$INCY Incyte Could Have a Problem (or 2!) on Its H

$INCY Incyte Could Have a Problem (or 2!) on Its Hands

Incyte Corporation's (NASDAQ: INCY) Jakafi is the only approved treatment for myelofibrosis, and that's turned Jakafi into a billion-dollar blockbuster drug. The company's enviable market position could be coming to an end, though, because two competing drugs are making their way toward the FDA.

Can Incyte maintain its dominance in this indication or will new drugs from Celgene (NASDAQ: CELG) and Geron Corp (NASDAQ: GERN) carve away at Jakafi's sales.



A big need for new treatment
Myelofibrosis is a tough-to-treat bone marrow disease with a poor prognosis and limited treatment options. It leads to an enlarged spleen, fatigue, and pain. Over time, it can turn into life-threatening leukemia.

The disease is characterized by decreased production of red blood cells in the bone marrow caused by scarring resulting from the overproliferation of abnormal cells. The only curative treatment is a bone marrow transplant; however, high mortality rates and complications make transplants risky for many people. As a result, thousands of patients are prescribed Jakafi, Incyte's $1.1 billion per year drug.

Jakafi's can keep JAK proteins that tell blood cells to divide and grow in check, but it's far from a perfect drug. In trials, Jakafi reduced spleen volume for many patients and overall survival was 63.5 months compared to 45.9 months for the control arm, but up to 75% of patients discontinue treatment within five years because of toxicity or intolerance.

A new option approaches
In January, Celgene acquired Impact Biomedicines to get its hands on fedratinib, a JAK inhibitor that's more selective than Jakafi.

Fedratinib was developed by Sanofi, but Sanofi shelved the drug in 2013 after the FDA halted clinical trials following reports of a few potential cases of Wernicke's encephalopathy (WE), an acute neurological condition. The trial halt was a big blow because fedratinib had already proven itself to be effective in both treatment-naive myelofibrosis patients and patients who had discontinued Jakafi.

Despite the FDA's decision, Sanofi researchers remained undaunted. In 2016, they founded Impact Biomedicines and secured the rights to fedratinib. Last fall, that gambit paid off after data the company submitted convinced the FDA to change its mind and lift its clinical hold.

With the FDA out of the way, Celgene acquired Impact Biomedicines earlier this year for $1.1 billion up front, plus future milestone payments.

Celgene plans to file fedratinib for FDA approval by the middle of 2018. It's anyone's guess if the FDA will approve it, but its efficacy suggests it may have a good shot, especially now that the FDA appears less concerned about its safety.

In trials, 55% of people who had discontinued taking Jakafi saw a reduction in spleen volume of 35% or more after taking fedratinib. Fedratinib also improved symptoms with 26% of patients achieving a 50% or greater reduction in total symptom score from their baseline score. Fedratinib was also effective in treatment-naïve patients. In phase 3 trials, 47% of patients saw a 35% or greater reduction in spleen size at 24 weeks and 36% of patients had a symptom score that improved by at least 50% at 24 weeks.