Crucell Terug naar discussie overzicht

Rabies...fase 2

1. [verwijderd] 1 oktober 2008 21:34

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Crucell N.V. (NL) - Crucell Announces Positive Results of Phase II Clinical Study ...‏
   Van: Crucell Press Release (ir@crucell.com)
   Verzonden: woensdag 1 oktober 2008 19:32:11
   Beantwoorden aan: ir@crucell.com
   Aan: Crucell E-mail list (ir@crucell.com)
   
   Published: 21:30 01.10.2008 GMT+2 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
   
   Crucell Announces Positive Results of Phase II Clinical Study Rabies Monoclonal Antibody Combination in US
   
   Additional Milestone Achieved in Collaboration Agreement with sanofi pasteur
   
   Leiden, The Netherlands, 1 October 2008 - Dutch biopharma company Crucell N.V. today announced the preliminary results of the first phase II clinical study of its investigational rabies monoclonal antibody combination, which started on 31 March 2008 in the US.
   
   Crucell has a collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies to be used in combination with rabies vaccine for post-exposure prophylaxis against this fatal disease.
   
   The preliminary results of the US study were presented today by Dr. Christophe Python, at the XIX Rabies in the Americas RITA conference in Atlanta, U.S.
   
   This phase II trial was set up as a randomized, single-blind, controlled study in 140 healthy volunteers and tested the antibody product in association with sanofi pasteur human diploid cell rabies vaccine. The study compared the rabies monoclonal antibody combination to a currently marketed human rabies immune globulin or placebo, in association with the rabies vaccine in a simulated rabies post-exposure setting.
   
   A total of 140 subjects were randomized into the study, 80 in the CL184 monoclonal antibody combination treatment group, 40 in the human rabies immune globulin group and 20 in the placebo group. All subjects completed the study. There was no serious adverse event reported. Most adverse events were mild or moderate in severity. Overall, the systemic safety was comparable in the placebo, the HRIG and the monoclonal antibody combination groups. Injection site reactions to the monoclonal antibody combination, the human rabies immune globulin or placebo were reported by 12.5%, 65 % and 30% of the subjects, respectively.
   
   The neutralizing activity against the rabies virus (a surrogate marker for protection) provided by the monoclonal antibody combination was comparable to that provided by the comparator. By day 14, all subjects administered the monoclonal antibodies combination together with the rabies vaccine reached the level of 0.5 IU/ml, a neutralizing activity levels thought to provide protection. Of note, the development of the immune response to the rabies vaccine was comparable in the monoclonal antibody combination and the human rabies immune globulin groups. These encouraging preliminary results are paving the way for the further development of this potentially life-saving medicine.
   
   On February 12th, 2008 Crucell announced that its rabies monoclonal antibody combination was granted Fast Track status by the US Food and Drug Administration (FDA). A second phase II clinical study started on May 13, 2008, in the Philippines, and is expected to be completed before year-end 2008. The trial, which is being carried out in 48 healthy adolescents and children, aims to generate safety data in these populations.
   
   "We are very pleased with our continued and rapid progress with this next generation rabies treatment," said Ronald Brus, Crucell's Chief Executive Officer. "These results and the milestone achieved put us another step closer to our ambition of reducing the global burden of this fatal disease."
   
   About rabies
   Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure. There is no proven treatment for rabies once symptoms of this fatal disease have appeared. Rabies is prevented by post-exposure prophylaxis (PEP) with the combined administration of a rabies vaccine and rabies immunoglobulin (RIG). Rabies is prevalent in Europe, Asia, Africa, North America and South America. Every year approximately 10 million people are vaccinated against the disease worldwide. An estimated 40,000 to 70,000 people die from rabies each year, mainly in Asia.
   
