DeBeurs.nl

MeawandMoo1 31 juli 2009 20:56

0

quote:
aossa schreef:
Re: uitspraak Viehbacher betreffende cellen:

Uit het verleden weten we dat Aventis-pasteur verschillende cellenlijnen heeft getest en
1. Voor de menselijke cellijn PER.C6 heeft gekozen.
2. Alleen SA de PER.C6 mag gebruiken voor flu vaccine (cfr. exclusief contract).

Derhalve kan Viehbacher in het openbaar stellen dat
Sanofi-Aventis proefondervindelijk heeft vastgesteld dat massaal produceren van flu-vaccine op cellenlijnen nog niet voor morgen is. Bedoelt dan de concurrentie imo en heeft derhalve de tijd om rustig zijn cellen_flu_vaccine te ontwikkelen zonder grote concurrentiele druk.

JMHO !

Ten aanzien van een flu-vaccine op Per.C6 basis staat mij bij dat Ronald Brus, bij uitspraken van de heer Viehbacher, verwees naar het enthousiasme van de heren:
Wayne Pisano en
Michel DeWilde.

Echter, op 31 Maart 2008 hebben deze beide heren een presentatie gehouden over:
Sanofi Pasteur: Positioning itself for Future Growth.

en.sanofi-aventis.com/binaries/08-03-...

Op pagina 12 wordt toch duidelijk weer gegeven:
Future expansions:
- New U.S. facility: 100+ M doses (2009)
- New France Formulation and Fill facility (2010/2011)
- New China facility: 25 M doses (2012)
- Packaging agreement with Birmex
- Cell based prodution part of longer term capacity plans.

Met deze laatste opmerking, derhalve absoluut niet in 2012. Mag ik de grafiek rechts geloven dan is 2016 reëel.

Op deze manier wordt Tuberculose eerder vermarkt dan Flu Cell. (zie draadje tuberculose, publicatie AERAS d.d. 30 juli 2009)

Wat nu mijn Beste Ronald B?

flosz 31 juli 2009 21:17

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Verhalen uit de oude doos, soms voor in het haardvuur(leuk boekje van Finkers btw).

Sanofi moet in ieder geval eerst nog bakken geld verdienen met eieren!!!

Gevonden voorwerp uit 2008.
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."

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."
Strategies for the Development of a
Pandemic Influenza Vaccine

• Short term (< 3 years): to develop as quickly as possible pandemic vaccines based on existing technology (Split vaccine/ egg-based technology)
• Medium / long term: to improve the performance of influenza vaccines and encourage R&D into new vaccine approaches, including cell culture technology
pacifichealthsummit.org/downloads/ppt...

josti5 31 juli 2009 21:20

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Het geëtaleerde enthousiasme van Ronald B. inzake rabiës is dus niet zonder reden...

Daarnaast heeft jouw WHO-vondst mij wel tot de overtuiging gebracht, dat het met Quinvaxem nog wel even snor zit, al zal er zeker van prijsdruk sprake zijn; zij het niet vanwege de 'kredietcrisis', dan zeker wel vanuit Indiase kringen, een en ander welwillend gadegeslagen door mijnheer V. van SA.

Voor Piet de Aandeelhouder blijft het zwalken tussen een nieuwe swing-up gevolgd door een touch-down, dan wel een uit persoonlijk/financieel belang voortgekomen overgave van MT/RvC + grootaandeelhouders aan een overnemer.

aossa 31 juli 2009 23:04

0

quote:
MeawandMoo1 schreef:
[quote=aossa]
Re: uitspraak Viehbacher betreffende cellen:

Uit het verleden weten we dat Aventis-pasteur verschillende cellenlijnen heeft getest en
1. Voor de menselijke cellijn PER.C6 heeft gekozen.
2. Alleen SA de PER.C6 mag gebruiken voor flu vaccine (cfr. exclusief contract).

Derhalve kan Viehbacher in het openbaar stellen dat
Sanofi-Aventis proefondervindelijk heeft vastgesteld dat massaal produceren van flu-vaccine op cellenlijnen nog niet voor morgen is. Bedoelt dan de concurrentie imo en heeft derhalve de tijd om rustig zijn cellen_flu_vaccine te ontwikkelen zonder grote concurrentiele druk.

