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Sanofi, Sanofi en nog eens Sanofi
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Although the H1N1 flu strain seems mild at present, health officials are worried it might return in a more virulent form in the northern hemisphere winter. Dealing with such an uncertain threat involves a careful balance by health authorities and companies, since making a new vaccine will take four to six months. Hedwig Kresse, an infectious diseases analyst at Datamonitor, thinks an immediate full-scale switch from seasonal to pandemic production is unlikely. "A more likely scenario is the sequential production of seasonal and pandemic vaccines for the northern hemisphere," she said. The WHO estimates manufacturers have the capacity to make up to 900 million shots annually against seasonal flu, which kills between 250,000 and 500,000 people a year. Kieny estimates that translates into pandemic capacity of at least 1-2 billion doses, because a simple pandemic vaccine contains only one ingredient, while the seasonal one has three. Even so, there will not be enough vaccine for the world's population of more than 6.5 billion.
SLEEPER CONTRACTS The rich nations of the world will likely be alright, thanks to recent investment in new factories such as the new Sanofi plant in the United States that won regulatory approval last week. Many wealthy governments also have "sleeper" contracts in place, guaranteeing vaccine supply in the event of a pandemic. Such pre-production contracts could leave the developing world high and dry, but the WHO is twisting arms to ensure that manufacturers set aside a chunk of production either for outright donation to poor countries or sale at very low prices. The U.N. agency's director-general, Margaret Chan, has summoned the heads of all the companies making flu vaccines to Geneva on May 19 to appeal to their sense of corporate responsibility. At least 20 companies make flu vaccines, including Sanofi, Glaxo, Novartis, Baxter, Australia's CSL, AstraZeneca, Sinovac, Solvay and Crucell. (Editing by Andrew Callus)
Svp bronvermelding.www.guardian.co.uk/business/feedartic... www.reuters.com/article/newsOne/idUST... Uit 2005(toen nog next generation vaccine maker…inmiddels Dutch vaccine powerhouse): …a nearly $3 billion shot in the arm to rocket vaccine science into the future.(Viehbacher-egg...sorry maar de geur blijft zo hangen).www.iex.nl/forum/topic.asp?forum=228&...
Correctie Apostel Judas Viehbacher. Viehbacher bedankt , voor die 15.66 vandaag (:->D)
Sanofi-Aventis Starts Construction Of EUR350M French Plant Last update: 5/12/2009 4:48:38 AM Edited Press Release Neuville-sur-Saône, France (Dow Jones) --The Sanofi Pasteur vaccines unit of French pharmaceuticals giant Sanofi-Aventis SA (SNY) Tuesday said it has begun construction of a manufacturing center here. The investment in this new vaccine production facility amounts to EUR350 million and is the largest investment in Sanofi Pasteur global vaccines industrial network. This facility will be equipped with state-of-the-art manufacturing technologies, the companys aaid. It will produce 100 million doses of the novel vaccine against dengue fever, currently under development, employ 200 people, and is expected to be operational in 2013, it added. Company Web site: www.sanofi-aventis.com (END) Dow Jones Newswires May 12, 2009 04:48 ET (08:48 GMT) Dirk
Who thrusts Sanofi not me! Apostel Viehbacher, dient in het water gejudast te worden.
novel "dengue fever vaccine" !
