Crucell Terug naar discussie overzicht

Shantha

1. flosz 1 mei 2010 14:08

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   quote:

   Dirk R. Wijnen schreef:

   Ik zal ze niet meer opnoemen om irritaties te voorkomen.
   

   Als je steeds de oude kadavers uit de sloot haalt kom je nooit een stapje verder imo!
   
   We entered the market at the end 2006 with a true five-in-one. And two additional competitors had entered the scene called Panacea from India,
   and Shanta Biotech also from India. And they also produce five in one vaccines. And what we've noticed is that two things really matter.
   First, as far as we can tell, we now have the largest production capacity. And we're also the most reliable supplier of UNICEF. And this is
   essential because the distribution across Africa, and all kinds of Asian countries, is extremely expensive. And if we do not supply in time, it
   would be a massive blow to UNICEF, because all people and distributors would sit there waiting for these vaccines. That's one very important
   aspect.
   Second, UNICEF is very enthusiastic about such vaccines. At this point, Quinvaxem is registered in about 72 countries. And we're noticing that
   around 2007, the market demand was about 40 million doses for pentavalent vaccines. And we supplied about half of that by 2008.
   The demand was about 70 million to 80 million doses. And we expect, in 2009, that the demand will be about 140 million doses. Now there's an
   important additional factor. India will become part of these UNICEF supplies as well. So UNICEF, or rather India, will be receiving vaccines via
   UNICEFs buyers.
   We're not exactly sure about the capacity of our Indian competitors, but we have a minor indication. And it's important to understand this. That if
   you were to produce 100 million doses of Quinvaxem, you need to make 500 different vaccines, because 100 million of each ingredient, is a
   vaccine. If you encounter a bottleneck or a capacity shortage in one of those ingredients, you'll never get that quantity.
   We believe that we're an order of magnitude; our capacity exceeds that of our Indian counterparts by an order of magnitude. And we'll try to
   ensure that we can provide pentavalent vaccine to as many countries as possible.
   
   Keyner: Will you allow me? With regards to India, you referred to 140 million of doses does that include or exclude India?
   Brus: I said that demand for liquid pentavalent vaccines had been estimated at about EUR140 million in 2011. That means that it will now about EUR90 million to EUR100 million higher because of India.
   
   Keyner: Right, so then it would be EUR230 million?
   
   Brus: Yes, that's possible.
   
   Keyner: And for 2009, EUR140 million?
   
   Brus: That is excluding India.
   hugin.info/132631/R/1323114/310383.pdf
   
   QV outlook:
   
   Market demand from UNICEF, PAHO, private markets
   • UNICEF demand through 3-year tenders
   • Market growing rapidly; global market estimate 80 mln doses in 2008; 2011/2012 estimate 200 mln doses (including India)
   • Crucell and GSK shared market until 2008
   • Crucell awarded US$500 mln in 2007-2009 tender period
   • Tender period 2010-2012: new Indian competition from Shantha (royalties for Crucell), Panacea
   • Crucell received US$300 mln, the first portion for new period 2010-2012
   • Crucell has stake in Shantha/Sanofi Pasteur pentavalent vaccine
   hugin.info/132631/R/1359009/331102.pdf
   
2. [verwijderd] 1 mei 2010 14:13

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   quote:

   flosz schreef:

   [quote=ronbanged2]
   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.
   [/quote]
   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.
   
   

   If I had to guess, I agree with April 26. And it doesn't say they have to have it fixed in two months...just determine the cause. And who says they have determined the cause? Shantha? or is there a version of the FDA within WHO that will independently confirm it? Or sanction their outcome?
3. [verwijderd] 1 mei 2010 14:58

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   quote:

   flosz schreef:

   [quote=Dirk R. Wijnen]
   Ik zal ze niet meer opnoemen om irritaties te voorkomen.
   [/quote]
   Als je steeds de oude kadavers uit de sloot haalt kom je nooit een stapje verder imo!
   
   

   Ik zeg toch dat ik ze NIET noem.
   
