Chemgenex Update - Key Value Drivers Imminent Print E-mail
By Mike Rabe   
Friday, 06 November 2009 03:00

Back in July, I introduced BioMedReports readers to a little known Australian biotech company, Chemgenex (CXS.AX) (Nasdaq:CXSPY).  Chemgenex is an Australian pharmaceutical company developing personalized oncology medicines.

You can read my July article here: http://biomedreports.com/articles/most-popular/2278-chemgenex-pharma-otccxspy-late-stage-pipeline-low-price.html

 

Since my July article, Chemgenex has filed its NDA with the FDA (in September), which was reported by BMR.

 

Very soon (expected this month) the FDA is expected to make a decision on whether OMAPRO™, Chemgenex’s lead drug, is eligible for Priority Review.  Receiving Priority Review can shorten the average amount of time from application to a decision by the FDA on whether to approve the drug for sale, from ten months to six months.  Granting of Priority Review would significantly accelerate market launch and expected revenues.

 

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.

For additional information on ChemGenex Pharmaceuticals, please visit the company’s website at http://www.chemgenex.com.

If the FDA approves OMAPRO™ in 1H 2010 (could come as early as March), Chemgenex should begin to see major revenues in mid-2010.


Chemgenex expects to file its MAA with the EMEA (European Medicines Agency) for OMAPRO™  toward the end of the year.  The latest buzz in Australian biotech circles is that a partnering deal for the European market could come before Christmas.  Chemgenex will go it alone for the U.S. market, but a deal with a partner for the European market will reduce the need for additional capital to be raised to fund the US launch later in 2010.

 

The Company expects to have approval and commercial launch for OMAPRO™ in Europe by Q4 2010.  By this time next year, Chemgenex could have substantial revenue streams from OMAPRO™ in the two largest pharmaceutical markets in the world.

 

Chemgenex’s stock on the Australian market has been on a run in recent days.  However, Chemgenex’s ADR (CXSPY) has been in a slumber the past few weeks.  That will not last long and it provides an opportunity for keen investors in the U.S.

 

For those considering a biotech with strong upside potential for 2010, you might want to take a close look at Chemgenex.  In terms of risk/reward ratios, I currently give Chemgenex one of my highest ratings.

 

Disclosure: Long Chemgenex




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