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Bird Flu - Archives

 
Drugs
 

Drug Companies - Ripping Off Poor Countries?
The World Health Organisation is under growing pressure from countries hit by bird flu to devise a new formula for the sharing of virus samples and the resulting benefits.

Indonesian Health Minister Siti Fadillah Supari said the WHO's 50-year-old sharing system was unfair to poor countries.

"There is an unfair mechanism in which avian flu virus samples are provided free by developing countries but drug companies patented this vaccine and are selling them at unaffordable cost for the developing countries," Supari told the assembly.

Genetic sequencing had been used in published research, commercialisation and patent requests without consent, she said. "Such practice violates the spirit in which virus is given."

May 16th, 2007

You Can't Be Serious
Indonesia - where bird flu is more of a problem than anywhere else - isn't happy about the new Australian bird flu vaccine:

News this week that the Australian pharmaceuticals company CSL had developed a vaccine against the H5N1 bird flu virus was met with alarm by Indonesian Health Minister Siti Fadillah Supari.

He says Indonesia is seeking intellectual property rights over the Indonesian strain of the virus on which the vaccine is based.

But CSL spokeswoman, Dr Rachel David, says it is not possible to "own" strains of bird flu.

Dr David also says the vaccine is not being developed for commercial purposes.

..."It's not something we can profit out of and in fact it's not something that we see as being a commercial exercise at all."

February 1st, 2007

 

New Vaccine
CSL is a well-regarded Australian pharmaceuticals company, with a particular strength in flu vaccines. It has now announced (pdf file) the development of a bird flu vaccine. That sounds like good new.
January 31st, 2007

 

Relenza - Safer Than Tamiflu?
Some good news for bird flu drug Relenza. It seems that it's less likely to lead to flu-resistant drug strains that its big rival Tamiflu. That's according to a new study, which was carried out (coincidentally??) by Glaxo (which markets Relenza) and Australia's Commonwealth Science and Industrial Research Organisation (which helped develop it).
August 19th, 2006

 

Breakthrough Bird Flu Drug
British scientists have claimed a breakthrough in developing a bird flu drug.

A team of scientists lead by John Skehel of London's National Institute of Medical Research say they have found a cavity in the N1 or neuraminidase part of the H5N1 virus that could be exploited as a potential weak point.

But a final version of the drug may take a further five years to develop.
August 17th, 2006

Bird Flu Vaccine - 10 Years Away
A "viable" bird flu vaccine could be 10 years away, according to experts at a bird flu summit in Paris.

Vaccine researcher Dr. David Fedson, a former professor of medicine at the University of Virginia School of Medicine, said H5N1 was proving very difficult to grow in culture, according to a BBC report. Researchers were also finding it tough to stimulate an immune system response in humans that would be strong enough to defend against the virus, he said.

"H5N1 is so poorly immunogenic and replicates so poorly that we could immunize globally, with six months of production, about 100 million people," Fedson told the BBC. Compared to the 300 million doses of seasonal flu manufactured each year, the number would be far too small. "From a public health point of view this is catastrophic," he said.

July 3rd, 2006
 

UK Tests Vaccine
Oxford scientists are excited about an experimental new vaccine, which has proved highly effective in producing immunity to bird flu in a group of volunteers.

The DNA vaccine, developed by PowderMed, of Oxford Science Park, has passed safety tests and will now be tried on larger groups of volunteers.

The virus's genetic material DNA is coated with gold particles which are propelled into the skin with helium gas, instead of using a needle.


...Powdermed's chief executive, Dr Clive Dix, said current stockpiles of bird flu vaccine could only treat 75 million people worldwide, because high doses were needed. But just one kilogram of his company's DNA vaccine could potentially treat 500 million people.

"The advantage of a DNA-based approach is that the vaccines can be manufactured very rapidly and in large quantities, while yielding an immune response at low doses," he said.

PowderMed will now start phase II trials later this year using both annual flu and bird flu strains. A vaccine against bird flu could be ready by 2008, said Dr Dix.

June 7th, 2006
 

Looking for the Next Tamiflu

Newsweek spotlights three novel treatments that could prove effective against bird flu:

 

- Fludase from NexBio Inc. temporarily disables receptors in the nasal passages and airways that the flu virus latches onto.

 

- DNA vaccines are a novel type of vaccine that could one day be useful against many diseases.

 

- Ampligen from Hemispherx Biopharma helps the body boost its production of inter-feron, a crucial component of the immune response—and one that appears to plummet in patients with avian flu.

