to Verispan LLC, a research company in Yardley, Pennsylvania.

The sales increase might have been ever larger had not Roche, based in Basel, Switzerland, temporarily suspended Tamiflu sales in late October to ensure that supplies would be available later.

Some doctors are refusing to comply with requests for the drug.

``We're trying to explain to parents that avian flu is really not a concern at this point for their children,'' said Kathryn Mandal, a 31-year-old pediatrician in Waldorf, Maryland. She said has declined to write Tamiflu orders for about 10 parents who requested Tamiflu during the past two months.

Upset Parents

``Most of them have gotten upset,'' Mandal says. ``Some parents told us they'd go to other sources.''

There have been 133 confirmed cases of the H5N1 avian influenza in humans -- resulting in 68 deaths in five Asian countries -- since late December 2003, according to the World Health Organization. Health authorities believe the victims came into direct contact with the feces or blood of infected poultry.

Experts at WHO, an arm of the United Nations, say the world appears closer to a flu pandemic than at any other time since 1968, as the H5N1 avian flu virus might mutate into a form readily transmissible between humans.

The extent to which Tamiflu would help fight a pandemic flu won't be known until such a virus emerges. The drug, available since 1999, can help someone with seasonal flu by blocking the virus from spreading once it is inside the body and has infected some respiratory cells.

Studies have shown that Tamiflu can cut as much as day off the period that the symptoms persist, its use by an infected person can reduce the virus's ability to spread to others, and taking the drug can lower one's risk of getting the flu.

Mouse Studies

Research this year found that mice infected with bird flu that were given large doses of Tamiflu were more likely to survive than those who received a regimen more like what is now prescribed to patients. No studies have been done in people infected with the bird virus.

Even if people correctly diagnose the flu, their timing must be precise to benefit from Tamiflu, Treanor said. Treatment must be initiated within the first 48 hours of symptoms such as fever, sore throat or muscle aches, according to Roche. The need for proper timing -- and the requirement that patients get the drug prescribed by doctors -- is one reason that the antiviral and a similar one from GlaxoSmithKline Plc. called Relenza have not proved popular in the past, according to infectious disease specialists.

While Tamiflu could be taken to protect against a flu, the price would add up. A flu season can extend several weeks or months. People who now have saved 10, 20 or 30 pills may have difficulty getting many more, given shortages of the drug as a result of Roche's production limits.

Zero Refills

Drugstore.com, citing shortages, says on its Web site that it currently will dispense no more than 10 capsules per person, ``with zero refills.'' Larger quantities may be dispensed in regions with flu outbreaks, the site said.

``The drug is effectively only while you are taking it,'' Treanor says. ``You need to administer it during the entire period'' -- that is, from beginning to end of the flu threat.

If a pandemic flu does hit, and just one member in a family falls ill, there is a question of whether giving Tamiflu to the sick person would increase danger to the others -- by making the virus resistant to Tamiflu.

``The chance of getting resistance in that person is very high, and then we lose the protective effect in the other family members,'' Stephen Wolinsky, a professor of medicine at Northwestern University in Evanston, Illinois, said at a conference on avian flu held on Nov. 16 in New York.

The unanswered questions haven't stopped people from squirreling away Tamiflu.

``It's human nature,'' says Stephen S. Morse, a 52-year-old associate professor of epidemiology at Columbia University in New York. ``There's almost a talismanic quality to it,'' Morse says. ``It's like having an amulet to ward off evil: It can give a false sense of security.''

State sets Tamiflu restrictions

2005-12-03T10:16:00.000-08:00

Officials want full supply available in case of emergency
By Annette Wells, Staff Writer

Thinking about stuffing your medicine cabinet this holiday season with Tamiflu?
If you don't have it, chances are, you won't get it in California unless you're elderly or chronically ill.

The state's Department of Health Services has issued guidelines for physicians who have pesky patients wanting to stockpile it in case of a bird flu pandemic.

Tamiflu, already in limited supply across the world, is used to treat flu symptoms. It can't stop you from getting the flu.

