|
http://www.minyanville.com/businessmarkets/articles/astex-ph… The negative vote, which was expected, is a setback for the drug’s developer Astex Pharmaceuticals (ASTX) and its partners Eisai of Japan and Johnson & Johnson (JNJ). Eisai sells the drug in North America, while J&J markets the product overseas. Astex receives royalties from sales. Today’s vote also is being watched by Celgene (CELG) and small-cap biotech Cyclacel Pharmaceuticals (CYCC), two companies developing their own treatments for AML, a cancer that starts in bone marrow. The cancer cells grow rapidly and replace a person’s healthy blood cells. The disease usually strikes people over age 60. AML is a tricky disease to treat. Pfizer (PFE) pulled an approved drug off the market in 2010 over questions about safety and effectiveness. That same year, Seattle Genetics (SGEN) said it scrapped development of its own drug after the treatment failed in a human trial. In 2009, Sanofi’s (SNY) Genzyme failed to win FDA approval of a therapy. Dacogen is approved to treat myelodysplastic syndrome, a disease that can lead to AML. A study of Dacogen for treating AML failed to show that the drug helped people live longer than those who received low doses of chemotherapy. So it was interesting that the FDA convened an advisory panel to discuss the drug rather than just reject the application for a new use. But it appears that the agency folks are struggling with simply rejecting a drug that potentially treats a serious unmet need. Indeed, some doctors on the panel struggled on the question of Dacogen’s benefits as they expressed desire for better treatment. Dacogen already is being prescribed by some doctors to treat AML even though the drug isn’t approved for that use. “The study failed to meet the primary endpoint, which according to FDA guidance means it isn't sufficient for approval,” says biotech industry consultant Michael Becker, who advises Cyclacel. “However, AML represents a disease with limited treatment options, which is why the (FDA) panel is debating the merits of Dacogen.” Read more: http://www.minyanville.com/businessmarkets/articles/astex-ph…#ixzz1lv4Riaoq |
|
| aus der Diskussion: | CYCC Cyclacel Phase3 Medikament gegen AML Leukämie etc |
| Autor (Datum des Eintrages): | medisana (09.02.12 21:43:42) |
| Beitrag: | 6 von 20 (ID:42728810) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |