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Sanofi-Aventis starts Phase II flu jab

142 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste | Omlaag ↓
  1. [verwijderd] 8 november 2007 22:05
    quote:

    robertix schreef:

    Dit bericht heb ik nu ook al 6x voorbij zien komen, willen jullie graag wat posten of zo, of lezen we niet eerst het forum voordat we wat plaatsen.....
    Het verbaast me nog steeds dat er mensen zijn die nieuws als eerste denken te posten als het al lang en breed bekend is.
    Of Flosz benaderen???........Vergeet het maar.....
    Als dat zo was, had ik er wel een apart draadje van gemaakt.
    Mij ging het erom dat het in ''dit straatje'' past en daarom heb ik het gepost. Er zal in dit stuk ongetwijfeld een iets andere text staan dan in de main-post...
  2. [verwijderd] 14 november 2007 19:22
    email bericht van crucell over de mijl stone betaling
    Geachte heer De Beer,

    De reden dat er geen persbericht is uitgegaan is omdat er pas een milestone betaling is bij afronding, niet bij de start van Phase II.

    Met vriendelijke groet,
    Investor Relations Crucell N.V.

    "Jack de Beer" <jackdebeer@home.nl>
    07-11-2007 14:32
    To <barbara.mulder@crucell.com>
    cc
    Subject fase 2





    ik heb even een vraag. waarom geen pb over een mijlstone betaaling van sanofi voor het flu vaccine dat naar fase 2 gaat groetjes jackdebeer@home.nl
    ----
    This message is intended only for the use of the named recipient(s) and may contain confidential and/or proprietary information. If you are not the intended recipient, please notify the sender immediately and destroy this e-mail and any attachments. Any unauthorised copying, disclosure or distribution of the material in this e-mail and any attachments is strictly forbidden.
    ----
  3. forum rang 4 aossa 29 april 2008 16:19
    www.in-pharmatechnologist.com//news/n...

    US govt pays Sanofi Pasteur $192m for bulk flu antigen

    By Gareth Macdonald

    29/04/2008- The US Department of Health and Human Services (HHS) has accepted a bulk stock of H5N1 influenza virus antigen, consisting of both hemagglutinin and neuraminidase, worth $192m (€123m) from French vaccines specialist Sanofi Pasteur.

    The stockpile will be used to produce around 39 million doses of a vaccine against the clade 2.2 strain of the avian type A H5N1 virus. This emergent serotype, which was first identified in migratory Barheaded geese in Qinghai Lake, China in 2005, currently predominates in bird populations in Europe, Africa and the Middle East.

    Sanofi began working with the HHS in 2004 when it was awarded a $97m contract to produce two million doses of bulk vaccine derived from the H5N1 viral strain. Subsequently, the Lyon-headquartered firm fulfilled a series of bulk orders, most recently in 2007 when it was paid $127m (€81m) for a supply of vaccine.

    Albert Garcia, an epidemiologist at Sanofi told in-PharmaTechnologist.com that: "the antigen had been produced last year at Sanofi's plant in Swiftwater [Pennsylvania] using the same egg-based technology that is used to manufacture seasonal influenza vaccine."

    Expands vaccine manufacturing capacity

    In June last year, Sanofi completed a $150m (€108.6m) expansion of the Swiftwater facility, increasing production capacity to more than 100 million doses a year. Prior to that, the firm announced plans to invest €200m in a new formulation and filling unit at its vaccines facility in Rouen, France,

    More recently, Sanofi said that it is to build a new production plant in Shenzhen, China. While the facility is primarily intended to produce seasonal influenza vaccine for the local population when it becomes operation in 2012, it will also be used as part of the firm's global response plan should a pandemic virus emerge.

    Mr Garcia said that, in addition to its ongoing pandemic preparedness program, Sanofi was expanding production capacity because "it anticipates a considerable increase in the demand for seasonal influenza vaccine." He added that the firm's manufacturing facilities: "can switch instantaneously to produce any pandemic strain upon WHO request."

    Cell culture to expedite production rates

    In March, the HHS released its fifth pandemic preparedness update, detailing efforts to expand US production capacity to 600m doses within six months of the emergence of a pandemic.

    The HHS also reported moves to stimulate the development of cell culture-based vaccine manufacturing methods, specifically that it has entered into a series of agreements designed to push the technology forward. Sanofi is one of the firms that is developing the technology, others include GlaxoSmithKline, Solvay and Novartis.

    Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years."
  4. maxen 29 april 2008 16:29
    quote:

    aossa schreef:

    Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years."
    Dus tot 2018 nog grote rol voor eieren. Gaat allemaal wat langzamer.
  5. gogogoo 29 april 2008 16:37
    quote:

    maxen schreef:

    [quote=aossa]
    Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years."
    [/quote]
    Dus tot 2018 nog grote rol voor eieren. Gaat allemaal wat langzamer.
    Er staat "will not replace". Dat wil nog niet zeggen dat het dan niet al een rol van betekenis kan vervullen. En als het eenmaal aanslaat dan kan het hard gaan met een nieuwe technologie.
  6. [verwijderd] 30 april 2008 08:40
    In ben bang dat de heer Garcia een wetenschapper is en geen econoom/procestechnoloog. Deze laatste professies zullen de technologie van Crucell over de streep drukken. De wetenschapper moet in de trails aantonen dat ie goed spul maakt. Daar wordt nu hard aan gewerkt en de HHS staat daar vierkant achter.

    Geduld.
  7. gogogoo 30 april 2008 09:10
    quote:

    Arabica k. schreef:

    In ben bang dat de heer Garcia een wetenschapper is en geen econoom/procestechnoloog. Deze laatste professies zullen de technologie van Crucell over de streep drukken. De wetenschapper moet in de trails aantonen dat ie goed spul maakt. Daar wordt nu hard aan gewerkt en de HHS staat daar vierkant achter.

    Geduld.
    Zomaar een gedachte....Het kan natuurlijk ook een manier zijn om de concurrentie het idee te geven dat het voorlopig nog niets is....om zo de markt straks als eerste te betreden en zo lang mogelijk als technology-monopolist/oligopolist nog steeds een hoge prijs te kunnen vragen tewijl de productiekosten stukken lager geworden zijn.
  8. maxen 30 april 2008 09:20
    quote:

    gogogoo schreef:

    [quote=maxen]
    [quote=aossa]
    Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years."
    [/quote]
    Dus tot 2018 nog grote rol voor eieren. Gaat allemaal wat langzamer.
    [/quote]
    Er staat "will not replace". Dat wil nog niet zeggen dat het dan niet al een rol van betekenis kan vervullen. En als het eenmaal aanslaat dan kan het hard gaan met een nieuwe technologie.
    Als je Garcia's klemtoon wat anders legt:
    "Zo rond 2018 heeft cell culture de traditionele egg-based technology grotendeels vervangen."
    Valt eigenlijk nog best mee.
  9. gogogoo 30 april 2008 09:26
    quote:

    maxen schreef:

    [quote=gogogoo]
    [quote=maxen]
    [quote=aossa]
    Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years."
    [/quote]
    Dus tot 2018 nog grote rol voor eieren. Gaat allemaal wat langzamer.
    [/quote]
    Er staat "will not replace". Dat wil nog niet zeggen dat het dan niet al een rol van betekenis kan vervullen. En als het eenmaal aanslaat dan kan het hard gaan met een nieuwe technologie.
    [/quote]
    Als je Garcia's klemtoon wat anders legt:
    "Zo rond 2018 heeft cell culture de traditionele egg-based technology grotendeels vervangen."
    Valt eigenlijk nog best mee.
    "He added" ik was er niet bij toen hij het zei maar het lijkt er op dat hij het uit eigen initiatief zei.....en niet desgevraagd. Dan zeg je dat met een bepaalde bedoeling.
  10. forum rang 4 aossa 30 april 2008 09:40
    quote:

    gogogoo schreef:

    "He added" ik was er niet bij toen hij het zei maar het lijkt er op dat hij het uit eigen initiatief zei.....en niet desgevraagd. Dan zeg je dat met een bepaalde bedoeling.
    Sponsors dienen nog return op hun investeringen in kippeneieren te zien (dankewel, merci_bien, voor de afgenomen $192m antigens) !

    Kippen en hun eieren zullen in de huidige economische omstandigheden alsmaar duurder worden wegens stijgende voedselkost (en schaarste) en dreigende inflatie.

    Laten we ook nog even niet van de veronderstelling uitgaan dat het ge_stockpilde H1N5 antigens wel eens ineffectief en dus nutteloos zou kunnen blijken te zijn indien het uitbreken van een echte pandemie anders verloopt dan voorzien (quod erat demonstrandum).

    En tenslotte kan er nog heel veel gebeuren in 10 jaar tijd en daar zit Crucell mee op de voorste rij. Hardop denk ik dan aan antibodies met een heel breed spectrum die zowel preventief als curatief zouden kunnen gebruikt worden. JMHO !
  11. flosz 30 april 2008 09:55
    quote:

    gogogoo schreef:

    Zomaar een gedachte....Het kan natuurlijk ook een manier zijn om de concurrentie het idee te geven dat het voorlopig nog niets is....om zo de markt straks als eerste te betreden en zo lang mogelijk als technology-monopolist/oligopolist nog steeds een hoge prijs te kunnen vragen tewijl de productiekosten stukken lager geworden zijn.
    O.a. Novartis loopt voor.

