ChemGenex Pharmaceuticals Limited Announces FDA Accepts NDA for Omapro(TM) (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status

MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro™ (omacetaxine mepesuccinate) 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. The NDA has also been granted Priority Review. A Priority Review designation is given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists, and generally denotes that the FDA review period is reduced to approximately six months. ChemGenex submitted the NDA on 8 September 2009.