Crucell Terug naar discussie overzicht

Draadje OT, bijzaken & geleuter in de marge! - Deel 2

1. [verwijderd] 6 november 2006 09:59

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   Crucell werkt samen met SingVax en......SingVax met Octoplus...EN....Octoplus heeft de belangstelling van....
   
   ---------------
   GlaxoSmithKline meldt belang 12,3% in OctoPlus
   06-11-2006 08:56:25
   
   Amsterdam (..NEWS) - GlaxoSmithKline heeft een belang van 12,3% in OctoPlus. Dit blijkt uit een initiele melding het kader van de Wet Melding Zeggenschap in ter beurze genoteerde vennootschappen (WMZ). Het belang wordt middellijk reeel gehouden. Op 4 oktober 2006 is de meldingsplicht ontstaan.
   
   ------------------------------------------
   
   November 6, 2006Home > ProductsJAPANESE ENCEPHALITIS VACCINE
   OctoPlus works together with SingVax , a Singapore-based vaccine development company, to co-develop a single-shot Japanese encephalitis (JE) vaccine.
   
   Single-shot vaccine innovation
   Existing JE vaccines typically require two or three doses. By creating a single-shot JE vaccine we aim to achieve increased patient compliance and greater efficacy of the vaccine. As such, it will help protect more people from this life threatening disease.
   
   Significant market potential
   We target a significant proportion of the estimated US$400 million global market for JE vaccines. To date, no single-shot JE vaccine exists that is available on an international scale.
   
   www.octoplus.nl/default.asp?id=00103
   -----------------------
   
2. [verwijderd] 6 november 2006 10:56

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   Product Development - Japanese Encephalitis (JE)
   SingVax is developing an improved JE vaccine, which will have significant advantages over existing products. SingVax aims to meet the demand in both the endemic and travel markets, for a JE vaccine with improved safety and increased compliance.
   
   SingVax's JE vaccine is based on the inactivated whole JE virus particles. In order to generate the JE viral particles, SingVax leverages upon the PER.C6 ® technology, licensed from Crucell N.V. , a European biotech company. SingVax has also partnered with OctoPlus to co-develop a single-shot JE vaccine.
   Due to limitations of the existing vaccine, there is a significant market potential for a JE vaccine, estimated at US$250 million.
   www.singvax.com
   ********************************
   
   Crucell Signs Commercial PER.C6® License Agreement with SingVax for Vaccines against Japanese Encephalitis
   Leiden, The Netherlands - March 22, 2005 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL) today announced the signing of a commercial PER.C6® license agreement with Singapore-based company SingVax Pte Ltd for the development and commercialisation of new vaccines against Japanese encephalitis.
   Under the agreement, SingVax will focus on the development and commercialisation of a Japanese encephalitis vaccine for the endemic population as well as for travellers to the Asia Pacific region.
   Crucell will receive upfront, annual and milestone payments under the agreement, as well as royalties on product sales. In addition, Crucell will have a preferred position to negotiate marketing rights outside the Asia Pacific Region with respect to a traveller's vaccine that may be developed under the agreement in case SingVax make such a product available for licensing. Further details of the agreement were not disclosed.
   Zie ook:
   www.iex.nl/forum/topic.asp?forum=228&...
   ****************************************
   .......Malaria Vaccines......
   TI Pharma
   Infectious Diseases
   
   Design of Predictive Models, Drug Delivery, and Live-virus Malaria Vaccines for the Developing World
   UMCN, UU, Crucell, OctoPlus
   
   www.iex.nl/forum/topic.asp?forum=228&...
   
3. [verwijderd] 6 november 2006 12:53

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   Nog even en Nicox is CRXL voorbij. Een spurt van 8 naar 15,25 in 2,5 maand. En daar was geen TA op te trekken volgens mij.
   
   Biopharm blijft onvoorspelbaar.
4. [verwijderd] 6 november 2006 14:41

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   quote:

   Nx4nX schreef:

   Nog even en Nicox is CRXL voorbij. Een spurt van 8 naar 15,25 in 2,5 maand. En daar was geen TA op te trekken volgens mij.
   
