Incyte (NASDAQ:INCY), a Wilmington, Delaware-based biotechnology company has received approval from the U.S. Food and Drug Administration for its drug Jakafi, the first approved drug to treat myelofibrosis, a bone marrow disease in which bone marrow is replaced with scar or fibrous tissue affecting the production of new blood cells.
Although it is characterized as an orphan drug treating a disease affecting less than 200,000 people, Jakafi, or ruxolitinib, is the first in a class of drugs known as JAK inhibitors to receive FDA approval. JAK inhibitors are being used in clinical trials to treat cancer and inflammatory diseases, and the FDA’s move to approve Jakafi could lead to other JAK inhibitors receiving the green light, particularly for rheumatoid arthritis.
The New York Times’ Prescriptions blog noted JAK inhibitors block the action of proteins called Janus-associated kinases, which are involved in signaling cells.
Pfizer’s drug tofacitinib, a JAK inhibitor, will be used to treat rheumatoid arthritis, a market it says is projected to grow 50 percent from 2010 to 2015. It may be approved as early as 2012.Sanofi-Aventis (NYSE:SNY) also has a JAK inhibitor in mid-stage clinical development.
In November 2009, Incyte agreed to sell Novartis, the ex-U.S. development rights for Jakafi, or ruxolitinib, for an up-front payment of $210 million and potentially $1.1 billion in developmental and commercialization milestone payments along with royalties. The next month, Incyte signed a lucrative deal with Eli Lilly for the development and commercialization of Incyte’s oral JAK1/JAK2 inhibitor, INCB28050, and certain follow-on compounds, for inflammatory and autoimmune diseases in exchange for an initial $90 million and up to $665 million for potential development, regulatory and commercialization milestones and royalty payments.
Although the twice-daily drug’s cost at an estimated $85,000 per year, its rheumatoid arthritis treatment could produce significantly larger sales, bringing Incyte an estimated $1.8 billion in royalties.