Crucell Terug naar discussie overzicht

Draadje vogelgriep - Deel 2

1. [verwijderd] 4 januari 2007 14:43

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   DJ Japan Plans To Buy Bird Flu Vaccine For 10M People -Kyodo
   
   01/03/2007
   Dow Jones News Services
   (Copyright © 2007 Dow Jones & Company, Inc.)
   
   
   TOKYO (AP)--Japan plans to buy prototype bird flu vaccine solutions for up to 10 million people, Kyodo News agency said Wednesday, on concerns that the country lacks an adequate stockpile of drugs to fight the virus.
   
   The Japanese government will earmark Y4.5 billion ($37.9 million) in its supplementary budget for the fiscal year ending March 31 to build up the stockpile, Kyodo reported, citing unidentified Health Ministry officials.
   
   Four Japanese vaccine makers are expected to complete production of two types of prototype vaccine for 10 million people by around February, Kyodo cited the officials as saying.
   
   Manufacturers cannot produce an actual vaccine until a flu outbreak has occurred, so they are creating a stopgap prototype vaccine based on samples of the H5N1 strain of the virus detected in Vietnam in 2004 and in Indonesia in 2005, Kyodo added.
   
   Health Ministry officials weren't immediately available for comment Wednesday evening, Kyodo said.
   
   The H5N1 strain of bird flu has killed 157 people worldwide, according to the World Health Organization. There have been no known human deaths in Japan.
   
   So far, the virus cannot move easily from human to human - but if this changes, experts fear it could lead to a deadly flu pandemic.
   
   Preparing for the worst, Tokyo also planned to have enough of the anti-flu drug Tamiflu for 25 million people under a program set up in December 2005. The program, however, set no timetable for reaching that target, government health officials say, according to Kyodo.
   
   Under the plan, the central government was to stock enough Tamiflu for 10.5 million people, and local governments would have stocks for another 10.5 million people. Stocks available in the market would cover an additional 4 million people, Kyodo reported.
   
   Stocks, however, are still short of those targets.
   
   The central government had Tamiflu for 7.5 million people and local governments had planned to buy enough for another 5.25 million people by March 2007, Health Ministry officials said in late November.
   
   The officials didn't know whether stocks available on the market had reached the target, Kyodo said.
   
   Tamiflu is a product of Hoffmann-La Roche Inc., the U.S. prescription drug unit of Switzerland's Roche Holding AG (RHHBY).
   
   
   
2. [verwijderd] 5 januari 2007 11:13

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   Thursday, Jan. 4, 2007
   
   HHS Pursues Advance Development of New Influenza Antiviral Drug
   
   HHS Secretary Mike Leavitt announced today that the Department has awarded a $102.6 million, four-year contract to BioCryst Pharmaceuticals, Inc. for advanced development of their influenza antiviral drug, peramivir.
   
   In laboratory studies to date, peramivir has shown effectiveness against a number of influenza strains. Funding provided under the new contract will support further studies to determine if peramivir can be an effective treatment for seasonal and life-threatening influenza, including highly pathogenic H5N1 influenza. Additional research may also examine the drug's potential use for prophylaxis to protect against influenza infection.
   "Antivirals are an important element of our pandemic influenza preparedness efforts," Secretary Leavitt said. "Our antiviral strategy includes not only stockpiling existing antiviral drugs but also seeking out new antiviral medications to further broaden our capabilities to treat and prevent all forms of influenza."
   Peramivir is a member of the neuraminidase inhibitor class of influenza antiviral drugs. While the other antiviral drugs in this class are either taken orally (oseltamivir/Tamiflu) or by an inhaler (zanamivir/Relenza), peramivir is being studied as a drug that can be administered parenterally, that is through intravenous or intramuscular injection. The ability to administer the drug through parenteral injection may be especially useful in hospital settings where it can be given to persons with life-threatening influenza upon admission to emergency rooms. Additional advantages to parenteral injection of peramivir include the potential for high levels of the drug to be achieved rapidly throughout the body and its ability to be administered to people too ill to take medications by mouth.
   Funding in this contract will support manufacturing of clinical investigational and consistency lots; Phase 2 and 3 clinical studies to support product approval in the U.S.; manufacturing process validation; and other product approval requirements. The advanced development of peramivir by parenteral injection has been given "Fast Track" designation by the Food and Drug Administration, which will expedite the agency's review of BioCryst's application for approval.
   The avian influenza H5N1 virus is widespread in bird populations in Asia, Africa and Europe, and nearly all human cases have been caused by direct contact with infected poultry. Although there have been a few isolated cases of human-to-human transmission, the virus does not currently transmit easily from human to human. The highly pathogenic H5N1 avian influenza virus has not been found in the United States in either birds or humans.
   The award made to BioCryst is part of a larger HHS initiative to pursue the development of new therapies and vaccines which may expand the ability of the United States to respond quickly to a potential pandemic.
   www.hhs.gov/news/press/2007pres/20070...
   
3. [verwijderd] 5 januari 2007 12:12

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   December 2006 Summary of Progress
   
   6.1.16.1. Complete HHS shall continue to support the advanced development of cell-culture based influenza vaccine candidates. Measure of performance: research grants and/or contracts awarded to develop cell-culture based influenza vaccines against currently circulating influenza strains with pandemic potential within 6 months.
   
   Pagina 14
   
   www.pandemicflu.gov/plan/federal/acti...
   