   Biopharm blijft onvoorspelbaar.
   

   En net een freeze op 15,87
5. [verwijderd] 6 november 2006 15:14

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   RTRS-CORRECTIE Abbott neemt cholesterol-specialist over
   V e r b e t e r d e herhaling, Nederlandse schrijfwijze
   cholesterol in kop en door hele bericht
   
   CHICAGO (ANP) - Het Amerikaanse farmacieconcern Abbott neemt
   voor 3,7 miljard dollar (2,9 miljard euro) een Amerikaanse
   farmaceut over. Kos Pharmaceuticals is specialist in het maken
   van voedingsmiddelen die het goede cholesterol in de mens
   versterken. De overname werd maandag door beide bedrijven
   bevestigd.
   
   Met de overname wil Abbott zijn aanwezigheid in de
   lucratieve markt voor cholesterolverlagende middelen vergroten.
   De aankoop leidt bij Abbott tot niet nader vrijgeven eenmalige
   lasten om Kos succesvol te laten integreren binnen het bedrijf.
   
   De prijs die Abbott per aandeel Kos in cash betaalt, is
   omgerekend 78 dollar. Het aandeel Kos sloot vrijdag op 50,09
   dollar. Het bod van Abbott ligt daarmee 56 procent boven de
   huidige marktwaarde.
   
   ((ANP Redactie Economie, email economie(at)anp.nl, +31 20
   504 5999))
6. Palmerston 6 november 2006 18:22

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   Ik ben benieuwd wat de kenners hebben te zeggen m.b.t. deze link. Kreeg ik van een vriend doorgemaild. Lijk t me allemaal sterk overtrokken. Misschien kunnne de kenners dat bevestigen?
   
   www.eqgen.nl/html/vaccins.html
   
   Groeten,
   
   Martin
7. [verwijderd] 6 november 2006 19:13

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   Martin, m.b.t. thimerosal zie ook:
   
   iex.nl/forum/topic.asp?forum=228&topi...
   
   PER.C6 vaccins zijn vrij van thimerosal, Vivotif(Berna) ook.
   
   gr. (Alive & Kicking... met dank aan (o.a.)al die geweldige vaccinaties).
8. voda 6 november 2006 20:08

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   quote:

   h.vdbilt schreef:

   RTRS-CORRECTIE Abbott neemt cholesterol-specialist over
   V e r b e t e r d e herhaling, Nederlandse schrijfwijze
   cholesterol in kop en door hele bericht
   
   CHICAGO (ANP) - Het Amerikaanse farmacieconcern Abbott neemt
   voor 3,7 miljard dollar (2,9 miljard euro) een Amerikaanse
   farmaceut over. Kos Pharmaceuticals is specialist in het maken
   van voedingsmiddelen die het goede cholesterol in de mens
   versterken. De overname werd maandag door beide bedrijven
   bevestigd.
   
   Met de overname wil Abbott zijn aanwezigheid in de
   lucratieve markt voor cholesterolverlagende middelen vergroten.
   De aankoop leidt bij Abbott tot niet nader vrijgeven eenmalige
   lasten om Kos succesvol te laten integreren binnen het bedrijf.
   
   De prijs die Abbott per aandeel Kos in cash betaalt, is
   omgerekend 78 dollar. Het aandeel Kos sloot vrijdag op 50,09
   dollar. Het bod van Abbott ligt daarmee 56 procent boven de
   huidige marktwaarde.
   
   ((ANP Redactie Economie, email economie(at)anp.nl, +31 20
   504 5999))
   

   Farmabedrijf Kos was maandag een grote blikvanger. Het
   aandeel ging 27 procent omhoog na een overnamebod van 3,7
   miljard dollar door de branchegenoot Abbott. Omgerekend is dat
   56 procent meer dan de slotkoers van Kos op vrijdag. Verder
   waren er biedingen voor Swift Transportation en OSI Restaurant
   Partners.
   
