Omapro New Drug Application

MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has notified the companions that the Oncologic Drugs Advisory Committee (ODAC) renowned monitory get-together scheduled for 10 February 2010 has been suspended due to offbeat withstand conditions in Washington D.C. The ODAC joining was scheduled to consideration two New Drug Applications, one of which was the perseverance submitted by ChemGenex for Omapro (omacetaxine mepesuccinate) for the care of adults with dyed in the wool myeloid leukemia (CML) who have failed former treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

ChemGenex submitted the NDA on 9 September 2009. The NDA was accepted by the FDA on 10 November 2009 and granted Priority Review. The FDA will hint the players of a experimental old-fashioned for the encounter as soon as possible. ChemGenex believes in the shelter and efficacy of Omapro for the therapy of patients with long-lasting myeloid leukemia (CML) who are averse to imatinib and have the Bcr-Abl T315I mutation.

The body is enlightened of the questions posed by the FDA and we are cool in our ability to answer these questions during the ODAC meeting. Omapro addresses a significant unmet dearth for patients with the T315I mutation, a marker for obstruction to tyrosine kinase inhibitors, who currently have no moving curing option and often have a poor prognosis. About ChemGenex Pharmaceuticals Limited ChemGenex is an oncology focused biopharmaceutical followers developing diminished molecules with inexperienced mechanisms of action to present malignancies with significant unmet medical needs.

A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients who have failed imatinib group therapy and have the Bcr-Abl T315I mutation.

ChemGenex has established a corporate pact with Hospira to age and commercialize omacetaxine in Europe, the Middle East and parts of Africa, and is seeking to instal commercial partnerships in the residue of the world. ChemGenex plans to commercialize omacetaxine itself in North America. ChemGenex trades on the Australian Stock Exchange under the logotype "CXS" For additional low-down on ChemGenex Pharmaceuticals, humour affect the company's website at. Omapro is a trademark of ChemGenex Pharmaceuticals Limited. Safe Harbor Statement Certain statements made herein (including for this objective sites to which a hyperlink has been provided) that use the words "estimate", "project", "intend", "expect", "believe" and like expressions are intended to relate forward-looking statements within the sense of the US Private Securities Litigation Reform Act of 1995.

These forward-looking statements count in known and strange risks and uncertainties which could cause the current results, engagement or achievements of the firm to be greatly unheard-of from those which may be expressed or implied by such statements, including, mid others, risks or uncertainties associated with the progress of the company's technology, the aptitude to successfully demand products in the clinical pipeline, the genius to rise full of promise therapeutics through clinical trials, the talent to ensconce our fully integrated technologies, the capacity to enter into additional collaborations and strategic alliances and stretch current collaborations and obtain milestone payments, the suitability of internally discovered genes for soporific development, the cleverness of the company to match its financial requirements, the ability of the company to mind its proprietary technology, potential limitations on the company's technology, the sell for the company's products, administration regulation in Australia and the United States, changes in try and other laws, changes in competition and the trouncing of key personnel. These statements are based on our management's in circulation expectations and are subject to a sum of uncertainties that could change the results described in the forward-looking statements. Investors should be knowing that there are no assurances that results will not conflict from those projected.

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