   Lezen, zegt Flosz altijd.
   
   LOL
   
   Dirk
4. MeawandMoo1 17 mei 2010 22:35

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   en.sanofi-aventis.com/binaries/20F_20...
   
   On August 31, 2009, sanofi-aventis took control of Shantha Biotechnics (Shantha), a biotechnology company based in Hyderabad (India), which develops, manufactures and markets several important vaccines to international standards. Shantha generated net sales of approximately €50 million in 2009. The purchase price amounted to €571 million. As of December 31, 2009, sanofi-aventis held approximately 95% of Shantha.
   
   Shantha has generated net sales of €17 million since the acquisition date.
   
   (€ million)
   Intangible assets 374
   Property, plant and equipment 122
   Deferred taxes (163)
   Other assets and liabilities —
   ___________________________________
   
   333 Net assets of Shantha as of August 31, 2009
   12 Assets and liabilities attributable to minority interests
   ___________________________________
   
   321 Share attributable to equity holders of the Company
   250 Goodwill
   ___________________________________
   
   571 Purchase price
5. [verwijderd] 17 mei 2010 23:07

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   quote:

   MeawandMoo1 schreef:

   ...
   Shantha has generated net sales of €17 million since the acquisition date.
   ...
   

   pagina 87, iets nauwkeuriger:
   "Shantha, consolidated from September 1, 2009, contributed net sales of €17 million in 2009."
6. [verwijderd] 18 mei 2010 09:35

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   quote:

   MeawandMoo1 schreef:

   en.sanofi-aventis.com/binaries/20F_20...
   
   On August 31, 2009, sanofi-aventis took control of Shantha Biotechnics (Shantha),
   
   ....
   ___________________________________
   
   321 Share attributable to equity holders of the Company
   250 Goodwill
   ___________________________________
   
   571 Purchase price
   

   Penny-wise, pound-foolish. Zou dat ook een frans spreekwoord zijn?
   Ben zeer benieuwd naar de volgende Shanta rapportage mbt de posten net-sales en goodwill.
7. aossa 20 mei 2010 12:43

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   Geen probleem in Bhutan met EasyFive van Pancea Biotech!
   
   www.investorvillage.com/smbd.asp?mb=2...
   
   Panacea vaccine gets clean chit from WHO
   20 May 2010, 0108 hrs IST,Khomba Singh,ET Bureau
   
   NEW DELHI: Panacea Biotec said on Wednesday that the World Health Organisation (WHO) has found no link between the company’s five-in-one vaccine and deaths of infants in Bhutan and asked it to resume supply that was stopped late last year.
   The Delhi-based drugmaker took off the shelves a batch of the blockbuster medication sold as EasyFive after the WHO launched a probe October last year into the deaths of four infants in Bhutan who had reportedly taken it.
   
   “Review of the clinical information did not provide any additional indication that a safety problem could be attributed to the use of EasyFive,” said Panacea Biotec joint MD Rajesh Jain, quoting a WHO letter.
   
   Panacea bagged a $222-million contract to supply the vaccine — used to treat diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B in babies — to the United Nations Children’s Fund (Unicef) for three years to 2012.
   
   “The vaccine was retested for abnormal toxicity and sterility in two additional reference laboratories and found to comply with (WHO) specifications,” Mr Jain said, adding that EasyFive remains on the list of WHO-approved vaccines.
   
   Following the WHO probe, the drug regulator had written to pediatricians asking them to prescribe EasyFive with caution. In the letter, Drug Controller General of India (DCGI) Dr Surinder Singh pointed to the deaths of five infants in Sri Lanka who had used the medicine.
   
   Dr Singh also asked pediatricians to report adverse reactions from the vaccine’s use. Panacea Biotec received the drug regulator DCGI’s approval to sell the vaccine in India in September 2007.
   
   Though the vaccine was launch, the company is yet to submit a post-marketing surveillance report that examines its safety and efficacy, DCGI told doctors in the letter sent earlier this year.
   