   PS:
   Met een premie van 56% lever ik mijn aandelen Crucell gaarne in:-)
   
9. [verwijderd] 6 november 2006 20:37

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   Dat is heel leuk voor die aandeelhouders,een flinke premie!!
   
   Maar Crucell,wordt niet overgenomen,als je de directeur mag geloven,weet je,al die speculaties,van wat het bedrijf wel niet gaat doen,of wat er wel niet aan staat te komen,....bullshit,Crucell staat aan de vooravond om zwarte cijfers neer te zetten,moeilijke is,even deze periode,ik denk het niet,dus,hup totaal aan de zijlijn,mijn gok,eenmaal stabiel,dus dat kan ook zomaar pas januari 2007 zijn,er weer volop in,ieder zijn timing,kop of munt,up or down,ha succes allen!!!
   
   RB
10. [verwijderd] 6 november 2006 21:10

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    Voda, waarvoor zit je hier nu????
    
    Ik heb de laatste tijd van je begrepen, dat je helemaal omgeturnd bent naar houden op lange termijn.
    
    Ik vraag me dan af, waarom je dan nu genoegen moet nemen met 56%.
    
    Ik heb ook wel eens gehoord, dat de aankoopprijs, die bij mij inderdaad laag ligt en bij jou wat te hoog, een verschil zou maken in de beoordeling van een aandeel.
    Lijkt mij een totaal foutief uitgangspunt.
    Als jij het met me eens bent, dat wij over een jaar of vier á vijf een koers van 80 á 100 halen, dan blijven wij toch allebei vrolijk fluitend zitten?? Je hebt dat vertrouwen, of je hebt dat niet!!!
    
    Tja, en zo denkt Snor ook, maar hij zit aan de zijlijn om te trachten, een koersdaling van slechts enkele euros te ontlopen. En als die daling niet komt, kan je zo maar enkele euros meer moeten betalen. Mij niet gezien!! En ik zeg nogmaals. Mijn uitgangspositie is gunstig, maar dat mag geen maatstaf zijn in de beoordeling van de huidige koers.
12. voda 6 november 2006 21:52

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    @oudje:
    ik schreef:
    PS:
    Met een premie van 56% lever ik mijn aandelen Crucell gaarne in:-)
    
    Zie je die smiley? Dat zegt al genoeg!
13. Palmerston 6 november 2006 22:23

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    Ok FLosz, bedankt maar weer.
    En ook ik leef nog steeds na vele vaccinaties.
    
    

    quote:

    flosz schreef:

    Martin, m.b.t. thimerosal zie ook:
    
    iex.nl/forum/topic.asp?forum=228&topi...
    
    PER.C6 vaccins zijn vrij van thimerosal, Vivotif(Berna) ook.
    
    gr. (Alive & Kicking... met dank aan (o.a.)al die geweldige vaccinaties).
    

