ChemGenex Pharmaceuticals, Ltd. (fkx ASX:CXS)

[Camaro1093]

Letter to Shareholders from 2009 Annual Report:

Dear Shareholders, Employees, Colleagues and Friends,

On 9 September 2009 ChemGenex announced the submission of its New Drug Application (NDA) for OMAPRO™
(omacetaxine mepesuccinate) to the US Food and Drug Administration (FDA). This major achievement capped an
outstanding year for the company that has seen it become recognized internationally as an innovator and leader in the
field of hematology therapeutic research and development.
With this submission to the FDA, and a planned parallel submission to the European Medicines Agency (EMEA) due in
Q4 2009, ChemGenex is on the threshold of drug approvals in the two major global therapeutic markets, and is well
positioned to deliver on our goal of improving patient outcomes and shareholder value.
These initial regulatory submissions describe the use of OMAPRO™ in chronic myelogeneous leukemia (CML) patients
who have failed therapy with the tyrosine kinase inhibitor, imatinib, and who have a particular gene mutation, the T315I
mutation, which renders them resistant to all approved CML therapies. Data from the clinical trial in this patient group
have been delivered as oral presentations at several international congresses over the past year, and the response from physicians and patient support groups has been very encouraging. In addition to the pivotal clinical trial in CML patients with the T315I mutation ChemGenex is conducting a complementary clinical study of OMAPRO™ in CML patients who have failed multiple tyrosine kinase inhibitors (regardless of their
mutation status). Data from this study have also been very encouraging, and may be used in future regulatory submissions.
Certainly it is ChemGenex’s belief that OMAPRO™ may provide new hope for CML patients who have failed treatment
with multiple tyrosine kinase inhibitors.
While CML is the short term focus for the development of OMAPRO™, our increasing understanding of the novel
mechanism of action of the drug supports its development more broadly in other hematologic cancers. ChemGenex has
an ongoing phase 2 study of OMAPRO™ in refractory or relapsed acute myeloid leukemia (AML) patients who have failed
intensive chemotherapy and we are also exploring further development opportunities in a range of other hematological
disorders.
The coming year could see the realization of years of effort, with the possible commercial launch of OMAPRO™ in mid
2010. Key milestones in the next 12 to 18 months could include:
* Completion of our first regulatory filings for OMAPRO™ in Europe
* Establishment of a partnership for the commercialization of OMAPRO™ in Europe
* Completion of the phase 2/3 trial of OMAPRO™ in CML patients who have failed multiple tyrosine kinase inhibitors
* Presentation of final clinical data from the T315I+ CML clinical trial at leading international conferences
* Possible approval and commercial launch of OMAPRO™ in the USA

We appreciate your continued support for ChemGenex and look forward to communicating with you during the exciting
year ahead.

Brett Heading
Chairman

Greg Collier
CEO and MD

Link to 2009 Annual Report w/ above letter: http://www.chemgenex.com/pdf/Annual_Report_2009_Final.pdf

GLTA.