TAIHUA: Chinese biopharmaceutical - new to AIM

ingredient producers must be at a premium going forward

pharmas can't get the stuff out fast enough

the FDS fast track procedure is evidence of the need for experimental drugs


(TAIH supply homoharringtonine)


eg

use of Ceflatonin(R) (homoharringtonine, HHT) in patients with chronic, accelerated and blast-phase chronic myeloid leukemia (CML) who have the T315I bcr-abl point mutation. That mutation is associated with resistance to Gleevec(R) and other tyrosine kinase inhibitor therapeutics recently approved or known to be in development, and it is increasing in prevalence among patients with CML.


Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases where there is an unmet medical need. The Fast Track designation will enable ChemGenex to file a New Drug Application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process.

"The FDA decision to award Fast Track status to Ceflatonin(R) was based on recent clinical data and the high unmet need for new treatments for patients failing Gleevec(R) and Sprycel(TM)," said Greg Collier, Ph.D., Chief Executive Officer and Managing Director of ChemGenex. "As we enter the final stages of clinical development, with significant interest in our trials being conducted in both the United States and Europe, we look forward to collaborating closely with the FDA to expedite the development and approval of Ceflatonin(R)."