* NDA filing on-track for Q2 2011
* Expects to launch drug by the end of next year
* Sees a 6-month review from FDA
* Shares up 6 pct after-mkt
(Adds analyst's comments, conference call details, updates
BANGALORE, Dec 20 Incyte Corp (INCY.O) said its
experimental drug to treat a kind of blood cancer met the main
goal of a late-stage study, and it expects to launch the drug
by the end of next year, sending the company's shares up 6
percent after the bell.
Patients treated with the potential treatment for
myelofibrosis showed a highly statistical response rate -- 42
percent -- compared with less than one percent in patients
given a dummy drug.
Myelofibrosis is a condition in which abnormal bone marrow
stem-cells are produced, resulting in the growth of connective
"I think it is pretty much in line with what we expected,"
Oppenheimer & Co analyst Bret Holley said.
"We have high expectations going in and it looks like the
top line results certainly conform to those high expectations."
Following the study, COMFORT-I, which was conducted on a
special protocol agreement with the U.S. health regulators, the
company remains on track to file for marketing approval of the
drug in the second quarter of 2011.
The drug, INCB18424, will not need to be tested in another
late-stage trial to gain approval from the U.S. Food and Drug
Administration, the Wilmington, Delaware-based company said.
On a conference call, the company said it expects a
six-month review from the FDA as the drug has already received
both fast-track and orphan drug status.
Novartis AG NOVN.VX, which holds the rights to the drug
in territories outside the United States, is currently
conducting a late-stage study in Europe comparing Incyte's drug
to best available therapy.
Incyte's drug has orphan drug status from both the FDA and
the European Medicines Agency. Incyte shares, which have risen
10 percent since it signed the special protocol agreement on
Sept. 13, were up 6 percent at $16.10 in extended trade. They
closed at $15.18 on Monday on Nasdaq.
(Reporting by Vidya L Nathan and Anand Basu in Bangalore;
Editing by Roshni Menon)