Pixantrone Regulatory Strategy

We are focusing on obtaining pixantrone approval based on the EXTEND (PIX301) phase III clinical trial of pixantrone for patients with relapsed aggressive NHL. Enrollment is complete in this trial, and we have announced that it achieved the primary efficacy endpoint based on a preliminary intent-to-treat efficacy analysis.

In August 2009 the U.S. Food and Drug Administration (FDA) accepted and filed for review our New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

OPAXIO Regulatory Strategy

In March 2008, we submitted and the European Medicines Agency (EMEA) accepted for review a marketing authorization application (MAA) seeking European approval for OPAXIO on equivalent effectiveness (non-inferiority) and improved safety as a single-agent in first-line PS2 NSCLC patients.

In the United States, we plan to seek approval for the drug’s use in maintenance of ovarian cancer following complete remission after first-line treatment.