100M$ voor Sanofi-pasteur global pandemic

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Press Release Source: Sanofi pasteur

Sanofi pasteur to Produce $100 Million Dollars of Vaccine Against H5N1 Influenza Virus for U.S. Government
Thursday September 15, 10:30 am ET
- Influenza Vaccine Leader Takes New Step in Global Pandemic Preparedness -

LYON, France and SWIFTWATER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group (NYSE: SNY - News), has entered into an agreement with the U.S. Department of Health and Human Services (HHS) to produce a vaccine to help protect against the H5N1 influenza virus strain, the so-called avian strain. Scientists believe the H5N1 strain could become the cause of a global influenza pandemic.
The contract is another major effort by sanofi pasteur to support efforts in both the U.S. and Europe to prepare the world for the possibility of an influenza pandemic.

The $100 million contract calls for sanofi pasteur to manufacture the vaccine in bulk concentrate form at its U.S. headquarters in Swiftwater, PA from early September through late October. The agreement provides for additional fees to be paid to sanofi pasteur for storage of the vaccine as well as for formulation and filling of the vaccine upon government request.

Sanofi pasteur's Global Commitment to Pandemic Preparation

In the U.S., the contract with HHS is sanofi pasteur's fifth pandemic- related agreement with the U.S. government.

* In May 2004, sanofi pasteur contracted with the NIAID to produce 8,000
investigational doses of the H5N1 influenza strain. The doses were
manufactured and shipped to the NIAID on March 2 and 3, 2005. The
clinical studies for the vaccine are being conducted by the NIAID.

* In September 2004, the company signed a contract with HHS to produce
two million doses of bulk vaccine derived from the H5N1 viral strain.
The bulk doses were produced and are being stored, and can be
formulated and filled upon government request.

* In November 2004, the HHS awarded a contract to sanofi pasteur for the
establishment and maintenance of flocks of egg-laying hens to allow the
company to manufacture pandemic influenza vaccine at current full
capacity on a year-round basis. The flocks will be fully available by
September. In addition, the contract calls for sanofi pasteur each
year to produce investigational doses for a potential pandemic
influenza vaccine. This year the company will produce 3,000
investigational doses of a vaccine to protect against the H7N7
influenza strain.

* In April 2005, the HHS awarded a contract to sanofi pasteur to speed
the production process for new cell culture influenza vaccines in the
U.S. and the design of a U.S.-based cell-culture vaccine manufacturing

In Europe, sanofi pasteur initiated and runs a large range of projects.

* Sanofi pasteur is sponsoring the first clinical trials to determine the
safety and immunogenicity of an H5N1 influenza vaccine. The clinical
trial is conducted in France. The strain was provided by the U.K.'s
National Institute for Biological Standards and Control (NIBSC). The
clinical lots are being developed in collaboration with the French
health authorities, NIBSC and the European Medicines Agency (EMEA). The
data from these studies will be used in a "mock dossier" submitted to
the EMEA to accelerate the license approval process in the event of a

* FLUPAN: Sanofi pasteur is the only vaccine manufacturer to participate,
along with the NIBSC and the University of Reading, in this E.U.-funded
collaboration. FLUPAN is intended to improve the level of pandemic
preparation in the E.U. The company will produce pandemic influenza
vaccine that will be used in a FLUPAN clinical study.

* Sanofi pasteur is in active discussions with governments, and European
authorities concerning production on H5N1 vaccines and production
option for pandemic vaccine.

In Australia, the government has a contract with sanofi pasteur for the supply of pandemic vaccine should there be an outbreak of pandemic influenza. The pandemic agreement was part of a three-year contract that covers interpandemic influenza vaccine supply as well. Sanofi pasteur was awarded 35% of the annual interpandemic vaccine supply.

The new contract illustrates sanofi pasteur's continued commitment toward the production of influenza vaccine to protect against possible pandemic strains, both in the U.S. and throughout the world.

Reliable Influenza Vaccine Supplier for Years

Influenza vaccines leader sanofi pasteur operates two manufacturing facilities to produce injectable influenza vaccine for the world, in Val de Reuil in France and Swiftwater in the U.S.

New Influenza Facilities Under Construction

* Sanofi pasteur began construction of a new 145,000 square-foot, $150
million manufacturing facility in Swiftwater that is currently expected
to be ready for production for the 2008 - 2009 influenza season. The
plant will replace the existing influenza manufacturing plant in
Swiftwater and will double the site's capacity for producing influenza

* The company is also investing in a major expansion of its Val de Reuil,
France, vaccine production plant.

Influenza Overview
There have been 68 laboratory-confirmed human cases of H5N1 avian influenza reported to the World Health Organization (WHO) between December 16, 2004 and August 5, 2005. Scientists believe the H5N1 strain could become the cause of a global influenza pandemic.