   Last month, Hyderabad-based Shantha Biotech had to recall 24 million doses of a similar vaccine after certain white sediments would not dissolve even after shaking.
   economictimes.indiatimes.com/news/new...
8. Barbier 20 mei 2010 16:09

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   UNICEF yanks Sanofi vax, calls in Crucell
   May 19, 2010 — 4:40pm ET | By George Miller
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   Sanofi's loss is Crucell's gain. As pediatricians in Kathmandu work to calm parents unable to have their infants vaccinated against five diseases, Sanofi Aventis' Indian unit Shantha is scrambling to find the cause of a white sediment in some vials of its Shan5 vaccine. Meanwhile, Crucell is ramping up to fill the gap.
   
   Shan5 is a prophylactic for diphtheria, pertussis, tetanus, Haemophilus influenza B, and hepatitis B. Reports of the sediment began in March, followed by a World Health Organization suspension of the vaccine for use in a distribution program. Shan5 represents a $340 million contract that the Indian drugmaker won last fall.
   
   Some Nepalese parents have decided to cough up $14 for another pentavalent vaccine available at some hospitals, despite assurances that shipments are on their way and the free-vaccine program will resume in a matter of weeks.
   
   The white sediment is reportedly difficult to disperse, even when the vial is shaken. It's not likely a contaminant because the vaccine passed QA tests prior to shipment, the company said in March. A more likely scenario is that part of the vaccine contents condensed in transit, perhaps due to improper storage or shipping conditions.
   
   UNICEF and the WHO in late April recommended the recall and destruction of vaccine still in stock--about 24 million doses--due to the mysterious sediment. The move has affected vaccination programs in seven countries, says the WHO. No safety issues or adverse events have been reported.
   
   The WHO and UNICEF want Shantha to find out what went wrong and to develop a corrective plan before the end of June. Shantha will otherwise be disqualified as a supplier. The company says it has put together a team of specialists to find the cause and resume shipments before the end of the year.
   
   Meanwhile, Dutch biotech Crucell has won a $110 million UNICEF order for its pentavalent Quinvaxem, giving the company a much-needed market boost against Shantha and Panacea Biotech, according to Reuters. The news agency cites a Crucell spokeswoman who said that the Quinvaxem order from UNICEF was due to supply problems experienced by "another company."
   
   Read more: www.fiercepharmamanufacturing.com/sto...
   
9. flosz 26 juni 2010 01:57

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   quote:

   flosz schreef:

   [quote=ronbanged2]
   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.
   [/quote]
   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.
   
   

   www.youtube.com/watch?v=Q3eEDDjtQxA
10. patient 26 juni 2010 02:09

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    quote:

    flosz schreef:

    [quote=flosz]
    [quote=ronbanged2]
    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.
    [/quote]
    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.
    
    [/quote]
    www.youtube.com/watch?v=Q3eEDDjtQxA
    

    Nu weet ik zeker dat ik niet meer in slaap val;Q)
12. [verwijderd] 26 juni 2010 02:45

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    [Modbreak IEX]: Gelieve op de inhoud van uw berichten te letten, bericht is bij dezen verwijderd.]
13. patient 26 juni 2010 03:04

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    quote:

    ronbanged2 schreef:

    [quote=flosz]
    [quote=flosz]
    [quote=ronbanged2]
    
    [/quote]
    www.youtube.com/watch?v=98ako31Qwss
    

    Symbolic!
    The rumble in the jungle:
    Killer Turtle Bruse against Birdman Viehbacher.
    
    Luckily for Birdman it was a quick death!
14. [verwijderd] 26 juni 2010 14:24

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    quote:

    patient schreef:

    [quote=ronbanged2]
    [quote=flosz]
    [quote=flosz]
    [quote=ronbanged2]
    
    [/quote]
    www.youtube.com/watch?v=98ako31Qwss
    [/quote]
    Symbolic!
    The rumble in the jungle:
    Killer Turtle Bruse against Birdman Viehbacher.
    