February 27th, 2006

 

Back from the Dead

The “dead-cat drug that just won’t die.” That’s how The Australian newspaper describes the Relenza anti-flu drug this morning.

 

In a lengthy article, the newspaper examines the controversy over the drug, noting that last week GlaxoSmithKline quietly reopened a Relenza production line at its factory here in Melbourne. The article suggests that the company is embarrassed at having earlier effectively deciding the drug had little future. Indeed, the paper cites court documents in which GSK states that Tamiflu is superior.

 

Relenza's return is an obvious by-product of a global hysteria over bird flu and the subsequent fear that we could face a new global flu pandemic.

 

The belated embrace of Relenza by the federal [Australian] Government was confirmed on December 16 with its order for 1.8 million "additional courses" of the home-grown flu drug. Additional indeed. Until that order, Australia's Relenza reserves stood at a grand total of 24,570 courses.

 

Not that we stood unprepared. Even though Australian taxpayers effectively spent $247 million on the development of Relenza, the Government ended up building its $555 million pandemic defence around Relenza's dominant competitor, Roche's Tamiflu.

 

So why did we spend $114 million on a Tamiflu stockpile? Most likely because Relenza's owners, GSK, had demonstrated such a palpable lack of confidence in the safety, effectiveness and value of the drug.

February 8th, 2006

 

Sanofi-Aventis Delivers
France's Sanofi-Aventis appears to be the most advanced in the race to develop a new bird flu drug. Confirmation comes with the news that it has completed production of an additional $50 million worth of bulk-concentrate vaccine for the US government.

And Didier Hoch, president of Sanofi Pasteur, has told the Financial Times that Europe’s readiness for pandemic flu could deteriorate into a “nightmare” unless EU members start to co-operate more closely over vaccines. He warned that each European country was only focused on its own national priorities, in a way that risked jeopardising supplies to the rest of the world
February 7th, 2006

 

A Quick Round-Up of Breaking Bird Flu News:

* Algerian health authorities have denied reports that a poultry breeder in Oran has died of bird flu.

 

* A Japanese group helping North Korean defectors claims that a woman in Pyongyang was infected with bird flu last month.

 

* GlaxoSmithKline expects to have a new bird flu vaccine in production by the end of the year.

 

* An Israeli virologist believes she has found a new remedy for bird flu, based on elderberries.

January 26th, 2006

 

New Drug from Avi BioPharma

Avi BioPharma, a small biotech company based in Portland, Oregon, has announced that three independent laboratories have confirmed that its new drug, Neugene, appears effective in fighting H5N1 flu. The company now plans to file with the Food and Drug Administration to begin human clinical trials. Shares in Avi BioPharma rocketed 50% on the news.

January 21st, 2006

 

Vaccine Update

Sanofi Pasteur, a unit of Paris-based pharmaceutical giant Sanofi-Aventis, is “leading the pack in the race to develop a vaccine that could help prevent an avian flu pandemic,” according to a report in Business Week. The journal says that the company has already signed contracts with the governments of France, Australia, and the US to produce more than five million doses of the vaccine to be stockpiled in case of emergency.


Meanwhile, the Science Daily website reports that The La Jolla Institute for Allergy & Immunology is making “significant strides” in the battle against bird flu, with “pre-clinical trials under way on a potential treatment conceived by one of its scientists.”

January 4th, 2006
 

Tests to Begin for Tamiflu Rival

A little Alabama biotech firm is “gaining on the front runner” in the race to develop an effective anti-flu treatment, according to a CNN report.

 

The company is BioCryst Pharmaceuticals, and it has just received US Food and Drug Administration approval to start human testing of its new drug, peramivir.

 

According to CNN:

 

Should the tests prove successful the drug could become an alternative to Tamiflu, the medicine currently considered the leading treatment for bird flu. And the effectiveness of that treatment has been called into question this week, with a report in the New England Journal of Medicine that bird flu patients died despite taking Tamiflu.


However, at the same time Business Week is reporting that Sanofi Pasteur of France "is leading the pack in the race to develop a vaccine that could help prevent an avian-flu pandemic."

December 23rd, 2005

 

High-Risk Bird Flu Vaccine Trials

Interesting report in the Chicago Sun-Times about planned human experiments on a new anti-flu drug.

 

In an isolation ward of a Baltimore hospital, up to 30 volunteers will participate this April in a bold experiment: A vaccine made with a live version of the most notorious bird flu will be sprayed into their noses.