Influenza is a highly contagious virus that is spread easily from person to person, primarily when an infected individual coughs or sneezes.

An influenza pandemic is a global epidemic of an especially virulent virus with the potential for severe morbidity and mortality. According to the World Health Organization (WHO), the next pandemic is likely to result in 1 to 2.3 million hospitalizations and 280,000 to 650,000 deaths in industrialized nations alone. Its impact will most likely be even more devastating in developing countries.

Tja, Crucell heeft de juiste partner.
Nu nog even wachten, dat we mooi mee profiteren.

Wait and see....
heerlijk om te lezen $$$ up to the 250.-- en julie zullen nooit meer iets van mij horen hier ...
alleen snap ik de reactie van de koers aandeel sanofi niet, schiet niet op de laatste dagen, wel even een boost (en nktr nog meer) toen het nieuwe inhalable insuline voor diabetes approvable werd verklaard.
nu nieuws over griep, en dat spul verkoopt zeker. koers? zakken over de laatste dagen, dat duppie van vandaag zegt me niets, maar goed we zijn ook verwend met laatst die euro erbij op crucell.
Van yahoo forum:

Sanofi-Aventis (NYSE:SNY, Paris:SAN.PA)
by: randstory (55/M/St. Davids, PA) 09/16/05 06:25 am
Msg: 68084 of 68085

Since Yahoo!Finance messages is being recalcitrant about posting this am (9/15/05)
I'll keep this minimal:

Please read the news item- Associated Press- from yesterday. In toto.

The market doesn't appear to get it yet, it may take a day or a week or two to sink in...

The U.S. has to have a "response" for avian flu. It needs 200 million plus, deliverable (injectable, or intranasally delivered) doses of effective influenza vaccine every year, plus 200 million plus deliverable doses of pandemic vaccine...

It is fasttracking cell-lines for both. These are through SNY, to be made at the Swiftwater,PA. plant. Per C. 6 and AdVac(R) tech. (CRXL) used in both.
Due 2008-2009 flu season. 3 years.
Effects: CRXL support @$24 and M-T to $30.
SNY support @$40- M-T to $45-$48.


Low-dose bird flu vaccine tested on humans
18:18 16 September 2005

The first clinical trials of a low-dose H5N1 bird flu vaccine are already under way, New Scientist can reveal.

Agnes Hoffenbach, head of pandemic research at manufacturer Sanofi Pasteur, says the results will be ready by December 2005.

Crucially, Sanofi Pasteur’s trial is testing low doses of killed vaccine virus combined with adjuvant - a chemical that stimulates the immune system.

Earlier in 2005, the US conducted the first clinical trials of another H5N1 vaccine made by Sanofi Pasteur (which is also the only firm which makes standard flu vaccine in the US). But those trials were on virus formulated without an adjuvant, in the 15 and 45-microgram doses now used in vaccines for ordinary flu.

As New Scientist reported at the time, previous experimental work on bird flu suggested that without adjuvant these doses of the virus would be unlikely to elicit much of an immune response.

Barrier to development
In August, Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases, revealed that this was exactly what happened: to get a significant immune response people needed to be given 90 micrograms of killed vaccine virus, in two doses four weeks apart.

That is 12 times as much virus as is needed to make an effective vaccine out of an ordinary influenza virus. That in turn means that the world’s vaccine-making capacity would be able to make a mere 25 million doses a year.

The Sanofi Pasteur trials currently under way are believed to involve doses as low as 3.5 micrograms, which if effective would quadruple the number of vaccine doses the world could produce per month.

Sanofi-Aventis (NYSE:SNY, Paris:SAN.PA)
by: randstory (55/M/St. Davids, PA) 09/16/05 06:25 am
Msg: 68084 of 68108

Since Yahoo!Finance messages is being recalcitrant about posting this am (9/15/05)
I'll keep this minimal:

Please read the news item- Associated Press- from yesterday. In toto.

The market doesn't appear to get it yet, it may take a day or a week or two to sink in...

The U.S. has to have a "response" for avian flu. It needs 200 million plus, deliverable (injectable, or intranasally delivered) doses of effective influenza vaccine every year, plus 200 million plus deliverable doses of pandemic vaccine...

It is fasttracking cell-lines for both. These are through SNY, to be made at the Swiftwater,PA. plant. Per C. 6 and AdVac(R) tech. (CRXL) used in both.
Due 2008-2009 flu season. 3 years.
Effects: CRXL support @$24 and M-T to $30.
SNY support @$40- M-T to $45-$48.


