Forum: Crucell » Draadje vogelgriep

gogogoo 13 oktober 2006 21:03

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Deze zal vast wel al eens geplaatst zijn maar ik kan 'm nergens vinden en lijkt me de moeite waard om het risico te nemen dat het dubbel geplaatst is:

july 2006

H5N1, a source in the making?
President & Chief Executive Officer Crucell N.V.
Few would be surprised if a human pandemic of H5N1 bird flu gripped the world today.. It was a different story in 430BC when the world’s first known pandemic gripped the Greek city of Athens, killing a quarter of the population over four years. In 1994 a mass grave was discovered beneath the Kerameikos cemetery in Athens, including many infants. In 2006 researchers from the University of Athens confirmed the presence of bacteria esponsible for typhoid fever in the pulp of teeth of the victims from this pandemic. By the 2nd Century AD a plague, most likely smallpox, hit the people of the Roman Empire killing almost 5 million. This extraordinary toll was surpassed by the first pandemic of the bubonic plague, the plague of Justinianus from AD541 that killed 40% of Constantinople’s population. In a second wave the disease spread further into Europe, leaving an estimated death toll of about 25 million. Nearly 800 years later the disease returned as the” black death” from Asia, spreading over Europe and killed 20 million Europeans in six years. The disease occurred repeatedly in Europe until the 1700’s, causing an estimated global death toll of 130 million. By 1816 Cholera took over and became truly global with seven pandemic outbreaks affecting virtually every continent. Although controlled by modern sanitation, Cholera is still a killer at present.

Today we are facing the threat of bird flu, given the license plate number “Influenza A H5N1” by virologists.

Since 1997 this virus has shown an unprecedented spread sweeping across Asia, Europe and Africa destroying flocks of poultry, affecting >200
humans and killing 113. The big question is, will H5N1 cause a human pandemic? Although the virus has apparently found its way directly to man, in its present form it does not seem to be very effective in its transmission to human and between humans.
This contrasts sharply with other influenza A viruses that have caused the great pandemics of the 20th Century. During pandemic of 1918, the H1N1 virus spread with breathtaking speed around the globe, killing 20-40 million. However, the present H5N1 virus is a moving target, and two distinct variants of it have already developed, one from Vietnam and one from Indonesia. Scientists believe that when the H5N1 virus succeeds in acquiring the tools that enable it to spread among humans, an apocalyptic pandemic superseding the 1918 flu may become a reality. Therefore, the bigger question is: are we prepared for it?
Flu vaccine manufactures are using embryonated eggs for the production of flu vaccines and they are increasing at high speed the capacity of their facilities to produce enough H5N1 vaccine in case a pandemic strikes. The realization that the “egg production platform” could fail to produce enough vaccine in a fast and flexible way in the event of a pandemic has boosted cell culture based flu vaccine production platforms including Crucell’s PER.C6 cell line. PER.C6 is a human cell line that efficiently promotes the replication of many viruses, including influenza viruses. The cell has been accepted by the FDA as a production platform for vaccines. The world’s largest Flu vaccine manufacturer sanofi pasteur has teamed up with Crucell to scale up the PER.C6 production platform for flu vaccine production in 20,000L tanks. The first clinical trial with a PER.C6 based pandemic vaccine is to start in September this year. In close collaboration with WHO and regulatory bodies like EMEA and FDA and governments, industries are working on scenarios and procedures to speed up the market introduction of flu vaccines in case of a pandemic. Over 30 clinical trials are planned or ongoing, with some already completed, to test prototype pandemic H5N1 vaccines. Results are discouraging as a large amount of viral antigen is required to evoke an immune response thought to be effective in preventing infection. That is why industries are also focusing on technologies aiming at improving the efficacy of flu vaccines. Crucell’s technology toolkit has something to add. The innocent common cold adenovirus can be used to carry genes encoding (parts of) proteins of pathogens for vaccination purposes.
This so called adenovector technology been proven by Crucell and its partners to constitute effective vaccines against other infectious diseases like Ebola and malaria and may be used for pandemic flu as well. Moreover, Crucell’s virosome technology used for its marketed epidemic flu vaccine, could increase the immunogenicity of a pandemic vaccine, a possibility being tested at the moment.
As H5N1 is a moving target the strategy of stockpiling H5N1 vaccines for the pandemic has been questioned. The real pandemic hit may come from a
mutated H5N1 or even completely different virus strains like H9 or H7. Industry players, including sanofi pasteur and Crucell are investing also in production of, and clinical trials with vaccines against these potential pandemic strains. The millions of wild ducks and other waterfowl, aggregating together every summer for their annual migration in the Canadian and Siberian lakes while shedding massive amounts of influenza viruses from their intestine, may come with a new surprise.
Could we quash an incipient pandemic? I am hopeful that with the present technologies we can.

www.ps.fmnsedu.rug.nl/foliolum/juli20...