JMHO !
[/quote]
Ten aanzien van een flu-vaccine op Per.C6 basis staat mij bij dat Ronald Brus, bij uitspraken van de heer Viehbacher, verwees naar het enthousiasme van de heren:
Wayne Pisano en
Michel DeWilde.

Echter, op 31 Maart 2008 hebben deze beide heren een presentatie gehouden over:
Sanofi Pasteur: Positioning itself for Future Growth.

en.sanofi-aventis.com/binaries/08-03-...

Op pagina 12 wordt toch duidelijk weer gegeven:
Future expansions:
- New U.S. facility: 100+ M doses (2009)
- New France Formulation and Fill facility (2010/2011)
- New China facility: 25 M doses (2012)
- Packaging agreement with Birmex
- Cell based prodution part of longer term capacity plans.

Met deze laatste opmerking, derhalve absoluut niet in 2012. Mag ik de grafiek rechts geloven dan is 2016 reëel.

Op deze manier wordt Tuberculose eerder vermarkt dan Flu Cell. (zie draadje tuberculose, publicatie AERAS d.d. 30 juli 2009)

Wat nu mijn Beste Ronald B?

Imo moeten de retrofit's van de facilities het tijdperk van de cellbased vaccines inluiden. De retrofit zal er in bestaan om de installaties zowel geschikt te maken voor eitjes als voor cellen. Moeten in staat zijn zowel seasonal als pandemic flu-vaccine te produceren. Vooral de capaciteit van de afvulling van de spuitjes dient uitgebreid te worden.

Eerst nieuwe fabriek in de USA, oude fabriek moet nog produceren in 2008 en 2009 en wordt daarna stilgelegd voor complete retrofit (volledige ombouw binnen en buiten). Stel dat dit kan aanvangen in 2010 en een 2-tal jaar in beslag gaat nemen. Kan mogelijk vertraging oplopen wegens noodzakelijkheid om de installatie in gebruik te houden voor parallel aanmaak van H1N1 mexikaanse griep, komt goed uit om de cell based vaccine wat op te schuiven in de tijd.

Er was voorheen ook sprake van 'cellbased vaccine submission in 2010' (einde 2010?). Past imo goed in het plan van de retrofits. Misschien enkele jaartjes vertraging wegens de nieuwe ontwikkelingen, maar 2016 lijkt me wat ver.

aossa 31 juli 2009 23:24

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En ik lees: "Cell based prodution part of longer term capacity plans".
Wat steek houdt met de retrofit's en uitbreidingen 'fill capacity.

PS 'new formulation + fill facilty' in France (2010-2011) => 20K liter tank in Lyon, staat er niet te rotten hoor!.

aossa 31 juli 2009 23:39

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Plaatje uit 2007 erbij:
"Planned initial submission in 2010"

Bijlage:

flosz 1 augustus 2009 07:26

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Merial: Strengthening our Presence in Animal Health
en.sanofi-aventis.com/investors/event...

Sanofi-aventis to Acquire Merck's Interest in Merial
Agreement includes option for sanofi-aventis to combine Merial with
Intervet/Schering-Plough Animal Health in new equally owned joint venture with the new Merck
Future joint venture would be a global leader in animal health
en.sanofi-aventis.com/binaries/200907...