We krijgen dus ook nog een royalty over Advac.

ps vreemd dat deze posting geen aandacht krijgt op yahoo forum, van mij krijgt ie alvast een aanbeveling.
Zeg nu zelf, wie nu niet in crucell instapt, met dit soort duidelijkheid en zekerheid, die heeft het aan zichzelf te wijten dat ie geen geld wil verdienen. De amerikaanse overheid en Sanofi zullen ervoor zorgen dat vaccin o.b.v. per.c6 er komt in 2008, hoe dan ook, met welke middelen dan ook.

De markt:
De griepvaccin markt zal enorm zijn, aangedreven vanuit noodzaak omdat birdflu rondwaart. Dan kijk je even naar de marktleider (sanofi) en kijkt wie eigenlijk de techniek levert en een exclusief contract levert, een klein bedrijfje uit Nederland genaamd Crucell, die over elk vaccin een double digit royalty ontvangt (>10%).

zie nu pas dat aossa dezelfde posting al had geplaatst. sorry.

25 break out companies van Fortune!

Each spring we conduct a rigorously unscientific survey—picking the brains of gurus and geeks to cull truly innovative companies from a frothy sea of poseurs. Today’s esprit de cool flows from San Diego to Beijing, encompassing touch recognition, noninvasive biopsies, and—at last!— self-heating coffee.

CRUCELL, Leiden, the Netherlands, crucell.com
If the deadly bird flu simmering in Southeast Asia
boils up into a pandemic, demand for influenza
vaccines will explode. So will Crucell’s stock price.
The company offers a line of human cells that’s
emerging as a key ingredient for making the vaccines.
Currently vaccine production entails growing flu
viruses in fertilized chicken eggs; the viruses are extracted,
deactivated, and processed into flu shots.
The eggs come from high-tech poultry farms that
would be hard to expand fast. Boosting vaccine production
with Crucell’s methods would be relatively
easy—its cells, in which flu viruses thrive, are kept
in big vats called bioreactors that can be readily multiplied
to expand capacity.
Recently the U.S. government awarded $97 million
to Sanofi Pasteur, the vaccine unit of Sanofi
Aventis, to fund its transition to Crucell technology
for making flu vaccines in the U.S. The process is
also being used to develop vaccines for malaria,
Ebola virus, and West Nile virus. Crucell is hawking
its technology to make many other bioengineered
medicines too. A raft of drugmakers, including Glaxo-
SmithKline and Roche, have licensed its “PER.C6”
cells for that purpose. If enough customers follow
suit, Crucell’s investors won’t have to wait for a flu
pandemic to see the stock take off.
US talks on Roche flu drug deal continue By Tom Armitage
Mon Sep 19, 5:48 AM ET

ZURICH (Reuters) - The United States is in talks with Roche to buy a batch of its Tamiflu influenza drug, the company said on Monday, but it declined to comment on a report that the contract could be worth $1 billion.

A spokeswoman for Roche in Basel confirmed that previously announced talks with the U.S. government over a stockpile of the drug continued. She declined to comment on calculations made by the Financial Times that the contract could be worth $1 billion.

"I can only confirm that the talks with the U.S. government are ongoing but we are not publishing the price," the spokeswoman said.

Roche's head of virology, David Reddy, said in an interview with the Financial Times that he would not elaborate on the value of a deal with the United States government.

"We are currently in discussion with the U.S. for the purchase of significant quantities of Tamiflu that would put it among the best prepared in the world," the paper quoted Reddy as saying.

Roche stock was up 1.1 percent at 184.50 Swiss francs at 0934 GMT.

The potential size of a U.S. government order has been the subject of analysts' attention in recent months as the market tries to work out how much additional revenue Roche will reap from sales of Tamiflu for government stockpiling.

The drug chalked up sales of 580 million Swiss francs in the first half of this year, and the firm expects another 300 million francs or more in the second half of the year as more government orders come through.


An order worth $1 billion from the U.S. government would far exceed current expectations and deliver a hefty one-off gain for Roche.

"If the U.S. order is as big as rumored, the sales will be recorded over 2005/2006, and possibly into 2007 depending on how much product Roche can deliver," Helvea analyst Andrew Fellows wrote in a note to clients.

Interessant artikel in NYT. Bevestigt en passant dat de ramp in NO maatregelen mbt pandemie bespoedigt.
Richer Nations Seek Protection From Bird Flu
International Herald Tribune

ROME, Sept. 18 - As World Health Organization officials repeat warnings about the potential for a deadly bird flu pandemic, wealthier countries are redoubling efforts to buy an experimental vaccine and antiviral drugs in the hopes of protecting their citizens from infection.

At the United Nations on Wednesday, President Bush proposed an "international partnership" to combat the disease, and the United States announced last week that it had placed orders for $100 million worth of a promising but technically unlicensed vaccine that is under development by the French drug maker Sanofi-Aventis.