    28/08/2007 - Novartis last week began construction of a major new flu vaccine manufacturing facility in North Carolina, the very first cell culture-derived flu vaccine plant in the United States.

    Breaking ground at the new site is the latest sign that Novartis is leading the pack in the cell-based flu vaccine race, following the June approval of its cell-based flu shot Optaflu in the EU.
    *************************************

    Wat ik lees: Sanofi is de eerste tien jaar niet van plan de eitjes voor influenza prod. te vervangen door per.c6.

    Vanuit Sanofi zijn al eerder soortgelijke opmerkingen voorbij gekomen...in de periode van de extra contracten mbt voldoende aanlevering eieren. (Zonder jaartal, maar wel duidelijk dat overgang op per.c6 nog een poos gaat duren.)
    O.a. een uitspraak van Len Lavenda, staat imo in de vogelgriepdraad, deel I………
    Ivm “eitjes-subsidies”, gaat en moet Sanofi imo eerst geld verdienen op eieren.
    Per.c6 gaat tzt wel volgen….slowly but surely.

    Uit berichtje van 23-07-2007:
    The new facility has been designed with the latest state-of-the-art technologies, with improved work flow, and increased sterility mechanisms, such as air lock barriers and filtration units, to keep the integrity of the product and reduce the chances of contamination, Sanofi Pasteur spokesman Len Lavenda told in-PharmaTechnologist.com.

    In terms of the manufacturing process, he said "it is fundamentally the same process" but "there is a significant improvement of certain technologies."

    The new facility, construction of which began in July 2005, is the second facility Sanofi Pasteur has in the US - the other plant is located a few hundred yards away and is to undergo a retrofit as part of a $77.4m grant from the US Health and Human Services, announced last month, which would give Sanofi the ability to contribute 150 million influenza doses to the US Government in the case of a pandemic.

    The new plant is expected to come on line late 2008 or early 2009, following the facility's licensing by the US Food and Drug Administration (FDA), at which time operations will cease at the other plant, which currently has a capacity of 50 million doses per year, and the retrofit activities will begin. This would include a complete overhaul of the building, inside and out, including replacing all equipment, Lavenda said.
    The company would be contributing approximately $25m toward the retrofit project.

    The two plants will only produce influenza; seasonal and if needed, pandemic, including stockpiling.

    The US plants are the only ones supplying influenza vaccine to the US, although the French and Canadian sites the company has, supply other vaccines to the US.

    Currently, the company's global capacity for influenza vaccine is 175 million doses - 50 million in the US and 125 million in France - representing about 40 per cent of the global capacity for influenza vaccine. In three years, Lavenda said the projected global capacity will be between 250 and 300 million doses.

    The Swiftwater site is situated on approximately 500 acres with room for future growth, Lavenda said.

    Sanofi Pasteur is the only company manufacturing egg-based inactivated influenza vaccine in the US.

    Uit 2004
    The contract to Aventis Pasteur is nearly $10 million for the base contract to develop and implement the egg supply plan for transition to a year round egg supply, to stockpile other vaccine manufacturing supplies, and to obtain initial investigational lots of pandemic influenza vaccine. Maintenance of the egg supply plan, which will provide an increased surge capacity for vaccine manufacturing, and more investigational lots of pilot pandemic influenza vaccines through 2008 may increase the overall contract value to $41 million.
    www.hhs.gov/news/press/2004pres/20041...
    2007:
    Swiftwater, Pa., and Lyon (France) – 14 June, 2007 – Sanofi pasteur, the vaccines division of
    the sanofi-aventis Group, today announced it has been awarded a $ 77.4 million contract by the
    United States Department of Health and Human Services (HHS) to retrofit its existing influenza
    vaccine manufacturing facility. Sanofi pasteur will contribute approximately $ 25 million to the
    overall project. The contract covers costs for design, retrofit and the maintenance of the facilities at
    a state of readiness so the company can switch to pandemic influenza vaccine manufacture at the
    HHS' request.
    The design phase will begin immediately. The retrofit will begin when the company’s new influenza
    vaccine manufacturing facility is licensed by the FDA and operational. The existing facility will then
    be phased out and decommissioned for the retrofit.
    The existing facility has been modified over the years to produce approximately 50 million doses of
    vaccine for the U.S. market during the course of the past several influenza seasons. When both
    facilities are validated, the company’s capacity will approximately triple from its current capacity.
    This award marks the company’s seventh pandemic influenza-related contract with the U.S.
    government. Previous contracts have covered the production of investigational doses for clinical
    trials; bulk vaccine for stockpiling; the establishment and maintenance of laying chicken flocks to
    enable year-round egg production (not just seasonal); as well as a contract to speed the production
    process for new cell culture influenza vaccines, including the design of a U.S.-based cell-culture
    vaccine manufacturing facility. www.sanofipasteur.com/sanofi-pasteur/...

