Crucell Terug naar discussie overzicht

Crucell & ADImmune Corporation.

1. MeawandMoo1 27 april 2010 21:24

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   Niet slecht voor een investering van EUR 8,7 miljoen.
   
   Destijds kreeg Crucell 20% van de Adimmune aandelen.
   Nu, na verwatering heeft Crucell 11,8% van de aandelen.
   
   Resultaten adimmune over 2008:
   5,844,000 Revenues
   (704,000) Profit/(loss) before tax
   
   Resultaten adimmune over 2009:
   30,282,000 Revenues
   18,464,000 Profit/(loss) before tax
   
   Natuurlijk heeft Adimmune geprofiteerd van de H1N1 omzet, maar met de nieuwe fabriek slechts halverwege 2009 echt in gebruik, voldoende potentie om verder te groeien.
   
   Aandeeltjes maar niet verder laten verwateren.
   
2. bilbo3 24 september 2010 20:32

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   Tussen al het overnamegeweld, is het goed om echte vooruitgang in de pijplijn (van partners) te zien. In dit geval Addimmune.
   
   Als ik het goed begrijp: volgend jaar flu-vaccin op basis van per.c6 in europa op de markt!!!
   
   Voor mij een (positieve) verrassing?
   
   Taiwanese vaccine maker's factory passes EU certification
   2010/09/20 22:30:46
   
   
   Taipei, Sept. 20 (CNA) Taiwan's only human vaccine manufacturer said Monday its production facility has been certified by the European Medicines Agency (EMA), the European Union's pharmaceutical regulatory body.
   
   Adimmune Corp. spokeswoman Shen Ya-hui said the company received EMA certification of its production facility in August thanks to the assistance of its Dutch cooperation partner Crucell.
   
   The company is scheduled to launch clinical tests of its cell-culture-based influenza vaccine on 400-plus people in Switzerland late this year, Shen said.
   
   "We expect to obtain the EMA's pharmaceutical certification for our flu vaccine next year," she added.
   
   In the future, Shen said, the company also intends to apply for U.S. Food and Drug Administration certification for the vaccine.
   
   When the partially government-owned company marketed its H1N1 vaccine last year amid a global outbreak of the flu, Shen recalled that quite a few people expressed doubts about the product's efficacy and quality.
   
   "Such misgivings were unnecessary, " Shen said. "Academic papers carried in prestigious medical journals, such as Vaccine and Lancet, have proved the safety and effectiveness of our product." (By Chen Ching-fang and Sofia Wu) enditem
3. flosz 24 september 2010 21:31

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   Zie ook www.iex.nl/forum/topic.asp?forum=228&...
   21 sep 10, 13:49
   
   **********
   PB Adimmune erbij:
   MIT vaccine internationally recognized journals; plant was completed vaccination certificate to enter the European Union; avian influenza, enterovirus vaccine developed country after another light MIT vaccine biotechnology in turn by the positive prospects for open access to influenza vaccine to fight time! Recalling last year's H1N1 strain caused by the new global influenza epidemic, leaving domestic vaccine appears to give the impression of doubt, but today the country of light biotechnology to support international journals and more articles to prove that a new influenza vaccine immunity MIT and security by international recognition, and Taiwan's leading countries in this treatment policy work, also published in the United States Center for Disease Control report Guoguang biotechnology, said a spokesman for the high holy Kay, past troubles, MIT vaccine has been highly positive, with the exception of Taiwan, and based on towards internationalization. By the end of August this year, has confirmed that its flu vaccine factory plant inspection by the European Union, on behalf of MIT vaccine into Europe just around the corner. In addition to the vaccine of egg embryo skilled production, the development of cell culture technology to produce human vaccines, has accumulated years of experience and technology, child care for each of the threat of enterovirus type 71 vaccine, already have developed the capacity. Summary H1N1 vaccine troubles MIT and safety of vaccination have been recognized internationally renowned journals Department of Health Immunization considered victims relief group VICP, received a total of 47 H1N1 vaccine inoculation for the death of a suspected case of victims, 46 have been completed consideration of the cause of death are nothing to do with vaccination. In addition to internal investigations almost get to the bottom, MIT vaccine efficacy and safety in international journals in July this year - vaccine (VACCINE) identity, published two people immunity and safety of the report, including children and youth, and the two older groups. Guo Guang Shen Yahui Medical Director, said Dr, H1N1 monovalent vaccines in the world belong to the new vaccine, but vaccination in children and adolescents, as well as the elderly population, the effect and safety is the most attention. Guoguang vaccine clinical trial data integrity, and in accordance with periodical review, the National Optical vaccine research clinical trials have the chance to board the well-known journals. Apart from these two studies, the vaccine (VACCINE) will soon publish another one of the elderly Chinese population of immune specificity. Compared to foreigners in the unvaccinated than 30% of the people before the resistant, senior citizens in the body of the virus resistant to only 3 % Below the base value is not the same, made the vaccine could meet the EU requirements the concentration of antibodies, vaccines, the quality is evident. Shen Kuo Kuang Medical Director Dr Avery said the review data for the future of tremendous help, people for the new influenza virus resistance Yanjiuguoqu never been carried out that the report is the coming future vaccine order at first be a reference Da evidence. In addition to international journals certainly MIT vaccine, the CDC also published an article, statistics of Taiwan in the new severe influenza epidemic began large-scale vaccination, so stop the number of classes, admissions plummeted. The other one is also made of pricking needles, large-scale facilities in Taiwan to lay, is the opportunity to make vaccine safety review, you can compare the facilities during vaccination, GBS incidence of polyneuropathy, it really Gao on weekdays during the period without vaccination. The integration of information and views, have a chance of fair treatment to a serious
   public health issue.
   
