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Home  /  Forum  /  Crucell  /  Shantha

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Shantha

259 Posts
Pagina: «« 1 ... 8 9 10 11 12 13 »» | Laatste | Omlaag ↓
  1. [verwijderd] 27 april 2010 13:37
    quote:

    maxen schreef:

    [quote=wilb52]
    DE markt gelooft het wel, niet dus,
    anders stond de koers van deze baggeraar , wel op 16.62 bij opening.
    ...
    [/quote]
    Op zich juist, er is geen sprake van nieuwe info die een hogere koers rechtvaardigt. Hooguit een bevestiging van extra kansen voor Quinvaxem.

    Maar als de koers eens WEL een paar dagen achter elkaar met menig procent stijgt hoor ik je NOOIT zeggen " de markt gelooft in Crucell, gezien de procenten stijging van de afgelopen dagen".

    Feit is dat de koers wat op en neer hobbelt, als ie daalt post je bagger-commentaar, als ie stijgt heb je GEEN commentaar. A la ronb dus.
    stijgt de koers dan met " menig ?? "procent op een dag dan weleens???
    Bij mijn weten al jjjjjjaaaaaaaaaaaaaaarrrrreeeeeen ,
    NIET.
    Want de volgende dag of week of maand er weer vanaf.

    Maar WEL erg goed om met xK wat binnen te harken voor de Aldi (:->D)

    Het grote geld met CruSELL komt er niet.
  2. maxen 27 april 2010 14:00
    quote:

    wilb52 schreef:

    [quote=maxen]
    [quote=wilb52]
    DE markt gelooft het wel, niet dus,
    anders stond de koers van deze baggeraar , wel op 16.62 bij opening.
    ...
    [/quote]
    Op zich juist, er is geen sprake van nieuwe info die een hogere koers rechtvaardigt. Hooguit een bevestiging van extra kansen voor Quinvaxem.

    Maar als de koers eens WEL een paar dagen achter elkaar met menig procent stijgt hoor ik je NOOIT zeggen " de markt gelooft in Crucell, gezien de procenten stijging van de afgelopen dagen".

    Feit is dat de koers wat op en neer hobbelt, als ie daalt post je bagger-commentaar, als ie stijgt heb je GEEN commentaar. A la ronb dus.
    [/quote]

    stijgt de koers dan met " menig ?? "procent op een dag dan weleens???
    Bij mijn weten al jjjjjjaaaaaaaaaaaaaaarrrrreeeeeen
    NIET.
    [/quote]
    Slechts in 2010:
    jan 25 - 2 feb (6 beursdagen):
    van 13.765 tot 14.48: +5.2%

    feb 25 - mar 16 (13 beursdagen):
    van 13.95 tot 15.62: +12.1%

    apr 16 - apr 20 (2 beursdagen):
    van 14.845 tot 15.56: + 4.8%

    [quote=wilb52]
    Want de volgende dag of week of maand er weer vanaf.
    ...
    Dat zeg ik: de koers hobbelt op en neer.

    Exact dezelfde onzin redenatie, maar dan omgedraaid:

    Daaaalt de koers met "menig??" procent wel eens dan?
    Al jaaaaaaaaaaaaaaaaaaaaaren NIET. Want de volgende dag of week of maand of jaar er weer bij.

    Feit:
    Over de meeste meer-jaarlijkse periodes gerekend doet Crucell het minder slecht dan de BAEX (Bagger-AEX).
  8. [verwijderd] 27 april 2010 16:57
    quote:

    aossa schreef:

    Extra omzet voor QV hangt imo af van de voortzetting van de vaccineprogramma's bmv pentavalent vaccine in de landen die voor Shan5 vaccine hebben gekozen.

    Het alternatief, zoals ook voorgesteld door Sanofi, dat ze terugvallen op het toedienen van afzonderlijke vaccines ipv de 5-combi, bv. 4-combi + tetanus afzonderlijk, of zich tevreden stellen met uitsluitend een 4-combi zonder tetanus vaccine.

    De 4+1 optie zou in versnelling kunnen komen indien Sanofi dit ter vervanging van hun foute Shan5 zou leveren (gratis uiteraard) ipv geldelijke compensatie.
    Het alternatief (4 plus 1) lijkt me gezien het feit dat het een tender betrof onmogelijk. Ben niet thuis in internationaal recht maar in de EU mag dit in ieder geval niet.
  10. forum rang 4 aossa 29 april 2010 13:37
    By Staff Reporter, 29-Apr-2010

    The WHO has called for recall and destruction of all batches of Indian drugmaker Shantha Biotechnics’ Shan5 vaccine after the discovery of “white sediment” in some vials.

