Novartis, Incyte ready worldwide apps as cancer drug clears Ph3

An experimental JAK inhibitor under development at Novartis and Incyte hit its primary endpoint in a second late-stage trial, putting the program on track to a second quarter NDA and a possible launch later this year. Novartis says that INC424, or ruxolitinib, significantly reduced spleen size in patients suffering from myelofibrosis--a rare type of blood cancer--compared to a group receiving standard therapy.

The Novartis data confirm the results of a separate Phase III study Incyte ($INCY) conducted earlier. And it represents the final stage of a lengthy series of studies that now leaves the program on the threshold of a likely worldwide roll-out. Novartis stepped in to snap up ex-US rights in the fall of 2009, offering more than $1 billion in milestones for the program and anteing up $150 million in upfront cash.

Analysts point out that the drug isn't likely to rack up big sales for the rare cancer condition. But Novartis prefers to push through to an approval for a narrow market and then try to expand through new indications. The mother lode market for JAK inhibitors lies in rheumatoid arthritis, which is Pfizer's target for a similar drug dubbed tofacitinib.

"INC424 illustrates our mission to turn the promise of innovative, pathway-based compounds into the reality of therapies for patients with unmet medical needs," said Hervé Hoppenot, president of Novartis Oncology.

- read the Novartis release
- get the story from the Wall Street Journal
- here's the story from Reuters