   Guoguang biotechnology process technology and equipment certified by the European Union State Department photo business vice president, said the high holy Kai, the country hopes to supply light in addition to the vaccine in Taiwan, but also actively planning to enter the international market, develop business opportunities, it actively works with the Dutch biotech Crucell Vaccines cooperation. In order to prepare the EU investigation EMA plant began in April last year, to start laying the groundwork for a positive, Crucell sent twice to view by checking, again in this year's vaccine plant in May to send independent investigators to Taiwan to simulate EU investigation works, confirm all manufacturing process, equipment and quality systems which adhere to requirements. But by the end of August this year, the EU EMA dispatch investigators to Taiwan to start a four-day investigation works, and agreed to. This will make the next Crucell Active in the European layout, this year held at two major medical centers in Switzerland more than 440 clinical trials, expected to get to Europe next year in the drug card.
   
   
4. flosz 24 september 2010 21:33

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   Vervolg.
   Seasonal influenza, avian flu intestinal virus vaccine research and development and global concern after another avian influenza, enterovirus vaccines, there has been a clear light the progress of the country. Avian flu because humans have no immunity, vaccine development is very important. State-ray will be the fourth quarter of this year, GMP plant inspections, and begin to implement toxicity, safety pharmacology, and reproductive toxicity testing, is expected to begin next year on July 1 human trials. The intestinal virus vaccine on, because there are several types of enterovirus, clinical symptoms are very diverse, the most to parents is to panic 71 Type of virus caused the brain stem spinal cord inflammation. Enterovirus is common in children under five years old on, he was three years of age in infants at high risk of severe, or if the brainstem spinal cord inflammation, infants and young children appeared myoclonic, persistent vomiting, limb weakness, shortness of breath, heartbeat acceleration, fever symptoms, for infants and young children caused by the threat to life. But for this type of intestinal virus protection, it seems to wash their hands, avoid contact to prevent infection, the only solution. Although domestic vaccine against enterovirus EV71 have been initial progress, but it is not clear whether the energy produced. Country and R & D Department, Optical Production Department deputy general manager Zhang Jin all that mass production of enterovirus vaccine to be produced as polio, rabies vaccine production, it is a through cell culture, rather than as the H1N1 vaccine is egg technology through the embryo. The ADImmune since 1999, that is, cell culture technology for the development of Japanese encephalitis and SARS-CoV vaccine poisoning death in order to establish the ability of process technology development. At present, has completed the establishment of cell culture process technology, enough to enter the amplification stage process to establish production EV71 Vaccine technology. Zhang stressed that all Vice President, National Optical quietly decade effort, has finally had a clear success, then look at when it can actually field. Guoguang biotechnology spokesman Gao Sheng Kai said China Light for influenza vaccine, enterovirus, and the bird flu vaccine program is conclusive, the gradual completion of animals, human clinical trials, helped people to Made in Taiwan vaccine confidence, as well as people's health protection worked hard to do.
   www.adimmune.com.tw/news.php?act=view...
   
