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
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