[verwijderd] 15 oktober 2006 11:06

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Vical's Vaxfectin(TM) Adjuvant Boosts Immune Response to Seasonal Influenza Vaccine; Suggests Potential Dose-Sparing Application for Pandemic Flu

TORONTO, Oct. 14 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq:
VICL) today announced that data from a study in mice showed an adjuvant
originally developed to boost the immune response to its DNA vaccines also
boosts the immune response to a conventional seasonal influenza (flu)
vaccine. Results from the studies suggest that the company's patented
vaccine adjuvant known as Vaxfectin(TM) has the potential to be used as a
dose-sparing agent with conventional flu vaccines against seasonal or
pandemic flu strains. The company is developing a Vaxfectin(TM)-formulated
DNA vaccine designed to protect against emerging strains of flu virus that
have the potential to cause a pandemic. Larry R. Smith, Ph.D., the
company's Vice President of Vaccine Research, presented the data Saturday
at the annual meeting of the Infectious Diseases Society of America
(Toronto, October 12 - 15).
Mice were vaccinated with Trivalent Inactivated Influenza Vaccine
(Sanofi-Pasteur Fluzone(R) 2005-2006 Formula commercial product), with or
without the Vaxfectin(TM) adjuvant, and evaluated for immunogenicity
through hemagglutination inhibition (HI) titers, the accepted standard
correlate of protection for conventional flu vaccines.
Vaxfectin(TM)-formulated vaccines yielded significantly higher HI titers
than unformulated vaccines at the same dose.
Vaxfectin(TM) is a novel adjuvant designed by Vical to increase the
immune response in DNA vaccines, and Vaxfectin(TM) formulations have
demonstrated good tolerability and adjuvant activity in DNA vaccine
applications in multiple animal models, including non-human primates. The
company holds patents in the United States covering both the novel
Vaxfectin(TM) adjuvant and its use with conventional vaccines against
infectious diseases and cancer, and in both the United States and Europe
covering the use of Vaxfectin(TM) with DNA vaccines. Vical's lead
Vaxfectin(TM)-formulated, three-component DNA vaccine candidate against
avian flu provided 100% protection in mice and ferrets against lethal
challenges with a highly virulent H5N1 virus, and is advancing toward human
testing.
www.prnewswire.com/cgi-bin/stories.pl...

[verwijderd] 15 oktober 2006 11:10

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Higher Antibody Responses Observed in Young Children Receiving MedImmune's Investigational Intranasal Influenza Vaccine Compared to Injectable Vaccine Data From 2004-2005 Flu Season Support Prior Findings of CAIV-T Effectiveness Across Influenza Strains

TORONTO, Oct 13, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- MedImmune, Inc. (Nasdaq: MEDI) today announced results of a study that demonstrated higher influenza serum antibody responses in children receiving its next-generation, investigational intranasal influenza vaccine, CAIV-T (cold adapted influenza vaccine, trivalent), than in children who received the traditional injectable trivalent inactivated flu vaccine (TIV). In this study involving 52 children between six and 35 months of age, CAIV-T prompted significantly higher seroconversion rates and higher antibody titers than TIV. CAIV-T also demonstrated significantly more cross-reactivity to the mismatched strain that predominantly circulated during the 2004-2005 season. The results were presented here today at the 44th Annual Meeting of the Infectious Diseases Society of America (IDSA).
"These data are consistent with the results from our Phase 3 study conducted during the 2004-2005 season that demonstrated CAIV-T's increased efficacy against matched and mismatched strains in children under five years of age compared to TIV," said Robert Belshe, M.D., director of the Center for Vaccine Development at Saint Louis University School of Medicine.
In the study titled Immunogenicity of Cold-Adapted Influenza Vaccine, Trivalent (CAIV-T) Compared with Trivalent Inactivated Influenza Vaccine (TIV) in Children 6-35 Months of Age, a group of influenza-vaccine-naive children (randomized 1:1) received two doses of CAIV-T or TIV approximately 35 days apart. The children's immune responses (measured by serum hemagglutination inhibition [HAI] antibody levels) were evaluated at the time of enrollment, just prior to and approximately 30 days after the second dose. Study results indicated that CAIV-T produced significantly higher antibody responses than TIV against vaccine-like virus strains (matched) as well as against mismatched viruses that were circulating during the 2004-2005 season in seronegative children. Higher antibody responses were seen for CAIV-T after both the first and second doses.

Strain-specific Seroconversion Rates in Seronegative Children

Post dose 1 CAIV-T vs. TIV Post dose 2 CAIV-T vs. TIV

Matched A/H1N1 Matched A/H1N1
53% vs. 0%* 94% vs. 8%*
Matched A/H3N2 Matched A/H3N2
100% vs. 29%* 100% vs. 100%
Mismatched A/H3N2 Mismatched A/H3N2
93% vs. 0%* 93% vs. 14%*
Matched B Matched B
67% vs. 17% 78% vs. 57%
Mismatched B Mismatched B
50% vs. 13% 100% vs. 60%*
*Significant difference between CAIV-T and TIV

Regulatory Status of CAIV-T
The U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental biologics licensing application (sBLA) submitted by MedImmune to switch formulations from frozen FluMist(R) (Influenza Virus Vaccine Live, Intranasal), currently approved in healthy individuals 5 to 49 years of age, to the refrigerator-stable CAIV-T formulation, for the same population. MedImmune has also submitted a separate sBLA to the FDA seeking an expanded label for CAIV-T for use in children between 12 months and 59 months of age who do not have a history of wheezing or asthma. A response from the FDA for this sBLA is anticipated in the second quarter of 2007 and pending positive outcome, MedImmune plans to commercially provide CAIV-T for the 2007-2008 influenza season.

phx.corporate-ir.net/phoenix.zhtml?c=...

[verwijderd] 16 oktober 2006 21:07

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48.6% Of All Global Human Bird Flu Infections Happened In Indonesia This Year
Main Category: Bird Flu / Avian Flu News
Article Date: 16 Oct 2006 - 8:00am (PDT)

There have been 256 cases of people infected with the H5N1 bird flu strain since the beginning of 2003 worldwide. 109 have become infected this year. 151 people have died since 2003, of which 73 died this year. 48.6% of all confirmed human infections this year have occurred in Indonesia.

