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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 vaccinehugin.info/132631/R/1359009/331102.pdf
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?
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
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
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."
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.
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...
UNICEF yanks Sanofi vax, calls in Crucell May 19, 2010 — 4:40pm ET | By George Miller Related Stories Sanofi retools French biotech, vax facilities Drug maker suffers trailer theft Sediment forces WHO to halt vax program Tools Subscribe Email Print Comment Contact Author Reprint 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...
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
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)
[Modbreak IEX]: Gelieve op de inhoud van uw berichten te letten, bericht is bij dezen verwijderd.]
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!
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.
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))
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.
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."
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.
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."
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?
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.
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Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
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RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
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Sunrun
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SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
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Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
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Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)
Indices
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