14. [verwijderd] 6 november 2006 23:41

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    New Insight into How Blood Clots
    By Corey Binns
    Special to LiveScience
    posted: 06 November 2006
    09:08 am ET
    When you slice your finger while chopping celery, it requires more than 80 different chemical reactions to clot blood and stop the bleeding. But one false reaction, and the clot could form in the wrong spot and be deadly.
    Clots sometimes form even when there's no wound to plug, and for years, scientists didn't understand the process or know how to tell when it might happen. Now researchers at the University of Chicago have developed a simple technique to predict the timing and location of blood clots.
    "The really cool part was that our observations were actually predicted by an artificial model of clotting that represented the 80 reactions of clotting in just three simple chemical reactions," said Christian Kastrup, a University of Chicago chemistry graduate student and study coauthor.
    The technique was detailed in the Oct. 16 online issue of the Proceedings of the National Academy of Sciences.
    Elements in our blood—round platelets, which are produced in bone marrow—are constantly flowing through the blood stream on the lookout for leaks in blood vessels to plug. When they find a tear in need of repair, they become "sticky," and clump together.
    Simultaneously, the thrombin system in the blood sets off a series of reactions that produces long, stretchy proteins. Individually, the fibrous proteins are the most flexible fibers in nature and can stretch up to three times their length, according to a recent study by scientists at Wake Forest University.
    The proteins, called clotting factors, form a flexible net that catches the platelets and holds them in place to stop blood flow. As a whole net, they lose some of their flex, but not all.
    This net of protein and platelets is the scab you see on your skinned knee.
    In the new study, Kastrup and his colleagues discovered that the placement of one of the clotting factors in the net, called tissue factor, plays a large role in determining whether platelets will clot.
    "When we exposed blood to tissue factor that was localized to large patches on surfaces, clotting initiated," Kastrup told LiveScience. "In contrast, when blood was exposed to tissue factor that was spread out within the sample, clotting did not occur."
    Because tissue factor clots blood only when there's a lot of it crowded around tissue patches of a certain size, scientists might be able to better predict clotting by monitoring a patient's tissue factor concentration. The method may someday be used as a diagnostic tool to prevent unwanted clotting.
    When the platelets, clotting factors, and other chemicals don't work as a team, they can cause excessive bleeding or, conversely, block blood flow by clotting unnecessarily. Each year, 600,000 Americans die from abnormal blood clots, according to the National Hemophilia Foundation.
    "Blood clotting is useful for stopping bleeding and tissue regeneration, but it is also related to a lot of diseases, like stroke and hemorrhage," said coauthor Feng Shen. "The inappropriate formation of blood clots around the heart or brain could be fatal. Predicting where and when a blood clot will occur could prevent patients from getting coagulation disease."
    www.livescience.com/humanbiology/0611...
    
    www-news.uchicago.edu/releases/06/061...

    Bijlage:
15. [verwijderd] 7 november 2006 08:22

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    WHO Executive Board shortlists candidates for Director-General
    6 NOVEMBER 2006 | GENEVA -- The Executive Board of the World Health Organization, meeting in Geneva, today agreed on a shortlist of five candidates for the post of Director-General.
    
    
    The short list of five candidates reads as follows (in alphabetical order):
    Dr Kazem Behbehani
    Dr Margaret Chan
    Dr Julio Frenk
    Dr Shigeru Omi
    Ms Elena Salgado Méndez
    On Tuesday, the Board will interview the five candidates, and on Wednesday it will nominate one of them for the post of Director-General of the Organization. This nomination will be submitted to the World Health Assembly, which will meet for a one-day special session on Thursday to appoint the next Director-General.
    The current election follows the sudden death of Dr LEE Jong-wook, WHO Director-General, on 22 May 2006. At its meeting on 23 May, the WHO Executive Board agreed on an "accelerated process" for electing a Director-General, which will culminate on 9 November with the appointment of the next Director-General.
    www.who.int/mediacentre/news/releases...
    
    Director-General election (2006)
    
    
    Date: 6-9 November 2006
    Location: Geneva, Switzerland
    The process to elect the next Director-General of the World Health Organization takes place in Geneva from 6-9 November 2006. First, the Executive Board will meet from 6-8 November to nominate a candidate. The World Health Assembly will then meet on 9 November for a special session to consider the executive board's nomination, and appoint a Director-General.
    www.who.int/mediacentre/events/2006/d...
16. [verwijderd] 7 november 2006 08:39

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    51E Heerlen (NL) / Evry (FR), 7 November 2006
    
    DSM invests in personalized healthcare company IntegraGen SA
    
    DSM Venturing, the corporate venturing unit of Royal DSM N.V., today announced that it has invested EUR 2 mln in IntegraGen, a French biotechnology company specialized in the development and delivery of genetic tests for rapid diagnosis and better (personalized) treatment of complex diseases.
    
    IntegraGen’s proprietary GenomeHIP™ technology platform identifies disease genes by allowing the rapid comparison of genomes of family members affected with the same disease. Using this platform IntegraGen has established a pipeline of tests in the areas of Metabolic Syndrome (e.g. MODY (Maturity Onset Diabetes of the Young); Type 2 Diabetes; Obesity) and Neuropsychiatric disorders (e.g. Autism; Bi-Polar Disorder).
    