    The product, which is designed to protect against diphtheria, pertussis, tetanus, haemophilus influenza B, and hepatitis B, was supplied under a $340m contract signed by Shantha with the world health organisation (WHO).

    In a statement this week, the WHO said it received several complaint about the vaccines’ quality over the last few months, all of which focused on the detection of “white sediment” which would not re-suspend even after vigorous shaking.”

    The organisation added that, while it had not received reports of adverse events linked to the vaccine, it was now asking all governments to return all remaining stocks to a central hub as a precautionary measure.

    The WHO action, which is based on the advice of an ad hoc committee of experts convened on 8 April, follows recommendations in February and March that distribution of Shan5 be halted until further notice.

    According to a report in India’s Economic Times, Shantha has already initiated the recall which amounts to some 24m doses of the 5-in1 vaccine products supplied between November 2008 and February this year.

    A company spokeswoman told the ET that: “Strong-focused investigations are going on with all the speed needed in such circumstances," and added that Shantha plans to file an action plan with the WHO in the next two months.

    The paper also reports that Shantha will be asked to cover the cost of replacement vaccines as well as transportation, handling and destruction of the recalled lots

    The announcement is also bad news for French drugmaker Sanofi Aventis given that Shantha’s vaccine business was a key motivation for its acquisition of an 80 per cent stake in the Indian firm in July last year.

    www.in-pharmatechnologist.com/content...
  11. forum rang 4 aossa 29 april 2010 13:44
    Indian Economic Times artikel: tinyurl.com/25o5lof

    NEW DELHI: Sanofi Aventis-owned Shantha Biotech is recalling several lots of its 24 million five-in-one vaccines globally after WHO found it unsuitable for use and raised concerns over its safety as certain white sediments in the vaccine was not dissolving.

    It cannot be ascertained how many of the 24 million vaccines, which were supplied between November 2008 and February 2010, have already been used. But an industry executive, familiar with WHO contracts of such vaccines, said the 24-million vaccines should be worth around $72 million or $3 a vaccine. Both Shantha and WHO spokeswomen said they cannot immediately determine the amount of vaccines that will be recalled or its value.

    WHO and UNICEF have asked Hyderabad-based Shantha Biotech to determine the root cause of the problem and prepare a corrective action plan within two months, failing which the company's vaccines will be disqualified from supply to the agency. This can cost the company another $340 million, in addition to the financial loss from the recall.

    But WHO has clarified that it is a precautionary measure and no adverse effect from use of the vaccine or change in efficacy has not been proven. It has also recommended against revaccination for children who had taken Shan5, used to protect babies from five diseases -diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B. "Strong-focused investigations are going on with all the speed needed in such circumstances," a Shantha Biotech spokeswoman said. The company plans to submit its action plan to WHO within the stipulated two months to resolve the issues raised by WHO and is confident to resume sales of Shan5 before the year-end, she added.

    This is a setback to Sanofi Aventis, which bought 80% in Shantha in July 2009, valuing the company at € 550 million.

    As first reported by ET last month, on March 12, WHO had temporarily suspended use of Shan5, following complaints from few countries that the white sediment in the vaccine sticks to its glass despite stirring. WHO had asked countries to quarantine the vaccines pending its investigation. In a joint statement on Monday, WHO and UNICEF said the step was taken on the advice of a committee. The experts said the quarantined batches are unsuitable for use and should be destroyed as the product has a different physical appearance to that which was prequalified. "There are uncertainties about the safety and immunogenicity profile of the vaccine in this situation (although, no reports of adverse events, following immunisation have been received); and the root cause of the change in physical appearance has not been established," it added.

    Shantha will be requested to cover the cost of replacement of the vaccines as well as costs associated with transportation, handling and destruction related to the return of the goods, WHO spokeswoman Alison Brunier said without elaborating how Shantha Biotec will cover the cost of replacement.

    Besides losses from the recall, if WHO disqualifies Shan5, the Indian company could lose a $340-million UNICEF contract to supply Shan5 for 2010-12. "Any such change in status would likely have an impact on supply arrangements," Ms Brunier added.

