FDA approves Incytes' Jakafi, first drug to treat MF; advisory panel backs Pfizer's Prevnar 13 for adults

USA-based Incyte (Nasdaq: INCY) saw its shares rise 10% to$13.90 on the news that the Food and Drug Administration had approved Jakafi (ruxolitinib), the first drug cleared to specifically treat patients with the bone marrow disease myelofibrosis (MF), ahead of the Prescription Drug User Fee Act (PDUFA) target date of December 3.

The drug is partnered with Swiss drug major Novartis (NOVN: VX), which acquired ex-USA commercialization rights for the compound in return for an upfront payment of $150 million (The Pharma Letter November 26, 2009). Incyte said it plans to launch Jakafi next week. The company said that Jakafi will cost $7,000 per month, or $84,000 for a year's supply for insured patients. Incyte plans to provide the drug free to uninsured patients and will offer co-pay assistance to patients with financial need.

No US sales projections for ruxolitinib have been reported. Novartis is aiming for annual sales in the MF indication of more than $500 million. However, the drug holds potential for turnover of $1 billion if its use is widened to include other indications such as polycythemia vera (PV), a rare blood disorder that in a very small number of cases can progress to leukemia, analysts have suggested (TPL: March 16).