    Uit 2004:
    Emeryville-based Chiron and the French-owned Aventis Pasteur make the only egg-based flu vaccines approved for use in the United States, and since cell-based vaccines remain years away from the market, Chiron isn't ready to abandon the egg-based process. "It does have the potential to reduce that time, Chiron spokesman Rod Budge said. "But it's not going to produce vaccines overnight." Egg-incubated vaccines will remain the dominant product for at least the next few years not only because of regulatory issues but also because building new factories will take time and money. Baxter also conceded that its initial vaccine shots will cost more than the ones currently available.

    Aventis Pasteur remains resistant to changing its egg-based process. Aventis spokesman Len Lavenda argues that the number of new factories and fermenters needed to satisfy demand for the flu shots are not available and will be expensive to build. Also, he said, this flu season is the first in which demand outstripped supply -- it may turn out to be an anomaly. "This is unprecedented because we can't remember a time when we ran out of flu vaccine," Lavenda said. "Public health needs will continue to be best met by egg-based vaccines."

    www.vaccinetruth.org/how_vaccine_is_m...

  12. flosz 30 april 2008 09:57
    Vervolg.

    "Vaccines in general and flu in particular are undervalued. Prices are not at the level they should be to attract new investments," Aventis' Lavenda agreed.
    Aventis has partnered with a company in the Netherlands, Crucell, to research using human and animal cells in place of eggs. These so-called cell cultures could be maintained indefinitely and ramped up on demand whenever vaccine is needed.
    It's pricey technology, but cost isn't the only obstacle. Some worry that the genetic material of these cells might interact with the flu viruses, creating dangerous hybrids and undercutting the purpose of the vaccine.
    "If it changes the virus, obviously, that would not be desirable," Chiron's Bryett said.
    Such technology is at least a couple years away, said Fauci, whose office is funding many such studies.
    "There are safety issues, consistency issues," he said. "That's the reason why you do research on it. If it was just sticking the virus in a cell culture and go, we would have done it a long time ago."
    So we're stuck with eggs for next year and probably several more.
    www.vegsource.com/talk/health/message...

    *************************
    AB aossa, die antibodies....daar moeten we het strakjes van hebben...gaat imo "groots" worden.
  13. flosz 30 april 2008 10:03
    Vaccines effective against a pandemic virus are not yet available. Although vaccines against H5N1 virus are under development, no vaccine is ready for commercial production and no vaccines are expected to be available until several months after the start of a pandemic. Clinical data on the use of anti-viral drugs to treat H5N1 virus infections is limited at this time.



    Crucell has discovered a total of twenty-one human monoclonal antibodies that have been found to neutralize the avian influenza H5N1 virus. The set of monoclonal antibodies, which was produced by Crucell researchers using phage display and Crucell PER.C6® technology, showed the potential to neutralize the broadest range of H5N1 viruses including A/Vietnam/11994/04, A/Hong Kong/213/03 and A/Hong Kong/156/97. The antibodies apparently recognize a part of the viral membrane protein that is present among all H5N1 viruses tested. The most potent neutralizing antibody was tested in pre-clinical models for the ability to protect against infection with the highly pathogenic A/Hong Kong/97 H5N1 virus and was also tested for its ability to stop the development of the disease caused by this virus. When the monoclonal antibody was given in a pre-clinical model, one day prior to infection with the H5N1 virus, it resulted in full protection against infection. Treatment with the antibody up to three days after infection resulted in 100% survival and cure of the disease. This antibody may therefore provide a powerful tool in pandemic preparedness.
  14. [verwijderd] 30 april 2008 16:08
    Opvallend is, dat er niemand is, die een MARKTbeschouwing op het geheel loslaat.
    Volgens mij is het bij de trouwe forumbezoekers bekend, dat de MARKT voor griepspuiten snel uitbreidt en snel BLIJFT uitbreiden. Onder andere door leeftijdsverlaging.
    Het is dus totaal niet gek, dat er nog steeds capaciteitsuitbreiding is op basis van eieren, zolang via de celtechnologie nog geen eindresultaten bereikt zijn.
    Maar zodra er via celtechnologie
    geproduceerd kan worden, zal iedere capaciteitsuitbreiding opgevangen worden en tevens langzaam maar zeker (denk aan de forse afschrijvingen) de eiercultuur vervangen worden.

    Ik reken er op, dat de groei van de MARKT in de eerstkomende 10 jaar zeer fors zal zijn en dat wij voldoende aan onze trekken zullen komen.
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