more on CXS from Greg regarding the FDA type A meeting

FDA Type A Meeting

Anyone here still following Chemgenex since its been delisted from nasdaq?
shareprice in the doldrums but i think the fundamentals are better than ever. FDA debacle wanting diagnostic validation has got nothing to do with efficacy of the drug.

Greg Collier's latest interview reply to investor questions here for those interested
insert-text-here

Thanks for posting!

GLTA

ODAC Feb. 10

No Financing...February ODAC.















Feb ODAC expected with date likely TBA in near term;milestones in coming months have eliminated need for financing near term-focus w/b on launch to 36 key US Cancer Centers 'upon/if' approval; several Cos were involved in DD with Chemgenex for Omapro EU rts-HSP is making Omapro a feature/focus of emerging oncology line;Approval expected by early March;details of commercialization plan coming in Q1.

ChemGenex, Hospira, Announce Agreement to License, Develop and Commercialize Leukemia Drug in Europe

* Press Release
* Source: ChemGenex Pharmaceuticals Limited
* On 6:59 pm EST, Sunday December 13, 2009

MELBOURNE, Australia & LAKE FOREST, Ill.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS - News) and Hospira, Inc. (NYSE:HSP - News) announced today that they have entered into an exclusive agreement to license, develop and commercialize ChemGenex’s product candidate omacetaxine mepesuccinate, a novel targeted cytotoxic pharmaceutical product, in Europe, the Middle East and parts of Africa (the Territory). Applications for marketing approval of the product have been accepted for regulatory review in both the United States and Europe for treatment of patients with chronic myeloid leukemia (CML) who have failed to respond to the current standard of care treatment, imatinib mesylate, and who have the Bcr-Abl T315I mutation.

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

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.

ASH Data-Bloomberg Article
















http://www.bloomberg.com/apps/news?pid=20601081&sid=a2UITb0CO2dU

CEO Loaded With Additional Options












http://www.asx.com.au/asxpdf/20091203/pdf/31mjmjnntk1q1p.pdf
with these 2mm he now has almost 7mm

No Chemgenex job postings







Why aren't they hiring with priority review and PDUFA in early March if they TRULY intend to launch themselves in US?
http://www.chemgenex.com/wt/page/openings
Four months until possible approval and no hiring...I think the promised EU deal before year end could morph into a company buyout or US Deal,if not I will question Omapro's commercial prospects as I do not see Pharma allowing a commercially promising oncologic to be brought here to market by a tiny Australian firm.

ASH Abstract Link





http://ash.confex.com/ash/2009/webprogram/start.html

Priority Review Granted

.80+ Aus breakout

No TA expert,but looks to me that on a 1 year chart CXS shaped a beautiful cup 'n handle @ .80..tonight she's broken through the high handle up 10%+ on 1mm+ shares.
Hard to believe that expectations for a smallish(relative to US)EU deal would drive the pps from .70 to .90 and that we'd see a breakout AHEAD of announced deal terms. Anything else that might be driving this? Might CXS's potential European partner want more than just Omapro EU rts?

Before Year end
1)EU Deal
2)MAA Filing
3)AHA Data/Pres.
4)FDA decision on priority review

Co's stated intent is to use $$ from EU Deal to underwrite US launch in Q2(assuming priority review and approval). I do not believe the European market for T315i is very large(thankfully).There will be off-label and line extension potential,but any guesses as to value/terms of the upcoming EU deal ? I hope it is large enough to avoid further dilution($50mm+ upfront).
Market potential in 6 months or so as well as the above developments and acquisition potential all for a US 200mm MC-nice opportunity,imo..although I'm not a fan of currency differential/foreign sec. holding fees.
A few followers have been posting at IV on this Co. as well.

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.

ChemGenex CEO Receives AusBiotech Award

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

October 28, 2009

ChemGenex Pharmaceuticals Limited (ASX:CXS) is pleased to announce Chief Executive Officer and Managing Director Greg Collier, PhD. was recognized this morning for his outstanding contribution to the advancement of biotechnology in Australia.

Dr Collier received the AusBiotech 2009 Chairman’s Excellence Award for outstanding contribution by an individual within a company. The Board and management of ChemGenex extend their congratulations to Dr Collier upon the receipt of this award.

About ChemGenex Pharmaceuticals Limited (http://www.chemgenex.com)

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 its lead product candidate OMAPRO™ (formerly omacetaxine) 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 OMAPRO™ 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://clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and http://www.tkiresistantcmltrials.com

ChemGenex Submits New Drug Application for OMAPRO™ (Omacetaxine Mepesuccinate) to U.S. FDA

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

September 09, 2009

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for OMAPRO™ (omacetaxine mepesuccinate). OMAPRO™ is being developed 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. Imatinib, a tyrosine kinase inhibitor (TKI), is the first-line standard of care for patients with CML. OMAPRO™ is a first-in-class cetaxine which works differently from imatinib, and the second-line TKIs nilotinib and dasatinib.

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. Interim data were recently presented at the American Society of Clinical Oncology Annual Meeting.

“If approved, OMAPRO™ would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options,” said Adam R. Craig MD, PhD, Senior Vice President and Chief Medical Officer. “We thank the investigators, their research staff and patients for participating in the pivotal study.”

If the FDA grants priority review for OMAPRO™ the examination period is expected to be approximately six months. If approved for marketing by the FDA following priority review, the launch of OMAPRO™ would be scheduled for mid-2010.

Greg Collier PhD, ChemGenex’s Chief Executive Officer and Managing Director, said, "The submission of the NDA for OMAPRO™ is a major milestone in the development of this novel product and we are now one step closer to delivering a new treatment for patients in an area of unmet medical need. This submission is a significant achievement in our strategic goal to commercialize OMAPRO™ independently in the U.S. oncology market.”  
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 newly diagnosed 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 OMAPRO™ (omacetaxine mepesuccinate)

Omacetaxine 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 mepesuccinate 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 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