MELBOURNE, Australia, and MENLO PARK, California U.S.A. (5 October 2010) –
ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today it has completed a pre-
NDA meeting with the U.S. Food and Drug Administration (FDA) concerning the potential
regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of
patients with Chronic Myeloid Leukemia (CML) who have failed two or more tyrosine kinase
inhibitors (TKIs).
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.
ChemGenex Contacts:
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Aust): +61 419 897501
Cell (USA): +1 650 200 8145
Email:
gcollier@chemgenex.com
Kyahn Williamson
Buchan Consulting
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Email:
kwilliamson@bcg.com.au
Dr. Andrew McDonald
LifeSci Advisors, LLC
Cell: +1.415.205.0591
Email:
andrew@lifesciadvisors.com
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