Fleas and fees: Evercore bags key Sanofi mandate
Fri Jul 31, 2009
By Quentin Webb
LONDON (Reuters) - In landing the first big mandate from Sanofi (SASY.PA) since the French drugmaker switched chief executives, U.S. boutique Evercore Partners (EVR.N) gets some $13 million of fees and a league-table boost.
On Thursday, Sanofi agreed to buy U.S. partner Merck & Co Inc (MRK.N) out of their animal-health joint venture Merial for $4 billion.
Sanofi, advised by Evercore, gains control of treatments such as flea and tick product Frontline. Merck, which was counseled by Credit Suisse (CSGN.VX), needed the deal so regulators would approve its $41 billion tie-up with Schering Plough Corp (SGP.N)
Freeman & Co, a merger consultancy, reckons Evercore will receive $13 million to $15 million and Credit Suisse $14 million to $16 million for their work on the Merial deal.
That deal helped propel Evercore to an eye-catching 5th place in this year's U.S. mergers and acquisitions (M&A) league tables and 10th place globally, according to Thomson Reuters data.
The boutique, founded in 1996 by former Lehman Brothers and Blackstone Group (BX.N) banker Roger Altman, is credited with roles in just 14 deals this year.
However, these included advising Wyeth (WYE.N), alongside Morgan Stanley (MS.N), on its $68 billion union with Pfizer (PFE.N), and work on the $61 billion sale of General Motors assets to a government-backed "New GM".
Evercore's team on Merial included Francois Maisonrouge, the pharmaceutical-industry specialist who was previously chairman of life sciences at Credit Suisse, where he spent nearly 15 years. He joined Evercore in 2007.
Evercore and Maisonrouge declined to comment.
Healthcare bankers have circled Sanofi Chief Executive Chris Viehbacher since he took over in December, hoping to undertake some lucrative M&A business for the former GlaxoSmithKline Plc (GSK.L) executive.
"Clients are now realizing that big banks have demands that aren't completely aligned with their own interests, and many of these corporations have determined that it does not make sense to rely solely on M&A advice from the same banks that are providing the financing for a transaction," Maisonrouge said in a recent interview with the Financial News. "Boutiques are well positioned to provide a role in such a case."
Viehbacher has not ruled out a mega-merger but wants to focus on small- and mid-sized deals, of up to about 15 billion euros, in generic drugs, emerging markets, vaccines, consumer health and biotech.
That potential openness to deals has led to Sanofi as being recently touted at as a possible buyer of Germany's Ratiopharm and Qiagen (QGEN.DE), Iceland's Actavis, Crucell (CRCL.AS) of the Netherlands, and the drug business of Belgium's Solvay (SOLB.BR), among others.
Its second-biggest deal under Viehbacher, the 550 million euro takeover of unlisted Indian vaccines maker Shantha Biotechnics, was accomplished without financial advisers, a Sanofi spokesman said. Shantha's owners were advised by mid-market boutique Bryan, Garnier & Co.
www.reuters.com/article/americasDeals...

aossa 1 augustus 2009 12:35

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Wat lees ik ?

"Its second-biggest deal under Viehbacher, the 550 million euro takeover of unlisted Indian vaccines maker Shantha Biotechnics, was accomplished without financial advisers, a Sanofi spokesman said. Shantha's owners were advised by mid-market boutique Bryan, Garnier & Co."

Lijkt te gaan om een 'overnight' beslissing van Viehbacher cs...

flosz 1 augustus 2009 13:05

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Wat een draad, Sanofi, Sanofi en nog eens Sanofi......

Pentacel ipv QV.

Vaccines could save 2.5m
Thu, 30 Jul 2009 15:45
The health department has introduced two new vaccines which could prevent 2.5 million child deaths a year.
The vaccines were introduced in Pretoria on Thursday. The two vaccines, rotavirus and pentavalent, will reduce the number of child mortalities by 2.5 million per year," said Dr Ntombenhle Ngcobo, a specialist on the department's expanded programme on immunisation.
health.iafrica.com/healthy_kids/18351...

aossa 1 augustus 2009 13:09

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"The pentavalent vaccine would replace the tetravalent vaccine."

Niet het QV wordt vervangen, maar een ouder combinatie-vaccine van waarschijnlijk dezelfde fabrikant. Beiden zijn 'interchangeable.

Prioriteit pneumokokken. Geen Hep-B vaccinatie ?

Vier maal Pentavalent inspuiten, werkt het dan zo slecht ?

:-D

aossa 1 augustus 2009 13:17

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quote:
aossa schreef:
Vier maal Pentavalent inspuiten.

