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aossa 29 juli 2009 12:42

0

Sanofi-Aventis heeft een 5-voudig vaccine met een polio component dat ze verkopen in de VS (marktprotectie ?).

Het Shanta 5-voudig vaccine is voor de WHO met 5 componenten die de WHO prioritair acht, zoals bij het Quinvaxem.

Mogelijk denkt Chris Viehbacher hardop dat het toevoegen van een 6e component snel moet kunnen gaan (hij kan zich vergissen imo) en dat ook de WHO erop zit te wachten.

Imo geeft WHO via GAVI een meerjarenbeleid en worden producenten verzocht daarop in te spelen en niet andersom. Dus wat Chris Viehbacher zegt of doet, maakt niet veel uit, tenzij hij een prijzenoorlog wilt ontketenen en 6 wilt gaan leveren voor de prijs van 5. Daarenboven moet Viehbacher maar eerst eens zien of hij voldoende capaciteit kan creëren om India (en China) te bevoorraden vanuit Shantha.

Mr sponge 29 juli 2009 12:55

0

quote:
aossa schreef:
Mogelijk denkt Chris Viehbacher hardop dat het toevoegen van een 6e component snel moet kunnen gaan (hij kan zich vergissen imo) en dat ook de WHO erop zit te wachten.

En helaas weten wij hoe "snel" Sanofi kan werken. Als het net zo snel gaat als het nieuwe PerC6 griepvaccin dan gaat dat nog wel even duren.
Die man zegt precies wat de pers/investeerders wil horen, maar kan hij dat waarmaken? Ik heb daar grote twijfels over.

flosz 29 juli 2009 13:02

0

pentacel.com/

Sanofi Hep B erbij en Crucell Polio………

Hep.B is de kritische component.

Hexavac

Uit 2008:
Sanofi’s Hexavalent, which has been wiithdrawn in Europe, supposedly because the Hepatitis B component had inadequate antibody formation. This group doesn’t buy that explanation, since those details are sorted out way before Phase 1 trials let alone years after phase three trials. They believe the reason for its withdrawal is something far more sinister. They also believe that the substitute vaccine, GSK InfanrixHexa, (which has just been added into the New Zealand schedule) is just as bad

Uit 2005
European Medicines Agency recommends suspension of Hexavac vaccine
www.bda.bg/bda_old/web_engl/pharmacov...

[verwijderd] 29 juli 2009 13:13

1

quote:
Mr sponge schreef:
[quote=aossa]

Mogelijk denkt Chris Viehbacher hardop dat het toevoegen van een 6e component snel moet kunnen gaan (hij kan zich vergissen imo) en dat ook de WHO erop zit te wachten.

[/quote]

En helaas weten wij hoe "snel" Sanofi kan werken. Als het net zo snel gaat als het nieuwe PerC6 griepvaccin dan gaat dat nog wel even duren.
Die man zegt precies wat de pers/investeerders wil horen, maar kan hij dat waarmaken? Ik heb daar grote twijfels over.

The dirty old man, vertraagt, treineert de ontwikkeling van griepvaccin op PerC6 , MET OPZET!!!!
Imo werkt Sanofi juist tegen ipv met, Crucell.

Maar ik kan er altijd naast zitten..........
NOT dus.

aossa 29 juli 2009 13:23

0

Slide #38 uit de Q2-09 presentatie van Sanofi-Aventis.
en.sanofi-aventis.com/binaries/200907...

SHANTHA BIOTECHNICS

* Portfolio of affordable vaccines for the Indian public market. International Funded Public Markets (IFPM) and international markets.

* 4 WHO pre-qualified vaccines (Shan5, Shantetra, ShanTT and Shanvac-B) and ShanChol, recently registered in India, seeking WHO pre-qalification.

* State-of-the art manufacturing facility in Hyderabad, India.

* Strong R&D pipeline (projects against Rotavirus, HPV, Typhoid).

* Proven track recors in UNICEF/GAVI supply.

* Sales objective for fiscal year ending March 2010 ~$90m.

=> Pursuing the development of Shantha Biotecnics as a regional base for high quality affordable vaccines to fuel growth in Emerging Markets.