 

…It's high-risk, high-reward" research, said Dr. Brian Murphy, who heads the NIH lab where Dr. Kanta Subbarao is brewing the nasal sprays -- including one for a different bird flu strain that appeared safe in the first crucial human testing last summer. "It might fail, but if it's successful, it might prevent hundreds of thousands of cases" of the next killer flu, Murphy said.

 

In a separate development, Gemini Science, owned by Japan’s giant Kirin Brewery, says it has developed an antibody that could prove effective in fighting bird flu.

December 19th, 2005

 

Relenza “Better Than Tamiflu”

The boss of Australian company Biota, which developed the Relenza flu drug, has claimed that it is superior to Tamiflu.

 

"Relenza has not demonstrated the resistance that Tamiflu has and appears to be efficacious in conditions where Tamiflu is not," he said.

December 17th, 2005

 

Bird Flu Round-Up

Tamiflu – a young Vietnamese girl, infected with mild influenza symptoms was given Tamiflu, and subsequently developed a strain of the avian flu virus that was highly resistant to the drug. Sixteen South Korean drugs companies have notified the Korea Pharmaceutical Manufacturers Association that they can produce Tamiflu. Twelve of them have already submitted samples.

 

Vaccines – Michael Fumento provides a most comprehensive round-up of the latest developments.

December 7th, 2005

 

Biota vs. GSK

Biota Holdings, which developed the Relenza anti-flu drug, has been unable to resolve its dispute with GlaxoSmithKline, which holds the license to market the drug. Consequently, Biota’s legal action against GSK has resumed. Biota claims that GSK breached the licensing agreement, and is seeking damages of A$308-430 million (US$227-317 million).

November 26th 2005

 

New Bird Flu Vaccine Could Take Two More Years

Australian newspapers are carrying some useful reports on the rush to develop new bird flu vaccines, based on remarks by Brian McNamee, the chief executive of local pharmaceuticals company CSL.

 

Among his comments:

 

"I think it likely that there will be a prototype vaccine that stimulates the immune response," Dr McNamee said. "What we don't know is what the dose is and whether we need an adjuvant (an ingredient or treatment that enhances the immune response) – they're the two questions.

 

"I think those questions will be answered in the next two years. It could be faster than that, but if you need an adjuvant it may take that long. We need to be realistic."

 

Dr McNamee said CSL was optimistic and working hard on developing a vaccine for the H5N1 strain of bird flu as soon as possible, but the company could not forecast the data it needed to develop a vaccine….CSL was one of four major companies globally trying to develop a bird flu vaccine, but all of the companies had agreed to share data.

 

"We would feel that Sanofi and ourselves probably have the best data coming out shortly, GSK (GlaxoSmithKline) have some interesting data as well, and Chiron are doing some interesting work with an adjuvanted vaccine," Dr McNamee said. "We well know that there's not enough manufacturing capacity in the whole world so we have to behave this way."

November 24th 2005

 

Up and Down

Shares in bird flu companies Roche Holding and its Japanese partner Chugai Pharmaceutical fell yesterday after reports that Tamiflu – made by Roche – might have caused two Japanese teenage boys to commit suicide. Roche has said there is no clear evidence that the drug was responsible.

 

But shares in Avant Immunotherapeutics soared more than 10% on news that it is developing a bird flu vaccine.

 

Also developing a vaccine is the Russian Flu Research Center, according to the Novosti news agency. It believes it could be ready for commercial production by February or March next year. Just one problem – not enough money.

November 15th, 2005

 

Hungary’s New Bird Flu Drug

Interesting report from the Australian Broadcasting Corporation on Hungarian claims to have developed an effective new bird flu vaccine. The report quotes the country’s chief medical officer: “A new vaccine is considered effective if there is a 2.5 times increase of antibodies in the blood. Our vaccine increased the levels of antibodies to a 10 times higher level.” However, WHO and the EU have expressed concerns about the speed at which the drug has been developed.

October 29th, 2005

 

Relenza Sales Booming

Anti-flu drug Relenza has some advantages over Tamiflu, according to Peter Molloy, chief executive of Biota, the drug’s developer. He was speaking at the company’s annual general meeting, here in Melbourne.

 

"In the current environment where Tamiflu's supply is severely backlogged and resistance concerns are emerging, we expect to see further significant orders for Relenza from other governments, including hopefully the Australian government," he said.

 

Mr Molloy said Relenza was effective against the latest strain of Avian flu both as a preventative and curative measure.

 

Mr Molloy said the worldwide sales potential of Relenza, which is licensed to global pharmaceutical giant GlaxoSmithKline (GSK), was in the hundreds of millions of dollars.