    WHO said UNICEF are working with other companies to meet and cover all requirements for 2010. This could provide limited business opportunity for other pentavalent suppliers such as India's Panacea Biotec and Novartis.
  12. bionerd 29 april 2010 16:25
    Beetje tendentieus stukje. Net of alle geleverde eenheden slecht zouden kunnen zijn geweest. Misschien is houdbaarheidsdatum een indicatie om vast te stellen over hoeveel eenheden het zou kunnen gaan. Wel een beetje vreem dat Crucell niet als partner genoemd wordt. Iemand enig idee waarom niet?
  13. z0n0p 29 april 2010 16:35
    quote:

    bionerd schreef:

    Beetje tendentieus stukje. Net of alle geleverde eenheden slecht zouden kunnen zijn geweest. Misschien is houdbaarheidsdatum een indicatie om vast te stellen over hoeveel eenheden het zou kunnen gaan. Wel een beetje vreem dat Crucell niet als partner genoemd wordt. Iemand enig idee waarom niet?
    BRUS!!!!
  14. forum rang 4 aossa 29 april 2010 16:40
    quote:

    bionerd schreef:

    Beetje tendentieus stukje. Net of alle geleverde eenheden slecht zouden kunnen zijn geweest. Misschien is houdbaarheidsdatum een indicatie om vast te stellen over hoeveel eenheden het zou kunnen gaan. Wel een beetje vreem dat Crucell niet als partner genoemd wordt. Iemand enig idee waarom niet?
    Geeft aan hoe men in de plaatselijke Indiase pers tegen de zaak aankijkt. Shantha (en bijgevolg Sanofi-Aventis) maakt daar geen goede beurt imo.

    Crucell is niet op de Indiase markt gekend, hebben daar ook niet getenderd. Novartis (naameigenaar van Quinvaxem) daarentegen is er aanwezig en heeft een joint-venture met Panacea Biotech aan wie ze basiscomponenten in bulk leveren voor EasyFive pentavalent vaccine zoals ze dat ook doen voor Quinvaxem.

    Geeft bijgevolg ook aan dat voornamelijk Novartis van de Shan5 situatie zal profiteren.
  15. [verwijderd] 29 april 2010 19:26
    NEW DELHI: Drug firm GlaxoSmithKline Pharmacueitcals today said it will launch 3-4 more products in India in the current year to fuel its growth.

    "We will be introducing 3-4 new products in domestic market to fuel our growth in the domestic market," GlaxoSmithKline (GSK) Director Finance M Kapadia told PTI.

    He said the company will introduce drugs from its parent company's portfolio in the branded generics segment and is going to launch more vaccines in the domestic market.

    "Vaccines would be the main focus area for us and are going to fuel its sales in the country as we are aiming for around 12 per cent our sales to come from the segment alone," Kapadia said.

    By the end of current year or early next year, it will launch Infanrix Hexa, which is a combination of six vaccines.

    Infanrix Hexa is indicated for six diseases -- Diphtheria, tetanus, pertussis, Hib, hepatitis B and polio.

    Besides this, the company will also introduce pneumococcal disease vaccine in the country.

    "Over the last few years, we were growing at lower rate compared to the average market growth in India. However in the next one-year, we are hopeful of outperforming the market," Kapadia said.

    economictimes.indiatimes.com/news/new...

    **********************************************************************

    Hoe staat het bij Crucell ?

  16. flosz 1 mei 2010 10:19
    30/04/2010
    WHO asks Shantha Biotechnics to recall Shan5 vaccine
    Mumbai: The World Health Organisation (WHO) has recommended recall and destruction of all lots of the Shantha Biotechnics (India)-produced five-in-one, or pentavalent, Shan5 vaccines as a precautionary measure, after the discovery of undissolved white sediments in the vaccine.
    Shantha Biotechnics plans to present an action plan to WHO within two months for resolving the issue, said French drug major SanofiAventis, which owns Shantha Biotechnics.
    Shantha Biotechnics supplied 24 million doses of the vaccine through Unicef and the Revolving Fund of the PanAmerican Health Organization between November 2008 and February 2010. The vaccine is also procured directly by a number of countries such as Nepal, India and Pakistan. The vaccine offers protection against five diseases -- diphtheria, pertussis, tetanus, haemophilus influenzae B and hepatitis B. The company did not disclose revenues earned from its sale.
    "The WHO decision to suspend the use of Shan5 is based on information that is available to date, regarding its abnormal visual appearance. This information is insufficient to make conclusions about the potential cause for the sediment sticking to the sides of the vial," said a spokesperson at Sanofi-Aventis.
    Several investigations are going on to establish the exact cause. Neither safety nor efficacy issues have been reported, according to the spokesperson.
    A statement from SanofiAventis said transient flocculation was a 'normal' physical phenomenon in all such vaccines and might also be seen during some of the manufacturing steps of the product. In this kind of products, complex interactions occur between all components, leading to occurrence of flocculation phenomenon. That is why the "visual appearance" specifications for such vaccines very often refer to "whitish suspension" and "shaking" before use is a classic "instruction for use".
    "The recommendation is based on the advice of an ad hoc committee of experts convened on April 8, following incidents of white sediments sticking to Shan5 vaccine vials that were difficult or impossible to re-suspend. There have been no reports of any side effects from the use of Shan5," said apress release from WHO.
    During recent months, WHO received several complaints about the vaccine's quality from Colombia, Comoros and Nepal, mainly on the detection of white sediments which would not resuspend even after vigorous shaking.
    On February 19, WHO recommended the temporary suspension of the distribution and use of specific lots of Shan5 vaccine as a precautionary measure pending investigation.
    Source: Business Standard
    news.in.msn.com/business/article.aspx...
    ***
    Recall and destruction recommended for Shan5 vaccines
    by Nick Rees on April 30, 2010
    A recall and destruction for all of the lots of Shantha Biotechnics pentavalent Shan5 vaccines has been recommended by the World Health Organization as a precautionary measure following the discovery of undissolved white sediments in the vaccine.