Waarschijnlijk omwille van de polio component.
Wat is het voordeel, buiten een grotere afzet voor de fabrikant?

flosz 1 augustus 2009 13:29

1

quote:
aossa schreef:
Niet het QV wordt vervangen, maar een ouder combinatie-vaccine van waarschijnlijk dezelfde fabrikant. Beiden zijn 'interchangeable.

Wat ik ermee bedoel is dat men heeft gekozen voor Pentacel ipv QV ter vervanging van de tetra.
Compiled by the Government Communication and Information System
Date: 30 Jul 2009
Title: New vaccines to curb child mortality
--------------------

By Edwin Tshivhidzo

Pretoria - In a further effort to combat child mortality in South Africa, the Department of Health is to roll-out three new vaccines in August.

The Rotavirus vaccine, Pentavalent vaccine and Pneumococcal Conjugate vaccine, which form part of government's Expanded Programme of Immunisation, are to be made available free at all public health facilities throughout the country.

A specialist involved the immunisation programme, Dr Ntombenhle Nqcobo, said government had set a target of reducing child mortality by two thirds by 2015.

The mortality rate in South Africa for children under five is high considering the level of economic development reached. The largest contributing factor in these cases is HIV and AIDS.

Worldwide, it is estimated that 10 million children die each year from preventable and treatable causes.

According to Dr Nqcobo, child mortality can be reduced by scaling up and intensifying vaccination strategies and therefore the department was determined to reach as many children as possible.

"We want to vaccinate more and more children with this new vaccine. Every child has a right to vaccination," she said.

According to the department, immunization prevents more than three million deaths a year.

Professor Shabir Madhi from the University of Witwatersrand encouraged the use of the Pneumococcal vaccine, saying it protects against severe life threatening diseases caused by a bacterium streptococcus pneumoniae, also known as pneumococcus.

The vaccine can be used in the fight against pneumonia, which affects the chest and the ability to give oxygen to the body, meningitis which affects the brain and spinal cord and septicaemia refers to a condition where bacteria multiply in the blood stream.

These diseases can lead to major complications such as deafness and brain damage and can even be fatal.

The Pneumococcal vaccine should be administered to children at 6 weeks, 14 weeks and 9 months.

The Rotavirus vaccine will help provide protection against the Rotavirus which causes diarrhea, leading to dehydration, electrolyte imbalances and death.

According to the department, the Rotavirus is a major problem in developing countries, as it is not always possible for infected children to reach a hospital in time and thus they are likely to succumb to the disease.

The Pentavelent vaccine is a combination vaccine with five components. It protects against five conditions, namely diphtheria, pertussis, tetanus, haemophilus influenza and polio.

The new vaccine replaces an older combination of four antigens, which is called Combact-Hib. The advantage of this vaccine lies in it being more advanced and causing less side effects.

All children should be vaccinated with Pentavelent at 6 weeks, 10 weeks and 14 weeks and at 18 months.
www.buanews.gov.za/news/09/0907301535...

In India:
5-in-1 booster shot for immunization
economictimes.indiatimes.com/News/New...

flosz 1 augustus 2009 13:36

1

quote:
flosz schreef:
Pentacel

Of toch niet.....
PentacelTM(Aventis Pasteur Limited)
Since 1997, PentacelTM has been used for the primary immunization and 18-month booster injection of all children living in Canada. PentacelTM is reconstituted immediately prior to administra- tion by combining a lyophilized powder containing Haemophilus influenzae type b tetanus protein-conjugate vaccine (Act-HibTM) with QuadracelTM, a liquid product containing acellular pertussis vaccine, adsorbed diphtheria and tetanus toxoids and inactivated polio vaccine. The pertussis vaccine has five components: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbrial proteins 2 and 3 (FIM2 and FIM3). The diphtheria and tetanus toxoids are denatured with formaldehyde. The three poliovirus types are propagated in human diploid cells and formalin inactivated.

PediacelTM(Aventis Pasteur Limited)
PediacelTM was approved for use in Canada in 2000 but has not been marketed. It differs from PentacelTM in that the Hib component comes pre-mixed in a liquid formulation with the other components in an ampoule. While the concentrations and types of the three poliovirus strains in PediacelTM are identical to those in PentacelTM, they are grown in Vero monkey kidney cell lines. The pertussis vaccine contains the five component antigens at the same concentrations as PentacelTM; the amounts of tetanus and diphtheria toxoids are also the same.

