FDA cleared Incyte Corp.’s first-in class JAK1/JAK2 inhibitor ruxolitinib for treatment of myelofibrosis, making it the first approved therapy for the progressive bone marrow cancer and setting Incyte up for its first product launch, which is set to commence next week, the company announced Nov. 16.

The PDUFA date on the NDA was Dec. 3, making the approval a quick one, especially considering the application was granted a six-month priority review. In fact, the drug has been on a fast track for a while. The time between dosing of the first patient, in Aug. 2007, and the approval was approximately four years, CEO Paul Friedman pointed out during a same-day call with analysts.

Jakafi (JAK-ah-fye) is indicated for treatment of patients with intermediate or high-risk myelofibrosis, enabling treatment of patients classified as intermediate-1, though clinical trials supporting the NDA were limited to intermediate-2 and high-risk patients. The approvalincluded primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF, or approximately 80% to 90% of myelofibrosis patients, according to Incyte.It carries no boxed warnings and requires no REMS.

Labeling also includes patient-reported outcomes data showing that 68% of patients (45.9) in the ruxolitinib arm of the pivotal COMFORT-I trial experienced a 50% or greater reduction on a measure of symptoms by week 24 compared to 8% (5.3) patients in the placebo group. Incyte had argued to have the patient-reported data included because of the magnitude of the difference.

“We’re very pleased that after a thorough review of all the safety and efficacy data, the FDA accepted nearly all of our proposed labeling, indicating their agreement with both the importance and interpretation of the data,” Chief Medical Officer Richard Levy, said.

In myelofibrosis bone marrow is replaced by scar tissue, resulting in blood cells being made in organs such as the liver and spleen. Jakafi is an inhibitor of Janus-Associated Kinases 1 and 2, which are linked to the debilitating effects of the cancer. The company reported positive results from both the COMFORT I and COMFORT II trials at the American Society of Clinical Oncology meeting in June ([A#110615d1]) and Also see "Incyte's Grip On Myelofibrosis Tightens With Release Of Positive JAK Data, FDA Filing" - Pink Sheet, 7 June, 2011..

Company Anticipates Slow Uptake

The wholesale acquisition cost for a 30-day supply of Jakafi is $7,000, in line with other chronic cancer therapies, Incyte Chief Commercial Officer Patricia Andrews said.

The drug will be manufactured in five dosing strengths to give physicians flexibility, but all five are priced the same, Andrews said. The flat pricing is easier for payers and ensures patients get the optimal strength they need, she said.

Incyte announced during its October third-quarter earnings call that it was contracting with five specialty pharmacies to distribute the drug and that it had hired 60 experienced sales professionals to detail it to around 6,500 treating physicians.

Nonetheless, the company is anticipating a slow uptake curve. Physicians don’t see this cancer very often and when they do they may be leery of the new mechanism of action, Andrews acknowledged. Also, depending on the severity of their disease, patients may be in the office as often as monthly or as seldom as every three to six months, she added.

Incyte declined to make sales predictions until the commercial picture clarifies, but CFO David Hastings revised fourth quarter revenue guidance upward from $82 million to $92 million based on a $10 million milestone payment from Novartis AG, with which Incyte is partnered on the drug.

The launch phase is often a critical one in the capital markets for biotechs, so Incyte may be particularly keen on managing expectations Also see "Sell The Launch: Going Commercial, Some Biotechs Are Left Hanging" - Pink Sheet, 5 September, 2011..

Incyte’s Jakafi Gets Broad Label, Early Approval For Myelofibrosis

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