 

"If these sales are realised, clearly Biota's royalty stream over the next nine years - that is, until the patents expire - could be substantial."

October 28th, 2005

 

Chiron to Provide Vaccine Stockpile

The US government has awarded a $62.5 million contract to pharmaceuticals company Chiron to provide a stockpile of H5N1 flu vaccine, for use in the case of an outbreak.

 

Reuters describes the vaccine as “a ‘pre-pandemic’ formulation that Chiron and other companies have been working on for more than a year now, Chiron said. Doctors and health officials hope it will be useful as a ‘priming dose’ that would help jump-start an immune response to be fine-tuned by a second vaccine.”

 

Last month, the US government awarded a $100 million contract to European drug company Sanofi-Aventis for bird flu vaccine.  And yesterday the US Senate voted to provide nearly $8 billion in funding in fiscal 2006 to stockpile anti-flu vaccines and other medicines.

October 28th, 2005
 

Biota – The Little Aussie Bird Flu Battler

A couple of months ago you could have bought Biota Holdings shares for around 50 cents. Last week they hit $2.60.

 

The reason – bird flu.

 

For Biota is the pharmaceuticals company behind Relenza (the marketing name for zanamivir), the ground-breaking anti-viral drug that is rated second only to Tamiflu in ability to fight bird flu.

 

Biota has its headquarters near Monash University, a 15-minute drive down Blackburn Road from my home here in the Eastern suburbs of Melbourne....continue reading Biota – The Little Aussie Bird Flu Battler.

October 25th, 2005


Has Roche Marketed Tamiflu Properly?

Details emerged over the weekend of accusations being leveled against Roche by Gilead Sciences, owner of the Tamiflu patent. Forbes reported:

 

Roche Holding AG has been accused of serious failings in the manufacture of Tamiflu by US biotech firm Gilead Sciences Inc, the owner of the patent on the highly sought after bird flu drug, UK Sunday paper The Observer reported citing court papers filed with the US Securities and Exchanges Commission.

Gilead, which is demanding termination of its licence agreement with Roche because it says that the Swiss drugmaker has failed to market the drug properly, has identified a number of incidents over the past three years which required Roche to issue product recalls, the paper said.

 

Read the entire report for more. This one looks set to run and run.

October 24th, 2005

 

Stock Market News

The Associated Press reports:

 

Shares of Quidel Corp. jumped Friday after the medical test maker said its QuickVue flu test not only showed high rates of accuracy in a recent study but can also detect the virus that causes avian flu….The company said an Australian study of its 10-minute QuickVue Influenza A+B test over the continent's summer flu season accurately diagnosed the presence of Type A flu virus 96 percent of the time and the absence of flu virus 97 percent of the time. In an earlier study conducted in Hong Kong and Japan, the test was shown to be able to detect the H5N1 virus.

October 22nd, 2005

 

Vaccine Test Results “By the End of This Year”

AFX News reports: “Sanofi-Aventis SA said the results from trials aimed at discovering a vaccine for the H5N1 bird flu strain should be known by the end of this year.”

October 20th, 2005

 

Hungary Tests New Flu Vaccine

Hungary’s Health Minister has reported that a new flu vaccine undergoing tests in the country appears to be effective. The BBC quoted him as saying: "The results are preliminary but I can say with 99.9% certainty that the vaccine works." No further details are available about the vaccine.

October 20th, 2005

 

Drugs Latest

One of the developers of Relenza has warned that the world faces “a deadly gap of several years” in finding new drugs to combat a flu pandemic, should the virus develop resistance to Tamiflu and Relenza. Professor Mark von Itzstein said there were no clinical trials in progress of new anti-bird-flu treatments. He said that in his Gold Coast laboratory alone there were three potential drugs that had not been developed due to lack of funding.

 

Meanwhile, Roche has said it will build a new US plant to produce more Tamiflu. And GlaxoSmithKline is to start production of Relenza here in Melbourne. Currently it is made only in France.  

October 19th, 2005

 

Generic Tamiflu

The Taiwanese Department of Health has written to Roche requesting negotiations on the generic production of Tamiflu. Meanwhile, Thailand is apparently going ahead with its own production, without consulting Roche.

October 18th, 2005

 

Thumbs Up for Tamiflu

An Aussie scientist has said Tamiflu will likely be effective against any bird flu that hits Australia.

