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PB Sanofi Pasteur Broadens Pandemic Preparedn

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babs11 schreef:

"The RD-3 virus has passed internationally-agreed safety tests has been used to produce an inactivated vaccine on the PER.C6 mammalian cell line.
A clinical trial of the H7N1 vaccine will begin in September 2006.
Surveillance of wild and domestic birds in Italy has shown that influenza viruses from several different subtypes (including non-pathogenic H5 and H7) have been in circulation.
A modified serological test has been developed with increased sensitivity for detection of antibody to H5 and H7 influenza viruses. This test can be used in serosurveillance to provide early warning of a possible pandemic. It also will be useful in vaccine evaluation."
Babs, behalve pagina 1, zie ook:
www.iex.nl/forum/topic.asp?forum=228&...
www.iex.nl/forum/topic.asp?forum=228&...

(FLUPAN news – September 2006 = FLUPAN news – September 2005)
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Berichtgeving....zonder vermelding Crucell:
Sanofi tests H7N1 flu vaccine for pandemic readiness
Sep 19, 2006 (CIDRAP News) – Sanofi Pasteur today announced the start of the first clinical trial of an H7N1 influenza vaccine, intended to guard against the threat of a pandemic caused by H7 strains of avian influenza.
Current concern about a flu pandemic focuses mainly on the H5N1 avian flu virus, which has infected at least 247 people and killed 144. But H7 avian flu viruses have caused a number of mild illness cases and one death in the past 3 years.
Sanofi Pasteur, part of the Sanofi-Aventis Group, said it launched a phase 1 trial of its H7N1 vaccine today at the University of Bergen in Norway. The vaccine is a split-virus product grown in cell culture rather than in eggs, the method usually used to produce flu vaccines.
Development of the H7N1 vaccine is part of a European Union (EU) collaborative effort, called FLUPAN, to boost pandemic preparedness in the EU.
"A highly pathogenic H7N1 avian influenza virus which caused outbreaks in Italian poultry in 1999 has been modified so that it is safe to use and grows well in mammalian cell culture," FLUPAN coordinator Dr. John Wood said in a Sanofi news release.
He said the vaccine virus was developed by the United Kingdom's (UK's) National Institute for Biological Standards and Control and the University of Reading, which are two of six partners in FLUPAN. The others are Sanofi Pasteur, the University of Bergen, Italy's Istituto Superiore di Sanita, and the UK Health Protection Agency.
The trial involves 60 healthy people between the ages of 20 and 40, who will receive two doses of either 12 or 24 micrograms of the vaccine, with or without an aluminum hydroxide adjuvant (immune response booster), said Dr. Lars R. Haaheim of the University of Bergen.
H7 avian flu viruses that have infected humans include the H7N7 strain that swept through Dutch poultry farms in 2003, forcing the destruction of about 30 million birds. The virus infected 89 people and caused generally mild symptoms, but one veterinarian died. In addition, two people were infected and suffered mild flu-like illnesses during a poultry outbreak of highly pathogenic H7N3 virus in British Columbia, Canada, in early 2004.
Also, a few Italian poultry workers were found to have antibodies to H7N1 and H7N3 viruses when they were tested in connection with avian flu outbreaks that occurred in Italy in 2002 and 2003. The workers did not report any flu-like illness at the time, but one reported conjunctivitis, according to a report in the Journal of Infectious Diseases in October 2005.
"While most vaccine development has focused on H5N1 strains, avian H7–containing viruses remain a significant pandemic threat and have caused infections in humans in Europe over the last three years," the Sanofi release says.
H5N1 and H7N1 are not the only avian flu strains considered to have current pandemic potential. Chiron Corp., now part of Novartis, is developing an experimental H9N2 vaccine under a contract with the US government. That strain caused serious illness in three people in Hong Kong in 1999 and 2003.
Sanofi Pasteur is producing an experimental H5N1 vaccine for the US government under a $150 million contract awarded in September 2005.
www.cidrap.umn.edu/cidrap/content/inf...
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Special report: Global fight against bird flu
PARIS, Sept. 19 (Xinhua) -- Sanofi Pasteur, the vaccines business of the sanofi-Aventis Group, has started the first clinical trial of a new generation of H7N1 pandemic vaccine to fight against bird flu, the company announced Tuesday in a statement.
"The trial with the vaccine would expand the Sanofi Pasteur's preparation to the flu pandemic, which is initiated with the development of H5N1 vaccine," the statement said.
The company also said that while most vaccine development has focused on H5N1 strains, the H7 avian viruses remain a significant pandemic threat.
The trial is the first to assess the safety and ability to generate an immune response of a split, inactivated prototype pandemic H7N1 vaccine produced on cells, Sanofi said.
This phase I clinical trail is conducted in a project of Flupan, a European Union (EU) funded collaboration, and financed by EU. Initiated on Tuesday in Bergen, Norway, the trial is intended to improve the level of pandemic preparation in EU countries. Enditem
news.xinhuanet.com/english/2006-09/20...
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COMUNICADO: Sanofi pasteur Broadens Pandemic Preparedness With First Clinical Trial of Novel Cell Based H7N1 Vaccine (y 2)