Edit: plaatje erbij

Bijlage:

aossa 2 augustus 2009 21:28

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Pentavalent vaccine likely to be introduced in India soon

Teena Thacker Posted online: Thursday , Jun 25, 2009 at 0121 hrs

New Delhi : The long-pending proposal to introduce pentavalent vaccine in the National Immunisation Programme is likely to take off soon. The plan has already been cleared by the Expenditure Finance Committee (EFC) and will be put up before the Cabinet soon.
The proposal hit the wall after former Union Health Minister Anbumani Ramadoss resigned in March this year. However, after Ghulam Nabi Azad took over as the Health and Family Welfare Minister, “he took it on priority basis and got over Rs 400 crore clearance for the project”, said a senior official in the ministry.

The Ministry is now looking at the vaccine availability, depending on which domestic tenders will be floated. The Ministry is also negotiating with the World Bank to get some funds for the scheme.
A single shot of the vaccine has antigens of five diseases —Diphtheria, Pertussis, Tetanus, Hepatitis B and HIB. Its introduction in India was recommended by the National Technical Advisory Group on Immunisation (NTAGI) two years ago.
Later, last year, the Health Ministry decided to introduce it as an HIB vaccine so as to protect children against Haemophilus Influenza type B (HIB), the bacteria which causes illnesses like meningitis, pneumonia and septic arthritis.
Experts say introducing this vaccine would be an excellent move. “We fully endorse the introduction of HIB vaccine. Its procurement, however, might become a challenge,” said Dr M K Bhan, secretary, Department of Biotechnology.
So far, more than 130 countries have shifted to pentavalent vaccines, while India still uses tetravalent vaccines in its National Immunisation Programme.
The Health Ministry has planned to initially introduce the vaccine in 10 states —Tamil Nadu, Kerala, Karnataka, Maharashtra, Goa, West Bengal, Andhra Pradesh, Gujarat, Himachal Pradesh and Punjab. “Its supply may be a
constraint. That’s why we have decided to introduce it in a phased manner. After covering these 10 states, the vaccine would be introduced all over the country,” Naresh Dayal, Health Secretary, said.
According to Dr Vinod Kumar Paul, professor and head of department of Paediatrics, All India Institute of Medical Sciences (AIIMS), 20 per cent of under-five mortality is due to pneumonia and since HIB virus causes the disease,
introducing the vaccine would be an important step towards wiping out the virus. “Introducing this would mean increasing the number of vaccines and protecting children against the deadly virus. It is a welcome effort,” Dr Paul said.

www.indianexpress.com/story-print/480...

"The Ministry is now looking at the vaccine availability, depending on which domestic tenders will be floated."

Duidelijk een Indiaase affaire...

aossa 2 augustus 2009 21:37

0

Bharat Biotech introduces pentavalent combination vaccine in India (2009-03-31)

www.expresspharmaonline.com/20090331/...

Our News Bureau - Mumbai

Bharat Biotech International (BBIL), a leading producer of vaccines and biotherapeutics in India has launched Comvac5 in India. Comvac5 is a single shot pentavalent combination vaccine containing diphtheria, pertussis, tetanus and hepatitis B, and haemophilus influenza type b (Hib). Few months ago MSD India also launched similar vaccine in the Indian market.

Dr Krishna M Ella, Chairman and Managing Director, BBIL, said, "The launch of Comvac5 is a milestone effort from Bharat Biotech in the field of research and, development. We have brought to market absolutely indigenous vaccine that helps and will reduce childhood sicknesses and deaths from preventable diseases at affordable cost. With a single injection this vaccine has the ability to protect children against multiple infectious diseases. This pentavalent vaccine demonstrates our commitment to consistently develop, safe and affordable vaccines for the emerging world."

As per company's press release, Comvac5 is a safe, efficacious and an affordable vaccine which offers complete protection against haemophilus influenza type b (Hib) antigen bacterium causes serious disease, often life-threatening illnesses in young children. Hib can cause meningitis and severe pneumonia, leading to three million cases of serious illness and 400,000 deaths each year in children under the age of five.

While other Indian manufacturers have imported conjugation and manufacturing technologies from Europe, and USA, the scientific, manufacturing and product development teams at Bharat Biotech have indigenously developed all processes required to manufacture Comvac5 in-house at Bharat Biotech. The company has made significant investments to the tune of several million dollars over the past four years, into its R&D capabilities and its manufacturing facilities to enable the development and manufacture of Comvac5.

Combination pentavalent vaccines have been approved by several countries and included in their respective national immunisation programmes for childhood vaccinations. It is highly recommended by WHO and other global regulatory agencies since they combine five antigens into a single dose, thus eliminating the need for multiple injections to infants. Combination vaccines have proven to improve compliance with parents and infants. The reduction of injections to infants has proven to reduce the amount of side effects, and reduce the probability of disease transmission through needle contamination.