Sanofi Pasteur Receives Order from U.S. Government to Produce New Influenza A(H1N1) Vaccine - Initial U.S. order for bulk vaccine valued at $190 million - Swiftwater, Pa. and Lyon, France – May 25, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today it has received the first of what is expected to be a series of orders from the U.S. Department of Health and Human Services (HHS) to commence production of a vaccine to help protect against the new influenza A(H1N1) virus. This order from HHS was issued pursuant to an existing pandemic stockpile contract between Sanofi Pasteur and the U.S. government that allows HHS to purchase vaccines for viruses with pandemic potential. In addition to this initial HHS order, the company is in discussions with other governments to address their needs for A(H1N1) vaccine. The HHS order provides for the production of the bulk vaccine and related activities. The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August. Final formulation, filling and distribution of the vaccine also have not been established at this time. The order is in the amount of $190 million. “This initial order for A(H1N1) vaccine received today under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic,” said Wayne Pisano, President and CEO of Sanofi Pasteur. “Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1 and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1).” Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine production from the U.S. Centers for Disease Control and Prevention (CDC). Once the seed is received, Sanofi Pasteur will begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to commence commercial scale production in June following certification of the working seed by the U.S. Food and Drug Administration (FDA). The company currently estimates it will have the first bulk concentrate vaccine in a few months. However, the company will be better able to determine the timing once the seed virus is received and development of working seed is underway. Sanofi Pasteur operates influenza vaccine production facilities in the United States - Swiftwater, Pa. - and in France - Val de Reuil. Production of the new A(H1N1) vaccine for HHS will initially occur in Sanofi Pasteur’s recently licensed influenza vaccine production facility in Swiftwater, Pa. Once ongoing seasonal influenza production concludes in the second facility in Swiftwater, A(H1N1) production can occur in both Swiftwater facilities. “Our philosophy is to maintain flexibility in our influenza vaccine production, to enable us to answer public health needs wherever they are,” said Pisano. “We know that seasonal influenza remains a global threat and, in many countries, especially developing countries, H5N1 is still a greater threat than A(H1N1). To this end, we continue our active discussions with WHO and governments around the world to ensure the accessibility of our life-saving vaccines to the greatest number of people.” Sanofi Pasteur Influenza Vaccine Production Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater, Pa. and Val de Reuil, France. In Swiftwater, Sanofi Pasteur has two licensed influenza production facilities. On May 6, 2009, the FDA licensed Sanofi Pasteur’s new influenza vaccine manufacturing facility in Swiftwater. When operating at full capacity, the new facility will have a capacity of approximately 100 million doses of seasonal influenza vaccine per year. An existing facility in Swiftwater is capable of producing 50 million doses per year and currently is producing vaccine for the 2009/2010 season. In total, the company will have a capacity equivalent to approximately 150 million doses of trivalent seasonal influenza vaccine per year in the United States when both facilities are operating at full capacity. The A(H1N1) production can occur in both Swiftwater facilities. In Val De Reuil, Sanofi Pasteur is currently producing the trivalent seasonal influenza vaccine for the 2009/2010 season, with the capacity of 120 million doses per year. Sanofi Pasteur’s production facility in Val De Reuil is also capable of producing the new A(H1N1) vaccine. Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and in the United States produced more than 45 percent of the influenza vaccines distributed for the 2008/2009 influenza season. The company also has developed the first and only U.S.-licensed avian influenza vaccine for humans. More information about Sanofi Pasteur’s pandemic preparedness efforts can be found at www.pandemic.influenza.com
“Our philosophy is to maintain flexibility in our influenza vaccine production, to enable us to answer public health needs wherever they are,” said Pisano. “We know that seasonal influenza remains a global threat and, in many countries, especially developing countries, H5N1 is still a greater threat than A(H1N1). To this end, we continue our active discussions with WHO and governments around the world to ensure the accessibility of our life-saving vaccines to the greatest number of people.” Een combinatievaccine misschien met Crucell's antibodies als adjuvant? Wie weet ... Imo gaan ze niet genoeg eieren hebben om 150MM doses, alleen al in The States, te fabriceren. In geval van combinatievaccine, het dubbel aantal eieren nodig. Dan toch beter de cellenproductie activeren imo. JMHO !
Het is duidelijk, dat de vraag naar griep-vaccins dit en komende jaren zal exploderen. Crucell zal hier ongetwijfeld enorm van profiteren, waarbij de winstmarge flink zal toenemen. Het ziet er naar uit, dat de markt dit nog niet in-geprijsd heeft. Zodra dit gebeurt zal de koersstijging enorm zijn, mede omdat onder invloed van de varkens-griep de druk om via cellen vaccins te produceren flink zal toenemen.
aossa schreef:
Imo gaan ze niet genoeg eieren hebben om 150MM doses, alleen al in The States, te fabriceren.
Ik denk het wel. OMEO
larsenterry schreef:
Het is duidelijk, dat de vraag naar griep-vaccins dit en komende jaren zal exploderen. Crucell zal hier ongetwijfeld enorm van profiteren, waarbij de winstmarge flink zal toenemen.
[/quote]
Valt wel mee. Het flu antigen dat Berna gebruikt voor de Inflexal vaccins is jammer genoeg de beperkende factor. Die aanvoer zal dankzij de Adimmune deal uit 2007 wel toenemen, maar van ENORM profiteren zal geen sprake zijn.
[quote=larsenterry]
Het ziet er naar uit, dat de markt dit nog niet in-geprijsd heeft. Zodra dit gebeurt zal de koersstijging enorm zijn, mede omdat onder invloed van de varkens-griep de druk om via cellen vaccins te produceren flink zal toenemen.
Nu heeft de ENIGE fabrikant die klassieke (dus niet met bv. Adenovirus-achtige constructies) reguliere en pandemische flu vaccins op Per.C6 mag maken, Sanofi Aventis, de laatste jaren enorm ge-investeerd in uitbreiding van de eitjes-capaciteit. Er moeten vreemde dingen gebeuren die de druk op Sanofi doen gaan toenemen om sneller op cellen te gaan produceren.