InfanrixTM-IPV/Hib [GlaxoSmithKline (GSK) Inc.]
InfanrixTM-IPV/Hib is a pentavalent vaccine that also requires reconstitution prior to administration. This is done by combining tetanus protein conjugate adsorbed Hib vaccine (HiberixTM) with the InfanrixTM-IPV, a product composed of acellular pertussis, adsorbed diphtheria and tetanus toxoids and inactivated polio vaccines. This vaccine differs from the PediacelTM and PentacelTM vaccines in that the pertussis portion is derived from only three component antigens: pertussis toxoid, pertactin, and FHA. The concentrations of each of these antigens are each 5 µg greater than in the five-component pertussis vaccines. The tetanus and diphtheria concentrations are 5 µg and 10 µg greater per dose, respectively, than in PentacelTM; however, there does not appear to be greater reactogenicity with this product based on reported adverse effects. The poliovirus strains, as in PentacelTM, are propagated in human diploid cells and inactivated.

MeawandMoo1 2 augustus 2009 16:12

1

Ik zie dat een kleine discussie een beetje weggevaagd is door de hoeveelheid informatie van flosz.

quote:
aossa schreef:
En ik lees: "Cell based prodution part of longer term capacity plans".
Wat steek houdt met de retrofit's en uitbreidingen 'fill capacity.

PS 'new formulation + fill facilty' in France (2010-2011) => 20K liter tank in Lyon, staat er niet te rotten hoor!.

Plaatje uit 2007 erbij:
"Planned initial submission in 2010"

Beste aossa,

Je verwijst naar de presentaie gehouden in 2007 terwijl ik verwijs naar de presentatie gehouden in maart 2008.
Daarom hecht ik minder waarde aan eerdere statements.
De presentatie van 2008 gaat dieper in, hoe de groeiende vraag naar griepvaccines kan worden voldaan.

en.sanofi-aventis.com/binaries/08-03-...

Op pagina 12 wordt toch duidelijk weer gegeven:
Future expansions:
- New U.S. facility: 100+ M doses (2009)
- New France Formulation and Fill facility (2010/2011)
- New China facility: 25 M doses (2012)
- Packaging agreement with Birmex
- Cell based production part of longer term capacity plans.

In mijn beleving, wanneer Wayne Pisano en Michel DeWilde aangeven dat Cell based production deel maken uit een langere termijn capaciteitsplan, dan neem ik aan dat deze niet in de grafiek verwerkt is. Dan zou je mogen concluderen dat zelfs 2016 een vraagteken is.

Vergeet niet dat juist Wayne Pisano En Michel DeWilde door Ronald Brus aangehaald zijn na de negatieve toon van C. Viehbacher (april 2009).
Misschien was Viehbacher niet zo incorrect als algemeen hier op het forum is aangegeven.

In mijn ogen is het incorrect om te verwijzen naar:
'new formulation + fill facilty' in France (2010-2011) => 20K liter tank in Lyon, staat er niet te rotten hoor!.

De new formulation is niet gebasseerd op op Per.C6 en heeft fase III al doorlopen en is aangemeld voor registratie. (Zie overzicht van 29 april 2009)
en.sanofi-aventis.com/research_innova...
Flu Cell Culture (new production method) staat op 29 april 2009 nog steeds als fase II vermeld.

En inderdaad:
"die 20K liter tank in Lyon, staat er niet te rotten hoor",
die gaat zonder problemen nog heel wat jaartjes mee. Men kan nog wel even iets langer wachten.

aossa 2 augustus 2009 20:10

0

Vraag was ook waar het enthousiasme van R.Brus vandaan kwam. De presentatie uit 2007 gaf duidelijk aan dat doorbraak voor FluCell voor na 2010 was.
Nou ja, deze timeline lijkt niet gehaald te gaan worden hoe graag Crucell dat ook zou willen.