   Leiden, The Netherlands, October 11, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced today that it has signed a non-exclusive PER.C6® commercial license agreement with the Taiwan-based vaccine company ADImmune Corporation.
   ADImmune intends to use the PER.C6® cell line technology to develop and commercialize a vaccine against Japanese encephalitis virus in Taiwan and China.
   
   Leiden, The Netherlands, March 22, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced it has completed an influenza alliance with Taiwanese-based ADImmune Corporation. Under the terms of the deal, ADImmune will use Crucell's virosome technology to produce a virosomal adjuvanted influenza vaccine for specified markets: Taiwan, Japan and Macau. Additionally, ADImmune will produce influenza antigen, which Crucell may purchase for the production of its vaccine product, Inflexal® V. Crucell will obtain a 20% equity stake in ADImmune. Financial details were not disclosed.
   
   SaPa juli: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."
   
5. [verwijderd] 24 september 2010 23:46

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   Helaas ......... Flosz....... de zo veelste indicatie dat ONS bedijf op zo VEEL takken van biotech al heel ver is .
   Uitgaande van de historie van de oprichters van het Crucell ligt er nog ontzettend veel op de plank aan ideeen.
   Is zo jammer dat wij als aandeelhouders WEL het risico hebben willen delen met Crucell , maar nu , in de fase dat Crucell sky high in biotech zich profileert , genoegen moeten nemen met een fooitje die ik mijn ochtendblad bezorger geef op nieuwjaarsdag.
   
   Ik wil jou bedanken voor jouw gigantisch inzet op dit forum om ons van relevante informatie te voorzien.
   Ik ben met jou bang dat dit forum eidig is , maar...... weet ook zeker dat het einde van wat dan ook het begin kan zijn van iets nog mooiers.
   TNXS Flosz..........
   
   Ian
6. [verwijderd] 25 september 2010 11:29

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   quote:

   bilbo3 schreef:

   ...
   Als ik het goed begrijp: volgend jaar flu-vaccin op basis van per.c6 in europa op de markt!!!
   
   Voor mij een (positieve) verrassing?
   
   Taipei, Sept. 20 (CNA) Taiwan's only human vaccine manufacturer said Monday its production facility has been certified by the European Medicines Agency (EMA), the European Union's pharmaceutical regulatory body.
   
   Adimmune Corp. spokeswoman Shen Ya-hui said the company received EMA certification of its production facility in August thanks to the assistance of its Dutch cooperation partner Crucell.
   
   The company is scheduled to launch clinical tests of its cell-culture-based influenza vaccine on 400-plus people in Switzerland late this year, Shen said.
   
   "We expect to obtain the EMA's pharmaceutical certification for our flu vaccine next year," she added.
   
   In the future, Shen said, the company also intends to apply for U.S. Food and Drug Administration certification for the vaccine.
   ...
   [/quote]
   [quote=gogogoo]
   By gogogoo.
   09/17/08 14:30
   
   Taiwan`s first vaccine production plant to be operational in 2009
   
   Taipe (ANTARA News/Asia Pulse) - The ADImmune Corporation (ADI) unveiled plans Tuesday to operate Asia's first vaccine production plant in line with European standards, with an aim to provide adequate supplies of influenza vaccines and to develop new vaccines.
   
   Under the NT$2.8-billion (US$87.28 million) project, the plant is expected to be completed next year and it will have the capacity to produce more than 30 million doses of egg-based influenza vaccines per year, according to ADI's chairman and CEO Chi Steve Chan.
   
   The vaccines target markets both at home and abroad through the network of the Dutch company Crucell, Chan said, adding that his company's products will be the first from Asia to be sold on the European market.
   
   Source:
   Business in Asia Today - Sept. 17, 2008
   published by Asia Pulse
   COPYRIGHT © 2008
   www.antara.co.id/en/arc/2008/9/17/tai...
   

   Destijds is expliciet aangegeven dat de nieuwe faciliteit EGG-BASED influenza antigens ging maken (zie pb hierboven via gogogoo). Het vernieuwende was/is dat deze flu antigens daarna in virosomes worden verpakt, om tot een Inflexal-type vaccin te komen. Echter, Per.C6 in verband met flu vaccin is NOOIT genoemd voor Adimmune.
   
