Preclinical	Phase I	Phase II	Phase III	Marketed
Pixantrone	The U.S. Food and Drug Administration (FDA) accepted for standard review our New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010.

A Potential Treatment for non-Hodgkin's Lymphoma

Pixantrone (pick-san-trone) dimaleate for injection (BBR 2778) is a next generation antitumor aza-anthracenedione with a molecular structure similar to other topoisomerase II inhibitors, such as anthracyclines like doxorubicin. It is under development for the treatment of non-Hodgkin's lymphoma (NHL).

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 or refractory 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.

The U.S. Food and Drug Administration (FDA) accepted for standard review our New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010.

Pixantrone has fast track status and its proposed indication is for the single-agent treatment of patients with relapsed or refractory aggressive NHL who have received two or more prior lines of therapy.

Pixantrone Clinical Research

The pivotal phase III EXTEND (PIX301) clinical trial explored the role of single-agent pixantrone treatment in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma who failed two or more prior therapies.

Pixantrone Proposed Target Profile

Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, breast cancer, and other diseases. Although anthracyclines are effective for use as first-line (initial) treatment, they can cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns.

Unlike other drugs in this class that cause serious tissue necrosis if they pass through the walls of vessels into surrounding tissue, pixantrone can be given through a peripheral vein and does not require a central implanted catheter.