Biotech Values

[drbio45]

FOR IMMEDIATE RELEASE
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status

MELBOURNE, Australia, and MENLO PARK, California U.S.A. (10 November 2009) –
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug
Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro™
(omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who
have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. The NDA
has also been granted Priority Review. A Priority Review designation is given to drugs that offer
major advances in treatment or provide a treatment where no adequate therapy exists, and generally
denotes that the FDA review period is reduced to approximately six months. ChemGenex submitted
the NDA on 8 September 2009.
“We are pleased that the FDA has accepted our NDA for Omapro and granted the filing Priority
Review status which underscores the critical need for a treatment option for the CML T315I+ patient
population,” said Greg Collier PhD, ChemGenex’s Chief Executive Officer and Managing Director.
“We look forward to working closely with the agency over the next several months as they review our
filing. If approved, we plan to launch Omapro in the U.S. as the first therapy specifically indicated for
CML T315I patients.”
Omapro has received Orphan Drug designation in the U.S. and in the European Union, and has
received Fast Track status from the FDA. Omapro demonstrated clinical benefit in the pivotal Study
202 in CML patients who had failed imatinib and have the T315I mutation.
About Omapro™ (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
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and
Grants the Filing Priority Review Status
Page 2 of 3
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: [phone] Facsimile: [phone]
Email: [e-mail] ABN 79 000 248 304
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 submitted to the U.S. Food and Drug Administration 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
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and
Grants the Filing Priority Review Status
Page 3 of 3
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: [phone] Facsimile: [phone]
Email: [e-mail] ABN 79 000 248 304
Contacts:
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Australia): +61 419
897501
Cell (USA): [phone]
Email:
[e-mail]
Rebecca Wilson
Buchan Consulting
Tel: [phone]
Cell: + 61 (0)417 382 391
Email: [e-mail]
Remy Bernarda
Blueprint Life Science Group
Tel: [phone] x 2022
Cell: +1.415.203.6386
Email:
[e-mail]
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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
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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.
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