Recently, Incyte Corporation (INCY) submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its lead candidate INCB18424 (ruxolitinib) for treating patients suffering from myelofibrosis (MF), a rare bone marrow disorder.
While submitting the application, Incyte requested the US agency to review it on a priority basis as MF currently has no approved therapy. The approval of this request would imply a six month review timeline as opposed to the normal ten month review period. We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy.
Approval has been sought on the basis of encouraging data from two late-stage COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy)- I (US trial) and COMFORT-II (European portion of the study). While Incyte was responsible for the COMFORT-I study, COMFORT-II was conducted by partner Novartis (). Incyte enjoys exclusive rights for the development and potential commercialization of INCB18424 in the US with Novartis having the same responsibility outside the US.
COMFORT-I was completed late last year. In December 2010, Incyte announced positive top-line data from the late-stage study in MF patients. Earlier in the year, positive data were presented from the COMFORT-II study, which revealed that there was significant reduction in spleen size in MF patients treated with INCB18424 compared to those treated with the best available therapy for MF. Detailed results from both studies were recently announced at the 2011 American Society of Clinical Oncology.
We believe the successful commercialization of the MF drug will be a path-breaking achievement for Incyte.
Our Recommendation
Currently, we have a Neutral stance on Incyte in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.
INCYTE CORP (INCY): Free Stock Analysis Report
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