Under the state's new guidelines, the drug is priority for the elderly and those who are at high risk of complications from seasonal flu such as very young children and people with chronic health conditions.

The guidelines note that inappropriate use of Tamiflu may promote the development and spread of influenza viruses and resistance to them.

"The intent of the guidelines is to help support physicians whose patients might be asking for a prescription for their own stockpiling purposes," said Leah Brooks, a spokeswoman for the department.

"We have anecdotally information that this has been happening."

The guidelines also encourage health-care providers to educate their patients about how to stay healthy during the current flu season.

This includes urging patients to get the flu vaccine, wash their hands and stay home from work or school if sick.

Some health officials have already seen an increase in Tamiflu prescriptions from last year. They too have put a stop to it.

"We did see a slight increase in prescriptions but that was 35 to 45 days ago," said Jennifer Resche-Silvestri, a spokeswoman for Kaiser Permanente Medical Center in Fontana.

"We've since held it back, not writing as many. We're trying to keep it in stock."

About a week ago, Riverside County's Department of Public Health sent out its own notice to the public about inappropriate stockpiling of Tamiflu, said Barbara Cole, director of disease control.

Cole praised the state for reinforcing Tamiflu restrictions.

San Bernardino County's Public Health Officer Eric Frykman also endorses the state's efforts.

"We're not against prescribing Tamiflu, we just don't want it going to people who do not have illness or aren't susceptible to illness," he said.

Last week, Frykman gave a brief presentation to the county's Board of Supervisors about bird flu and the possibility of an outbreak here.

During the meeting, he said we were overdue for a flu pandemic.

Whether or not it will be Avian flu or when that pandemic might occur is unknown.

In an effort to keep school-aged children from getting the seasonal flu and spreading it, public health will be vaccinating students with FluMist, a nasal spray.

Shipments of the nasal spray are expected to arrive sometime this week, Frykman said. They have been donated by manufacturer MedImmune Vaccines, Inc.

Several school districts have shown interest in participating.

Arrowhead Regional Medical Center in Colton is piloting a similar program within the Colton Unified School District.

Approximately 1,000 of the FluMist vaccines have been administered, said Gerald Greene, chairman of the Department of Pediatrics at Arrowhead Regional. Greene estimates that one-third of the 25,000 students in the district and students will get the vaccine must have parental consent.

"There are some statistical models and research suggesting that if we could protect children, it would reduce the spread of influenza throughout the community," said Greene, an unpaid adviser for MedImmune.

"This is the first time there has been an organized approach like this in junior high and high schools. We hope once the flu season is over to go ahead and query families, both those who got the vaccine and those who didn't and maybe get some results."

While the state does have some Tamiflu in stock, Brooks said it's not enough. She said it is actively pursuing more of the drug from the federal government, though its stock is nearly dry as well.

In preparation for a potential bird flu pandemic, President George W. Bush has announced a $7.1 billion plan that calls for spending $1 billion to stockpile antiviral drugs such as Tamiflu.

No sustained or ongoing transmission of bird flu among humans has occurred and there is no evidence of bird flu in humans or birds in the United States.

On Wednesday, several Japanese quail were discovered suffering from a low pathogenic strain of the bird flu at a Sun Valley quail farm in Los Angeles County.

The state Department of Food and Agriculture confirmed three cases of bird flu were found at the L.A. Quail Farm, but said the low pathogenic strains are not uncommon.

Brooks said the state Department of Health Services is aware of the Sun Valley quail situation and is monitoring it.

The Associated Press contributed to this report.

Philippines and Thailand free to make Tamiflu

2005-11-29T09:17:00.000-08:00

ZURICH: Thailand and the Philippines are free to begin making their own versions of the anti-viral drug Tamiflu in preparation for a bird flu pandemic, the medicine’s maker Roche Holding said on Monday.

The pill, which governments are stockpiling as a precaution against a virulent outbreak of flu, does not have patent protection in either country, meaning that the Thai and Philippine governments are free to make their own versions. The move follows a similar decision by Indonesia last week and could create a source of cheap Tamiflu for other developing countries who are unable to afford the Roche-branded drug.