   Destijds KON/MOCHT er geen influenza antigen met behulp van Per.c6 gemaakt worden, dat is immers Flucell en alleen Sanofi mocht dat. Pas sinds teruggave van deze Flucell-licentie op 8 juli 2010 mag Crucell (en wellicht dus ook Adimmune, als Crucell stiekem Adimmune een licentie heeft verstrekt) dit.
   
   En nu reeds zou de vooruitgang tussen 8 juli en 25 september zodanig zijn, dat de productiefaciliteit voor Per.C6 based antigen gereed is en certified?
   Ik heb zo m'n twijfels, en ga er vooralsnog van uit dat het PB onjuist is, en dat i.p.v. 'cell-based' bedoeld wordt 'virosome-based'.
   Het alternatief zou zijn dat in Taiwan, ergens in/bij de egg-based production plant, reeds ver voor 8 juli al begonnen is met installatie Per.C6-based flu antigen production plant, en dat Crucell ervoor kiest om EERST via Adimmune de nieuwe cell-based Inflexal te maken, VOOR dat het in het eigen Bern dat gaat doen. En ZONDER dat in een PB te melden.
   Lijkt me ongeloofwaardig.
   Een ander, nog veel onwaarschijnlijker alternatief is nog dat Adimmune al langer werkte aan cell-based, maar dan met CHO, omdat Per.c6 al aan Sanofi was vergeven.
   
   Kortom: ik denk dat dit pb niet klopt.
7. [verwijderd] 25 september 2010 11:44

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   quote:

   bilbo3 schreef:

   ...
   Adimmune Corp. spokeswoman Shen Ya-hui said the company received EMA certification of its production facility in August thanks to the assistance of its Dutch cooperation partner Crucell.
   
   The company is scheduled to launch clinical tests of its cell-culture-based influenza vaccine on 400-plus people in Switzerland late this year, Shen said.
   
   "We expect to obtain the EMA's pharmaceutical certification for our flu vaccine next year," she added.
   
   In the future, Shen said, the company also intends to apply for U.S. Food and Drug Administration certification for the vaccine.
   ...
   [/quote]
   Als je dit stukje heel erg goed bestudeert, staat er wel iets wat waar zou kunnen zijn, maar wat heel makkelijk verkeerd ge-interpreteerd kan worden:
   
   [quote=pb]
   Adimmune woordvoerster Shen zij dat Adimmune in Augustus EMA certificatie had gekregen voor zijn Taiwanese (egg-based) productie-faciliteit, dankzij de hulp van Crucell.
   
   Crucell (en dus NIET Adimmune) heeft gepland om later dit jaar in Zwitserland klinische test van Per.C6-based influenza vaccin (Inflexcell) te beginnen.
   
   “Wij, Adimmune (dus NIET Crucell) verwachten Europese EMA certificatie voor ONS vaccin (type egg-based inflexal) volgend jaar.
   
   In de toekomst verwacht Adimmune ook US certificatie aan te vragen voor het nieuwe egg-based inflexal vaccine.

   Als met "The company" Crucell wordt bedoeld dan klopt het pb dus wel, en staat er NIET dat er eind volgend jaar een Per.C6-based vaccine op de markt is. Zoals het er nu staat, wordt m.i. echter gesuggereerd dat "the company" Adimmune is, en dan klopt het pb denk ik niet (zie vorige post).
   
8. flosz 4 april 2012 10:10

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   ????Crucell????2-3?
   
   Adimmune: de Crucell bestellingen zullen stijgen met 2-3 keer
   
   Fabrikanten van vaccins Adimmune (4142) zal vermeld worden op 3 mei gehouden in Frankrijk, zei gisteren zei dat van de zesde 's werelds grootste fabrikant van influenza vaccin van Crucell orders dit jaar dan vorig jaar een veelvoud groei van vorige maand, heeft toegepast op het vasteland griep medicijn kaart, die naar verwachting aan het einde van dit jaar, begin volgend jaar te verwerven zijn, wordt de darm virus en dengue koorts vaccin naar verwachting na 2016 als opvolger van de drug kaart te verkrijgen, wereldwijde mogelijkheden voor toekomstige groei onbeperkt te grijpen.
   