    IntegraGen focuses on the medical/pharma side of personalized healthcare but recognizes the potential of its know how in personalized nutrition, one of the emerging business areas DSM focuses on to realize its longer-term innovation ambitions as formulated in the corporate strategy program Vision 2010 – Building on Strengths.
    This joint interest has led to a collaboration program in the area of weight management, which is one of the important focus areas within the field of Personalized Nutrition.
    
    Following DSM’s acquisition of Lipid Technologies Provider and the investment in Sciona, this investment is a next stepping stone in weight management and Personalized Nutrition, which moves DSM into an excellent position for future developments in these fields.
    
    DSM Venturing
    DSM Venturing is an active investor in start-up companies and Venture Capital Funds in DSM’s strategic growth fields Nutrition, Pharma and Performance Materials. DSM Venturing's mission is to explore emerging markets and technologies in these strategic growth fields in order to enhance DSM's product portfolio and create value. DSM Venturing also plays an active role in the development of several new DSM business opportunities in the so-called emerging business areas Biomedical Materials, Industrial (White) Biotechnology, Specialty Packaging and Personalized Nutrition. For more information about DSM Venturing see www.dsm venturing.com.
    
    IntegraGen
    IntegraGen is a pioneer in the field of personalized healthcare. The company is dedicated to discovering genes associated with complex diseases and commercializing molecular diagnostic tests to enable individualized diagnosis, prevention and treatment. IntegraGen’s proprietary gene mapping technology GenomeHIP™ provides fast, reliable, and cost-effective discovery of genetic loci. Paired with strong biostatistics, bioinformatics and fine mapping genotyping capabilities, IntegraGen has successfully identified and patented genes associated with early and late onset diseases. Founded in 2000, IntegraGen has 34 employees. IntegraGen is headquartered in Evry, near Paris. More information can be found at www.integragen.com.
    
    About DSM
    DSM is active worldwide in nutritional and pharma ingredients, performance materials and industrial chemicals. The company creates innovative products and services that help improve the quality of life. DSM’s products are used in a wide range of end markets and applications such as human and animal nutrition and health, cosmetics, pharmaceuticals, automotive and transport, coatings, housing and electrics & electronics (E&E). DSM’s strategy, named Vision 2010 – Building on Strengths, focuses on accelerating profitable and innovative growth of the company’s specialties portfolio. Market-driven growth, innovation and increased presence in emerging economies are key drivers of this strategy. The group has annual sales of over
    EUR 8 billion and employs some 22,000 people worldwide. DSM ranks among the global leaders in many of its fields. The company is headquartered in the Netherlands, with locations in Europe, Asia, Africa and the Americas. More information about DSM can be found at www.dsm.com.
    
    For more information:
    DSM Corporate CommunicationsNelleke Barningtel. +31 (0) 45 5782017 fax +31 (0) 45 5740680 e-mail media.relations@dsm.com DSM Investor Relations Dries Ausemstel. +31 (0) 45 5782864fax +31 (0) 45 5782595e-mail investor.relations@dsm.com
    
    
17. [verwijderd] 7 november 2006 13:41

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    Er zal wel weer een koopaanbeveling komen van Golddamn Sex.
    
    :-)
    
    =DJ 2nd UPDATE: Acambis 3Q Swings Back Into Profit >ACAM
    
    11/07/2006
    Dow Jones News Services
    (Copyright © 2006 Dow Jones & Company, Inc.)
    
    
    (This updates an item published at 0733 GMT with additional details, analyst and CEO comments and fresh share price information.)
    
    
    By Elena Berton
    
    Of DOW JONES NEWSWIRES
    
    
    LONDON (Dow Jones)--Vaccine maker Acambis PLC (ACAM) Tuesday said its third-quarter earnings swung back into profit and reiterated its sales outlook for the full year.
    
    The Cambridge, England-based company reported a net profit of GBP4.9 million in the quarter ended Sept. 30, compared with a loss of GBP11.1 million in the same quarter a year earlier, thanks to a $19 million settlement from its partner Novartis AG (NVS) and the sale of its travel vaccine sales unit.
    