   ************************************
   
   Uit de dagdraad by wpw:
   
   Second, HHS committed over $1 billion during 2005 and 2006 for advanced development of cell-based influenza vaccine production methods. This investment will make possible a more flexible alternative to egg-based production methods. It sets the stage for the modernization and expansion of domestic production capacity that must occur if the US is to be able to acquire 300 million treatment courses of a human vaccine within six months after the emergence of a pandemic virus.
   Third, recognizing the need to expand egg-based vaccine production capacity along with cell-based capacity, HHS in July 2006 sought proposals to adapt existing egg-based manufacturing facilities for emergency production of pandemic influenza vaccine. Contracts are expected to be awarded this December.
   www.pandemicflu.gov/plan/pdf/panflure...
   
   www.iex.nl/forum/topic.asp?forum=228&...
4. [verwijderd] 5 januari 2007 16:19

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   Canada approves Relenza to prevent flu; Denmark orders GSK's pandemic vaccine
   Published: Thursday, January 4, 2007 | 7:06 PM ET
   Canadian Press
   TORONTO (CP) - Health Canada has given pharmaceutical giant GlaxoSmithKline permission to market its flu drug Relenza for the prevention of influenza, not merely the treatment of the illness.
   The Canadian approval, announced by GSK on Thursday, follows in the footsteps of similar approvals by regulators in the United States and 15 European Union countries.
   Other flu drugs on the market here - Tamiflu and the generic drug amantadine - were already approved for prevention of influenza.
   One might consider taking a flu anti-viral for prevention or prophylaxis, as it's called, if a member of a household comes down with infectious virus and others want to avoid getting sick. As well, flu drugs are often used on a preventative basis to protect vulnerable seniors in long-term care facilities during flu outbreaks.
   GSK, the world's second biggest manufacturer of flu vaccine, also announced Thursday it had entered into a contract to provide flu vaccine to Denmark in the case of a pandemic.
   Denmark has agreed to buy 4.6 million doses of a vaccine, enhanced with GSK's unnamed proprietary adjuvant, for an undisclosed price.
   Adjuvants are chemicals that boost the immune response induced by a vaccine. Adding them to vaccine allows a smaller dose to achieve an equal or greater immune response than a dose of unadjuvanted vaccine - a feature that could be critical in a pandemic, when demand for vaccine will far outstrip supply.
   The vaccine for Denmark will be made in GSK's European manufacturing facilities, the company said in a release.
   Canada was the first country to sign a deal with a vaccine manufacturer for pandemic vaccine. The 10-year deal, signed in 2001, requires the designated manufacturer to be at the ready to produce pandemic vaccine at all times.
   The contract was initially signed with Shire Biologics. When Shire sold its Quebec-based flu vaccine operations to ID Biomedical in 2004, that company acquired the pandemic contract. But in the fall of 2005 GSK bought IDB's vaccine production operations, becoming Canada's pandemic vaccine manufacturer.
   
   www.cbc.ca/cp/health/070104/x01049A.html
5. gogogoo 10 januari 2007 21:46

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   Ahead of the Bell: Bird Flu
   Wednesday January 10, 8:14 am ET
   Companies Working on Bird Flu Treatment May Gain Amid New Concerns in Asia
   
   NEW YORK (AP) -- Bird flu concerns swooped back into the news Wednesday, bringing companies trying to find treatments for the deadly virus back into focus.
   
   The H5N1 bird flu virus typically spreads during traditional flu season as temperatures drop in winter months. The virus is transmitted mostly among birds, but has transferred to humans who are in close contact with them, and health officials fear the H5N1 strain may become pandemic in the future.
   
   Some officials worry this year will be a repeat of last winter when the virus was reported in many countries for the first time, including India, Iraq, Azerbaijan, Niger, France and Egypt.
   
   The virus killed a 14-year-old Indonesian boy on Wednesday, just days after he was hospitalized, and recently resurfaced in Vietnam after a year-long hiatus. China reported Wednesday that a Chinese farmer contracted the deadly H5N1 strain in December, but has recovered and been released from a hospital.
   
   Several companies may see their shares climb on the heightened concerns, including pharmacutical company Novavax Inc., which licensed drug delivery technology last week from IGI Inc. for use in developing a bird flu vaccine.
   
   The disease has claimed at least 157 lives worldwide since 2003, according to the World Health Organization.
   
   biz.yahoo.com/ap/070110/bird_flu_ahea...
   
   
6. [verwijderd] 16 januari 2007 08:31

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   H5N1-virus opgedoken in Japan
   UTRECHT/TOKIO - 16-01-2007 - Japan is voor het eerst in drie jaar getroffen door een uitbraak van het voor mensen gevaarlijke H5N1-virus. Het vogelgriepvirus is aangetroffen op een pluimveebedrijf in het zuiden van Japan, waar kippen in het weekeinde massaal ziek werden.
   
   Mensen zijn voor zover bekend niet ziek geworden in Miyazaki. De ziekte woedt momenteel vooral in Vietnam en Indonesië, waar een ziekenhuis deze week is overspoeld door mensen die aan de gevaarlijke ziekte lijden. De vogelgriep is ook weer opgedoken in Thailand.
   
   
7. [verwijderd] 16 januari 2007 08:31

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   Vogelgriep duikt weer op in Azië
   Azië is weer in de ban van de vogelgriep. Voor het eerst in drie jaar is Japan getroffen door een uitbraak van de voor mensen gevaarlijke variant H5N1.
   