Stel 1 miljoen kippen: Eerste leg (jan, feb, mrt): voor 50MM seizoensgebonden vaccine (nu in productie) Bij lang daglicht gaat het leggen vlotter: 2e leg (apr, mei, jun, jul, aug): voor H1N1 vaccine vanaf augustus in de nieuwe fabriek (capaciteit 100MM) Nog wat forceren: 3e leg (sept, okt, nov, dec): voor 50MM H1N1 vaccine voor de vrijgekomen capaciteit in de seizoensgebonden fabriek (vanaf nov-dec09 ?) Nu zijn de kippen gaar voor bouillonblokjes! Dan wil SA ook klaar zijn voor H5N1 virus, dus extra voorraad, kippen en eieren stand-by nodig.
maxen schreef:
Nu heeft de ENIGE fabrikant die klassieke (dus niet met bv. Adenovirus-achtige constructies) reguliere en pandemische flu vaccins op Per.C6 mag maken, Sanofi Aventis, de laatste jaren enorm ge-investeerd in uitbreiding van de eitjes-capaciteit. Er moeten vreemde dingen gebeuren die de druk op Sanofi doen gaan toenemen om sneller op cellen te gaan produceren.
Er zal zeker in eenspanningsverplichting in de exclusieve overeenkomst tussen Crucell en Sanofi Aventies zijn opgenomen. Er kan dus niet tot in het oneindige met eitjes worden geproduceerd. ;-)
Als ... het nieuwe virus slecht te vermenigvuldigen is op eieren (QED) het H5N1 virus de kippen en hun embryo's aanvalt (QED) dan heeft PER.C6 een mega-kans !
Sanofi receives H1N1 strain and gears up for production By Gareth Macdonald, 28-May-2009 Sanofi Pasteur, the vaccines unit of French drug major Sanofi Aventis, has received a reference strain of the H1N1 swine flu virus from the US CDC and expects to complete work on an industrial “seed stock” in the next two weeks. Earlier this week Sanofi announced a $190m (€136.5m) Department of Health and Human Services (HHS) contract to produce H1N1 vaccine and suggested that other orders would follow. The Centers for Disease Control and Prevention (CDC) confirmed that it has sent the virus to Sanofi and several other drug makers, meaning that the race to produce pilot lots of vaccine for safety and efficacy testing is underway. The CDC has approved two H1N1 seed strains, one produced via the classical egg based culturing method and another made using a patented reverse genetics method developed by Maryland-based MedImmune for its inhaled influenza vaccine FluMist. Wayne Pisano, CEO of Sanofi Pasteur, said that the firm: “looks forward to quickly understanding how this virus performs in a vaccine manufacturing environment.” Development will be carried out at Sanofi’s newly certified facility in Swiftwater, Pennsylvania with work on seasonal influenza vaccine development usually carried out at the site being relocated to a nearby plant also owned by the firm. In contrast, GlaxoSmithKline (GSK) has not yet been sent a reference strain by the CDC but “should receive it soon” according to comments made by spokesperson Marie-Christine Beauchemin in The Canadian Press. According to a recent report by the World Health Organization (WHO) there have been 12,515 cases in 47 countries, with over 90 people believed to have died after contracting H1N1. In addition, the WHO said that human to human transmission has been observed in at least two countries, making rapid industrial scale-production of an effective vaccine even more of a priority.
"The CDC has approved two H1N1 seed strains, one produced via the classical egg based culturing method and another made using a patented reverse genetics method developed by Maryland-based MedImmune for its inhaled influenza vaccine FluMist." Ahumm... www.iex.nl/forum/topic.asp?topic=1198...
Toch is het raar dat bijna de hele vaccinwereld geld krijgt voor het ontwikkelen van een vaccin. Dit terwijl de antibody's van Crucell al getest worden en waarschijnlijk ook werken. Waarom krijgt Crucell geen geld uit de USA? En waarom niet van de Nederlandse staat? De Nederlandse regering gingen toch inzetten op innovatie.... Maar nee hoor, ze gaan een vaccin bestellen dat nog ontwikkeld moet worden.aossa schreef:
"The CDC has approved two H1N1 seed strains, one produced via the classical egg based culturing method and another made using a patented reverse genetics method developed by Maryland-based MedImmune for its inhaled influenza vaccine FluMist."
Ahumm...
www.iex.nl/forum/topic.asp?topic=1198...
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