    However, sales for the quarter declined 39% to GBP2.8 million from GBP4.6 million in 2005, when the company booked more government contracts.
    
    Acambis said it's on track to deliver 10 million doses of smallpox vaccine ACAM2000 to the U.S. government by year end.
    
    Assuming a timely delivery, the company reiterated its previous revenue guidance for 2006, which was increased to around GBP30 million from below GBP20 million in September.
    
    Given the expected timing of deliveries, the cash associated with this delivery is likely to be received during January 2007, Acambis said.
    
    At 0834 GMT, Acambis shares were up 1.6%, or 2.5 pence, at 157.5p in a higher broader market.
    
    "There are no real surprises," said Nomura Code analyst Chris Redhead, who has a neutral recommendation on the stock.
    
    Acambis specializes in vaccines against infectious diseases, with the bulk of its revenues coming from government contracts to supply its ACAM2000 smallpox vaccine, as well as an attenuated form of the jab which is suitable for people with compromised immune systems.
    
    However, the company has been developing other types of vaccines.
    
    Chief Executive Gordon Cameron told Dow Jones Newswires that in the medium-to-long term, the majority of Acambis' business will come from non-biodefense products, such as vaccines for Japanese encephalitis, West Nile and universal influenza.
    
    "There is potential to add new things to that pipeline," Cameron said, adding that the company is considering acquiring or in-licensing therapeutic vaccines, rather than products that target infectious diseases.
    
    Cameron also said Acambis would be open to a settlement with Danish rival Bavarian Nordic A/S (BAVA.KO), which has claimed Acambis's attenuated smallpox vaccine infringed its own patents.
    
    Although Acambis received an initial favorable ruling from the International Trade Commission in September, Cameron said the company would be willing to negotiate. "A settlement would be attractive to us - on the right terms," he said.
    
    
    Company Web site: www.acambis.com
    
    
    -By Elena Berton, Dow Jones Newswires; 44 20 7842 9267; elena.berton@dowjones.com
    
    
    
18. [verwijderd] 7 november 2006 13:59

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    Inovio Biomedical Grants Wyeth Pharmaceuticals License to Develop Infectious Disease DNA Vaccines
    
    
    SAN DIEGO--Nov. 7, 2006--Inovio Biomedical Corp. (AMEX: INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that it has granted Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), a worldwide non-exclusive license to its DNA delivery technology for intramuscular applications of certain therapeutic DNA vaccines. Under the terms of the agreement, Inovio will receive from Wyeth a $4.5 million upfront license fee, annual license maintenance fees, research support, and up to $60 million in payments based on successful completion of clinical and regulatory milestones. Inovio would exclusively supply Wyeth with electroporation devices for the vaccines included in the license agreement and would receive royalties on the sale of products covered by the license.
    
    "We are pleased to add Wyeth to the list of corporate partners using our enabling MedPulser® DNA Delivery System to develop DNA vaccines for the treatment of debilitating diseases caused by a variety of viruses," stated Avtar Dhillon, MD, president and CEO of Inovio. "We believe this speaks to the enabling capabilities of our technology, the breadth of our clinical experience as well as the strength of our DNA electroporation patent estate. We remain committed to commercializing our delivery technology with a top-tier vaccine company such as Wyeth as we strive to build the world's leading DNA vaccine delivery franchise."
    
    About Inovio's DNA Delivery Technology
    
    DNA vaccines have the potential to by-pass the numerous problems that plague conventional vaccines. For example, DNA vaccines may be better in stimulating cellular immunity necessary to fight chronic infection or diseases such as cancer. Despite this promise, vaccination using DNA plasmids alone, without enhanced delivery, has not been shown to reach the threshold for clinical benefit.
    
