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ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that following discussions with its commercial partner in Europe, Hospira, a decision has been made to align the European regulatory strategy for omacetaxine with the approach being pursued in the USA. As such, ChemGenex has informed the European Medicines Agency (EMA) that it wishes to withdraw its current Marketing Authorization Application (MAA) for CML patients who have failed imatinib therapy and who have the T315I mutation. In parallel ChemGenex has informed the EMA that it intends to submit a new MAA for CML patients who have failed therapy with two or more tyrosine kinase inhibitors (TKIs). This submission is planned for H2 2011.

The new MAA will use combined data from ChemGenex’s two pivotal studies, CGX-CML-202 and CGX-CML-203 which were designed to evaluate the safety and efficacy of subcutaneously administered omacetaxine in patients who; (a) had failed imatinib and had the T315I mutation, or (b) were intolerant to two or more TKIs. ChemGenex will submit this combined data in its New Drug Application (NDA) which is scheduled for submission to the U.S. Food and Drug Administration (FDA) in H2 2011. Data on the therapeutic profile of omacetaxine in this patient population were presented at the 52nd Annual American Society of Hematology (ASH) Meeting in Orlando, Florida on 5 December 2010.

“Harmonization of the regulatory strategies in the USA and Europe offers significant operational and potential commercial benefits,” said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex. “With this approach we will maximize the efficiency of our clinical and regulatory teams, focusing on data analysis and preparation rather than preparing responses to questions arising from the current MAA filing. We are confident that these questions can be addressed but believe that the most appropriate option at this stage is to file a new MAA for the expanded indication. The population of patients who fail to respond adequately to two or more TKIs is ChemGenex to Align European and US Regulatory Strategies for Omacetaxine also significantly larger than the sub-set of patients with the T315I mutation, which is commercially attractive.”