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Chemgenex Update - Key Value Drivers Imminent PDF | Print | E-mail
Written by Mike Rabe
Friday, 06 November 2009 00:00

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.

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.

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