    Luckily for Birdman it was a quick death!
    

    Please, someone explain.
    
    I posted a link to a youtube video and it gets removed by the Moderator.
    
    Why?
    
    That's all I posted, no commentary, just a clip of a video I thought was cool to watch, and of something totally unexpected.
15. patient 26 juni 2010 14:43

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    quote:

    ronbanged2 schreef:

    [quote=patient]
    [quote=ronbanged2]
    [quote=flosz]
    [quote=flosz]
    [quote=ronbanged2]
    
    [/quote]
    [Modbreak IEX(forum@iex.nl): Quote verwijderd.]
    [/quote]
    Symbolic!
    The rumble in the jungle:
    Killer Turtle Bruse against Birdman Viehbacher.
    
    Luckily for Birdman it was a quick death!
    [/quote]
    Please, someone explain.
    
    I posted a link to a youtube video and it gets removed by the Moderator.
    
    Why?
    
    That's all I posted, no commentary, just a clip of a video I thought was cool to watch, and of something totally unexpected.
    

    Normally i ask a fee for consult, but because you were once a true believer in the good cause, its for free now.
    
    May be it has to do with unfriendly public relation, bad image and intimidation by repeadatly harrasment.
    By the way i liked the clip. :Q))
16. [verwijderd] 26 juni 2010 15:59

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    quote:

    patient schreef:

    [quote=ronbanged2]
    [quote=patient]
    [quote=ronbanged2]
    [quote=flosz]
    [quote=flosz]
    [quote=ronbanged2]
    
    [/quote]
    [Modbreak IEX(forum@iex.nl): Quote verwijderd.]
    [/quote]
    Symbolic!
    The rumble in the jungle:
    Killer Turtle Bruse against Birdman Viehbacher.
    
    Luckily for Birdman it was a quick death!
    [/quote]
    Please, someone explain.
    
    I posted a link to a youtube video and it gets removed by the Moderator.
    
    Why?
    
    That's all I posted, no commentary, just a clip of a video I thought was cool to watch, and of something totally unexpected.
    [/quote]
    
    Normally i ask a fee for consult, but because you were once a true believer in the good cause, its for free now.
    
    May be it has to do with unfriendly public relation, bad image and intimidation by repeadatly harrasment.
    By the way i liked the clip. :Q))
    

    LOL- criticism of company and management...unfriendly public relation...Enron could have used more of that, so AIG and the others caught up in the economic meltdown.
    
    Bad image-in the eye of the beholder
    
    intimidation?-I do not look up people who post on message boards and create files on them.
    
    FWIW-Month Moratorium on any Criticism on Crucell and Management if...in the next month...they do one of the following
    
    Announce what the hell the Wyeth deal is about
    
    Put an end to the Sanofi Flucell nonsense
    
    Collect a milestone...from anybody
    
    Bump guidance
    
    Get the share price over 17.80 euros
    
    Announce they did something that brings in "new" income in the next year.
    
    
17. aossa 8 juli 2010 10:30

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    Leiden, the Netherlands (July 8, 2010) - Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced that Crucell and sanofi pasteur reached an agreement on a series of transactions to restructure their long standing partnership.
    
    Crucell will waive its right to terminate an existing license agreement between Crucell Switzerland and sanofi pasteur's subsidiary Shantha Biotechnics Limited (Shantha) for the development of paediatric vaccines, based on Haemophilus influenzae b. This termination right was triggered by the acquisition of Shantha by sanofi pasteur in July 2009.
    
    At the same time, sanofi pasteur will return to Crucell the commercial rights that sanofi pasteur held under an exclusive license agreement for the development and commercialization of a cell-based influenza vaccine (FluCell), based on Crucell's PER.C6® technology. The exclusive license, agreed upon in December 2003, left Crucell with marketing rights for FluCell in Japan only. With the return of the world-wide marketing rights, Crucell will assume full responsibility for the FluCell program and will commence immediately with the development of a cell-based influenza vaccine.
    