   Adimmune werd opgericht in 1965, Adimmune is wereldwijd de achtste EU-GMP-certificering te verkrijgen griepvaccin productiebedrijf, wordt eerste vaccin Asia-fabriek worden verkocht in Europa.
   
   Adimmune voorzitter Zhanqi Xian, zei een vaccin fabriek in de bevestiging proces, de bouw van de validatie aan de drug kaart te verkrijgen, voor en na het duurt ongeveer consumeren een decennium, dit zijn de waarde van het vaccin plant, de internationale farmaceutische bedrijven op zoek naar partners is de sleutel tot .
   
   De Adimmune bedrijf vice-president, High St Kay wees erop dat, na de voltooiing van de nieuwe fabriek van het bedrijf met een jaarlijkse capaciteit zal 25 miljoen doses te bereiken, waarvan 20 miljoen, voornamelijk zal Crucell 'te leveren. Crucell vorig jaar door de grote internationale bedrijven, J & J (Johnson & Johnson) fusie, de toekomstige verkoop van vaccins markt zal naar verwachting uit te breiden door de Europese Unie en de Verenigde Staten, de Adimmune vorig jaar overgedragen aan order van de klant van ongeveer 2 miljoen, voornamelijk voor de menselijke klinische proeven drug-kaart zal naar verwachting in juni van dit jaar, verkocht in Europa vanaf juli dit jaar zal bestellingen groeien 2,3 maal ten opzichte van vorig jaar. Crucell vaccin dope vraag zal geleidelijk worden overgedragen aan vol de Adimmune de meest specifieke bron van inkomsten de groei worden in drie jaar.
   
   Bedrijven naar schatting de toekomst van de Adimmune van Crucell's bestellingen per jaar, stabiele 740 miljoen yuan van inkomsten grootste injecteren voor single-seizoen ommekeer in de tweede helft van dit jaar, wordt volgend jaar zal naar verwachting stabiel winst.
   
   news.chinatimes.com/tech/171701/11201...
   
9. flosz 4 april 2012 18:50

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   Vaccine developer to list on TWSE May 3
   2012/04/04 18:04:40
   Taipei, April 4 (CNA) Adimmune Corp., a Taiwan-based vaccine developer, said Tuesday that it is scheduled to list on the Taiwan Stock Exchange (TWSE) May 3.
   
   According to a prospectus posted on the exchange's website, the company, which was established in 1965 and is capitalized at NT$1.64 billion (US$55.59 million), is planning to issue 19.53 million shares to raise about NT$976.50 million as working capital.
   
   While Adimmune has set a tentative issue price of NT$50 for the shares, market analysts said the actual price is expected to range between NT$40 and NT$43.
   
   Adimmune, which is the only vaccine manufacturer in Asia to have obtained GMP (Good Manufacturing Practice) certification from the European Union, specializes in the development of influenza vaccine, Japanese encephalitis virus vaccine and tetanus vaccine.
   
   Adimmune has teamed up with Dutch-based biotech company Crucell, which ranks as the world's sixth-largest flu vaccine manufacturer, fortechnological cooperation, while it has also partnered with Japan's largest flu vaccine developer, the Kitasato Institute.
   
   Currently, Crucell holds an 11.39 percent stake in Adimmune to serveas one of the local company's majority shareholders, according to the prospectus.
   
   Adimmune Chairman Steve Chan told investors that his company completed animal testing for an H5N1 avian flu vaccine at the end of last year and is expected to begin human testing this year.
   
   In addition, Chan said, its enterovirus 71 vaccine, which is undergoing clinical trials, is scheduled to hit the market in 2017, while a dengue fever vaccine is expected to be launched in 2019.
   
   Last year, the company sold about 1.5 million flu vaccine doses in Taiwan, taking a 55 percent share of the domestic flu vaccine market. The company expects its market share to fall to about 50 percent in 2012.
   
   In addition, it has anticipated it will be granted permits to sell flu vaccine in China at the end of this year at theearliest.
   
   Adimmune posted NT$290 million in sales for 2011, while incurring NT$2.87 in net loss per share due to an unsatisfactory capacity utilization rate.
   
   However, on the back of rising production, its capacity utilization rate is expected to range between 70 percent and 80 percent in the second half of this year and is likely to exceed 90
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