Total Human H5N1 Bird Flu Cases and Deaths (WHO)

Azerbaijan
Cases - 8 (all this year)
Deaths - 5 (all this year)

Cambodia
Cases - 6 (2 this year)
Deaths - 6 (2 this year)

China
Cases - 21 (12 this year)
Deaths - 14 (8 this year)

Djibouti
Cases - 1 (1 this year)
Deaths - 0 (none this year)

Egypt
Cases - 15 (all this year)
Deaths - 6 (all this year)

Indonesia
Cases - 72 (53 this year)
Deaths - 55 (43 this year)

Iraq
Cases - 3 (all this year)
Deaths - 2 (all this year)

Thailand
Cases - 25 (3 this year)
Deaths - 17 (3 this year)

Turkey
Cases - 12 (all this year)
Deaths - 4 (all this year)

Viet Nam
Cases - 93 (none this year)
Deaths - 42 (none this year)

Total
Cases - 256 (109 this year)
Deaths - 151 (73 this year)

Written by: Christian Nordqvist
Editor: Medical News Today

[verwijderd] 18 oktober 2006 08:32

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Monday, October 16, 2006
COLORADO STATE UNIVERSITY RECEIVES $2.6 MILLION FROM CENTERS FOR DISEASE CONTROL TO STUDY AVIAN FLU TRANSMISSION BETWEEN BIRDS, HUMANS
FORT COLLINS - Researchers in Colorado State University's College of Veterinary Medicine and Biomedical Sciences recently were awarded $2.6 million from the Centers for Disease Control to study how interactions between humans and birds may lead to more widespread transmission of avian influenza.
The three-year study, with partners from organizations including the University of Colorado Health Sciences Center, focuses on Western states where H5N1 avian influenza has not been detected and in central Indonesia where the virus has been detected in both birds and humans. The researchers will track how birds enter Western states and how humans interact with them in an effort to strengthen current efforts to monitor for and prevent an outbreak of the virus in poultry and humans in this region.
In addition, researchers will study how infected humans interacted with infected birds in Indonesia and study the impacts that substandard vaccinations given to birds in that area may contribute to elevated risk to humans.
"It is abundantly clear that we need to better understand avian flu in humans and animals, as well as the interactions among these two groups in order to devise and implement effective prevention and control strategies," said Richard A. Bowen, principal investigator on the grant and a professor of biomedical sciences at Colorado State. "It is also critical to understand how the differences in ecological areas may affect these interactions."
Small, non-commercial or semi-commercial flocks of poultry kept by individuals in rural and urban settings, often called backyard flocks, are numerous in Western United States. However, these flocks are poorly monitored for health. In fact, the number and location of these flocks is unknown, but hundreds likely exist in Colorado alone, according to agricultural officials. Scientists believe that these birds represent the most significant interface between humans and avians that could carry H5N1, such as chickens and ducks.
The people who feed and care for these flocks would come into close contact with avian influenza if a flock became infected, greatly increasing the risk of transmission of the virus to these humans. Most backyard flock owners don't take simple biosecurity measures to protect themselves and their birds from diseases, such as wearing gloves while caring for the flock, according to agricultural officials. In addition, birds within these flocks are often transported around the region, but little is known about these transportation patterns. Infected birds could easily spread the disease from flock to flock during movement.
Similar flocks exist in Indonesia, where they also are poorly monitored.
By learning more about these flocks, the researchers hope to help officials better monitor the health of the birds, track potential risks, develop a system to track the spread of the disease if an outbreak occurs and provide education to flock owners about biosecurity and avian influenza.
The study also will establish a system to trace infected humans and their associated poultry in Indonesia, providing scientists with important clues. The information will help scientists understand specific interactions between humans and poultry when the virus is transmitted and will help to identify genetic risk factors in humans.
In addition, researchers involved in the project believe that the viruses can still be spread in Indonesia by birds that have been vaccinated against avian flu. Inferior vaccines may have produced partially immune poultry that may help the virus to mutate into a strain that is more efficient for avian-to-human transmission.
"In humans and animals, appropriate vaccination against influenza has been and remains the cornerstone of influenza prevention," said Bowen. "However, the Chinese Agriculture Minister has voiced concerns that poultry in Indonesia received vaccines that did not meet effective potency. The affects of these vaccines may cause animals to be partially immune and appear to be completely healthy while still spreading avian influenza to other animals. And, even more important, the continued circulation of the highly pathogenic H5N1 virus among these partially immune chickens may allow the virus to mutate into a strain that is more efficiently spread from birds to humans."
The first human case of H5N1 was detected in Indonesia in July 2005.
The study involves Colorado State University's Veterinary Diagnostic Laboratory, where all samples from Colorado poultry are tested for avian flu. Colorado State researchers are Kristy L. Pabilonia, Helle Bielefeldt-Ohmann, Gabriele A. Landolt and Hana Van Campen. Additional partners include Eric Simoes and James Ruttenber from the University of Colorado Health Sciences Center; Kathe E. Bjork from PriMetrics Inc.; Cissy B. Kartasasmita from the Universitas Padjadjaran in Bandung, Indonesia; and Martin L. Hibberd from the Genome Institute of Singapore, where avian and human study samples from Indonesia will be tested for H5N1.
newsinfo.colostate.edu/index.asp?url=...

ved 18 oktober 2006 17:23

ved

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Sanofi reports 'encouraging' H5N1 prepandemic vaccine data

Last Update: 10:28 AM ET Oct 18, 2006

LONDON (MarketWatch) -- The Sanofi Pasteur unit of Sanofi-Aventis said a Phase I trial shows its H5N1 pre-pandemic vaccine induces antibodies that neutralize additional H5N1 circulating virus not included in the original vaccine formulation

www.marketwatch.com/News/Story/Story....