   Ook in Vietnam en Thailand is de ziekte weer opgedoken. En een Indonesisch ziekenhuis werd gisteren overspoeld door nieuwe patiënten. Terwijl Indonesië juist dacht, het virus enigszins onder controle te hebben, zegt correspondent Michel Maas.
   
   
8. voda 16 januari 2007 21:13

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   Vogelgriep duikt op in Japan
   
   TOKIO - Japan is voor het eerst in drie jaar getroffen door een uitbraak van het voor mensen gevaarlijke H5N1-virus.
   Sindsdien zijn ongeveer vierduizend kippen aan de ziekte bezweken. Voor zover bekend zijn geen mensen ziek geworden in Miyazaki, zoals de streek heet.
   
   De dode kippen zijn verbrand en de overige kippen van het bedrijf zijn preventief geruimd. Zestien boerderijen in een omtrek van tien kilometer rondom het besmette bedrijf zijn geruimd en er is een vervoersverbod van pluimvee en eieren ingesteld.
   
   Landelijk zullen alle pluimveebedrijven worden gecontroleerd. Ook wordt onderzocht of trekvogels het virus van elders uit Azië hebben meegebracht. De ziekte woedt momenteel vooral in Vietnam en Indonesië, maar er zijn ook al zieke dieren opgedoken in Thailand.
   
   In Indonesië zijn opnieuw twee vrouwen overleden aan de ziekte.
   
   Het totaal aantal doden is daarmee opgelopen tot 61.
   
   In Japan werd in 2004 voor het eerst sinds tientallen jaren vogelgriep geconstateerd.
   
   Eén persoon is sindsdien met de H5N1-variant besmet geraakt, maar die heeft het overleefd. (AP, Reuters)
   
9. gogogoo 16 januari 2007 22:31

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   Europe warned over resurgence of bird flu
   
   By John Aglionby in Jakarta
   
   Published: January 14 2007 18:21 | Last updated: January 14 2007 18:21
   
   The deadly H5N1 strain of avian influenza is making a seasonal resurgence in Asia and could easily spread to Europe again this year, the World Health Organisation warned on Sunday.
   
   The alarm follows four human deaths in Indonesia in the last five days, the first human case in China for six months (though the infected man has since recovered) and new poultry outbreaks in Vietnam – despite a huge campaign against it – and northern Nigeria.
   
   “We are convinced that we’re in a repeat of last year and the year before when the virus began to get very active again [in the northern hemisphere winter] and spread from Asia into the Middle East and beyond,” said Peter Cordingley, the WHO spokesman for the western Pacific region.
   
   Indonesia, where 61 people have died since 2005, remained the “biggest flashpoint” but nowhere in the region “has got it licked”. “Most countries are becoming better prepared and the countries that were caught out last year, especially wealthier ones in Europe and close to Europe, we hope are going to be better prepared,” he said. “But we’re still losing more than we’re winning.”
   
   The strain detected in Asia is a mutation of last year’s but “it is not showing any sign of moving to a strain that would be more dangerous to humans or have a greater likelihood of human-to-human transmission,” Mr Cordingley said.
   
   All four human fatalities in Indonesia contracted the virus from infected birds, authorities say. Experts fear that H5N1 will combine with a human flu strain to mutate into a form that would cause a global human pandemic.
   
   Tri Satya Naipospos, the deputy head of Indonesia’s bird flu commission and a persistent critic of the country’s efforts, said Jakarta was still not allocating adequate financial or human resources to the issue.
   
   The latest outbreak in Vietnam, in six southern provinces, comes despite a widespread poultry cull and tight controls on birds that had resulted in no human cases since 2005.
   
   In signs that neighbouring nations view south-east Asia as the most likely source of a pandemic, both China and Australia announced new assistance at a regional leaders’ summit. Japan’s Miyazaki prefecture yesterday began the disposal of 12,000 chickens after confirming the first outbreak of avian influenza since January 2006 and tests will determine whether it is the deadly H5N1 strain.
   
   Additional reporting by Amy Kazmin in Bangkok, Roel Landingin in Cebu and David Pilling in Tokyo.
   
   Copyright The Financial Times Limited 2007
   
   www.ft.com/cms/s/e9f79c66-a3f9-11db-b...
10. [verwijderd] 17 januari 2007 11:05

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    quote:

    flosz schreef:

    December 2006 Summary of Progress
    
    6.1.16.1. Complete HHS shall continue to support the advanced development of cell-culture based influenza vaccine candidates. Measure of performance: research grants and/or contracts awarded to develop cell-culture based influenza vaccines against currently circulating influenza strains with pandemic potential within 6 months.
    
    Pagina 14
    
    www.pandemicflu.gov/plan/federal/acti...
    
    ************************************
    
    Uit de dagdraad by wpw:
    
    Second, HHS committed over $1 billion during 2005 and 2006 for advanced development of cell-based influenza vaccine production methods. This investment will make possible a more flexible alternative to egg-based production methods. It sets the stage for the modernization and expansion of domestic production capacity that must occur if the US is to be able to acquire 300 million treatment courses of a human vaccine within six months after the emergence of a pandemic virus.
    Third, recognizing the need to expand egg-based vaccine production capacity along with cell-based capacity, HHS in July 2006 sought proposals to adapt existing egg-based manufacturing facilities for emergency production of pandemic influenza vaccine. Contracts are expected to be awarded this December.
    www.pandemicflu.gov/plan/pdf/panflure...
    
    www.iex.nl/forum/topic.asp?forum=228&...
    

