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Genmab dürfte bald auch die Zulassung von Arzerra gegen CLL in Europa erhalten. Einen großen Einfluss auf den Kurs hat das nicht. Spannender werden die in nächster Zeit erwarteten Zalutumumab PIII-Daten. Offen ist, ob sich Zalutumumab irgendwie von z.B. Erbitux absetzen kann. Die Erwartungen sind eher negativ. http://www.reuters.com/article/idUSLDE60L0WE20100122 UPDATE 1-Glaxo, Genmab win EU backing for leukaemia drug * EMEA recommends Arzerra for chronic lymphocytic leukaemia * Move follows U.S. FDA approval in October * Genmab shares up 5 pct, Glaxo flat (Updates with details on drug, sales forecast, shares) LONDON, Jan 22 (Reuters) - GlaxoSmithKline (GSK.L) and Genmab (GEN.CO) won European backing for their leukaemia drug Arzerra on Friday, following a green light for the medicine from U.S. regulators in October. Arzerra is the first drug to reach the market from the labs of Genmab and shares in the Danish biotech rose 5 percent on the news. Glaxo stock was flat. The European Medicines Agency said it was recommending Arzerra, or ofatumumab, as a treatment for chronic lymphocytic leukaemia in patients who do not respond to Genzyme's (GENZ.O) Campath or the chemotherapy drug fludarabine. Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Glaxo bought global rights to Arzerra in December 2006 in a deal worth up to $2.1 billion, a record sum for a biotech product agreement at the time. The world's second biggest drugmaker is also banking on Arzerra working in other diseases beyond CLL. But hopes for its use in patients with another blood cancer called non-Hodgkin's lymphoma (NHL) were dealt a blow in August when it failed to help patients as much as expected in a clinical trial. Current consensus analyst forecasts for Arzerra, which is also being developed for rheumatoid arthritis, suggests annual sales will reach $465 million in 2013, according to Thomson Pharma. Genmab and Glaxo aim to position Arzerra as a rival to Roche (ROG.VX) and Biogen Idec's (BIIB.O) blockbuster treatment Rituxan. Both Arzerra and Rixtuxan belong to a class of medicines known as anti-CD20 antibodies. mfg ipollit |
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| aus der Diskussion: | Biotech Depot 2010 |
| Autor (Datum des Eintrages): | ipollit (24.01.10 19:29:59) |
| Beitrag: | 92 von 334 (ID:38800820) |
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