[verwijderd] 18 oktober 2006 17:39

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quote:
ved schreef:
Sanofi reports 'encouraging' H5N1 prepandemic vaccine data

SANOFI PASTEUR H5N1 PRE-PANDEMIC VACCINE NEUTRALIZES
ADDITIONAL CIRCULATING H5N1 VIRUS
Vienna, Austria – October 18, 2006 – Sanofi pasteur, the vaccines business of the sanofi-aventis
Group, today announced that its H5N1 pre-pandemic vaccine induces antibodies that neutralize
additional H5N1 circulating virus not included in the original vaccine formulation. These data,
presented at the 2nd International Conference on Influenza Vaccines for the World held in Vienna,
Austria, further demonstrate the value of sanofi pasteur candidate vaccine for pandemic
preparedness.
“These encouraging data show the potential for a pre-pandemic vaccine to offer broad protection
by inducing antibodies that neutralize H5N1 from more recent circulating viruses. Improving the
repertoire of antibody response is an important goal for pandemic influenza vaccines” said Maria
Zambon, MD, Deputy Director Virus Reference Division, Health Protection Agency, London, who
conducted the laboratory tests.
Analysis of blood samples from volunteers who participated in the first phase I clinical trial
conducted in 2005 with H5N1 pre-pandemic vaccine from sanofi pasteur showed the potential of
the vaccine to protect against recent H5N1 circulating viruses.
Vaccinated volunteers developed serum antibodies that were able to neutralize diverse H5N1
viruses (A/turkey/Turkey/1/2005 wt (wild-type) and rg (reverse-genetic) clade 2, and
A/Vietnam/1194/2004 wt and rg clade 1). The tested vaccine contains the A/Vietnam/1194/2004 rg
strain. These more recently circulating H5N1 viruses have caused human infections in several
European countries in 2005 and 2006, and continue to cause infections in parts of South East
Asia.
sanofi pasteur sanofi pasteur
Alain BERNAL Len LAVENDA
Vice-President Corporate Communications U.S. Media Relations
Tel: + 33-(0)4-37-37-78-97 Tel: +1-570-839-4446
Fax: +33-(0)4-37-37-77 89 Len.Lavenda@sanofipasteur.com

Among volunteers who developed antibodies to the vaccine, cross-neutralization results were
similar in those who received high antigen (30μg) and those who received lower antigen (7.5μg)
vaccine doses. Results were also similar in volunteers who received alum-adjuvanted and nonadjuvanted
vaccine (alum is an additive commonly used to increase the immune response to
vaccines). The ability to provide cross-protection against diverse influenza strains with less antigen
is an important feature for any pandemic or pre-pandemic vaccine, as it will allow for production of
more doses to protect the largest number of people in the case of a pandemic.
These new data reinforce conclusions of the sanofi pasteur phase I study published in May 2006
[1] which demonstrated multiple dosage formulations of the H5N1 pre-pandemic vaccine candidate
generates an immune response with and without an adjuvant.
Data answer World Health Organization (WHO) calls for demonstration of cross-reactivity
The latest data on the sanofi pasteur pre-pandemic candidate vaccine provide information called
for in World Health Organization (WHO) recommendations that data be gathered on crossreactivity
and cross-protection against viruses from different clades as an essential element of
pandemic preparedness [2].
H5N1 Viruses isolated from animals and humans since 2003 separate into two distinct genetic
groups (clades) of closely related viruses. Clade 1 viruses circulated in Cambodia, Thailand and
Viet Nam and were responsible for human infections in those countries in 2004 and 2005. Clade 2
viruses circulated in birds in China and Indonesia in 2003-2004. In 2005–2006, Clade 2 spread
westwards to the Middle East, Europe and Africa [2].
Pandemic Influenza Overview
Influenza is a highly infectious virus that spreads 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, newly infectious for humans, with the potential to cause 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 is expected to be even more devastating in developing countries. In an attempt to minimize
the impact of a pandemic, many countries are developing national and transnational plans against
an eventual influenza pandemic situation.

Sanofi Pasteur and Pandemic Preparedness
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, is committed to global
pandemic preparedness. As the world leader in research, development and manufacturing of
influenza vaccine, sanofi pasteur is actively involved in other projects in the U.S. and Europe, with
the goal of developing a vaccine to protect against a pandemic influenza virus.
Sanofi pasteur is investing in a major expansion of its influenza vaccine production capacity in the
US, and also of its vaccine production capacity in France (Val de Reuil facility).
In Europe, sanofi pasteur initiated and runs a large range of projects:
· In France, sanofi pasteur sponsored the first clinical trials of an H5N1 influenza vaccine
candidate that compared vaccines with and without adjuvants [1].
· In France, sanofi pasteur was awarded a contract by the French Ministry of Health to
produce a 1.4 million dose stockpile of the H5N1 candidate studied in the above-mentioned
trial. By this agreement, the company could also provide enough vaccine to protect up to
28 million people in France in the event of a pandemic being declared, once the actual virus
strain responsible is identified.
· In Italy, in February 2006, sanofi pasteur provided candidate H5N1 vaccine to the Ministry
of Health and entered into an agreement to provide an actual pandemic strain of vaccine,
once a pandemic has been declared.
In the U.S., sanofi pasteur has a number of pandemic-related agreements with the U.S.
government involving development of pandemic vaccine stockpiles, production of investigational
doses and the development of cell culture technology, including:
· In May 2004, sanofi pasteur contracted with the U.S. National Institutes for Allergy and
Infectious Diseases (NIAID) to produce investigational doses. The doses were shipped to
the NIAID in March 2005. The studies were completed in 2005 and the results were
published in New England Journal of Medicine [3].
· 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 to expand and safeguard
the egg supply needed to produce influenza vaccine and to formulate each year
investigational doses for a potential pandemic influenza vaccine.
· In April 2005, the HHS awarded a contract to sanofi pasteur to accelerate the development
of a cell-culture influenza vaccine in the U.S. and to design a U.S.-based cell-culture
vaccine manufacturing facility.