    Posting van maxen uit de dagdraad mag hier imo niet ontbreken!
    
    Dit verslag uit december 2006 is overigens "slechts" het voortgangsraport naar aanleiding van het oorspronkelijke "National Strategy for Pandemic Influenza Implementation Plan (Implementation Plan)" uit May, 2006:
    
    www.whitehouse.gov/homeland/nspi_impl...
    
    Op pagina 133 van 233 staat daar dus:
    "6.1.16.1. HHS shall continue to support the advanced development of cell-culture based influenza vaccine candidates. Measure of performance: research grants and/or contracts awarded to develop cell-culture based influenza vaccines against currently circulating influenza strains with pandemic potential within 6 months."
    
    In het voortgangsraport op p 14. wordt deze doelstelling opnieuw weergegeven, met daarbij de mededeling "complete" en de concrete actie die in het afgelopen halfjaar is genomen (cursief):
    
    "We announced awards totaling over $1 billion for advancing cell culture technology on May 4, 2006. We provided draft guidance to industry, "Clinical Data Needed to Support the Licensure of Pandemic
    14 Influenza Vaccines, March 2, 2006" and "Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines, March 2, 2006."
    
    Dit betrof dus de serie opdrachten van Mei vorig jaar waar Sanofi/Crucell niet bijzat, alswel "GlaxoSmithKline, MedImmune, Novartis Vaccines, DynPort Vaccine, and Solvay Pharmaceuticals". De genoemde doelstelling is dus reeds gehaald, en betreft dus niet een nieuwe doelstelling voor 2007. Overigens, om andere redenen, bv. omdat er nog niet genoeg voorraad is, en er nog budget voor over is, zou je alsnog kunnen verwachten dat er nog meer vaccin orders te verwachten zijn.
    
    En trouwens,geen nood. In de oorspronkelijke "Strategy" staan ook nog de punten (p133):
    
    "6.1.16.2. HHS shall support the renovation of existing U.S. manufacturing facilities that produce other FDA-licensed cell-based vaccines or biologics and the establishment
    of new domestic cell-based influenza vaccine manufacturing facilities, within 36 months. Measure of performance: contracts awarded for renovation or establishment of domestic cell-based influenza vaccine manufacturing capacity."
    
    en
    
    "6.1.17.1. HHS shall continue to support the development and clinical evaluation of novel vaccines and vaccination strategies (e.g., adjuvants, alternative delivery systems, common epitope vaccines). Measure of performance: research grants and/or contracts awarded to support the development of influenza vaccines (including polyvalent influenza vaccines), adjuvants and dose-sparing strategies, and more efficient delivery systems within 12 months, leading to initiation of phase I and II clinical trials to evaluate influenza vaccines and vaccination strategies."
    
    , die respectievelijk binnen 36 maanden (nu nog 30 maanden) en 12 maanden (nu nog 6 maanden) moeten worden afgerond, en waarvoor Sanofi en/of Crucell ook voor aanmerking kunnen komen. Beide punten staan niet vermeld in de voortgangsrapportage, omdat ze volgens de tijdsplanning nog niet afgerond hoeven te zijn. Het eerste punt, 6.1.16.2, is volgens mij het punt waarop Sanofi/Crucell de eerste grant heeft gekregen voor het ontwerp van een cell-based fabriek, dus het zou best wel logisch zijn dat ze hier binnen 30 maanden een vervolg-opdracht voor krijgen, voor daadwerkelijke bouw van de fabriek, of in de vorm van daadwerkelijke vaccin-orders.
    
    Het tweede punt,6.1.17.1., voor vernieuwende vaccin technieken, is iets minder waarschijnlijk voor Sanofi subsidie, maar kan wel als ze een goed adjuvant ontwikkelen. Wellicht iets voor Berna's virosome technologie? Of Novavax' vergelijkbare VLP's. Of voor andere ontwikkelaars die vaccins tegen ALLE varianten van het griepvirus ontwikkelen...Deze subsidieronde zou in de 1e helft van 2007 moeten afgerond zijn.
    
    www.iex.nl/forum/topic.asp?forum=228&...
11. [verwijderd] 17 januari 2007 17:59

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    17/01/2007, 2007, 5.30 PM CET
    
    Novartis receives US government contract to further develop a novel antigen technology that could extend vaccine supplies in a pandemic outbreak
    