Comvac5 also provides protection against Hepatitis B virus, which causes, severe disease of the liver causing an estimated 5.7 million cases of acute hepatitis B infection and more than 521 000 deaths from hepatitis B-related disease. In addition to providing protection against diphtheria, pertussis, and tetanus, which cause severe childhood diseases .This vaccine has been included into the national immunisation programme across several countries.

BBIL has supplied 400 million doses of Biopolio, oral polio vaccine to the government of India during 2008-2009. The company has a strong pipeline of vaccines and therapeutics to combat malaria, rotavirus, staph aureus (MRSA) and Japanese Encephalitis infections.

aossa 2 augustus 2009 21:38

0

COMVAC5(R), Single Shot Pentavalent Combination Vaccine Containing Diphtheria, Pertussis, Tetanus And Hepatitis B, And Haemophilus Influenza Type
02 Mar 2009

Bharat Biotech International (BBIL) a leading producer of vaccines and biotherapeutics in India with a strong focus on product-oriented research and development announced today the launch of COMVAC5®, a single shot Pentavalent Combination vaccine containing Diphtheria, Pertussis, Tetanus and Hepatitis B, and Haemophilus Influenza type b (Hib).

COMVAC5® is safe, efficacious and an affordable vaccine that offers complete protection against Haemophilus influenza type b (Hib) antigen bacterium causes serious disease, often life-threatening illnesses in young children. Hib can cause meningitis and severe pneumonia, leading to ~3 million cases of serious illness and 400,000 deaths each year in children under 5 years of age.

Making the announcement Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech International, said, the launch of COMVAC5® is a milestone effort from Bharat Biotech to research, develop and bring to market absolutely indigenous vaccine that helps reduce childhood sicknesses and deaths from preventable diseases at affordable cost. With a single injection this vaccine has the ability to protect children against multiple infectious diseases. This Pentavalent vaccine demonstrates our commitment to consistently develop, safe and affordable vaccines for the emerging world.

Combination Pentavalent vaccines have been approved by several countries and included in their respective National Immunization programs for childhood vaccinations. Combination vaccines come highly recommended by WHO and other global regulatory agencies since they combine 5 antigens into a single dose, thus eliminating the need for multiple injections to infants. Reduction of injections to infants has proven to reduce the amount of side effects, and reduce the probability of disease transmission through needle contamination. Combination vaccines have proven to improve compliance with parents and infants since the # of doctor visits can be reduced. Pentavalent vaccines have also proved to be more cost effective to the patient than individual vaccines effectively reducing the cost of manufacturing and cost of administration.

COMVAC5® also provides protection against Hepatitis B virus, which causes, severe disease of the liver causing an estimated 5.7 million cases of acute hepatitis B infection and more than 521 000 deaths from hepatitis B-related disease. In addition to providing protection against Diphtheria, Pertussis, and Tetanus, which cause severe childhood diseases .This has been already included into the national immunization program and given to every single new born in India.

While other Indian manufacturers have imported conjugation and manufacturing technologies from Europe, and USA, the scientific, manufacturing and product development teams at Bharat Biotech have indigenously developed all processes required to manufacture COMVAC5® in-house at Bharat Biotech. Bharat Biotech has made significant investments to the tune of several million dollars over the past 4 years, into its R&D capabilities and its manufacturing facilities to enable the development and manufacture of COMVAC5®.

About Bharat Biotech International Limited

Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech was established in the year 1996, is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA). Bharat Biotech is also a WHO prequalified manufacturer of vaccines for supply to UNICEF and global procurement agencies.

Bharat Biotech sprawls over a picturesque campus at Genome Valley, Hyderabad, built with an investment of over USD 100 million, the facility's Manufacturing, Control Procedures and Protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena. Bharat Biotech is the largest primary manufacturer of Vi Capsular Polysaccharide Typhoid vaccine, TYPBAR™, Bharat Biotech has commercialized India's first recombinant Epidermal Growth Factor, REGEN-D® to combat diabetic foot ulcers, burns. Bharat Biotech's INDIRAB™ (anti-rabies vaccine) is a market leader in protection against rabies infections from dog bites. Bharat Biotech is a world leader in Hepatitis B vaccines with the first company the world to manufacture REVAC-B MCF™, a cesium chloride free hepatitis B vaccine and the first company in India to manufacture a Thiomersol free hepatitis B vaccine. Bharat Biotech has supplied ~ 400 million doses of BIOPOLIO®, oral polio vaccine to the Govt of India during 2008-2009. Bharat Biotech has a strong pipeline of vaccines and therapeutics to combat Malaria, Rotavirus, Staph Aureus (MRSA) and Japanese Encephalitis infections.

www.bharatbiotech.com

Important information about forward-looking statements

Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.