[verwijderd] 18 oktober 2006 17:40

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In September 2005, the HHS awarded a contract to sanofi pasteur to produce a vaccine to
help protect against the H5N1 influenza virus strain. The $150 million contract calls for
sanofi pasteur to manufacture the vaccine in bulk concentrate form at its U.S. headquarters
in Swiftwater, PA. 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.
· In February 2006, sanofi pasteur supplied NIAID with 15,000 investigational doses of H5N1
vaccine formulated with and without alum adjuvant for use in NIAID-sponsored clinical
studies.

In Australia:
· A contract has also been signed with the Australian government for the supply of vaccine in
the event of a pandemic influenza outbreak.
About sanofi-aventis
The sanofi-aventis Group is the world’s third-largest pharmaceutical company, ranking number one
in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis
Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold more than a billion doses
of vaccine in 2005, making it possible to protect more than 500 million people across the globe.
The company offers the broadest range of vaccines, providing protection against 20 bacterial and
viral diseases. For more information, please visit: www.sanofipasteur.com / www.sanofipasteur.us
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical
facts. These statements include financial projections and estimates and their underlying
assumptions, statements regarding plans, objectives and expectations with respect to future
events, operations, products and services, and statements regarding future performance.
Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,”
“intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management
believes that the expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ materially from those
expressed in, or implied or projected by, the forward-looking information and statements. These
risks and uncertainties include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F
for the year ended December 31, 2005. Other than as required by applicable law, sanofi-aventis
does not undertake any obligation to update or revise any forward-looking information or
statements.
###
References
[1] Bresson JL, Perronne C, Launay O, et al. Safety and immunogenicity of an inactivated split-virion
influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006 May
20;367(9523):1657-64.
[2] www.who.int/csr/disease/avian_influen...
[3] Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated
subvirion influenza A (H5N1) vaccine. N Engl J Med 2006 Mar 30;354(13):1343-51.
en.sanofi-aventis.com/index.asp

[verwijderd] 18 oktober 2006 17:49

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Scientific Advisory Panel
o.a.
Valentine Delore (Sanofi-Pasteur, Lyon, France)
Reinhard Glück (Berna Biotech, Switzerland)
Albert Osterhaus (Erasmus University, Rotterdam, The Netherlands)
*************************************
Second Circular and Provisional Conference Program
The Second International Conference on
Influenza Vaccines for the World
18-20 October 2006, Palais Ferstl, Vienna, Austria
‘The control and management of influenza are currently based on the surveillance, prevention and treatment of the disease. Almost all European countries have influenza immunization policies for populations considered as being at-risk, but there are large disagreements about the meaning of ‘risk’ and the levels of vaccine use vary greatly country by country. In the near future, new vaccines and specific anti-viral drugs will need to adapt and to extend current recommendations…’
– Rene Snacken (Scientific Institute of Public Health-Louis Pasteur, Belgium)
‘The natural history of influenza suggests it is only a matter of time before another influenza pandemic occurs… Vaccinating predefined segments of the population will be one of the major strategies for reducing the impact of pandemic influenza, and the net return, in dollars, from vaccination is an important economic measure of the costs and benefits associated with vaccination.’
– Martin Meltzer (CDC, AtIanta, USA)
‘The pandemic clock is ticking; we just don’t know what time it is.’
– Edgar Marcuse (University of Washington School of Medicine, USA)
IVW 2006 – The World Influenza Vaccination Conference
IVW 2006 is the follow-up meeting to the successful IVW 2004 meeting held in Lisbon, Portugal in May 2004. A clear indicator from IVW 2004 was a desire for another IVW conference to be scheduled and IVW 2006 will now take place in Vienna. There is a clear demand for an international conference that aims to focus on ‘Influenza vaccination issues’. IVW 2006 will build on the success of the Lisbon conference and will aim to complement the ESWI conference series and also the ‘Options for Control and Prevention of Influenza’ series of events.
IVW 2006 will be an international forum for world renowned experts in the field of influenza vaccines and related issues to report the latest data and trends associated with current and new influenza vaccines and their availability/delivery worldwide.
Scientific Advisory Panel
Nancy Cox (CDC, Atlanta, USA)
Klaus Stöhr (WHO, Geneva, Switzerland)
Valentine Delore (Sanofi-Pasteur, Lyon, France)
Rob Lambkin (Retroscreen Virology Ltd, London, UK)
Reinhard Glück (Berna Biotech, Switzerland)
Martin Meltzer (CDC, Atlanta, USA)
John Wood (NIBSC, UK)
John S Tam (Chinese University of Hong Kong, Hong Kong)
Douglas Fleming (RCGP, Birmingham, UK)
Albert Osterhaus (Erasmus University, Rotterdam, The Netherlands)
Jim Robertson (NIBSC, Potters Bar, UK)
Bram Palache (IVS International Task Force Representative)
John S. Oxford (Queen Mary’s School of Medicine & Dentistry, London, UK)
Ada Minutello (Novartis Vaccines, Morburg, Germany)
www.meetingsmanagement.com/ivw_2006/

[verwijderd] 18 oktober 2006 19:21

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By Maggie Fox, Health and Science Editor

WASHINGTON, Oct 17 (Reuters) - A third of countries trying to plan for a possible bird flu pandemic have not made any decision on who would be first in line for scarce vaccinations and antiviral drugs, U.S. and Israeli researchers said on Tuesday.