    
    Latest contract, for USD 55 million, marks fourth award for Novartis from the US Department of Health and Human Services to support the government's pandemic preparedness efforts
    MF59 adjuvant technology could extend vaccine supplies by allowing smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive
    Basel, January 17, 2007 - Novartis announced that it has received a contract from the US Department of Health and Human Services (HHS) of approximately USD 55 million. The contract supports the company's efforts to bring the antigen-sparing capabilities of the MF59 adjuvant to the United States. An adjuvant is a substance added to a vaccine to enhance the body's immune response to the vaccine's active constituent, called the antigen.
    "Novartis is committed to the development and supply of vaccines to help protect against both seasonal influenza as well as the possible emergence of pandemic influenza. The use of our proprietary adjuvant MF59 with influenza vaccines has shown to be dose sparing and to provide additional immunogenicity against a broader range of potential pandemic influenza strains, while using lower amounts of viral antigen for the vaccine," said Dr. Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics.
    This latest HHS contract supports development efforts in the US to evaluate the safety and effectiveness of the MF-59 adjuvant in a cell cultured based pandemic influenza vaccine. The award will also support the design, equipment and validation for a US-based MF59 production facility in Holly Springs, North Carolina. In May 2006, Novartis received a contract from the HHS to develop a cell culture based influenza vaccine and to develop and design a manufacturing facility for such a vaccine in the US. Separately, in October 2005 and November 2006 Novartis was awarded contracts for a pre-pandemic vaccine by the HHS to contribute to the US National Strategic Stockpile, which is being built in accordance with the US Pandemic Preparedness Plan.
    While normal seasonal influenza vaccines use 15 micrograms of antigen per influenza strain in each single dose of trivalent vaccine, current clinical data show that similar H5N1 pandemic vaccines may require up to 90 micrograms of antigen per dose, with two doses necessary to achieve the desired immunogenicity in people[1]. However, several studies have found that the addition of the MF59 adjuvant from Novartis may reduce the amount of antigen necessary. In addition, the adjuvant holds the potential to provide cross-protection against drifted strains of an avian influenza virus
    www.novartis.com/
    **************
    
    17 January 2007
    
    GlaxoSmithKline awarded $63 million HHS contract for pandemic vaccine research and development: Company begins government and retail shipments of its antiviral Relenza®
    Philadelphia, PA – January 17, 2007-- GlaxoSmithKline [NYSE: GSK], one of the world’s largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK’s ongoing pandemic vaccine research in using the company’s innovative adjuvant technology in combination with antigens to induce a strong immune response.
    Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the US Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event a flu pandemic. The 5-year contract also gives the US Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
    “A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines,” said David Stout, President of Pharmaceuticals at GlaxoSmithKline. “GSK’s research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK’s short and long-term vision of helping governments around the world in their pandemic preparedness efforts.”
    
    www.gsk.com
    
12. voda 17 januari 2007 18:02

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    Weer netjes "gefoszt", Flosz.
13. [verwijderd] 17 januari 2007 18:14

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    En nog een....Iomai Corp.
    
    SAN FRANCISCO (MarketWatch) -- The Department of Health and Human Services on Wednesday said it has awarded contracts totaling $132.5 million to three drug companies for the development of H5N1 influenza vaccines. The government awarded five-year contracts to GlaxoSmithKline Plc
    for $63.3 million and to Novartis for $54.8 million. HHS also awarded Iomai Corp $14.4 million for 15 months to complete Phase 1 clinical trials of their candidate vaccine, and said the company may receive an additional $114 million in funding upon successful completion of the trials. Under the contracts, each company will build up its capacity to produce, within six months of the onset of an influenza pandemic, either 150 million doses of an adjuvant-based vaccine or enough adjuvant for 150 million doses of vaccine. An adjuvant is a substance that may be added to a vaccine to increase the body's immune response to the vaccine's active ingredient. The contracts also require each company to provide its adjuvant for government-sponsored evaluation with influenza vaccines from other manufacturers.
    
14. [verwijderd] 17 januari 2007 18:44

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    In addition to supporting the development of each company's antigen-sparing vaccine
    candidate, the contracts also require each company to provide its
    proprietary adjuvant for U.S. Government-sponsored, independent evaluation
    with influenza vaccines from other manufacturers.
    *************************
    
    HHS Funds Advanced Development of H5N1 Influenza Vaccines
    
    
    Three New Contracts Will Focus on Antigen-Sparing Vaccines
    
    WASHINGTON, Jan. 17 /PRNewswire-USNewswire/ -- HHS Secretary Mike
    Leavitt announced today that the department has awarded contracts totaling
    $132.5 million to three vaccine makers for the advanced development of H5N1
    influenza vaccines using an immune system booster called an adjuvant. An
    adjuvant is a substance that may be added to a vaccine to increase the
    body's immune response to the vaccine's active ingredient, called antigen.
    "In the event of an influenza pandemic, a vaccine that uses adjuvant
    could provide a way to extend a limited vaccine supply to more people,"
    Secretary Leavitt said. "These contracts are a continuation of our
    aggressive multi- pronged approach to a potentially critical public health
    challenge."
    The Department has awarded five-year contracts to GlaxoSmithKline for
    $63.3 million and to Novartis Vaccines and Diagnostics, Inc. for $54.8
    million. In addition, HHS is funding IOMAI Corporation for $14.4 million
    for 15 months to complete Phase 1 clinical trials of their candidate
    vaccine. IOMAI may receive an additional $114 million in funding upon
    successful completion of the Phase 1 trials. Phase 1 trials are the first
    stage of testing in people and normally include a small (usually less than
    100) group of healthy volunteers. Overall the three contracts support
    advanced development work through Phase 3 clinical trials in the U.S. that
    are aimed at obtaining U.S. licensure for the product. In addition, the
    contracts support the establishment of U.S.-based manufacturing
    capabilities.
    Under the contracts each company will build up its capacity to produce
    within six months after the onset of an influenza pandemic either 150
    million doses of an adjuvant-based pandemic influenza vaccine or enough
    adjuvant for 150 million doses of a pandemic influenza vaccine. In addition
    to supporting the development of each company's antigen-sparing vaccine
    candidate, the contracts also require each company to provide its
    proprietary adjuvant for U.S. Government-sponsored, independent evaluation
    with influenza vaccines from other manufacturers.
    Initial clinical studies of H5N1 vaccine in humans have shown that two
    90- microgram doses of the vaccine are required to stimulate a level of
    immune response that researchers anticipate would provide protection for an
    individual against the H5N1 strains that have been spreading among birds in
    Asia. However, the addition of adjuvant to these candidate vaccines may
    reduce the amount of antigen (active ingredient) per dose needed to achieve
    effective individual protection.
    HHS' effort to pursue adjuvant-based vaccine is part of a broader
    effort by the department to accelerate the development and production of
    new technologies for influenza vaccines within the U.S. For example, in May
    2006 HHS announced a $1 billion investment to support the advanced
    development of cell-based production technologies for influenza vaccines
    and will help to modernize and strengthen the nation's influenza vaccine
    production by creating an alternative to producing influenza vaccines in
    eggs.
    The H5N1 strain of avian flu has spread to more than 40 countries and
    has led to the deaths of hundreds of millions of additional birds, which
    has heightened concern about the possibility of a human flu pandemic.
    Furthermore, the number of avian flu cases in humans has reached more than
    260 cases in 10 countries. More than half of those persons infected have
    died. To date, H5N1 avian influenza has remained primarily an animal
    disease, but should the virus acquire the ability for sustained
    transmission among humans, the potential for an influenza pandemic would
    have grave consequences for global public health.
    More information on pandemic preparedness including information on
    vaccines can be found online at
    www.pandemicflu.gov/vaccine/index.html.
    Note: All HHS press releases, fact sheets and other press materials are
    available at www.hhs.gov/news.
    