    Intramuscular delivery of DNA vaccines using Inovio's proprietary electroporation technology has been shown in primate studies to boost the immune response by orders of magnitude over DNA plasmid alone. Plasmid-based vaccines induced higher levels of antibodies and T-cell responses when delivered via electroporation, suggesting the potential to provide better protection from infectious diseases such as HIV and hepatitis C.
    www.inovio.com
19. [verwijderd] 7 november 2006 17:12

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    Rexin-G(TM), The World's First Tumor-Targeted Gene Therapy Vector, Stymies Metastatic Cancer
    Main Category: Genetics News
    Article Date: 07 Nov 2006 - 0:00am (PST)
    
    Epeius Biotechnologies today announced the publication of clinical data from studies conducted at the University of the Philippines, Asian Hospital and Medical Center, Makati Medical Center, Manila, Philippines and Lutheran Medical Center, New York, USA, revealing the safety and single agent efficacy of Rexin-G(TM) for the treatment of a broad spectrum of chemotherapy-resistant cancers.
    
    The milestone article, appearing in this month's issue of the International Journal of Oncology, reports on 3 clinical studies involving patients with various chemo-resistant tumor types who received Rexin-G in Phase I/II and expanded access protocols. In the first study, progressive tumor reduction and/or necrosis were noted in 83% (n = 6) of patients with advanced or metastatic pancreatic cancer, while in the second study, an objective tumor response was observed in 64% (n = 11) of patients with metastatic breast, colon, uterine, muscle and vocal cord cancer, as well as malignant melanoma. Median survival after Rexin-G treatment was 10 months in the first study, and greater than six months in the second study. In the third study, wherein an innovative mathematically calculated optimal dose of Rexin-G (designated "Calculus of Parity") was given to three patients, tumor reduction and/or necrosis were achieved in 100% of patients. Based on these studies, the following conclusions were reached: (i) the functionality of the targeted gene delivery system is profound, (ii) the genetic construct exhibits broad spectrum activity in many resistant tumor types, and (iii) the targeted genetic medicine is exceptionally safe. The lack of systemic toxicity, taken together with the reduction of tumor burden and the enhanced quality-of-life experienced by patients receiving Rexin-G infusions, constitute meaningful clinical benefits that underscore the need for the expedited development of Rexin-G for pancreatic cancer and, potentially, for all solid tumors.
    
    In a statement to the press, Dr. Frederick L. Hall, President and CEO of Epeius, stated "Whereas logistics had previously stymied the delivery of genetic medicine to target lesions within the human body, intravenous infusions of Rexin-G has stymied intractable cancers without collateral damage to normal organs." The results, compiled in these pioneering studies, had convinced the US FDA to grant Rexin-G orphan drug status for pancreatic cancer, and subsequently, to provide federal support to continue clinical trials using Rexin-G in the United States. Further, based on these studies, the Philippine Bureau of Food and Drugs recently granted Rexin-G accelerated marketing approval for the treatment of all chemotherapy-resistant tumor types.
    
    About Epeius Biotechnologies
    
    Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer-gene therapy, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced GMP and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide. To learn more about Rexin-G and Epeius' pipeline of proprietary therapeutics currently available for partnership, please visit us at www.epeiusbiotech.com.
    
    This release was issued on behalf of the above organization by Send2Press(R), a unit of Neotrope(R). www.Send2Press.com.
    
    Epeius Biotechnologies
    www.epeiusbiotech.com
    
20. [verwijderd] 7 november 2006 20:04

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    Novartis pain drug battles Vioxx stigma
    Novartis' Prexige approved in EU, but similarities to Vioxx could present a hard time getting past the FDA.
    By Aaron Smith, CNNMoney.com staff writer
    November 7 2006: 1:31 PM EST
    
    NEW YORK (CNNMoney.com) -- Novartis plans to bring a new arthritis painkiller to the U.S. market, but analysts say its similarity to the disgraced drug Vioxx could kill its chances of becoming a billion-dollar blockbuster.
    
    The Swiss drug giant Novartis AG (up $0.32 to $61.55, Charts) said Tuesday that its painkiller Prexige was given a green light in the European Union for the treatment of arthritis. Novartis plans to "resubmit" the drug to the Food and Drug Administration in 2007, following the agency's request for more information in 2003.
    