And not a single country has guidelines on how to distribute limited numbers of ventilators and face masks in case of such a global epidemic, the survey of 45 national plans showed.

The H5N1 avian influenza virus still mostly infects birds, but it continues to infect the occasional person -- 256 in total -- and has killed 151 people in nine countries.

The World Health Organization considers H5N1 the most likely cause of the next flu pandemic, but stresses that there is no predicting what a flu virus will do. The world has been on alert since 2003, when the virus re-emerged in China and Korea.

"I don't think it is necessarily the case that countries have forgotten about bird flu," said Lori Uscher-Pines of the Johns Hopkins University School of Public Health, who helped conduct the study.

But she said it is difficult to set priorities when a pandemic is so unpredictable. To start a pandemic, H5N1 or any other flu virus would have to first acquire the ability to pass easily from person to person and it is not clear what other changes would occur along with that.

"One of the problems that is inherent in priority-setting now is there a lot of uncertainty about what the strain is going to look like and how infectious it is going to be," Uscher-Pines said in a telephone interview.

The teams at Johns Hopkins and Ben-Gurion University of the Negev in Israel reviewed 45 national pandemic influenza plans from developed and developing countries. Continued...

[verwijderd] 18 oktober 2006 19:22

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Writing in the online journal Public Library of Science-Medicine, they said the plans would apply to 3.8 billion people, or two-thirds of the world population.

Of the plans, 28 listed individual population groups to receive vaccines in a pandemic and 22 prioritized groups that would get antiviral medications.

VACCINES WOULD BE LIMITED

Several companies are working on vaccines against H5N1 and other types of avian flu, but vaccines must match the circulating strain of flu to work well, and a pandemic H5N1 strain has not evolved yet. And flu vaccine production takes months.

Older flu drugs do not work well any more against any kind of influenza but two newer drugs do -- Roche AG's (ROG.VX: Quote, Profile, Research) and Gilead Sciences' (GILD.O: Quote, Profile, Research) oseltamivir or Tamiflu, and GlaxoSmithKline's (GSK.L: Quote, Profile, Research) (GSK.N: Quote, Profile, Research) and Biota's (BTA.AX: Quote, Profile, Research) zanamivir, sold under the brand name Relenza, according to the World Health Organization.

"At current capacity, we cannot expect to vaccinate more than 14 percent of the world's population within a year of a pandemic," the researchers wrote.

"Similarly, although manufacturing capacity has recently quadrupled, it is estimated to take a decade to produce enough of the antiviral medication oseltamivir for 20 percent of the world's population."

This is even with generic drug manufacturers in Bangladesh, Algeria, India, and China producing the drug.

Most countries that do have a plan for distributing drugs and vaccines, including the United States, put health care workers at the top of the list.

Some place children high up, while others target essential service workers, such as communications and telecommunications workers, fire fighters, key government decision makers and power supply workers, the survey found.
yahoo.reuters.com/news/articlehybrid....

[verwijderd] 19 oktober 2006 08:28

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Switzerland to purchase GSK’s H5N1 vaccine for pre-pandemic use

Issued – Wednesday 18 October 2006, Bern, Switzerland, London, UK and Rixensart, Belgium - GlaxoSmithKline (plc) today announced that a supply contract has been signed by the Swiss Federal Office of Public Health and GlaxoSmithKline for 8 million doses of GSK’s H5N1 antigen influenza vaccine and its proprietary adjuvant for pre-pandemic use. The order provides enough doses, one per head of the entire Swiss population, to help prepare the immune system against the threat of a human influenza pandemic and is the first national programme to do so. Supply and stockpiling of the pre-pandemic vaccine is expected in early 2007 once the Swiss regulatory agency, Swissmedic, has reviewed and approved GSK’s regulatory file.
************************************
GlaxoSmithKline’s new generation flu vaccine shows a significant increase in seroprotection rate in the over 65 population

GSK Phase III programme for rapid licensure of new generation flu vaccine underway
EMBARGOED until 17.00 GMT, Wednesday 18 October 2006, London, UK and Vienna, Austria - New data released today demonstrate significantly better immune responses in the age range 65 and above when vaccinated with GSK’s new generation (adjuvanted) seasonal flu vaccine compared to a traditional seasonal flu vaccine. These new data are highly important, since the disease burden and death toll is highest among the elderly in each flu season. The data, presented at the Influenza Vaccines for the World (IVW) 2006 Congress, showed the seroprotection rate (90.5%) achieved by the new adjuvanted vaccine in the elderly to be more than 25% higher than that reported in the age matched comparator group. Moreover, it greatly exceeds the European licensing requirement for seroprotection, which requires at least 60% seroconversion independent of age (CHMP criterion). Encouraged by these excellent results, GSK has started a Phase III registration trial for the vaccine with 3500 patients across three countries in Europe* and in the US.

www.gsk.com

[verwijderd] 19 oktober 2006 08:37

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INCREASING Pandemic Influenza Vaccine Supply

If an influenza pandemic were to occur in the near future, there would be a shortage of several billion doses of the pandemic influenza vaccine needed to protect the global population.