    
15. [verwijderd] 17 januari 2007 20:27

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    IV, By: donnbonn
    
    Vaccine Market Draws VC Interest
    (AP) NEW YORK
    The $7 billion vaccines market is dominated by companies like GlaxoSmithKline PLC and Novartis AG, but many venture capital investors are betting that the next great advances in this field will come from biotech start-ups.
    Several vaccine companies have drawn venture backing recently, including Juvaris BioTherapeutics, which in December raised $6 million of a planned $12 million first round from Kleiner Perkins Caufield & Byers; Variation Biotechnologies Inc., which last week announced that it had raised a $35.7 million first round led by Clarus Ventures; and VaxInnate Corp., which drew $40 million in a third-round financing in October led by New Leaf Venture Partners.
    The outbreak of pandemic flu, the threat of bioterrorism, and concern about seasonal influenza create opportunity for companies capable of rapidly producing protective vaccines. But, the field appeals for other reasons as well.
    Improved understanding of immune-system function has led to creative strategies for provoking an immune response against viral and bacterial invaders. Animal and early human studies are usually excellent predictors of how a vaccine will fare in larger studies, and start-ups don't have to rely exclusively on venture dollars to fund their research - the National Institutes of Health and various foundations offer grants and other types of non-dilutive financing.
    Also, pharmaceutical companies are making a stronger push into vaccines. In November, for example, Pfizer Inc. acquired PowderMed Inc., a developer of vaccines for influenza, herpes, HIV and other indications, for an undisclosed amount of cash. SV Life Sciences, Oxford Bioscience Partners, Abingworth Management and others provided the Oxford, England, company with about $45 million in venture capital.
    In vaccines, big drug makers see opportunity to enter a growing market and to counter the perception that they are preoccupied with lifestyle drugs and television ads.
    "Vaccines are about as good a PR story as they can tell," says Gregory M. Weinhoff, a partner of CHL Medical Partners, which seeded VaxInnate in 2002.
    In addition, some major drug makers are focusing on vaccines to help bridge the gap between older drugs facing increased generic competition and newer drugs yet to reach the market.
    Several start-ups have technology enabling them to rapidly churn out vaccines to new strains of pathogenic viruses. Influenza, or flu, vaccines today are produced in egg-based manufacturing systems. Production of a seasonal flu vaccine takes several months.
    But Alan Shaw, chief executive of VaxInnate, Cranbury, N.J., says his E. coli system for making vaccines is far more efficient - yielding 50 million doses of its hemagglutinin vaccine for seasonal flu in two weeks, he says. That vaccine should enter the clinic in early 2008, Shaw says.
    Another seasonal vaccine, which targets an antigen called M2 that doesn't change from year to year - as the hemagglutinin antigen does - is expected to enter clinical trials in April, according to Shaw.
    Variation Biotechnologies, of Ottawa, says it can produce vaccines against a seasonal as well as pandemic influenza and many other pathogens. Before raising its first venture round, Variation funded its research with money from private investors and grants from the National Research Council of Canada's Industrial Research Assistance Program and other Canadian government agencies.
    Juvaris, Pleasanton, Calif., recently tapped Kleiner Perkins' new pandemic and biodefense fund to raise its first-round capital. The company's vaccines are complexes of lipids and DNA. The capital will enable it to advance vaccines for influenza into clinical trials in the first quarter of 2008, according to Chief Executive Martin D. Cleary.
    One company looking for venture funds is Vaxin Inc., a Birmingham, Ala., company that has raised $4.5 million from venture investors such as Emerging Technology Partners and corporations, including Crucell. The company is raising a $10 million Series B to fund a Phase I/II clinical trial of a seasonal flu vaccine that's delivered intranasally, according to Chief Executive Kent Van Kampen. It expects to put a vaccine for avian flu into Phase I this summer, Kampen says. Delivering vaccines intranasally is less painful than by injection. And since the nose is rich in cells that can trigger a powerful immune response to an antigen, intranasal vaccines may also be more potent than injected ones, he says.
    www.kiplingerforecasts.com/apnews/Xml...
    
    www.investorvillage.com/smbd.asp?mb=2...
16. [verwijderd] 17 januari 2007 20:58

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    quote:

    flosz schreef:

    One company looking for venture funds is Vaxin Inc., a Birmingham, Ala., company that has raised $4.5 million from venture investors such as Emerging Technology Partners and corporations, including Crucell.
    