Gelukkig staat FluCell nog op het programma van Sanofi-Aventis en gaat in de tussentijd het programma ivm uitbreiding van de capaciteit met bi-valente productiemogelijkheid (eitjes en cellen) verder. Voor mij is deze uitbreidingsstap het begin van de doorbraak waarbij geleidelijk de cell productie techniek de eitjes zal gaan verdringen.

Een tank van 20K Per.C6 cultuur is imo ook nog voor andere vaccines te gebruiken, alhoewel de noodzaak aan zulke grote tanks door nieuwe technologie, uitgewerkt door DSM, achterhaald gaat worden. Maar het bewijs leveren van een geslaagde opschaling naar 20K tank was wel een voorwaarde in het flu pandemie contract met de VS, remember. En na seizoen 2009 zou de oude fabriek in de VS stilgelegd moeten worden ivm volledige retrofit. Wachten op nieuws dus.

aossa 3 augustus 2009 11:50

0

ING houdt op met het analyseren van Sanofi-Aventis. Blijkbaar kunnen ze het niet meer volgen wat C.Viehbacher uitspookt.

aossa 3 augustus 2009 14:46

0

Gedaan met uitstapjes naar het luilekkere leven @Alnwick voor Sanofi-Aventis stafmembers:

Sanofi may sell Alnwick R&D facility
28-Jul-2009

French drugmaker Sanofi-Aventis may put its Alnwick Research Centre in Northumberland, UK up for sale, according various media reports.

Site director Roland Jurke told the Northumberland Gazette earlier this month that: “It is not anticipated that the Alnwick site will form part of Sanofi Aventis' future research and development site network.”

Although Sanofi has yet to comment on the speculation, a recent article in French newspaper Le Figaro suggested that a potential Alnwick sale could be part of the reorganisation plans that the firm announced on June 30.

Around 170 people are currenctly employed by Sanofi at the facility in a variety of research and development (R&D) roles.

www.sanofi-aventis.co.uk/live/gb/en/l...

Our Alnwick site is a purpose-built pharmaceutical research and development centre - one of 28 in the sanofi-aventis group.

Established in 1982, it employs around 200 people, who are mainly professional scientists. All our Alnwick people share a dedication to improving human health and combating disease by using the most advanced technologies to develop innovative, effective and safe new medicines.

Specialising in the pre-clinical development of potential new therapies, the centre’s scientific disciplines include chemistry, dosage form design, analytical control and safety evaluation. The main purpose of these activities is to support the submission of dossiers through to achieving marketing authorisation.

Close to the majestic Northumbrian coastline and countryside yet only 30 minutes from Newcastle-upon-Tyne, the centre is in pleasant rural surroundings about a mile from Alnwick town centre. Alnwick, the county town of Northumberland, has been voted the ‘Best place to live in Britain’.

Staff facilities include a modern restaurant and a Sports and Social Club that organises a programme of events throughout the year, such as theatre visits, go-karting, ten-pin bowling and shopping trips. Staff are updated about company news via a weekly newsletter.

Our Alnwick staff choose a charity to support every year through activities such as book sales, charity auctions and sponsored events.

In 2004, the centre won awards from the Northumberland Wildlife Trust for its commitment to conservation, the environment and wildlife. Deer, foxes and various bird species are encouraged to frequent the 30-acre site.

ved 6 augustus 2009 22:56

0

quote:
aossa schreef:
Gelukkig staat FluCell nog op het programma van Sanofi-Aventis en gaat in de tussentijd het programma ivm uitbreiding van de capaciteit met bi-valente productiemogelijkheid (eitjes en cellen) verder. Voor mij is deze uitbreidingsstap het begin van de doorbraak waarbij geleidelijk de cell productie techniek de eitjes zal gaan verdringen.

vertraging retrofit van de oude Swiftwater plant:

"Sanofi Pasteur of Swiftwater, Pa., part of French drug giant Sanofi-Aventis SA, had a little luck this year: It just got a new manufacturing plant in Swiftwater, in the Pocono Mountains, approved in May. Instead of closing the older one for a planned renovation, it has been running both factories "24 hours a day, seven days a week," Lavenda said, noting the company has hired about 200 additional workers there and is looking for more for the two plants.