-- 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
www.europapress.es/europa2003/noticia...
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Overige berichten (23 stuks) zijn prima in orde.
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Correct me if I am wrong, maar dit is de eerste klinsche fase I op basis van PERC.6. Een belangrijk feit. Een belangrijke mijlpaal.

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Alaskan Timber schreef:

Correct me if I am wrong, maar dit is de eerste klinsche fase I op basis van PERC.6. Een belangrijk feit. Een belangrijke mijlpaal.

www.crucell.nl/Partners%20-%20General...
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Hallo Babs,

Ik begrijp best dat je een hogere koers verwacht. Inmiddels staan we ook al leuk wat hoger. Echter, waar het om gaat bij de koers van een aandeel is de koers/winst verhouding. Die is nu veel te hoog en dat zien de zekere Heinen niet zitten. Groot gelijk hebben ze! Moeten vooral geen CRXLlen kopen, want dat gaat ze nog heel veel slapeloze nachten opleveren. Obligaties zijn een stuk beter voor die types. Bij Crucell is het echt de LT die zijn werk moet gaan doen. Mij interesseert de koers van vandaag geen biet. Leuk als we wat hoger komen te staan, maar echt belangrijk is het natuurlijk niet. Die ene Euro is over een paar jaar de schommeling per minuut. Dus waar maak je je druk om? Uiteindelijk zal de koers/winst verhouding van CRXL de koers gaan bepalen. Tegen die tijd zitten we op een koers van boven de €100. Ik maak me dus nergens druk om. De stroom PB's blijft constant en met goed nieuws. Dat is wel heel belangrijk. (En uiteraard houd ik ook liever wat aan m'n opties over aan het einde van het jaar, want die zijn helaas nog steeds alleen maar voor de KT te verkrijgen).

Ik spreek je wel weer op de nieuwjaarsborrel.

Groeten, :) Frank
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February 13, 2007: Paris Information Meeting - 2006 Full-Year Results
Commercial Operations and Research & Development Review
Recorded video webcast of the meeting held on February 13, 2007, in French and English with simultaneous and alternated translation.
Successive Speakers: Mr. Jean-François Dehecq, Mr. Gérard Le Fur, Mr. Hanspeter Spek, Mr. Wayne Pisano, Mr. Jean-Claude Leroy, Mr. Marc Cluzel, Mr. Pierre Chancel

en.sanofi-aventis.com/Images/070213_E...

Pagina 25.

Focused on pre- pandemic preparedness and
developing flu vaccination market

Pre-pandemic preparedness
Nov 2006 contract with HHS
valued up to 117.9 M$ for new
type H5N1
Increasing seasonal
vaccinations & capacity
Filing H5N1 mock dossier in
EU
Ongoing development with
novel adjuvants

Pursuing new technology,
partnership with Crucell
Began trials in 2006 with cell
culture vaccine
Developed H7N1 candidate
vaccine as part of FLUPAN

North America / Europe:
• ACIP moving towards universal recommendations
• Strong focus on market expansion / patient access
• Continued collaborations with NIAID, HHS,
FLUPAN, EU, etc

Latin America:
• Low immunization rates
• Focused on market
development
• Local partnerships to
increase supply

Asia:
• Undeveloped markets
• Developing local
manufacturing
presence

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Pagina 34.
Flu Cell
Influenza (new production
method)

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Pagina 35.
Calendar of Planned Submissions - Vaccines

2007
Flu micro injection EU
Flu Pandemia H5 EU
2008
HEXAXIM™ DTP-HepB-Polio-Hib
Flu new formulation
Pediacel® EU
Flu micro injection US
2009
Flu Cell
UNIFIVE™ DTP-HepB-Hib
Menactra® Toddler U.S.

clients.dbee.com/sanofi/20070213/en/
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Ja daar staat ie weer Flosz , pagina 34 Flucell, en nieuws in 2007 verwacht.
Ben toch wel heel benieuwd met wat voor nieuws ze gaan komen dit jaar.
aossa
0
Als ik het goed begrijp is Flucell de naam voor het cell-based seizoensvaccin, niet het pandemic vaccin dus. Dat is toch nieuw(s) !
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