   About Crucell's rabies monoclonal antibody program
   Crucell's rabies monoclonal antibody product is a combination of two human monoclonal antibodies, generated using Crucell's MAbstract® technology and produced using Crucell's PER.C6® technology. Crucell's rabies monoclonal antibody combination offers the potential to replace the traditional serum-derived products that are currently used for rabies post-exposure prophylaxis. Phase I clinical trials data conducted in the United States and India supported further clinical development. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. The Fast Track program facilitates the development and expedites the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.
   
   In December 2007, Crucell and sanofi pasteur signed an exclusive collaboration and commercialization agreement for Crucell's rabies monoclonal antibodies, next-generation rabies biologicals, to be used with rabies vaccine for post-exposure prophylaxis against this fatal disease. Under the terms of the agreement, Crucell will continue to perform the development activities. Crucell will be responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF. Crucell received an initial payment of €10 million following the execution of the agreement and will be eligible for milestone payments of up to €66.5 million.
   
   Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
   
   About PER.C6® technology
   Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. The strengths of the PER.C6® technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
   
   About MAbstract® technology
   Crucell's proprietary MAbstract® technology can be used to discover drug targets, such as cancer markers or proteins from infectious agents including bacteria and viruses, and identify human antibodies against those drug targets.
   
   About Crucell
   Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biotechnology company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat primarily infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera
2. [verwijderd] 1 oktober 2008 21:35

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Aanbevolen dus.
3. gogogoo 1 oktober 2008 21:38

   auteur info

   • gogogoo

     Lid sinds: 28 feb 2006

     Laatste bezoek: 10 aug 2023

   • Aanbevelingen

     Ontvangen: 1600

     Gegeven: 808

   •    Aantal posts: 6.042

   Daar werd vanaf 16:00 uur alvast een voorschot op genomen.
4. [verwijderd] 1 oktober 2008 21:38

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Ah, je ws me net voor Henk.
   
   Dirk
5. [verwijderd] 1 oktober 2008 21:38

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
   
   valt mij zwaar tegen
6. [verwijderd] 1 oktober 2008 21:39

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   heb de indruk dat er weer met voorkennis ingestapt is...hoge omzetten van tijdje terug...sterk blijven liggen afgelopen tijd(in beursmalaise) en ah slot vandaag up...
   
   Gedurende het trajekt worden resultaten bekend en gaat er wat tijd overheen eer er resultaten gepubliceerd worden.
   
   Voorkennis kan vanuit vele hoeken komen, van betrokken mederwerkers en wetenschappers tot management...maar iig iemand die contact heeft met grotere jongens.
   
   Alles samengenomen wel weer mooie opsteker voor CRXL!
   
   ivet
7. Sir Piet 1 oktober 2008 21:39

   auteur info

   • Sir Piet

     Lid sinds: 20 sep 2004

     Laatste bezoek: 18 apr 2024

   • Aanbevelingen

     Ontvangen: 933

     Gegeven: 2457

   •    Aantal posts: 3.590

   Mark clark neem je dit ook even mee. Voorkennis daar ben ik het niet mee eens. Wij hier op dit forum weten als geen ander dat dit er allemaal zit aan te komen ( bahalve mark natuurlijk). Vroeg of laat komt er ook star nieuws (en dat weten we ook allemaal). Er zit gewoon zoveel in het vat dat er van nu af veel meer "verrassingen " gaan komen. Voor ons een weet voor anderen een vraag.
8. [verwijderd] 1 oktober 2008 21:41

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   quote:

   willemn schreef:

   Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
   
   valt mij zwaar tegen
   

   toch is dat al tijden terug gecommuniceerd(dus hoe dat NU kan tegenvallen snap ik niet)...maar als men morgen het aandeel ff aan wil stampen op deze 'enorme tegenvaller'...GRAAG!
   
