The ODAC meeting will consider ChemGenex’s application for OMAPRO™ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and who have developed the Bcr-Abl T315I mutation.

As an independent panel of experts the role of the ODAC committee is to review safety and efficacy data and make recommendations to the FDA concerning approval.

“The ODAC meeting is a significant milestone in the review process for OMAPRO, our team is well-prepared and we are looking forward to presenting to the ODAC panel” said Greg Collier, PhD, CEO and Managing Director of ChemGenex.

The ODAC meeting was scheduled to review two New Drug Applications, one of which was the application submitted by ChemGenex for OMAPRO™ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy 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 notify the company of a new date for the meeting as soon as possible.

ChemGenex believes in the safety and efficacy of OMAPRO™ for the treatment of patients with chronic myeloid leukemia (CML) who are resistant to imatinib and have the Bcr-Abl T315I mutation. The company is aware of the questions posed by the FDA and we are confident in our ability to answer these questions during the ODAC meeting. OMAPRO addresses a significant unmet need for patients with the T315I mutation, a marker for resistance to tyrosine kinase inhibitors, who currently have no effective treatment option and often have a poor prognosis.

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December 17, 2009

Under the terms of the agreement, Hospira will make an initial payment of €11.1 million (A$ 17.8 million), with the potential for up to an additional €74.1 million (A$ 119.4 million), in performance milestone payments based on the successful development and commercialization of omacetaxine.  In addition, following successful commercialization, Hospira will pay ChemGenex a royalty on product sales in the Territory.

ChemGenex will complete registration of omacetaxine in its initial indication with the European Medicines Agency (“EMEA”), while Hospira and ChemGenex will collaborate to explore future applications in a variety of hematological malignancies. Hospira will have responsibility for commercializing omacetaxine in the Territory.

“We are very excited by the promise omacetaxine holds to improve outcomes for seriously ill patients who have stopped responding to other treatments available for their condition,” said Michael Kotsanis, President Europe, Middle East and Africa, Hospira, Inc. “This agreement is a further step in Hospira’s strategy to build upon our strong portfolio of oncology and hematology products.” 

“We are very pleased to announce this important agreement, in keeping with our corporate strategy of partnering in Europe and other parts of the world, as we prepare for the launch of omacetaxine in the U.S., if approved,” said Greg Collier, CEO and Managing Director ChemGenex. “We look forward to working with the Hospira team to realize omacetaxine’s potential in the hematology-oncology space in Europe.”

About Omacetaxine

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).

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 subsequent indications within 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.

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 Authorisation Application has been validated by the European Medicines Agency for CML patients with 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 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.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com

ChemGenex Contacts:

Hospira Contacts:

Safe Harbor Statement

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.

Private Securities Litigation Reform Act of 1995 –
A Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including projections of certain measures of Hospira’s results of operations, projections of certain charges and expenses, and other statements regarding Hospira’s goals and strategy. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Hospira’s operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Hospira’s latest Annual Report on Form 10-K filed with the Securities and Exchange Commission, which is incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.

MELBOURNE, Australia, and MENLO PARK, California U.S.A.

December 09, 2009

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who are resistant or intolerant to two or more tyrosine kinase inhibitors (TKI). New data were presented at the 51st Annual American Society of Hematology Meeting in New Orleans, Louisiana.
At the Oral Session titled “Chronic Myeloid Leukemia - Therapy: New Trends in Management,” Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, and a lead investigator in the study, presented data on behalf of ChemGenex and a team of investigators from leading U.S. and European clinical research centers. Completing his presentation, Dr. Cortes concluded that Omapro represents a new potential therapy for patients with multi-TKI resistant CML.
Data were presented from 89 CML patients: 44 in chronic phase, 25 in accelerated phase and 20 in blast phase. Highlights of the data were:

* Complete hematologic responses (CHR) in 82% of chronic phase patients, median response duration 4.8 months
* Cytogenetic response rate of 27% in chronic phase patients, with major cytogenetic response (MCyR) rate of 23%
* Overall hematologic responses in 80% of accelerated phase patients, with 52% achieving a CHR (median duration 3.1 months).
* Overall hematologic responses in 50% of blast phase patients with 35% achieving a CHR (median duration 2.5 months)
* Investigators reported that omacetaxine is safe for self-administration, is well tolerated, and that reversible and manageable myelosuppression is the most common side effect

