UPDATE 2-Incyte's cancer drug meets study goal; eyes 2011 launch

Mon Dec 20, 2010 6:09pm EST

* 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 share movement)

BANGALORE, Dec 20 (Reuters) - 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 tissue fibers.

"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)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

A tourist takes a plunge as she swims at Ngapali Beach, a popular tourist site, in the Thandwe township of the Rakhine state, October 6, 2013. Picture taken October 6, 2013. REUTERS/Soe Zeya Tun (MYANMAR - Tags: SOCIETY) - RTR3FOI0

Where do you want to go?

We look at when to take trips, budget considerations and the popularity of multigenerational family travel.   Video