   Verzoekje: naar de 7-8euro is voldoende hoor!
   
   bvd ivet
9. [verwijderd] 1 oktober 2008 21:41

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Henk
   Bedankt voor je snelle actie,ik lees net de headlines op Binck.
   Wim
10. ved 1 oktober 2008 21:45

    auteur info

    • ved

      Lid sinds: 08 aug 2001

      Laatste bezoek: 19 apr 2024

    • Aanbevelingen

      Ontvangen: 518

      Gegeven: 4934

    •    Aantal posts: 3.041

    biertje erbij?: www.cafepress.com/rabies.231045702

    Bijlage:
11. Sir Piet 1 oktober 2008 21:48

    auteur info

    • Sir Piet

      Lid sinds: 20 sep 2004

      Laatste bezoek: 18 apr 2024

    • Aanbevelingen

      Ontvangen: 933

      Gegeven: 2457

    •    Aantal posts: 3.590

    quote:

    invoorentegenspoed schreef:

    [quote=willemn]
    Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
    
    valt mij zwaar tegen
    [/quote]
    
    toch is dat al tijden terug gecommuniceerd(dus hoe dat NU kan tegenvallen snap ik niet)...maar als men morgen het aandeel ff aan wil stampen op deze 'enorme tegenvaller'...GRAAG!
    
    Verzoekje: naar de 7-8euro is voldoende hoor!
    
    bvd ivet
    

    Willemn zit short, dus dit bericht valt even tegen. Hij denkt dat dit Fortis is. (beerput)
12. [verwijderd] 1 oktober 2008 21:51

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Was het maar alvast 3 november,ben heel benieuwd hoe ze er nu voorstaan,zeker met de dollar nu. Denk dat ik beursjaar met winst afsluit. Thanks Crucell.
13. [verwijderd] 1 oktober 2008 21:52

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    U$ reageert hier totaal niet op.
    
    Dirk
14. [verwijderd] 1 oktober 2008 21:57

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    quote:

    Dirk R. Wijnen schreef:

    U$ reageert hier totaal niet op.
    
    Dirk
    

    nee natuurlijk niet
    zeg ik toch
    valt zwaar tegen
    trouwens,valt er weleens iets mee bij Cru?
15. [verwijderd] 1 oktober 2008 22:04

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    De goednieuws show die Crucell heet.
    40 euro. Echt wel.!!
16. aossa 1 oktober 2008 22:05

    auteur info

    • aossa

      Lid sinds: 23 mei 2003

      Laatste bezoek: 18 apr 2024

    • Aanbevelingen

      Ontvangen: 4028

      Gegeven: 3336

    •    Aantal posts: 17.585

    quote:

    willemn schreef:

    Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
    
    valt mij zwaar tegen
    

    De zeven_mijls_laarzen weer aangetrokken ?
    
    Zowel CRXL als SNY gaan zowat 2,5% omhoog.
17. Dr. acula 1 oktober 2008 22:08

    auteur info

    • Dr. acula

      Lid sinds: 28 sep 2004

      Laatste bezoek: 26 jul 2022

    • Aanbevelingen

      Ontvangen: 189

      Gegeven: 64

    •    Aantal posts: 930

    quote:

    Sir Piet schreef:

    [quote=invoorentegenspoed]
    [quote=willemn]
    Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
    
    valt mij zwaar tegen
    [/quote]
    
    toch is dat al tijden terug gecommuniceerd(dus hoe dat NU kan tegenvallen snap ik niet)...maar als men morgen het aandeel ff aan wil stampen op deze 'enorme tegenvaller'...GRAAG!
    
    Verzoekje: naar de 7-8euro is voldoende hoor!
    
    bvd ivet
    [/quote]
    Willemn zit short, dus dit bericht valt even tegen. Hij denkt dat dit Fortis is. (beerput)
    

    300 miljoen dollar per jaar aan extra omzet is mooi
    vind ik. En niemand kan in de toekomst kijken.
    Misschien is het meer en misschien komt er wel een concurrent.
    Het is in ieder geval fijn dat ze weer een stap verder zijn. Zeker voor al die mensenlevens die in de toekomst gered kunnen worden.
    
