ChemGenex Pharmaceuticals Limited, an integrated biopharmaceutical development company, is a company we are working with that engages in the discovery and development of hematology and oncology drugs. We believe the Company is well-positioned in the oncology space and is developing two lead pipeline candidates, which are both in Phase 2/3 of development and they are OMAPRO? (omacetaxine mepesuccinate) and Quinamed? (amonafide dihydrochloride). ChemGenex' Management will be available to meet in NYC on Monday, February 14th.
ChemGenex (ASX: CXS, P=$0.49, MC=$139MM, Cash=$12.8MM, EV=$126M)
Generally, investors evaluate ChemGenex with respect to its lead pipeline candidate, OMAPRO (omacetaxine), a ribosomal A-site cleft inhibitor now in Phase III studies for CML patients who have failed 2 or more TKIs. An NDA filing is expected 2H11.
The original NDA for OMAPRO for the treatment of chronic myelogenous leukemia (CML) in patients with the Bcr-Abl T315I point went to an FDA Advisory Committee in March 2010.
The Advisory Panel recommended, and the FDA concluded that an FDA-approved companion T315I diagnostic would be required for OMAPRO approval.
FDA then advised ChemGenex to combine data from their 2 Phase II/III clinical trials and submit a new NDA for patients who have failed 2 or more TKIs (a broader population).
The new NDA (2 or more TKI failures) filing is expected in 2H2011.
OMAPRO has Orphan Drug Designation and Fast Track Status with the FDA (and EMA).
Similarly, a new MAA will also be submitted in parallel with the upcoming NDA filing.
Recently, ChemGenex welcomed Cephalon Inc. (CEPH) as a substantial investor.
Cephalon issued ChemGenex a A$15MM convertible note (9.6% ownership, $0.50 conversion price)
Cephalon retains an option to purchase up to 19.9% of ChemGenex common stock at A$0.70 from existing shareholders. The option can be exercised anytime before March 31, 2011 and 1 week after patient data collection and analysis.
Read-through of the deal term suggests that Cephalon may want to acquire more of ChemGenex if they like what they see.
ChemGenex is partnered with Hospira to commercialize OMAPRO in Europe, the Middle East and parts of Africa. ChemGenex has retained North American rights and is actively seeking partnership in other areas of the world.
The Company?s management will be accepting meetings on Monday (14th). Please respond directly through us.
All the best,
Michael Rice
Phone: 917 282 3242
Email: [email protected]
LifeSci Advisors LLC
www.lifesciadvisors.com
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