Incyte's Jakafi Fails to Provide RELIEF in Polycythemia Vera
Incyte Corporation (INCY) announced disappointing top-line results from the phase III RELIEF study (n=110) on Jakafi in the polycythemia vera (PV.V) indication. The RELIEF study is evaluating PV patients treated with Jakafi in comparison to those being treated with hydroxyurea.
Results revealed that a significant proportion of patients treated with Jakafi failed to achieve more than 50% reduction in a defined cluster of symptoms including tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 from baseline. Consequently the study did not meet its primary endpoint. Jakafi treated patients managed to show a 43.4% symptom response rate compared to a symptom response rate of 29.6% in the hydroxyurea arm.
Last month, the company had submitted a supplemental New Drug Application (sNDA) for Jakafi in the U.S. for the PV indication based on positive results from the RESPONSE study also announced in June. (Read more: Incyte Gains on Positive Jakafi Data).
Incyte stated that if approved, Jakafi will be the first JAK1/JAK2 inhibitor to be available for patients suffering from PV. We note that Jakafi was launched in the U.S. in Nov 2011 for treating patients suffering from intermediate or high-risk myelofibrosis (:MF). Jakafi contributed around $69.7 million to Incyte’s top line in the first quarter 2014, representing an increase of 44% from the year-ago quarter.
Incyte has a collaborative agreement with Novartis (NVS) to market Jakafi outside the U.S. The drug has also been approved by the European Commission to treat adults suffering from primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF.
Our Take
Although Jakafi’s sNDA submission was based on the results from the RESPONSE study, disappointing data from the RELIEF study will be a matter of concern for Incyte as far as Jakafi’s PV indication is concerned. Currently, Incyte is primarily dependent on the success of its only approved product, Jakafi. Successful label expansion of the drug will boost sales. However, any setback in the process will also weigh heavily on the stock.
Incyte, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Some other stocks worth considering in the same sector include The Medicines Co. (MDCO) and BioMarin Pharmaceutical Inc. (BMRN). While The Medicines Company carries a Zacks Rank #1 (Strong Buy), BioMarin holds a Zacks Rank #2.
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