Incyte Drug Nails Phase III Trial (again)

Delawareonline, Written By: Jonathan Starkey, March 15, 2011

Incyte’s experimental blood cancer treatment, ruxolitinib, has delivered in another Phase III trial, this one led by co-developer Novartis in Europe.

The drug, which could become the first approved treatment for myelofibrosis and Incyte’s first drug on the market, significantly shrank patients’ spleen size in the study. Enlarged spleens, which can cause pain by crowding out other organs, is a hallmark sign of the deadly disease. We wrote in January that the drug could be a gamechanger for Alapocas-based Incyte.

Incyte is preparing an application to submit to the U.S. Food and Drug Administration seeking approval to market the drug. Approval is expected by the end of this year, and Incyte is preparing to beef up its sales and customer relations teams.

Analysts expect ruxolitinib, previously known as INCB18424, could generate $900 million for Incyte by 2016. Novartis, a Swiss drugmaker, purchased marketing rights outside of the U.S. in a November 2009 deal that could be worth more than $1 billion. That deal included $210 million up front.

In December, Incyte said that the drug met its primary endpoint in another Phase III clinical study involving 309 patients in more than 100 sites in the U.S., Australia and Canada.