-- What activities are required to increase future pandemic influenza

vaccine production capacity?

-- Who will undertake this action?

-- How long will it take to fill the gap and how much will it cost?

-- What are the challenges?

-- What characteristics would an ideal pandemic influenza vaccine have?

WHAT: News conference to release the new World Health Organization Global pandemic influenza action plan to increase vaccine supply. The 14-page Global Action Plan will be posted at www.who.int/vaccines-documents/DocsPD...

at 14:00 CET on 23 October 2006.

WHEN: Monday, 23 October 2006; 14:00-15:00 (2 p.m. to 3 p.m.) Central European Time (CET)

WHERE: UN Palais des Nations, Geneva, Switzerland, Room III.

Journalists based around the world may listen to the news conference and ask questions. The telephone number to dial into the news conference is: +41 (0) 22 917 0900. The code which must then be entered is 41417.

WHO:

Dr Marie-Paule Kieny, Director, Initiative for Vaccine Research, World

Health Organization;

Dr David L. Heymann, acting Assistant Director-General for Communicable

Diseases and Representative of the Director-General for Polio Eradication,

World Health Organization;

Dr Keiji Fukuda, Coordinator, Global Influenza Programme, World Health

Organization;

For more information, please contact:

Melinda Henry,

WHO Department of Immunization,

Vaccines and Biologicals, Geneva

Tel: +41-22-791-2535

Mobile: +41-79-477-1738

Email: henrym@who.int

Web: www.who.int/immunization

Dick Thompson,

Team Leader,

Pandemic and Outbreak Communications

Tel: +41-22-791-2684

Email: thompsond@who.int

SOURCE World Health Organization

-0- 10/18/2006 P

/Xinhua-PRNewswire -- Oct. 18/

/Web Site: www.who.int /

am1993 19 oktober 2006 11:14

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H5N1 Isolation Failures at USDA Raise Pandemic Concerns
Recombinomics Commentary
October 18, 2006

The USDA National Veterinary Services Laboratories (NVSL) confirmed the presence of H6N2 through virus isolation in a pool of five samples of the 11 samples collected from wild Green-winged Teals in the Rice Lake Conservation Area of Fulton County, Illinois. Initial screening results announced on Sept. 29 indicated that H5 and N1 subtypes might be present in the collected samples, but further testing was necessary to confirm the H and N subtypes as well as pathogenicity.

The failure to isolate the H5N1 in the Green-winged Teal samples from Illinois is cause for concern. This failure may be due in part to pooling of samples, which can lead to an isolation failure because of overgrowth by a serotype not detected in the testing of the pooled samples. A similar failure was reported for Northern pintail samples from Montana. One sample was positive for H5N1, but H5N3 was detected even though sixteen samples were H5 positive. It remains unclear if the H5N3 serotype was from samples that were H5 positive but N1 negative, or was from the H5N1 positive sample. In any even, no isolation of H5N1 in Montana was reported.

The number of isolation failures remains unclear. H5N1 has been isolated in Maryland, Michigan, and Pennsylvania. H5 was detected in a live market in New Jersey, but no mandatory OIE report was filed. Media reports suggested it was not H5N1, but all H5 infected poultry, regardless of N serotype, requires an OIE report. Similarly, media reports indicate H5 has been found in California, Washington State, and possibility Alaska, but addition detail from the USDA have not been announced. Similarly, serotypes other than H5N1 are announced only for H5N1 positive samples. It is unclear what, if anything is isolated from the H5 positive samples.

These isolation failures raise concerns that low levels of HPAI H5N1 could be missed due to pooling of samples, low sensitivity in the isolation procedure, or other technical issues including collection / transport / degradation issues.

Isolation of HPAI H5N1 from health wild birds is rare. Although such isolations have been reported in Russia, the vast majority of H5N1 isolates have come from dead birds or live poultry on farms that have fatal H5N1 infections.

Thus, although isolation of HPAI H5N1 from live wild birds is rare, the above protocol involves pooling samples, lowering the sensitivity of the isolation procedure. Repeated failures to isolate any H5N1 from H5N1 positive samples raise concerns about assurances on the detection of low path H5N1.

The USDA testing cannot exclude mixtures of low path and high path H5N1 in samples that are H5N1 positive.

H5 was detected in a dead gosling on Prince Edward Island. Only one dead goose was tested, but four died suddenly after displaying bird flu symptoms. Low path H5 rarely causes sudden death in waterfowl, although the Qinghai strain of H5N1 is known to kill waterfowl, including thousands of bar headed geese at Qinghai Lake in May, 2005. This strain has been transported and transmitted by long range migratory birds into Europe, the Middle East, and Africa. The H5N1 has been found in flyways that connect to northwestern and northeastern North America. Sequence data from North American H5 isolates have polymorphisms that are predominantly found in Asia. Similarly, North American polymorphisms have been found in the Qinghai stain in Asia.

Recent sequence data from China, shows that recombination is extensive in H5N1 infect poultry and wild birds. These recombination events have moved sequences into Indonesia and have generated swine H5N1 sequences with polymorphisms found in the Qinghai strain of H5N1 as well as H5N1 found in human isolates on Java as well as isolates from the Karo cluster.

