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Incyte's Jakafi Gets FDA Approval for Polycythemia Vera

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Incyte Corporation’s (INCY) Jakafi gained FDA approval for the treatment of patients with polycythemia vera (PV.V) who have had an inadequate response to or are intolerant of hydroxyurea. This makes Jakafi the first and only product to be approved by the FDA for this indication.

Jakafi is already approved in the U.S. for the treatment of patients suffering from intermediate or high-risk myelofibrosis (:MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.

According to the press release issued by Incyte, PV affects nearly 100,000 patients in the U.S. alone, out of which roughly 25,000 patients are resistant to or intolerant of hydroxyurea. This makes Jakafi the only treatment which provides consistent hematocrit control, spleen volume reduction and complete hematological remission by targeting the overactive JAK pathway.

We are encouraged by the label expansion of Jakafi. Jakafi generated sales of $251.5 million in the first nine months of 2014 compared with $162.6 million in the first nine months of 2013. Meanwhile, Jakafi’s label expansion should boost sales over the long term. The company raised Jakafi’s net product sales guidance for 2014 to the range of $350 million to $360 million (old guidance: $330 million to $340 million).

We remind investors that Incyte has a collaborative agreement with Novartis (NVS) for the commercialization of Jakavi in ex-U.S. markets.

Meanwhile, Incyte is working on expanding Jakafi’s label further. Incyte is evaluating Jakafi in advanced or metastatic pancreatic cancer patients. Data from two phase III studies (JANUS 1 and JANUS 2) for this indication are expected in 2016. Additionally, baricitinib – a JAK1 and JAK2 inhibitor is being evaluated in rheumatoid arthritis patients with data expected in late 2014 or early 2015. Incyte is collaborating with Eli Lilly (LLY) for baricitinib.

Incyte currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is Biogen Idec Inc. (BIIB) carrying a Zacks Rank #1 (Strong Buy).

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