“Omapro continues to show that it may provide clinical benefit for CML patients who have developed resistance to currently approved therapies independent of the T315I point mutation” said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex. “We would like to thank Dr. Cortes and all of our investigators for their efforts to complete this trial.”
About the Study
The study was designed to evaluate the safety and efficacy of subcutaneously (SC) administered omacetaxine in patients who are resistant or intolerant to two or more TKIs. Eligible patients were adult CML patients in chronic, accelerated, or blast disease phase (CP, AP, BP). Patients were given 1.25 mg/m2 SC omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy. For maintenance therapy, patients were dosed 1.25 mg/m2 SC omacetaxine twice daily for 7 days every 28 days. Eighty nine patients were described in this presentation (44 CP, 25 AP and 20 BP). The median age was 59 years (20-78) with a median CML disease duration of 72, 92 and 60 months in CP, AP and BP patients, respectively.

MELBOURNE, Australia, and MENLO PARK, California U.S.A.

December 07, 2009

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.  New data was presented at a pre-conference press showcase at the 51st Annual American Society of Hematology Annual Meeting in New Orleans, Louisiana.

At the press conference titled “Advances in Diagnosing and Treating Leukemia and Myeloproliferative Disorders” Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, a lead investigator in the study, presented data on behalf of a team including investigators from ChemGenex and leading U.S. and European clinical research centers. Completing his presentation, Dr Cortes concluded that Omapro represents a new potential therapy for patients with T315I+ CML.

Data were presented from 81 CML patients: 49 in chronic phase, 17 in accelerated phase and 15 in blast phase. Highlights of the data were:

• Complete hematologic responses (CHR) in 86% of chronic phase patients, median response duration 9 months
• Total cytogenetic response rate of 41% in chronic phase patients, with major cytogenetic response (MCyR) rate of 27%
• Overall hematologic responses in 35% of accelerated phase patients (median duration 7  months)
• Overall hematologic responses in 47% of blast phase patients (median duration 2 months)
• Investigators reported that omacetaxine is safe for self-administration, is well tolerated, and that reversible and manageable myelosuppression is the most common side effect

“We are delighted with the positive data presented today that continues to show that Omapro can provide clinical benefit to patients in this very difficult to treat sub-set of CML where there are no other approved treatment options,” said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex.  “We would like to thank Dr. Cortes and all of our investigators for their efforts to produce this data.  These results support our regulatory filings, and we look forward to working with the agencies in the U.S. and Europe over the next several months as we seek approval for Omapro in 2010.”

Applications for marketing approval for Omapro are currently under review by the U.S. Food & Drug Administration (priority review), and the European Medicines Evaluation Agency. 

The complete oral presentation by Dr. Cortes detailing this study will take place:

Date/Time:        Monday, December 7, 2009 at 4:45 p.m., U.S. Central Time

Abstract/Title:    #644: Safety and Efficacy of Subcutaneous-Administered Omacetaxine Mepesuccinate in Imatinib-Resistant Chronic Myeloid Leukemia (CML) Patients Who Harbor the Bcr- Abl T315I Mutation – Results of An Ongoing Multicenter Phase 2/3 Study

Oral Session:    Chronic Myeloid Leukemia - Therapy: Managing Resistance and Residual Disease

Location:          Conference Auditorium AB (Ernest N. Morial Convention Center)

About the Study

The study was designed to evaluate the safety and efficacy of subcutaneously (SC) administered omacetaxine in patients with imatinib resistant T315I+ Philadelphia chromosome positive CML. Eligible patients include adult CML Patients in chronic, accelerated, or blast disease phase (CP, AP, BP) with a confirmed Bcr-Abl T315I mutation and resistance to imatinib therapy. Patients were given 1.25 mg/m2 SC omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy. For maintenance therapy, patients were dosed 1.25 mg/m2 SC omacetaxine twice daily for 7 days every 28 days. Eighty one patients were described in this presentation (49 CP, 17 AP and 15 BP). The median age was 58 years (19-83) with a median CML disease duration of 54 months (5-286). All patients had failed prior imatinib therapy, and 79% had failed two or more prior TKIs. The presence of baseline T315I mutation was confirmed in all patients.

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 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 Authorisation Application has been validated by the European Medicines 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

Contacts:

Safe Harbor Statement

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.

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

Contacts:

Safe Harbor Statement

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.

“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.