The JPMorgan Healthcare Conference currently under way in San Francisco is arguably the most important event of the entire year for the health-care sector. This is one of the rarest opportunities for biotechnology, pharmaceutical, and medical device companies to open up about where they've been and where they're headed, so it pays to take notice.
One of the presenting companies yesterday that I had a watchful eye on was Incyte (INCY 0.19%). Incyte's only drug currently approved by the Food and Drug Administration is Jakafi, a JAK1/JAK2 enzyme inhibitor that regulates blood and immunological functions and is licensed out to Novartis (NVS -0.55%) abroad. The FDA approved Jakafi in November 2011 to treat moderate to severe cases of myelofibrosis, or MF, a disorder of the bone marrow often characterized by a large spleen and bone pain.
Prior to Jakafi, very few treatments were available to MF patients and they were predominantly palliative in care -- Jakafi is attempting to change that. Of course, there are multiple other treatments waiting in the wings -- including a JAK2 inhibitor known as pacritinib, which Cell Therapeutics (CTIC) acquired from S*BIO, currently in late-stage trials; and YM BioSciences' (NYSEMKT: YMI) encouraging results from CYT387. Still, Jakafi is far and away the only viable treatment option for MF patients at the moment.
Unsurprisingly, Incyte spoke very briefly about its other drugs in development and focused solely on growing Jakafi as an honor student parent would talk endlessly about their child. The two key takeaways from Incyte's presentation are (1) that Incyte plans to focus on getting physicians to prescribe Jakafi earlier in the disease progression process and (2) that it needs to reinforce even more just how safe and effective the drug is.
Incyte's increased physician awareness starts with two recently completed long-term study trials known as Comfort 1 and Comfort 2. Both trials demonstrated better survival over competing therapies that physicians would consider for MF patients, leading Incyte to believe this data might encourage physicians to prescribe Jakafi to a wider audience of MF patients. Also, these studies examined the use of various dosage levels and found advantages to Jakafi and spleen size reduction without severe drops in hemoglobin even at low dose levels.
In relation to reinforcing Jakafi's safety, Incyte plans to focus on educating physicians about the differences between disease-induced cytopenias (low blood counts) and drug-induced cytopenias. Any irregularities in blood count caused by Jakafi are usually short-lived, speaking to the safety of the drug. Incyte plans to focus its efforts on the positive results demonstrated so far and expects physicians will respond by prescribing Jakafi more often.
When Incyte wasn't raving about Jakafi for MF -- which was few and far between -- it did note that its late-stage trial utilizing Jakafi for the treatment of polycythemia vera should deliver results in the latter half of this year with an expectation of a new drug application filing by the first-half of 2014 assuming all endpoints are met. It also has an ongoing mid-stage trial for Jakafi for the treatment of pancreatic cancer.
Incyte noted as well that its second JAK1/JAK2 inhibitor, baricitinib -- which is licensed out to Eli Lilly (LLY -0.64%) for the treatment of rheumatoid arthritis -- began its late-stage trial in November and looks poised to become a major player in the RA field assuming the data continues to meet its endpoints. Incyte has been exploring the idea of using baricitinib to treat psoriasis and diabetic nephropathy as well.
All told, the future is looking bright for Incyte. It'll need to capitalize on recent long-term safety data from its Comfort trials to demonstrate to physicians how safe and effective Jakafi is over longer dosing periods, while also balancing what could be a blockbuster in baricitinib on its plate. I'm going to continue to maintain a CAPScall of outperform on Incyte and fully expect the drugmaker to charge higher from here.