    Uit 2006:
    
    HFD - 19 juni 2006 13:50
    'Crucell neemt 5%-belang in vaccinontwikkelaar Vaxin'
    AMSTERDAM (FD.nl/Betten) - Crucell neemt een belang van 5% in Vaxin, een Amerikaanse ontwikkelaar van vaccins. Dat meldt de Birmingham Business Journal dit weekeinde. Financiele details werden door de krant niet onthuld.
    
    Bestuursvoorzitter Kent Van Kampen van Vaxin zegt in de Amerikaanse regionale zakenkrant dat de deelneming een erg grote belofte inhoudt voor de toekomstige ontwikkeling en marketing van de vaccins van zijn onderneming. Volgens Van Kampen biedt Crucell zijn bedrijf een mondiaal platform.
    
    Crucell is van oorsprong een biotechbedrijf dat zich bezighoudt met de ontwikkeling van nieuwe technologieen. Maar sinds de overname van het Zwitsers Berna Biotech begin dit jaar mag de onderneming zich ook een belangrijke speler noemen op het gebied van het ontwikkelen, produceren en wereldwijd op de markt brengen van vaccins en immunotherapeutica.
    
    Beide ondernemingen kennen elkaar al vijf jaar. In juni 2001 ging Crucell een samenwerking aan met Vaxin om nieuwe types vaccins te ontwikkelen die geschikt zijn om toe te dienen zonder injecties. In september 2004 sloten de ondernemingen een non-exclusieve licentie-overeenkomst af voor het gebruik van Crucell's PER.C6-technologie.
    
17. gogogoo 17 januari 2007 21:59

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    quote:

    flosz schreef:

    [quote=flosz]
    One company looking for venture funds is Vaxin Inc., a Birmingham, Ala., company that has raised $4.5 million from venture investors such as Emerging Technology Partners and corporations, including Crucell.
    [/quote]
    
    Uit 2006:
    
    HFD - 19 juni 2006 13:50
    'Crucell neemt 5%-belang in vaccinontwikkelaar Vaxin'
    AMSTERDAM (FD.nl/Betten) - Crucell neemt een belang van 5% in Vaxin, een Amerikaanse ontwikkelaar van vaccins. Dat meldt de Birmingham Business Journal dit weekeinde. Financiele details werden door de krant niet onthuld.
    
    Bestuursvoorzitter Kent Van Kampen van Vaxin zegt in de Amerikaanse regionale zakenkrant dat de deelneming een erg grote belofte inhoudt voor de toekomstige ontwikkeling en marketing van de vaccins van zijn onderneming. Volgens Van Kampen biedt Crucell zijn bedrijf een mondiaal platform.
    
    Crucell is van oorsprong een biotechbedrijf dat zich bezighoudt met de ontwikkeling van nieuwe technologieen. Maar sinds de overname van het Zwitsers Berna Biotech begin dit jaar mag de onderneming zich ook een belangrijke speler noemen op het gebied van het ontwikkelen, produceren en wereldwijd op de markt brengen van vaccins en immunotherapeutica.
    
    Beide ondernemingen kennen elkaar al vijf jaar. In juni 2001 ging Crucell een samenwerking aan met Vaxin om nieuwe types vaccins te ontwikkelen die geschikt zijn om toe te dienen zonder injecties. In september 2004 sloten de ondernemingen een non-exclusieve licentie-overeenkomst af voor het gebruik van Crucell's PER.C6-technologie.
    
    

    Was dat niet een ruil voor een PER.C6 licentie verlening? Zoiets van: Geef mij please, pleeeeaaase een PER.C6 Licentie dan krijg je 5% van mijn organisatie!
18. [verwijderd] 18 januari 2007 11:30

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    Vaccine scientist to depart WHO for Novartis unit
    
    January 18, 2007
    Klaus Stoehr(Stöhr), the veterinarian who led the World Health Organization's battle against bird flu until last year, said he will leave the international health agency to take a position with Novartis AG.
    Stoehr will take a senior position in Swiss-based Novartis AG's flu vaccine division, he said. Novartis gained flu vaccine manufacturing when it bought Chiron Corp. last year.
    Novartis and other companies are racing to develop vaccines that can be produced in large amounts. Novartis yesterday got a $55 million (U.S.) grant from Washington to develop chemicals to stretch vaccine supplies.
    www.thestar.com/Business/article/172251
19. [verwijderd] 18 januari 2007 12:10

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    Nature
    Published online: 17 January 2007; | doi:10.1038/445237a
    
    Concern as revived 1918 flu virus kills monkeys
    Questions raised over safety of revived microbe.
    Kerri Smith
    The 1918 influenza virus, which killed some 50 million people worldwide, has proved fatal to macaques infected in a laboratory. The study follows Nature's controversial publication1 of the virus's sequence in 2005, alongside a paper in Science that described the recreation of the virus from a corpse and its potency in mice2.
    
    Some scientists question the wisdom of reconstructing such a deadly virus. Do the benefits outweigh the risks?
    
