Chemgenex completes NDA submission for its omacetaxine mepesuccinate to the FDA

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for OMAPRO™ (omacetaxine mepesuccinate). OMAPRO™ is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. Imatinib, a tyrosine kinase inhibitor (TKI), is the first-line standard of care for patients with CML. OMAPRO™ is a first-in-class cetaxine which works differently from imatinib, and the second-line TKIs nilotinib and dasatinib.

OMAPRO™ has received Orphan Drug designation in the U.S. and in the European Union, and has received fast track status from the FDA. OMAPRO™ demonstrated clinical benefit in the pivotal Study 202, in CML patients who had failed imatinib and have the T315I mutation. Interim data were recently presented at the American Society of Clinical Oncology Annual Meeting.

“If approved, OMAPRO™ would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options,” said Adam R. Craig MD, PhD, Senior Vice President and Chief Medical Officer. “We thank the investigators, their research staff and patients for participating in the pivotal study.”

If the FDA grants priority review for OMAPRO™ the examination period is expected to be approximately six months. If approved for marketing by the FDA following priority review, the launch of OMAPRO™ would be scheduled for mid-2010.

Greg Collier PhD, ChemGenex’s Chief Executive Officer and Managing Director, said, "The submission of the NDA for OMAPRO™ is a major milestone in the development of this novel product and we are now one step closer to delivering a new treatment for patients in an area of unmet medical need. This submission is a significant achievement in our strategic goal to commercialize OMAPRO™ independently in the US oncology market.”