    Grootoorvleermuis
    
18. [verwijderd] 1 oktober 2008 22:12

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Human rabies vaccine shortage means protecting pets is vital
    
    By James Beaty
    Senior Editor
    
    The Centers for Disease Control and two other federal agencies have issued an alert because of a shortage of rabies vaccine — not for animals, but for people.
    
    Joining the CDC in issuing the alert were the U.S. Department of Health and Human Services and the Food and Drug Administration.
    
    The pinch has already been felt at the McAlester Regional Health Center and across Oklahoma, as well as the rest of the nation.
    
    MRHC Emergency Room Nurse Manager Les Williams said the hospital no longer has a supply of the rabies vaccine on hand. Williams used the term vaccine to refer not only to preventative inoculations given prior to exposure, but to also shots given to individuals after they have been exposed to rabies.
    
    Because of the shortage, being bitten by a strange dog or cat may not be enough to get treatment through rabies shots. Who gets it must now be decided on a case-by-case basis.
    
    The process now in place requires a certification of need from a state rabies health official. In Oklahoma, that’s Dr. Kristy Bradley at the Oklahoma State Department of Health.
    
    Even after a need is certified, a health service provider must be given a password so that the post-exposure rabies serum can be ordered.
    
    “The rabies vaccine is administered two different ways,” Williams said.
    
    “It’s not uncommon for people who work for veterinarian services to get a preventative vaccine.”
    
    The most common way that people who don’t work in the health care industry have a need for vaccinations is after being bitten by a dog or a cat, Williams noted.
    
    However, “The two animals that put humans at the highest risk are skunks and raccoons,” Williams said.
    
    As a result of the shortage, the CDC is emphasizing that people should avoid exposure through wildlife contact. The CDC is also stressing that pets and livestock should be vaccinated.
    
    The shortage is being felt not only across the U.S., but worldwide.
    
    “There are two major companies that make vaccines for humans, Williams said. “One is a French company and one is an American company.”
    
    MRHC gets its supplies for rabies vaccine through IMOVAX, which is the French company.
    
    The CDC’s Web site says the interruption in supply occurred after Sanofi Pasteur began renovating its IMOVAX rabies vaccine production facility in France to stay in compliance with current requirements of the FDA and the French regulatory body.
    
    “Prior to these renovations, Sanofi Pasteur established an inventory based on historical levels of sales and projected market demand,” the CDC said.
    
    “After the renovations began, Novartis, the other supplier of rabies vaccine for the United States, was unable to meet the projected rabies vaccine supplies.”
    
    Novartis has been supplying its vaccine for post-exposure use only, and the increase in demand for IMOVAX is outpacing the company’s historical level of supply, according to the CDC.
    
    Based on historical trends at the McAlester hospital, Williams doesn’t think the shortage will substantially affect the ability of people who need the post exposure rabies treatment to get it.
    
    “Normally, if you were exposed or bitten today, you don’t have to start the vaccine for 72 hours,” he said, which should be time enough to complete the newly-required process.
    
    Also, a rabies immune globulin is available which can provide temporary protection until the vaccination is received, he said.
    
    “The people who will be affected most are the people who would use this as a preventative vaccination,” Williams said.
    
    “Those people aren’t going to be able to do that now
    
19. aossa 1 oktober 2008 22:12

    auteur info

    • aossa

      Lid sinds: 23 mei 2003

      Laatste bezoek: 18 apr 2024

    • Aanbevelingen

      Ontvangen: 4028

      Gegeven: 3336

    •    Aantal posts: 17.585

    Nog belangrijker dat Rabies antibody het eerste PER.C6 inside product op de markt kan worden voor gebruik in mensen, gemaakt door DSM in opdracht van Crucell.
20. [verwijderd] 1 oktober 2008 22:12

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Vleermuis. We doen het natuurlijk voor al die
    mensen. Al die vreselijke ziektes. En. Een beetje voor mijn portemonnee.