Thus far, only four genes of an H5N2 isolate from British Columbia in August, 2005 has been released. This isolate has acquired North American swine sequences, as well as HPAI H5N1 sequences from Asia. These acquisitions indicate dual infections and associated recombination is common in H5 in North America. No other H5 sequences from 2005 isolates in Canada or any 2006 H5 isolates from the United States or Canada have been released. The explosion in the detection of H5 in Canada last year, as well as Canada and the United State this year raises concerns about the evolution of H5 in North America as well as the repeated isolation failures at the USDA

www.recombinomics.com/News/10180601/H...

Vooral de verzamelde nieuwsberichten over H5N1 van de laatste 2 maanden doen de haren weer te bergen rijzen. Je hoort nauwelijks iets in het nieuws, maar vogelgriep lijkt fors in opmars.
Site om goed te volgen de komende tijd.

AM1993

[verwijderd] 20 oktober 2006 09:52

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Bird Flu Suspected in Nine More Indonesians on Sulawesi Island

By Karima Anjani

Oct. 20 (Bloomberg) -- Tests for bird flu are being run on nine people from a province of Indonesia's eastern island of Sulawesi, where one of the patients, a 1-year-old boy, probably died of the virus this week.

The child from the South Sulawesi district of Maros died Oct. 17, hours after he was admitted to the Wahidin Sudirohusodo Hospital in Makassar with flu-like symptoms, said Halif Saleh, a doctor who treated the infant.

Samples from the boy are being tested for the H5N1 strain of avian influenza, Runizar Ruesin, head of the health ministry's avian flu center, said in a phone interview today.

If confirmed, the child would be the 152nd person to die from the virus since 2003. World health experts say millions could die if H5N1 mutates to become easily transmissible between humans. Almost half the 109 cases reported this year have occurred in Indonesia, the world's fourth-most populous country.

Tests for the H5N1 virus are being run on eight others being treated in the Wahidin Sudirohusodo Hospital. They are all from South Sulawesi province, where the disease is known to have infected poultry, Ruesin said. It wasn't immediately known whether the patients are related, he said.

A 14-year-old girl died on June 24 of the H5N1 strain in the provincial capital, Makassar, the World Health Organization said last month.

The virus is reported to have killed a person every four days worldwide this year, more than double the 2005 rate, creating more chances for it to become more contagious to people. At least 256 people in 10 countries have caught H5N1 since late 2003, the WHO said on Oct. 16.

Human Spread

Almost all human H5N1 cases have been linked to close contact with sick or dead birds, such as children playing with them or adults butchering them or plucking feathers, according to the WHO. While the virus doesn't spread easily between people, some human-to-human transmission may have occurred.

Indonesia attracted international attention in May when seven members of a family from the island of Sumatra contracted H5N1, six of them fatally. The cases represented the largest reported cluster of human cases and the first laboratory-proven instance of human-to-human transmission.

Clusters of cases may signal the virus is becoming more adept at infecting humans, not just birds.

To contact the reporter on this story: Karima Anjani in Jakarta at kanjani@bloomberg.net .

Last Updated: October 20, 2006 00:46 EDT

aossa 20 oktober 2006 14:10

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AP
Vical Says Bird Flu Vaccine Shows Results
Friday October 20, 7:55 am ET
Vical Says Bird Flu Vaccine Candidate Provides 100 Percent Protection in Ferrets

NEW YORK (AP) -- Vical Inc., a developer of gene-based therapies, on Friday said a trial of its single dose avian influenza DNA vaccine candidate provided 100 percent protection in ferrets against a lethal strain of bird flu.
The San Diego-based company said previous studies have shown that two doses of the vaccine candidate provided total protection in mice and ferrets against the H5N1 avian influenza virus, commonly known as bird flu.

Vical said its DNA vaccine candidate uses two influenza virus proteins plus the H5 avian influenza virus surface protein and is formulated with the company's patented Vaxfectin adjuvant, a sort of catalyst.

The company hopes to begin human testing as soon as possible.

biz.yahoo.com/ap/061020/vical_avian_f...

biz.yahoo.com/prnews/061020/laf003.ht...

[verwijderd] 20 oktober 2006 15:48

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vical 15% up!!!!!!

[verwijderd] 20 oktober 2006 16:32

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Kennelijk zijn er Vical-liefhebbers, die denken, dat ze Sanofi-Aventis kunnen kloppen.

[verwijderd] 20 oktober 2006 17:00

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op deze wijze zou Crucell , wel meerder malen 15% kunnen stijgen met dergelijke berichten.
Met Vical blijf ik mbt hun berichtgeving toch zeer argwanend , omtrent de reden ervan.

sammie

[verwijderd] 20 oktober 2006 17:30

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Akzo's Intervet krijgt EC-steun voor vogelgrieponderzoek

AMSTERDAM (Dow Jones)--Akzo Nobel nv-onderdeel Intervet krijgt een subsidie van EUR1,37 miljoen van de Europese Commissie over een periode van drie jaar voor onderzoek naar een vaccin tegen vogelgriep, meldt het verf-, chemie- en farmabedrijf vrijdag.

Het project is een van de zeventien initiatieven die de Europese Commissie ontplooit in de strijd tegen vogelgriep.
Intervet voert het onderzoek uit in samenwerking met het Friedrich Loeffler Institute Riems en Bommeli ag.

Het primaire doel van het project is de ontwikkeling van een vogelgriepvaccin gebaseerd op levende vaccins, dat op grote schaal toegepast kan worden door middel van spray, drinkwater of oogdruppels.

- Door Arien Stuyt, Dow Jones Nieuwsdienst; +31-20-5890270; arien.stuyt@dowjones.com
(END) Dow Jones Newswires
October 20, 2006 11:13 ET (15:13 GMT)

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