"One is making seasonal (vaccine) and the other is making H1N1" concentrate in bulk, he said."

Bron:Seasonal flu vaccine shipping early, demand up
By LINDA A. JOHNSON (AP)

www.google.com/hostednews/ap/article/...

[verwijderd] 7 augustus 2009 12:56

0

Sanofi:Supplemental Application To FDA For Type A Flu Vaccine
Last update: 8/7/2009 2:11:09 AM

PARIS (Dow Jones)--French drug company Sanofi-Aventis (SNY) said Friday that its vaccines division Sanofi Pasteur has submitted to the U.S. Food and Drug Administration a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine.

MAIN FACTS:
-Responding to recent recommendations by the FDA, the company's supplemental application requests the FDA's evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.

-The supplemental application follows recent recommendations by the FDA to evaluate the influenza A (H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines. Sanofi Pasteur's influenza A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a non-adjuvanted vaccine.

-Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began August 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine.

Company Web site: www.sanofipasteur.com -By Paris Bureau, Dow Jones Newswires; +33 1 4017 1740; alice.dore@dowjones.com

Dirk

flosz 7 augustus 2009 13:09

0

Ter aanvulling.

Sanofi Pasteur submits supplemental application for A(H1N1) pandemic vaccine to U.S. FDA
Company responds to FDA recommendation for influenza virus strain change supplement -

Lyon, France and Swiftwater, Pa (United States) – August 7, 2009 -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today the company has submitted to the U.S. Food and Drug Administration (FDA) a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine. Responding to recent recommendations by the FDA, the company’s supplemental application requests the FDA’s evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
“Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1) 2009 virus,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”
The supplemental application follows recent recommendations by the FDA to evaluate the influenza A (H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines. Sanofi Pasteur’s influenza A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a non-adjuvanted vaccine.
While these strain change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began August 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine. More information on the influenza A(H1N1) 2009 vaccine clinical trials is available at www.clinicaltrials.gov. (Zie ook post 27 jul 09, 12:07 www.iex.nl/forum/topic.asp?forum=228&... )
en.sanofi-aventis.com/binaries/200908...
*************
The Foundation for the National Institutes
of Health and sanofi-aventis
announce unprecedented product donation
by sanofi-aventis in the United States.
Bethesda, Maryland, USA and Paris, France - August 5, 2009 - The Foundation for the
National Institutes of Health and sanofi-aventis (EURONEXT : SAN and NYSE : SNY) announced
today an unprecedented donation from the global pharmaceutical leader providing approximately
$1.3 million in pharmaceutical therapies for ongoing use in clinical trials and other therapeutic
treatments at the National Institutes of Health (NIH) Clinical Center.
Designated by the Foundation for NIH as the Clinical Center Drug Donation Project, this gift has
been provided by sanofi-aventis U.S. to be used for scientific purposes as defined and overseen
by the NIH. The donation of three medicines – Taxotere® (docetaxel), Eloxatin® (oxaliplatin) and
Lovenox® (enoxaparin sodium) – will be made over the course of one year.
“At a time when the costs of managing clinical trials are on the rise and budgets are extremely
tight, receiving pharmaceutical products at no cost enables us to extend the Center’s resources to
continue its groundbreaking research in many promising areas such as cell processing, imaging
sciences and critical care,” said Charles M. Sanders, M.D., chairman of the Foundation for NIH.
“We are grateful to sanofi-aventis for advancing NIH-sponsored clinical research with this
generous donation and hope that other pharmaceutical companies will follow its lead.”
“We are proud to support the ability of the NIH to pursue new and cutting-edge research by
freeing up much needed resources,” added Marc Cluzel, M.D. Senior Vice President Research &
Development at sanofi-aventis. “We have been committed to supporting clinical research in key
therapeutic areas for more than 50 years, and this partnership is another example of the
company’s steadfast commitment to advancing research, and ultimately, helping patients.”
en.sanofi-aventis.com/binaries/200908...

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