    Those who carried out the macaque study say yes, as a better understanding of how it acts in a system similar to humans' will help scientists treat future pandemics. The study was carried out in the biohazard level 4 labs of the Public Health Agency of Canada in Winnipeg. Yoshihiro Kawaoka of the University of Wisconsin-Madison and his colleagues infected macaques with the 1918 virus or a contemporary flu strain3. Whereas the contemporary virus caused mild symptoms in the lungs, the 1918 flu spread quickly throughout the respiratory system and the monkeys died within days. The damage parallels reports of human patients in 1918.
    
    The team reports that the 1918 virus caused the monkeys' immune systems to go into overdrive, causing immune proteins to be expressed at abnormally high levels and attack the body — what immunologists call a cytokine storm.
    The research suggests that 1918 flu might work in a similar way to other viruses, such as West Nile, that can also cause a massive auto-immune reaction. This suggests a route towards treatment, says Michael Gale, a virologist at the University of Texas Southwestern Medical Center. Drugs that target over-zealous immune responses, such as those that control an immune protein called interleukin-6, are being developed for other diseases. Tweaked versions might work for pandemic flu.
    
    But despite the promise of treatments, the results echo what had already been found in mice, and Gale feels there is a more important issue to be addressed. "The pathogenesis is interesting," he says. "But the key question is: how was it spread so efficiently?"
    
    A team at the Mount Sinai School of Medicine has already started to investigate. Peter Palese is working with Adolfo Garcia-Sastre and Jeffery Taubenberger, who first reconstructed the virus, to find out how it spreads. Working with ferrets, they have found that a change of only one or two amino acids in the flu sequence is enough to stop transmission. They will publish the result in Science. Identifying which sections of the genome are responsible for transmission "has huge predictive value for whether strains will become pandemic or not", says Guus Rimmelzwaan at the World Health Organization's National Influenza Centre in Rotterdam, the Netherlands.
    
    The next move for Kawaoka's team is along similar lines — they will be swapping sections in and out of the virus to establish exactly which bits make it so lethal.
    
    But the latest results haven't assuaged everyone's concerns. Richard Ebright, a bacteriologist at Rutgers University, New Jersey, believes the virus should never have been recreated. "The key implication is that the material is now present in at least two locations," he says. The new study, he argues, increases the risk that the virus could escape and sets "a dangerous precedent" for other labs to follow.
    Ebright argues that publishing the study in Nature, when similar research on more mundane pathogens regularly appears in lower-impact journals, could in itself increase the proliferation risk, if it tempts research groups to work on high-risk pathogens simply to get more recognition. Similar views were expressed off the record by other scientists. Ritu Dhand, Nature's chief biological sciences editor, defends the decision to publish, arguing that because the 1918 virus is not like other flu viruses, gaining insight into what makes it is so virulent in humans is of scientific interest.
    
    Gale agrees that understanding the 1918 flu strain better could have huge public-health benefits. But he says there might be better ways to study this, and admits that some research might be driven as much by historical interest as by the potential health benefits.
    
    Jens Kuhn, a virologist at Harvard Medical School who advises on arms control, also feels divided. "Everything I say, I make 'enemies' on one or the other side," he says. "I am torn sometimes between the two worlds."
    www.nature.com/news/2007/070115/full/...
20. aossa 18 januari 2007 12:32

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    quote:

    gogogoo schreef:

    [quote=flosz]
    [quote=flosz]
    One company looking for venture funds is Vaxin Inc., a Birmingham, Ala., company that has raised $4.5 million from venture investors such as Emerging Technology Partners and corporations, including Crucell.
    [/quote]
    
    Uit 2006:
    
    HFD - 19 juni 2006 13:50
    'Crucell neemt 5%-belang in vaccinontwikkelaar Vaxin'
    AMSTERDAM (FD.nl/Betten) - Crucell neemt een belang van 5% in Vaxin, een Amerikaanse ontwikkelaar van vaccins. Dat meldt de Birmingham Business Journal dit weekeinde. Financiele details werden door de krant niet onthuld.
    
    Bestuursvoorzitter Kent Van Kampen van Vaxin zegt in de Amerikaanse regionale zakenkrant dat de deelneming een erg grote belofte inhoudt voor de toekomstige ontwikkeling en marketing van de vaccins van zijn onderneming. Volgens Van Kampen biedt Crucell zijn bedrijf een mondiaal platform.
    
    Crucell is van oorsprong een biotechbedrijf dat zich bezighoudt met de ontwikkeling van nieuwe technologieen. Maar sinds de overname van het Zwitsers Berna Biotech begin dit jaar mag de onderneming zich ook een belangrijke speler noemen op het gebied van het ontwikkelen, produceren en wereldwijd op de markt brengen van vaccins en immunotherapeutica.
    
    Beide ondernemingen kennen elkaar al vijf jaar. In juni 2001 ging Crucell een samenwerking aan met Vaxin om nieuwe types vaccins te ontwikkelen die geschikt zijn om toe te dienen zonder injecties. In september 2004 sloten de ondernemingen een non-exclusieve licentie-overeenkomst af voor het gebruik van Crucell's PER.C6-technologie.
    
    [/quote]
    
    Was dat niet een ruil voor een PER.C6 licentie verlening? Zoiets van: Geef mij please, pleeeeaaase een PER.C6 Licentie dan krijg je 5% van mijn organisatie!
    

    En een zitje van Jaap Goudsmit in hun directieraad.
    www.vaxin.com/KeyPersonnel.htm