    "We are excited to have the cell-based influenza program back at Crucell. Together with our Taiwanese partner Adimmune, we have been able to successfully increase the future availability of flu antigen for Inflexal® V, our virosomal adjuvanted influenza vaccine," said Crucell's Chief Executive Officer, Ronald Brus. "The introduction of cell-based Inflexal® V will be the next giant leap for Crucell's respiratory franchise."
    
    "Combining our intensified PER.C6® production system with our proven virosomal technology creates an exciting new method to produce an influenza vaccine both at large scale and very competitive cost levels," said Crucell's Chief Medical Officer, Jerald Sadoff. "I am confident that we will be able to accelerate this program and expect to apply for licensure in 2014. In addition, our successful partnership with sanofi on the development of our rabies antibody program is progressing well. This progress with the next generation rabies treatment brings us closer to the moment when all-in-need will get adequate treatment against rabies."
18. aossa 8 juli 2010 10:36

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    Benieuwd wat er nu met Shan5 en WHO-prequalificatie gaat gebeuren...
    
    "De in de markt gevonden flesjes Shan5 komen niet overeen met de stalen in ons bezit uit de WHO-goedkeuring" (aldus vrij vertaald een WHO-woordvoerder).
    
    Imho is Shantha zichzelf en aan de WHO verplicht om Shan5 terug te brengen naar de onderzoeksfase om na succesvol doorlopen van het goedkeuringstraject uiteindelijk een nieuwe WHO-goedkeuring aan te vragen.
19. aossa 8 juli 2010 10:49

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    Vertaling via Google:
    
    "Crucell zal afzien van zijn recht op een bestaande licentie-overeenkomst tussen Crucell Zwitserland en Sanofi Pasteur's dochteronderneming Shantha Biotechnics Limited (Shantha) voor de ontwikkeling van pediatrische vaccins, gebaseerd op Haemophilus influenzae B. te beëindigen Dit opzeggingsrecht werd veroorzaakt door de overname van Shantha door Sanofi Pasteur in juli 2009."
20. bionerd 8 juli 2010 12:47

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    Mocht Shanta opnieuw goedkeuring moeten vragen hoe lang gaat dit dan duren? Indien erg lang dan kan Crucell nog meer contracten ontvangen voor Quinvaxem. Kan de fabriek in Korea meteen optimaal gebruikt worden. Toch wel goed nieuws voor Crucell wat in mijn ogen wat lauwtjes ontvangen wordt.
    
    Heeft iemand een idee wat voor % aan royalties van Shanta krijgt? Enkel digit of dubbel?
    
    
21. aossa 8 juli 2010 13:22

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    quote:

    bionerd schreef:

    Mocht Shanta opnieuw goedkeuring moeten vragen hoe lang gaat dit dan duren? Indien erg lang dan kan Crucell nog meer contracten ontvangen voor Quinvaxem. Kan de fabriek in Korea meteen optimaal gebruikt worden. Toch wel goed nieuws voor Crucell wat in mijn ogen wat lauwtjes ontvangen wordt.

    Niet direct alles geloven wat ze hier op het forum schrijven ;-)
    
    Na vertalen van de tekst zie ik het wat anders:
    "Crucell zal afzien van zijn recht op een bestaande licentie-overeenkomst... *te beëindigen*."
    
    Indien WHO-goedkeuring gebaseerd was op de gelicenceerde productiemethode verleend door Crucell (ex-Berna) dan kan Shantha op deze wijze verder produceren: licentie overeenkomst tussen Crucell en Shantha blijft namelijk bestaande (cq. niet beëindigd).
    
    Voor Shantha het voordeel om snel weer in de running te zijn met Shan5 zonder extra gezichtsverlies. Voor Crucell het voordeel van de extra royalties (3% ?) op Shan5 en het feit C.Viehbacher in wurggreep te hebben gehad ivm exclusiviteits-licentie Flucell.
    
    Hopelijk bloeit er na de krachtmeting weer wat moois tussen SA en Crucell.