CXS Chemgenex Fpo

ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

The recent Type A Meeting, which included discussion of a regulatory path forward, addressed outstanding issues regarding the previously received Complete Response letter dated 8 April 2010.

Based on the discussion with the FDA, ChemGenex intends to combine data from its two pivotal studies, Study 202 and Study 203, and submit a New Drug Application (NDA) for OMAPRO for those patients with CML who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors (TKIs). The proposed indication of this new NDA will be for the treatment of CML patients who have failed two or more TKIs, regardless of their mutation status.

“The FDA’s agreement that a combined data set could serve as the basis of an NDA in a third-line setting provides us with a pathway to an expanded indication for OMAPRO to treat CML patients who are resistant to at least two TKIs,” said Adam Craig, MD, Chief Medical Officer of ChemGenex.

“We also appreciate FDA’s invitation to discuss this approach further in a pre-NDA meeting," he added. “We welcome the opportunity granted by the agency to submit combined data from our two completed pivotal studies and to potentially provide a new therapeutic choice for this significant group of patients who currently have very limited treatment options.”

Greg Collier Ph.D., Managing Director and Chief Executive Officer of ChemGenex added: “We are pleased with the outcome of this Type A meeting as it provides another option for advancing the development timeline for OMAPRO. By pursuing this new indication for multi TKI-resistant patients, OMAPRO can potentially treat a significantly larger patient population in the United States, and we plan to submit our new NDA to the FDA by the end of the year.”

ChemGenex is continuing its discussions with the FDA’s Center for Devices and Radiological Health towards approval of a diagnostic test for the T315I mutation, and the existing NDA for T315I positive CML patients who have failed imatinib remains open.

The Company also has a Marketing Authorisation Application under review with the European Medicines Agency for CML patients who have failed imatinib and have the T315I mutation. This review is on track, with a potential approval in Europe in the first quarter of 2011.

The updated corporate overview for ChemGenex is available on the company’s website.

Investor teleconference

ChemGenex will host an investor teleconference today: Wednesday 14th July 10.30am Australian Eastern Standard Time / Tuesday 13th July 5.30pm Pacific Daylight Time

To join the call please dial the access number below for your location. A participant pin number is not required.

Dial-In numbers:      

1800 131 617

       

Australia Free Call

866 746 2596

USA/Canada Free Call

  +61 7 3107 0222 International / Metered Number 0800 446 958 New Zealand Free Call 800 120 4406 Singapore Free Call 800 962 283 Hong Kong Free Call 001 803 011 4106 Indonesia Free Call 0044 22 132 558 Japan Free Call 0800 376 8339 UK Free Call 0800 330 2094 Germany Free Call 0805 111 476 France Free Call 0800 001 230 Switzerland Free Call

A recording of the call will be made available on the ChemGenex website.

About OMAPRO™ (omacetaxine mepesuccinate)

Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are up-regulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc).

Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as well as Fast Track status by the FDA.

About Chronic Myeloid Leukemia (CML)

Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of greater than 100,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body’s defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.

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. 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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