 

Professor Bill Rawlinson, a virologist from the Prince of Wales Hospital, said there was no need for people to panic that Tamiflu was no longer an effective vaccine….A bird flu outbreak in Australia would be the result of a new strain able to spread from humans to humans, and such a strain was more likely than not to be sensitive to Tamiflu, he said. Australian health officials have stockpiled Tamiflu, as well as a similar drug, Relenza. Professor Rawlinson said any strain of flu resistant to Tamiflu was likely to also be resistant to Relenza. "If bird flu comes to Australia, it is possible that resistance will be a problem - but it is unlikely," he said.

October 17th, 2005

 

Tamiflu Update

First we hear that several companies plan generic versions of Tamiflu. Now we learn that there’s not enough star anise.

 

Production of Tamiflu, made by the Swiss company Roche, is being hampered by a shortage of star anise, a star-shaped fruit grown in China and the source of shikimic acid from which Tamiflu is made in a year-long process. Ninety per cent of the harvest is already used by Roche.

October 16th, 2005

 

The Headline Says It All

Bird Flu Virus That Is Drug-Resistant Is Found in Vietnamese Girl
Washington Post

 

In other drug developments:

 

The Philippine Department of Health has urged local drug manufacturers to try to make their own versions of Tamiflu. “[Health Undersecretary Alex] Padilla said the Bureau of Food and Drugs would issue a certificate of product registration authorizing the sale of a locally produced vaccine in the Philippine market. ‘It’s up to (Roche) to file a complaint.’”

 

Sanofi-Pasteur is to begin clinical trials in (northern) spring 2006 of its vaccine.

Two bloggers, Stephen Gordon and Andrew Sullivan, call for Roche to be forced to allow generic production of Tamiflu. Says Sullivan: "We have no time to waste."

October 15th, 2005

 

Indian Company to Make Generic Tamiflu

Cipla, India’s third-largest drugs manufacturer, says it plans to start producing a generic version of Tamiflu. The company says it has finished reverse engineering the drug, and believes it can have small commercial quantities available as early as January. This is despite claims from Roche, holder of the Tamiflu patent, that it could three years for another company to be able to produce the drug.

October 14th, 2005
 

Vaccine Update

New Scientist has placed online a lengthy article on bird flu vaccine developments. It repeats what has already been said, that even if a vaccine is developed, it may not be possible to produce enough. The article also points to commercial and political obstacles. Its conclusion:

 

If the political will were there, we could already be taking steps to protect ourselves against the first wave. When researchers at the vaccine maker Chiron tested the blood of people who had received an experimental vaccine against a 1997 strain of H5 bird flu, they found it cross-reacted strongly with the H5 flu that killed people in Vietnam last year. This raises hopes that a vaccine against 2004 or even 1997 H5, say, might work against an H5 pandemic strain, even if it differs slightly. "We are confident that a vaccine is feasible even if it is not fully matched to the pandemic strain, as long as there is a strong adjuvant," Giuseppe del Giudice of Chiron told New Scientist. While it may not protect 100 per cent, it might mean that H5 does not kill so many people. And it would act as a "priming" dose, meaning people would later require only one shot of vaccine matched to the pandemic strain.

October 14th, 2005

 

Roche to Boost Tamiflu Production

Roche has taken steps to boost production of Tamiflu. However,

 

the 12 months it takes to make Tamiflu means governments that have yet to order will have to wait, Swiss pharmaceutical company Roche Holding AG said Wednesday…."We asked governments several years ago to make Tamiflu orders for pandemic purposes well in advance," Roche spokesman Alexander Klauser told The Associated Press. "We explained the procedure to them, how it works and that we had to start production well in advance or we wouldn't be able to produce Tamiflu in the required amounts on time."…Roche said there are 10 complex steps to make Tamiflu and it would be unrealistic to outsource the complete procedure, as outside companies would need up to three years to set up production as well as gain the capacity and know-how.

October 14th, 2005

 

Roche “Won’t Share Patent”

The San Francisco Chronicle reports that Roche Holdings is not prepared to allow generic production of its Tamiflu anti-flu drug. This follows reports that public health officials in several countries are calling for the company to be forced to share the patent with other drug manufacturers, in order to ensure adequate supplies in the event of a major outbreak of bird flu.

 

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.

October 13th, 2005

 

Tamiflu Generic Production Urged

Roche Holdings is reportedly under pressure to allow production of generic versions of its anti-flu drug Tamiflu. The reports say the company believes the drug is so complex that generic maker would struggle to produce significant quantities. This is contradicted by Taiwanese authorities, who believe they could begin manufacture within months of receiving permission.

October 12th, 2005