Aronex Atragen
Executive Summary
Injectable tretinoin liposome receives "non-approvable" letter because clinical trials did not establish an identifiable population of acute promyelocytic leukemia patients requiring a non-oral formulation, company says. Aronex needed to show efficacy in a population in which I.V. administration is required because of the orphan exclusivity of Roche's oral tretinoin Vesanoid. Aronex plans to study Atragen for non-Hodgkin's lymphoma in a Phase III 200-patient trial. The company will lay off most its 85 employees, retaining only clinical and regulatory personnel