“Tamiflu is not patent protected in these countries and so there is no question about granting a licence or sub-licence (for production),” a Roche spokesman said.

There will be no financial consequences if the two South-East Asian countries begin their own production of the drug, he said.

Taiwan, where the drug has a patent, has said it will produce Tamiflu under compulsory licence if its stocks run dry, surprising the Swiss firm which says it can meet demand. The drug is protected in China and has a patent pending in India. Roche maintains that Tamiflu is hard to produce, taking around a year since it requires a chain of different processes, some of which are dangerous.

The spokesman declined to comment on how close any of the three governments are to being able to produce Tamiflu domestically. “It is not up to us to speculate about that. As a responsible company we remain willing to discuss with them whether we can contribute,” the spokesman said. Indonesia, which has confirmed 12 cases of human infection with the H5N1 avian flu virus, said on Saturday it will begin making the anti-viral drug in three to five months.

State official seeks $22 million for 500,000 doses of Tamiflu

2005-11-17T15:15:00.000-08:00

State official seeks $22 million for 500,000 doses of Tamiflu
Thursday, November 17, 2005
KIM CHANDLER
News staff writer
MONTGOMERY - State Health Officer Don Williamson said he'll ask for an extra $22 million to stockpile 500,000 doses of Tamiflu - enough to treat one-ninth of the state in case of a deadly bird flu outbreak.

President Bush's war on bird flu announced last month calls for states and the federal government to stockpile antiviral agents, such as Tamiflu, designed to ease flu symptoms and lessen the risk of death. Alabama should have 500,000 doses on hand, according to the plan, Williamson said. Alabama's share of the cost for buying those doses would be $22 million.

Williamson said he plans to ask Alabama lawmakers to make the money available. The antiviral drugs are not readily available now, but Williamson said he hopes the money can be allocated to buy the drugs when they are available.

Avian flu is a disease found in birds that has ravaged poultry stocks in Asia. Some humans have caught the disease, likely from contact with infected animals. There have been 126 confirmed human cases in Asia and 64 deaths.

The strain, known as H5N1, does not spread easily from person to person, but public health experts fear it could easily mutate into the next killer flu.

Bird flu in humans so far carries a 50 percent mortality rate. If the disease mutated to one that humans could transmit to each other, the mortality rate likely would drop. But Williamson said health officials fear the strain still would be lethal.

Alabama Department of Public Health projections predict a pandemic flu could kill 1,778 to 4,146 people in Alabama, overwhelming state morgues.

While the 500,000 doses would cover only a fraction of Alabama's population, the federal government could make more Tamiflu available if Alabama were hit hard as part of a pandemic. Williamson said that, overall, the Bush plan calls for buying 81 million doses of Tamiflu, enough to cover 25 percent of the U.S. population.

There were three flu pandemics in the 20th century, the most severe in 1918. The others occurred in 1957 and 1968.

Japan to stock up on Tamiflu

2005-11-14T10:34:00.000-08:00

TOKYO (AFX) - The government announced plans to stock up on Tamiflu as the deadly bird flu virus spreads across the world, fearing that an outbreak here could cause up to 640,000 deaths.

Japan already buys more than 60 pct of the world's Tamiflu, seen as the main weapon against a global bird flu pandemic, as the government has encouraged both the public and private sectors to keep the drug in stock.

A health ministry plan calls for Japan to keep enough Tamiflu to treat 25 mln patients for five days. The previous target was 15 mln people for three days.

Japan has been spared the deadlier strain of bird flu, which has killed more than 60 people in Southeast Asia since 2003 and since last month has been found in Europe, Canada and the Middle East.

In a worst-case scenario, up to 640,000 people could die in Japan, the health ministry said.

Chief Cabinet Secretary Shinzo Abe said the Japanese government would use the plan to 'work on developing new vaccines and taking other measures' against bird flu.