Bharat Biotech International Limited

www.medicalnewstoday.com/articles/140...

aossa 2 augustus 2009 21:45

0

clinicaltrials.gov/ct2/show/NCT00674908

Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

This study has been completed.

First Received: May 6, 2008 Last Updated: June 24, 2009 History of Changes

Sponsored by: Shantha Biotechnics Limited
Information provided by: Shantha Biotechnics Limited
ClinicalTrials.gov Identifier: NCT00674908
Purpose

The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.

Biological: Shan 5
Biological: Easy Five

etc...

July 21, 2008
World Health Organization pre-qualifies two pentavalent vaccines
www.hibaction.org/news/newsletter/foc...

[verwijderd] 3 augustus 2009 09:47

0

Het fabriekskoor van Shantha is iig opgetogen.

www.youtube.com/watch?v=rSUvboSVZlQ

:-)

Dirk

aossa 3 augustus 2009 11:03

0

Algemene repetitie (oefenen voor 1 april):
www.youtube.com/watch?v=YKaSzeByG2M

Deze trekt er helemaal nog niet op:
www.youtube.com/watch?v=0kNDNfgw7CI

[verwijderd] 7 augustus 2009 07:47

2

Omvang tender pentavalentvaccin voor 2010/2011/2012 is 600 mln. doses waarvan 135 mln voor India 51/42/42 en 470 mln. voor rest Unicef 160/150/150. Toewijzingen zullen uiterlijk volgende week aan kandidaatleveranciers medegedeeld worden.

MeawandMoo1 7 augustus 2009 08:48

0

quote:
nederbelg schreef:
Omvang tender pentavalentvaccin voor 2010/2011/2012 is 600 mln. doses waarvan 135 mln voor India 51/42/42 en 470 mln. voor rest Unicef 160/150/150. Toewijzingen zullen uiterlijk volgende week aan kandidaatleveranciers medegedeeld worden.

Tnx,
Toewijzing naar alle waarschijnlijkheid na de cijfers van CRXL.
Tenderomvang is gemakshalve gelijk aan hetgeen men eerder heeft aangegeven. (zie plaatje).
Naast de belangrijkste tender nemen organisaties ook separaat af. (Wat op dat moment beschikbaar is.) Sanofi heeft hier vorig jaar goed van kunnen profiteren.
Momenteel is het afwachten wanneer Novartis begint.

Bijlage:

[verwijderd] 7 augustus 2009 08:58

0

Hier is al zo vaak over vergadert dat er al veel mensen op de hoogte zijn van de uitkomst.

aossa 26 maart 2010 10:24

1

Polio IPV vaccine toevoegen aan pentavalent vaccine of niet? Het is één van de vragen die Bill&Melinda Gates Foundation zich stellen.

www.polioeradication.org/content/gene...

Huidige capaciteit IPV: 120 milj doses ruim voldoende productiecapaciteit

Geplande capaciteit IPV: 260 milj doses

Potentiele capaciteit IPV: 460 milj doses

Momenteel 4 grote producenten die leveren in bulk: GSK, Sanofi-Aventis, NIV (Nederlands Vaccin Instituut) en SSI (Satens Serum Institute).

aossa 6 juni 2010 17:07

2

Op AVA 4/06/2010 is gemeld dat 2e Indische leverancier van pentavalent vaccine slechts gedeeltelijk werd goedgekeurd (niet 'all in one'). Iemand meer info?

Is het 5-vaccine van:
* Bharat Biotech: COMVAC5 ?
* Panacea Biotech: EasyFive (er zijn2 formuleringen) ?
* Serum Institute of Indie (4 liquid + 1 dry component) ?

Imo claimde Bharat met COMVAC5 om mee te doen in de Indiase immunisatie campagne maar is/was nog niet WHO goedgekeurd. Is een volledig eigen ontwikkeling (zie artikels hiervoor).

EasyFive van Panacea heeft 2 versies:
1e versie met toegeleverde componenten is WHO goedgekeurd (4 componenten van Novartis).
2e versie met eigen Hib-component is/was nog niet goedgekeurd.

aossa 6 juni 2010 17:24

2

www.iapcoi.com/combos.htm

Combination Vaccines Currently Licensed in India

DTwP+Hib, DTwP+Hep B, DTwP+Hib+Hep B

These are available in two forms.

