ChemGenex Pharmaceuticals Limited Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for OMAPROTM
Published: Oct 05, 2010
At the meeting the FDA agreed that the proposed New Drug Application (NDA) for OMAPRO for CML patients who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors (TKIs) could be submitted based on combined data from ChemGenex’s two pivotal studies, Study 202 and Study 203.
It was agreed that no further clinical trials are required to complete this NDA submission, however further data will need to be collected from participating clinical centres. ChemGenex believes that based on the timing required for collection of this additional data, the NDA for OMAPRO for the treatment of CML patients who have failed two or more TKIs regardless of their mutation status, will be submitted in H2 2011.
Greg Collier Ph.D., Managing Director and Chief Executive Officer of ChemGenex said: “We appreciate the guidance that the FDA has given the company as it prepares this new NDA, and look forward to working with the FDA to seek approval for the use of OMAPRO to potentially treat a significantly larger patient population in the United States.”
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. A New Drug Application is under review by the U.S. Food and Drug Administration and a Marketing Authorisation Application is under review by the European Medicines Agency for CML patients who have failed imatinib therapy and have the Bcr-Abl T315I mutation. An additional New Drug Application is in preparation for CML patients who have failed two or more currently approved tyrosine kinase inhibitors. ChemGenex has established a corporate alliance with Hospira to develop and commercialize omacetaxine in Europe, the Middle East and parts of Africa, and is seeking to establish commercial partnerships in the rest of the world. ChemGenex plans to commercialize omacetaxine itself in North America. ChemGenex trades on the Australian Stock Exchange under the symbol "CXS". For additional information on ChemGenex Pharmaceuticals, please visit the company’s website at http://www.chemgenex.com. OMAPRO™ is a trademark of ChemGenex Pharmaceuticals Limited.
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