Action plan readied to battle new strain of flu

2005-11-13T20:26:00.000-08:00

Action plan readied to battle new strain of flu
11/14/2005

By KOTA TAKEDA The Asahi Shimbun

Amid a growing international sense of crisis about the potential for an influenza epidemic, the government unveiled an action plan on Saturday designed to stave off what it predicts could be 640,000 deaths.

The plans covers measures from the order of priority for treatment in the event of an epidemic, to restrictions on activities by the public, such as limiting overseas travel and closing down schools.

The government is expected to call a meeting of relevant Cabinet ministers as early as Tuesday to begin full-scale preparation of the measures.

The plan hypothesizes that, if a new strain of highly contagious influenza were to spread widely within Japan, one in four people would be affected.

Based upon that, it projects that deaths would range between 170,000 and 640,000, the number of hospitalized between 530,000 and 2 million and the number of persons seeking medical help between 13 million and 25 million.

The plan spells out the roles of various government ministries in such a crisis. The Ministry of Health, Labor and Welfare will be responsible for stocks of Tamiflu, a drug to fight influenza.

The Ministry of Agriculture, Forestry and Fisheries would set out measures to prevent outbreaks among poultry.

The Foreign Ministry would issue the travel advisories.

If the domestic spread of the flu from person to person is confirmed, the plan calls for the health ministry to work closely with other ministries--for example, working with the education ministry to request that special days off be declared at schools in affected areas.

The plan also proposes imposing social restrictions in the event of an epidemic, such as recommending that large-scale non-urgent gatherings be cancelled and large entertainment venues be closed. It also calls for warning employees of companies where flu patients have been found to stay away from work and to undergo medical checks.

Further, if the flu spreads among a large number of people across many different regions, the health ministry will declare a national state of emergency. That would involve such measures as temporarily closing schools across the country.

To grapple with a potential shortage of flu medication, the plan has established a sort of most-needy list.

First priority will be given to hospitalized flu patients. Next will be those working to maintain needed social functions, such as doctors. Following them, in order, are urgent patients, such as those suffering from heart disease; infants and the elderly; and, finally, general outpatients.

It also makes changes to the way in which the country maintains its stockpiles of Tamiflu.

Currently, stock levels are based on providing 25 million people a dosage of two tablets per day for three days. The new plan revises that to the international standard of five days.

In addition, national and local authorities will be given enough of the drug to provide for 21 million people. The remainder is to be held in the open market, by hospitals and manufacturers.

Until the plan, things were essentially reversed, with the market holding enough dosages for 20 million people and authorities only 5 million.

Roche Halts Tamiflu Sales in China

2005-11-08T07:39:00.000-08:00

Roche Halts Tamiflu Sales in China

BEIJING, Nov. 8, 2005
--------------------------------------------------------------------------------

(AP) Swiss drug-maker Roche said Tuesday it had stopped selling the antiviral drug Tamiflu in China and was turning over supplies to the government as local officials were ordered to prepare to treat possible human cases of bird flu.

Tamiflu supplies are "now being transferred to China's Ministry of Health for centralized allocation and distribution," the Chinese arm of Roche Holding AG said in a written statement. Sales were halted in China on Nov. 1, it said.

There is no approved human vaccine for bird flu, which is almost always caught from close contact with infected birds. But Tamiflu is one of the few drugs believed to be effective against bird flu.

In the event of a possible human flu pandemic, Roche said, "the government is in the best position to handle rapid response and distribution."

The company didn't say how much Tamiflu it turned over to the government or whether it would be compensated.

Concerns that private suppliers might be hoarding Tamiflu have prompted Roche to limit sales in other countries, including the United States, Switzerland, Germany and Canada.

The World Health Organization advises governments to keep enough antiviral drugs and regular human flu vaccines for at least 25 percent of their populations.

China hasn't reported any infections in humans from the virulent H5N1 strain of the virus, which has killed at least 62 people elsewhere in Asia. But health officials say a case is inevitable if China can't stop repeated outbreaks in poultry. Authorities fear that H5N1 could mutate into a form that is easily passed from human to human, sparking a possible pandemic.

