Aronex looking at strategic options

In the wake of the US Food and Drug Administration declining, for asecond time, to approve its drug for acute promyelocytic leukemia, Atragen (liposomal tretinoin for injection; Marketletter January 15), Aronex Pharmaceuticals says it is evaluating its ongoing clinical development programs. This involves an evaluation of Atragen, its liposomal nystatin formulation Nyotran and Annamycin (liposomal anthracycline) for refractory breast cancer "based on each product's likelihood for approval, the cost of the proposed clinical trial and the inherent risk profile." Aronex has engaged the services of Robertson Stephens to assist in this process and explore strategic alternatives.

Addressing the Atragen issue, chief executive Geoffrey Cox said that the firm is in a continuing dialog with the FDA to clarify its concerns about the drug. He added that the company is also asking for specific guidance from the agency regarding its interpretation of the Orphan Drug Act relating to Atragen, but acknowledged that "it may take some time to reach a resolution to this matter."

Aronex says it "continues to believe strongly in the clinical value of Atragen," and anticipates filing for regulatory approval for the APL indication in countries outside the USA, including Europe.