1) As ready to use liquid preparations: DTwP+ Hep B (Tritanrix HBTM, SII Q-VacR, ComvacTM4-HB, Shantetra), DTwP+Hib (Easy four, ShanHib- DPT), DTwP+Hep B+ Hib (Shan5, Easy five, ComvacTM5) and

2) When lyophilized Hib needs to be reconstituted with DTwP/ DTwP + Hep B from the same manufacturer: DTwP + Hib (Tetraact Hib), DTwP+ Hib + Hep B (Tritanrix HBTM + HiberixTM, SII Q-VacR + HibproR, ComvacTM4-HB + BioHibTM).

Though the antibody response to Hib is reduced in these combination vaccines as compared to separate administration, most subjects attain the seroprotective level of 1 ìg/ml and there is no reduced efficacy against Hib disease. The antibody responses to diphtheria, pertussis, tetanus and Hep B are unchanged. The liquid and the lyophilized formulations have similar immunogenicity and safety for both primary and booster immunization.

DTaP+Hib, DTaP+Hib+IPV
Currently the DTaP/Hib is available as lyophilized Hib which needs to be reconstituted with liquid DTaP just prior to administration (InfanrixTM + HiberixTM, TripacelTM + ActHibTM) or with DTaP + IPV (PentaximTM). Antibody responses to diphtheria, pertussis, tetanus and if applicable polio are satisfactory and comparable to those obtained after administration as separate doses.

The primary concern and debate with these vaccines is Hib immunogenicity as studies showed a significant reduction in Hib titer/percentage of children achieving the long term protective level of 1 ìg/ml, when these combination vaccines are used as compared to separate administration of Hib vaccines in primary immunization. This reduction in Hib immunogenicity is not noted when these vaccines are used for booster vaccination even in subjects who had been administered combination vaccines for primary immunization. The reduction in Hib antibody titers was noted across all studies with different formulations of DTaP (exception Canadian five component DTaP vaccine) and different Hib conjugate vaccines and was more significant when vaccination was administered earlier in life and in premature babies. Studies with the five component Canadian vaccine combination vaccine with Hib did not show reduced Hib immunogenicity. Experts did not attach much significance to lower Hib immunogenicity of these combination vaccines as the serologic correlates of protection for Hib were derived from studies with the polysaccharide vaccines which provided poor quality antibodies and no immunologic memory. Hence DTaP+ Hib combination vaccines were initially licensed in Europe for both primary and booster immunization but in the USA only for booster vaccination.

An increased incidence of Hib disease was noted in the UK but not in other European countries following shift to DTaP+ Hib combination vaccines. This was initially attributed to the lower immunogenicity of the combination vaccine but later conclusively attributed to other factors mainly non administration of a booster dose at 18 months. The US FDA and ACIP has recently approved DTaP (5 component) + IPV + Hib combination vaccine (Pentacel TM) for primary immunization (June 2008).

aossa 6 juni 2010 19:49

0

AVA 4/06/2010:
Door overgang oude naar nieuwe fabriek zal productie Hib een tijdje stilliggen. Daarom wordt er voorraad Hib-bulk opgebouwd.

Wat betreft productie Quinvaxem zal er overlap bestaan.

[verwijderd] 6 juni 2010 20:26

0

@Aossa: complimenten voor het speurwerk. AB-tje.

Het blijft overigens vreemd dat Crucell zich nog niet waagt aan een verhoging van de omzet-/winstverwachting voor 2010. Want de dollar zou nu toch ook nog echt mee moeten beginnen te werken.

[verwijderd] 6 juni 2010 21:18

0

quote:
xynix schreef:
@Aossa: complimenten voor het speurwerk. AB-tje.

Het blijft overigens vreemd dat Crucell zich nog niet waagt aan een verhoging van de omzet-/winstverwachting voor 2010. Want de dollar zou nu toch ook nog echt mee moeten beginnen te werken.

I know I am not as brilliant as Leon Kruimer, but of course revenues have to increase as the euro slides.
They are paid in dollars for Quinvaxem, then they convert those dollars to euros. Is it possible that other currencies may reduce the profit on those revenues...yes. But!!!!Revenues have to increase when the euro slides 10%+ compared to the dollar. Profits... considering the Won/Dollar/Franc/Euro interaction...do not.

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