Health Minister Gao Qiang ordered local officials to step up efforts to prevent human infections and preparations to treat possible cases, the official Xinhua News Agency said.

In a nationwide video conference, Gao told officials on Monday "to strengthen work at three key links, namely monitoring, control and treatment," Xinhua said.

The government has ordered increasingly strict preventive measures.

On Monday, authorities closed live poultry markets in Beijing and were going house-to-house in the Chinese capital seizing chickens and ducks raised in private homes.

Roche announces further progress in Tamiflu production expansion

2005-11-07T14:57:00.000-08:00

November 7, 2005
Roche's current production network on track to produce 300 million treatments as of 2007
Over 150 requests received from third parties - first negotiations initiated

Roche announces today that it will have increased its own production capacity by the end of 2006 to then be in a position to produce 300 million treatments of Tamiflu annually. The expansion will be achieved by a further stepwise scale-up of Roche's production network. It means a ten fold increase over the capacity in 2004 when the decision was taken to increase production, without any firm pandemic orders in place, in order to meet government's needs for pandemic planning.

William M. Burns, CEO Division Roche Pharma, commented: "Patients' needs in case of a pandemic remain our top priority. We have continually increased our production capacities and are now putting in place the means to increase production of Tamiflu to 300 million treatments as of 2007. In addition, we have entered into discussions with a number of interested parties to expand world wide supply, so governments can be as prepared as possible for when the influenza pandemic happens."

More than 150 requests from third parties have been received to date and Roche production experts have already been in initial talks with 8 companies, amongst them large generic manufacturers and major pharmaceutical companies, as well as with a number of governments, including Taiwan and Vietnam. The goal is to be in a position to select potential partners for more detailed discussions by the end of November. Selection criteria are quality, technical ability, capacity and the speed of bringing that capacity on stream.

About pandemic planning

Roche has been working with many governments over the last few years to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 50 countries.

Roche has also pledged to donate 3 million treatments to the WHO for use where an influenza pandemic may start. This amount, according to experts, could contain or stop the spread of a potential pandemic at the source of the outbreak, if delivered rapidly.
Recently Roche has donated Tamiflu to Turkey and Romania, following the emergence of the avian influenza virus in these countries

About Tamiflu (oseltamivir)

Tamiflu is designed to be active against all clinically relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian H5N1 strain circulating in the Far East. (3)

It works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.

Tamiflu delivers:

- 38 percent reduction in the severity of symptoms (1)
- 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals (2)
- 37 percent reduction in the duration of influenza illness (5, 3)
- Tamiflu was shown to provide up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients (4)

In children, Tamiflu delivers:

- 36 percent reduction in the severity and duration of influenza symptoms (5)
- 44 percent reduced incidence of associated otitis media as compared to standard care (6)

As with any antiviral, a theoretical potential exists for an influenza virus to emerge with decreased sensitivity to a drug. Extensive monitoring, by Roche and the independently established Neuraminidase Inhibitor Susceptibility Network (NISN) measured the incidence of resistance to NAIs. From around 4000 patients treated with Tamiflu resistance was encountered in 0.4 per cent in adults and 4 per cent in children aged one to 12. This resistant virus was found to be less virulent than the wild type virus and did not affect the course of the illness.

The greatest use of Tamiflu today is in Japan. To illustrate this, there were an estimated 16 million influenza infections in Japan over the 2004/2005 influenza season. Roche estimates that around 6 million of those individuals infected with the influenza virus received Tamiflu. Even with this degree of usage, resistance appears very infrequent.

Avian Influenza and Pandemics

Most avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely new in composition, so vaccines developed and administered to date to protect humans during seasonal epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection. Experts believe the next influenza pandemic could result from such a mutation of virus strains.

Please see Tamiflu Purchase for more info on Tamiflu.

People's Daily Online -- Denmark decides to increase Tamiflu supply

2005-11-05T04:57:00.000-08:00

People's Daily Online -- Denmark decides to increase Tamiflu supply: "Denmark decides to increase Tamiflu supply

Denmark's supply of influenza medicine to treat a bird flu outbreak is to increase by over 10 million doses after the parliament have agreed to appropriate 8.9 million euros to purchase more of the anti-viral drug Tamiflu, Ritzau news bureau reported on Friday.
The decision was one aspect of a parliamentary decision to improve the country's preparedness for a flu outbreak.
'We are requesting the parliament's budget committee to earmark 8.9 million euros and now in order to buy Tamiflu so that we have a ready supply if we need it,' said Health and Interior Minister Lars Loekke Rasmussen, who initiated the proposal.
Health officials already have a supply of the medicine, but it is only predicted to be enough for about 30,000 people for five days.
The health minister admitted the level was insufficient and said the increased supply would be enough to treat as much as 19 percent of the population.
In addition to purchasing more medicine, the parliament also agreed to use 1.3 million euros annually for vaccination insurance, which will ensure all Danes can be vaccinated in the event of an outbreak. "

2005-11-04T19:50:00.000-08:00

Technorati Profile

2005-11-03T09:43:00.000-08:00

BRUSSELS, Nov 3 (Reuters) - Swiss drugmaker Roche Holding AG has given assurances it is talking to other firms to raise output of its Tamiflu, seen as the most effective anti-viral drug currently available for bird flu, an EU spokesman said on

EU says Roche to lift anti-viral output

2005-11-03T08:09:00.000-08:00

EU says Roche to lift anti-viral output

Roche will not stop European countries from stockpiling its Tamiflu anti-viral drug in preparation for a possible flu pandemic.

The Swiss pharmaceutical company said on Thursday that it would allow other companies to produce the drug under licence, even though it holds the exclusive patent rights.

Roche will also expand its own production capacity to cope with increasing demand.

The company’s chief executive, Franz Humer, made the commitments during talks with EU Health Commissioner Markos Kyprianou on Thursday.

The spread of bird flu to Europe has raised fears of a human flu pandemic caused by a mutated strain of the avian virus.

Kyprianou has called on every EU member state to stockpile anti-viral drugs such as Tamiflu or Relenza, made by GlaxoSmithKline, in preparation for an eventual outbreak.

But several smaller member states are concerned that they will be overlooked as companies strive to fill orders from much larger countries.

A European Commission spokesman said that Roche treated orders on a first-come, first-served basis, but that it had capacity to fill smaller orders at the same time as larger ones.

The spokesman also confirmed that five member states have yet to provide details of their anti-viral stocks, although he declined to say which countries were concerned.

Doctors find way to double supplies of Tamiflu using WWII tactic - report

2005-11-02T09:45:00.000-08:00

AFX News Limited
Doctors find way to double supplies of Tamiflu using WWII tactic - report
11.02.2005, 11:15 AM

PARIS (AFX) - Doctors believe they have found a way to double supplies of the anti-flu drug Tamiflu, manufactured by Roche AG, thanks to a tactic pioneered in World War II, the British science journal Nature reported.

The idea is to use Tamiflu alongside a second drug that halves the amount of Tamiflu that is excreted from the body in urine. As a result, a single dose of Tamiflu could be used to treat two people.

The helper drug, probenecid, is commonly used to stop the active ingredients of antibiotics from being filtered out of the blood by the kidneys.

The technique was invented during World War II to 'stretch' supplies of penicillin.

It is still used today, notably to treat gonorrhoea and syphilis, where quick, high doses of antibiotics are needed to treat infected people.

The idea of using probenecid to stretch supplies of Tamiflu was spotted last week by an emergency-medicine specialist, Joe Howton, medical director of the Adventist Medical Center in Portland, Oregon.

While preparing for a talk on bird flu, Howton noted that in 2002 Roche itself published a study which said probenecid doubled the length of time Tamiflu was in the blood, doubled the blood concentration of Tamiflu's active ingredient and multiplied 2.5-fold the patient's total exposure to the drug.

Studies are being proposed that will investigate the safety of using probenecid with Tamiflu.