    “The recommendation is based on the advice of an ad hoc committee of experts convened on April 8, following incidents of white sediments sticking to Shan5 vaccine vials that were difficult or impossible to re-suspend," the WHO said in a statement. "There have been no reports of any side effects from the use of Shan5."

    French drug maker Sanofi-Aventis, which owns Shantha Biotechnics, plans to present the WHO with an action plan to resolve the issue within two months.

    Twenty four million doses of the vaccine were supplied by Shantha Biotechnics through Unicef and the Revolving Fund of the Pan-American Health Organization between November 2008 and February 2010.

    Shan5 offers protection against diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B.

    “The WHO decision to suspend the use of Shan5 is based on information that is available to date, regarding its abnormal visual appearance," a Sanofi-Aventis spokesman told Business-Standard.com. "This information is insufficient to make conclusions about the potential cause for the sediment sticking to the sides of the vial."

    Multiple investigations have been launched to establish the cause of the sediment, which has not resulted in safety or efficacy issues, the spokesperson said.
    vaccinenewsdaily.com/news/212905-reca...
  17. [verwijderd] 1 mei 2010 12:42
    From a previous article

    "Indian Economic Times artikel: tinyurl.com/25o5lof

    NEW DELHI: Sanofi Aventis-owned Shantha Biotech is recalling several lots of its 24 million five-in-one vaccines globally after WHO found it unsuitable for use and raised concerns over its safety as certain white sediments in the vaccine was not dissolving.

    WHO and UNICEF have asked Hyderabad-based Shantha Biotech to determine the root cause of the problem and prepare a corrective action plan WITHIN TWO MONTHS(emphasis mine), failing which the company's vaccines will be disqualified from supply to the agency. This can cost the company another $340 million, in addition to the financial loss from the recall."

    WITHIN TWO MONTHS-starting when? If it started at the original halt and concern, that was around March 15, so two months would be up on May 15th.

    If it when WHO ordered the destruction of all lots, then this was on @April 26.

    What is the likelihood that Shantha will not be able to figure out what went wrong and be able to fix it? How much of the $72 million destoyed vaccine will Crucell replace (@ 55 million euro).

    Obviously Crucell would get the lions share of a new allotment if Shantha is disqualified. Perhaps Sanofi might bite the bullet and put in an offer for Crucell.

  19. flosz 1 mei 2010 13:46
    quote:

    ronbanged2 schreef:

    WITHIN TWO MONTHS-starting when? If it started at the original halt and concern, that was around March 15, so two months would be up on May 15th.

    If it when WHO ordered the destruction of all lots, then this was on @April 26.
    Org. art. WHO dd 12 maart, 2010:
    www.who.int/immunization_standards/va...
    Hierin spreekt men niet over twee maanden etc. etc.

    Org. Art. WHO d.d. 26 april, 2010:
    www.iex.nl/forum/topic.asp?forum=228&...
    ....If, however, the
    manufacturer is not able to identify the root cause of the quality issue and prepare a robust
    plan for corrective action within a period of two months, the product will be removed from the
    list of WHO prequalified products.
    www.iex.nl/forum/topic.asp?forum=228&...
    www.who.int/immunization_standards/va...
    Imo m.i.v. d.d. 26 april, 2010.
259 Posts
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