Aronex' Atragen denied by FDA again

Aronex Pharmaceuticals lost three-quarters of its share price value at astroke after the US Food and Drug Administration declined, for a second time, to approve the company's drug for acute promyelocytic leukemia. Aronex' share price fell 73% to $1.22 on the news that the agency felt its dossier for Atragen (liposomal tretinoin for injection), an intravenous version of a drug marketed in capsule form by Roche, was not strong enough to warrant approval. The FDA said in a non-approvable letter to the company that Aronex' data did not establish an identifiable population of patients who need tretinoin and cannot use the oral formulation, according to the company.

Aronex' chief executive, Geoffrey Cox, said that the company plans to initiate steps to conserve cash by reducing staffing levels and other operating expenses. However, he remains optimistic about the drug's prospects of reaching the market. "We believe we have a clear strategy for the clinical development of Atragen in other indications with potentially larger markets," he noted, adding that the firm is planning to begin a Phase III study in the treatment of non-Hodgkin's lymphoma, and already has Phase II trials ongoing in hormone-resistant prostate cancer and acute myelogenous leukemia. Additionally, in the first quarter of this year, Aronex intends to submit a Marketing Authorization Application in Europe for the acute promyelocytic leukemia indication.