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How Did Incyte’s Jakafi Perform in the US?

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Jakafi

As discussed earlier, Incyte’s (INCY) Jakafi is the only FDA-approved drug for the treatment of myelofibrosis and polycythemia vera, both of which are rare types of blood cancer. Incyte sells the drug on US markets and has entered a collaboration with Novartis (NVS) for the commercialization of the drug outside US markets. Incyte receives royalties for drug sales outside the US markets.

During 3Q16, the revenues for Jakafi rose over 39% to $223.9 million as compared to $161.3 million in 3Q15 revenues. These revenues are reported from the sales in US markets. The increase in revenues is because of volume growth as well as price increases for the drug in 3Q16. The above chart shows revenues for Jakafi over the last few quarters.

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Other details about Jakafi

  • Jakafi, Incyte’s first product, has been approved for sale in US markets.
  • The company has patents that cover the composition of matter and the use of Jakafi through November 2026. Extensions have been granted for these patents through late 2027.
  • The FDA has granted orphan drug status to Jakafi for myelofibrosis, polycythemia vera, and thrombocythemia.
  • On December 30, 2016, Incyte announced the first patient was treated in REACH-1, the pivotal clinical trial for Jakafi for the treatment of patients with acute graft-versus-host (or GVHD) disease. In June 2016, the US FDA granted “Breakthrough Therapy” designation to Jakafi for GVHD.
  • On September 27, 2016, the National Comprehensive Cancer Network (or NCCN) clinical practice guidelines in oncology recommended Jakafi for the treatment of myelofibrosis.
  • Jakafi is the first FDA-approved Janus-associated kinases (or JAK) inhibitor for any indication. It is an oral JAK1 and JAK2 inhibitor.
  • The FDA approval was based on the two phase III studies, Comfort-I and Comfort-II, demonstrating significant reductions in splenomegaly (or enlarged spleen) through the use of Jakafi.
  • The company has established a patient assistance program called IncyteCARES where “CARES” stands for “Connecting to Access, Reimbursement, Education and Support.”

Investors can consider ETFs like the iShares Nasdaq Biotech ETF (IBB), which holds ~3.4% of its total assets in Incyte, 8.9% in Celgene (CELG), 8.3% in Gilead Sciences (GILD), and 3.8% in Mylan (MYL).

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