But probenecid is already widely used as a helper drug and has a long history of safety, which means that regulatory approval could be fast-tracked, Nature said.

2005-11-01T10:42:00.000-08:00

Drug combo could stretch Tamiflu supplies-doctors
Tue Nov 1, 2005 5:52 PM GMT

By Patricia Reaney

LONDON (Reuters) - Scarce supplies of Tamiflu, which is being stockpiled by governments in case of an influenza pandemic, could be stretched by giving it with another drug, doctors said on Tuesday.

Governments have been advised to stock up on Tamiflu, a prescribed drug for seasonal flu, because it will be a first line of defense if the H5N1 bird flu circulating in Asia and reported in other areas mutates into a human pandemic strain.

Joe Howton, a medical director at the Adventist Medical Center in Portland, Oregon believes probenecid, a treatment for gout which is used with some antibiotics to boost effectiveness, could have a similar impact with Tamiflu.

No one knows how effective the drug will be against a pandemic strain but it is considered the best option until a vaccine can be developed.

Howton was browsing through safety data published by the drug's Swiss manufacturer Roche when he noticed that giving Tamiflu with probenecid doubles the number of hours its active ingredient is in the blood.

Probenecid works by preventing the drugs from being removed from the body by the kidneys.

"It dawned on me that the data potentially represented a tremendous therapeutic benefit," he told the science journal Nature.

If he is right, half a dose of Tamiflu with probenecid would be as effective as a full dose without it.

LACK OF APPROVAL

But Roche, which published the data on probenecid in 2002, said it could not advocate combined treatment because of the lack of clinical data and regulatory approval.

"Given where we are, with the potential for a pandemic, the clearest vision we can have is to dramatically increase the availability of this drug and make all information available," said David Reddy, Roche's influenza pandemic task force leader.

"We're working with external groups to determine the activity of Tamiflu against H5N1 isolates as they emerge and on other relevant clinical studies," he added.

More than 60 people have died from the H5N1 strain in Asia. Medical experts fear it could spark a global pandemic if it mutates into a highly infectious virus in humans.

President George W. Bush asked the U.S. Congress for $7.1 billion on Tuesday to prepare for a pandemic flu, including $1.2 billion for 20 million doses of a vaccine against H5N1 bird flu.

Roche has cranked up production of the drug but even the most optimistic estimates suggests the company can only meet a small fraction of global demand for the drug.

It halted deliveries of Tamiflu to the United States and Canada last week until the start of the flu season because the firm feared demand by companies and individuals could deplete stocks.

2005-10-24T11:44:00.001-07:00

Bangkok Post - Breaking News: "Experts to meet on bird flu in Canada tonight

Washington (dpa) - The search for a global strategy to ward off the threat of a major avian flu pandemic was at the heart of a gathering on Monday night (Thailand time) in the Canadian capital Ottawa, where the heads of international health agencies and senior officials from more than 30 countries were set to meet.

At issue is the dreaded H5N1 bird flu virus, which is spread by migrating wild birds with lethal effect to domestic poultry. In a few cases, the disease has jumped from fowl to human, killing more than half of the victims and raising the spectre of a global pandemic if the virus becomes contagious among humans.

On Sunday alone, the Palestinian Authority and United Emirates governments issued restrictions to confine the spread, following the lead of the European Union last week and many Asian countries. The virus has been found throughout Asia, but especially Vietnam and Thailand; in Russia, Croatia, Britain and Sweden.

The leaders are to discuss the current stage of international preparations for a global human outbreak of the deadly virus, according to Ian Shugart, Canada's assistant deputy health minister.

Canada organized the meeting, the latest in a series of urgent global talks.

The disease has infected about 120 humans in bird-human transmissions, and killed sixty-three. The latest victim was confirmed in Thailand on Thursday.

The top U.S. health official, Mike Leavitt, was scheduled to attend the gathering. The European Union and the Association of Southeast Asian Nations (ASEAN) were to send delegates.

International health leaders will include the directors-general of the World Health Organization (WHO) and the Food and Agriculture Organization, Jong-W"