"We cannot afford to face the pandemic unprepared," Lee Jong Wook, the director of the World Health Organization, said Thursday at the United Nations.

The health agency and the European Union have been urging countries for months to prepare for the possibility of a human pandemic caused by the bird flu virus, even as they have acknowledged that there is no current risk. The virus, A(H5N1), which has killed millions of birds, only rarely infects humans and does not normally spread from person to person - a basic requirement for human epidemics.

But scientists are worried that it could someday acquire that ability through one of several biological processes. In the wake of the unprecedented damage caused by Hurricane Katrina, calls for better disaster planning against disease seem to have taken on new urgency.

Roche Pharmaceuticals was struggling to fill huge recent orders from 30 countries for antiviral drugs, placed as part of disaster planning, said Martina Rupp, a spokeswoman for the company. Those countries include Australia, France, England, Singapore and South Korea.

"We have learned in the past weeks that bad things can happen very fast," said Michael O. Leavitt, the secretary of health and human services, as he explained the need for the new partnership to fight bird flu.

Specialists say planning for the possibility of a worldwide pandemic is difficult because the vaccines are novel and the drugs have not been used in this capacity before.

But as countries spend tens of millions of dollars to prepare for bird flu, they are investing in uncertain and untested strategies, WHO officials acknowledge.

The basic problem is that the A(H5N1) virus has not changed in a way that would allow for widespread human infection. What is more, health officials said they would not know precisely how to combat the virus until after it mutated, when they would be able to study its composition and how deadly it was.

"We know we're overdue for an influenza pandemic strain, and we know it will occur, but we don't know when or even exactly what virus will cause it," said Dick Thompson, a WHO spokesman. "It is possible that the virus won't be H5N1 at all or that this virus will change in a way so that the vaccine under development doesn't work against it."

He said the health agency would not comment on whether it was rational for countries to spend so much on medicine orders. But, he added, "We think it is wise because it encourages the companies to do the research and development on this very difficult problem."

The bird flu virus has two characteristics that make it capable of igniting a pandemic. It is a new virus, so humans have no defenses against it. It produces severe disease, killing about half of those infected, almost all through contact with sick birds.

"H5N1 has pandemic potential but it is not a pandemic virus," Mr. Thompson said, because it does not spread easily among humans.

But flu viruses are prone to mutation and exchanging genetic material when they infect an animal together. So one big fear is that an ordinary human flu virus and the bird flu virus could mix genes, creating a new type of lethal human bird flu virus.

Because many viruses only attack certain species, this would most likely only occur in humans or pigs, scientists say. But no one knows how likely this is. If it happened, the health agency estimates that it could kill 2 million to 7.4 million people worldwide. Others have made estimates in the tens of millions.

To prepare for the possibility of human bird flu, governments are racing to buy the only two types of medicine known to have potential against the disease.

The first is a novel vaccine that is in the final stage of clinical trials. The second strategy is to buy one of several antiviral drugs, which are known to shorten the duration of influenza among those already infected and to reduce the likelihood of serious and deadly complications.

World has slim chance to stop flu pandemic
20 Sep 2005 05:55:21 GMT

Source: Reuters

NOUMEA, New Caledonia, Sept 20 (Reuters) - The initial outbreak of what could explode into a bird flu pandemic may affect only a few people, but the world will have just weeks to contain the deadly virus before it spreads and kills millions.

Chances of containment are limited because the potentially Scientists estimate that between 300,000 and one million people will immediately need anti-virals, but there are only limited stocks. WHO will receive one million doses by the end of 2005 and a further two million by mid-2006.

Even when an avian flu vaccine is fully developed, production limitations will mean there will not be enough vaccine.

"Right now we have a timeframe of four to six months to develop and produce a certain quantity of vaccine and that may not be fast enough," said Oshitani.

Last week French drug maker Sanofi-Aventis won a $100 million contract to supply the United States a vaccine against H5N1. The United States has also awarded a $2.8 million contract to Britain's GlaxoSmithKline for 84,300 courses of an antiviral. The purchases are part of a U.S. plan to buy vaccine for 20 million people and antivirals for another 20 million.

Oshitani said the early vaccines were unlikely to protect against the pandemic virus. "The vaccine should match the pandemic strain. So a vaccine developed for the virus in Vietnam now may not protect you from another virus," he said.

But Oshitani fears that once a pandemic occurs, the world's rich nations may dominate vaccine supply.

"The distribution of a vaccine will be a major issue when a pandemic starts. There is no mechanism for distribution," he said. Asked whether poorer Asian nations such as Cambodia and Vietnam would get a vaccine, Oshitani said "probably not".

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