    
    Compared to Vioxx from Merck & Co., Inc., (up $0.33 to $46.14, Charts) Prexige has a better profile with regard to heart attack and stroke risks. Nonetheless, the drug is a member of the Cox-2 inhibitor class of drugs -- the same as Vioxx -- and could have a hard time winning the approval of American doctors and patients, not to mention the FDA.
    
    "Doctors will be afraid to use this drug and ultimately that's what limits its potential," said Gbola Amusa, analyst for Sanford C. Bernstein. "Even when it's approved, doctors will see a safety issue with the drug and not use it as much."
    
    The big threat to Big Pharma
    Novartis spokeswoman Sherry Pudloski said that clinical trials have shown that Prexige is 79 percent better in terms of gastric bleeding than the NSAIDs, with a "comparable level" of cardiovascular risk. In theory, this presents Prexige with an iron-clad profile, as it would have reduced risks of heart attacks, strokes and stomach bleeding.
    
    But despite its solid safety profile, the Vioxx stigma could prevent Prexige from becoming a billion-dollar blockbuster, analysts said.
    
    "By no means does it have blockbuster potential," said Amusa of Bernstein, estimating annual sales of less than $500 million.
    
    "I think that blockbuster is an optimistic assessment," said Les Funtleyder, analyst for Miller Tabak. "In the right population, this is a good drug, except the right population isn't everybody with a pain. The right population is people with severe problems who also have stomach issues. Obviously, the [drug] class comes with some baggage."
    
    Novartis originally submitted Prexige years ago, but the review process was stymied on Sept. 30, 2004. That is Merck's day of infamy, when the company pulled its arthritis painkiller Vioxx off the market after a study showed that the drug increased the risk of heart attacks and strokes. Not only did Merck bid adieu to $2.5 billion in annual sales, but more than 20,000 lawsuits have been filed against the No. 4 U.S. drugmaker since that time. Thousands of former Vioxx patients and their family members blame the drug for their heart attacks, fatal and non-fatal.
    
    The Cox-2 scandal also affected Pfizer Inc (up $0.30 to $27.29, Charts)., the biggest drugmaker in the world. At the request of the FDA, Pfizer took its arthritis painkiller Bextra off the market, losing $1.3 billion in annual sales. But Pfizer's other arthritis painkiller, Celebrex, was never taken off the market.
    
    Clock ticking for Celebrex's U.S. monopoly
    Celebrex is the only Cox-2 inhibitor available to U.S. patients and Pfizer is on track to meet its blockbuster sales goal of $1 billion for the year. But that pales in comparison to the Celebrex sales tally of $3.3 billion in 2004. The drug's sales are affected by the Cox-2 stigma. In July of 2005, the FDA made Pfizer add a "black box" warning, the most severe type of warning, to its Celebrex label to reflect risks of heart attacks, strokes and gastrointestinal bleeding.
    
    Vioxx, Celebrex, Bextra and Prexige are all Cox-2 inhibitors. These anti-inflammatories kill pain by reducing swelling in arthritic joints. They have been marketed and prescribed (until 2005, in the case with Celebrex) as easy-on-the-stomach alternatives to over-the-counter members of the non-steroidal anti-inflammatory drugs (NSAID), like ibuprofen and naproxen, which have been linked to stomach bleeding. This class includes Aleve from the German drugmaker Bayer (up $0.10 to $51.45, Charts).
    
    A hard sell to the FDA
    Amusa, the Bernstein analyst, said "if there's any other Cox-2 that's going to overcome the safety issues, it's going to be Prexige." But it will still be a hard sell with the FDA, he said, because the agency is trying to repair its reputation from approving Vioxx.
    
    "The FDA is certainly more conservative now than [the European regulators,]" said Amusa. "Let's not forget that they're the ones that got blamed for Vioxx. They don't want to get embarrassed twice. Ultimately, the FDA is going to be very, very cautious here."
    
    
21. danicole 8 november 2006 08:01

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