MELBOURNE, Australia & MENLO PARK, Calif. - (Business Wire) ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the European Medicines Agency ("EMEA") has determined that the Marketing Authorization Application ("MAA") for omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation is valid. Validation of the MAA indicates that ChemGenex’s application, submitted on 29 October 2009, is complete and that the review process has begun. The filing is based on data from pivotal Study 202 where omacetaxine demonstrated clinical benefit for the treatment of T315I positive CML patients. This additional regulatory milestone follows the acceptance earlier this month of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for marketing approval for omacetaxine (filed under the trade name Omapro™) in the U.S.A.
“The submission and validation of this MAA shortly after our NDA submission and acceptance shows the commitment by ChemGenex to offer a treatment option to patients suffering from this life threatening condition,” said Greg Collier, PhD, Chief Executive Officer and Managing Director. “This milestone marks another major accomplishment for ChemGenex this year, and we remain dedicated to expanding the use of omacetaxine within CML as well as with other leukemias.”
Omacetaxine has received Orphan Drug designation from the EMEA and the FDA, and has received fast track status and Priority Review from the FDA. The MAA filing has been submitted in accordance with the centralized procedure and will be assessed by the EMEA. An opinion by the EMEA is expected in the fourth quarter of 2010. If approved, the marketing license will be valid simultaneously in all EU Member States plus Iceland, Liechtenstein and Norway. Orphan Drug designation will give omacetaxine market exclusivity for a period of ten years.
About omacetaxine mepesuccinate
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for CML and has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status by the FDA.
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 upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to be insensitive to TKIs.
About Chronic Myeloid Leukemia (CML) and the Bcr-Abl T315I Mutation
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of approximately 200,000 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.
The majority of CML patients initially respond well to treatments with drugs called tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients fail, or become intolerant to, one or more TKIs. In many of these situations the cause of failure can be traced to the emergence of Bcr-Abl mutations. A common mutation called T315I renders CML resistant to all currently approved TKIs, and has created a significant unmet medical need in the management of CML.
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. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorization Application has been validated by the European Medicines Evaluation Agency for CML patients with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize omacetaxine independently in North America and to establish commercial partnerships in the rest of the world. ChemGenex currently 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.
Details on the clinical trials can be accessed from the following websites: http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9; and http://www.tkiresistantcmltrials.com.
Omapro™ is a trademark of ChemGenex Pharmaceuticals Limited.
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Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) that use the words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company’s technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company’s technology, the market for the company’s products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management’s current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.
ChemGenex Pharmaceuticals Limited
Dr. Greg Collier
CEO and Managing Director
Cell (Australia): +61 419 897 501
Cell (USA): +1 650 200 8145
Email: gcollier@chemgenex.com
or
Buchan Consulting
Investor Relations – Australia
Kyahn Williamson
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Email: kwilliamson@bcg.com.au
or
Blueprint Life Science Group
Investor Relations – USA
Remy Bernarda
Tel: +1.415.375.3340 x 2022
Cell: +1 415.203.6386
Email: rbernarda@bplifescience.com
