Bristol-Myers Squibb's New Psoriasis Drug Has Echoes of Humira
- By Matt Winkler
Could Bristol-Myers Squibb (BMY) be the one to come out with the next Humira? Probably not, but its new drug candidate for plaque psoriasis BMS-986165 at least has a shot to come within the same ballpark. For shareholders, that may be enough.
How did Humira get to be the best-selling drug of all time, and why should Bristol-Myers' new candidate dare at all compare? Well, Humira was the very first fully human monoclonal antibody to ever be approved by the FDA, hence its trade name Humira. It had a huge head start in a market that would soon become saturated with competitors. More importantly than being first though, Humira is prescribed for so many common and lucrative indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis and others.
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Bristol-Myer's new drug BMS-986165 has the potential, eventually, to be approved for a litany of lucrative indications as well. Newly released results for the drug, a tyrosine kinase 2 (TYK2) inhibitor for plaque psoriasis, knocked it out of the park. Seventy-five percent clearance of plaque psoriasis was achieved in 67-75% of patients compared to only 7% for placebo, giving a P-value of less than 0.001. Twenty-five percent on the highest dose achieved 100% clearance of symptoms. Serious adverse events were only three in the active arm and two in placebo out of 267 patients enrolled, so safety is not an issue so far.
The psoriasis market by itself won't bring BMS-986165 to near the level of Humira. That market is worth about $20 billion, and plaque psoriasis specifically much less, but the drug has much more potential than just plaque psoriasis. For one, TYK2 inhibitors like BMS-986165 have shown promise for lupus patients, a common autoimmune disorder that attacks the kidneys, another $3 billion market.
They have also shown promise for acute lymphoblasic leukemia (ALL) patients, another $3.4 billion market, which opens the door to the oncology sector. Early research has also shown evidence of effectiveness against rheumatoid arthritis, Humira's bread and butter market. It's too early to tell just yet, but TYK2 inhibitors may also have a better safety profile than Humira.
How would an approval affect Bristol-Myers here? The pharma giant currently has four blockbusters, and its top three best sellers account of 70% of its top line. Its best seller is Opdivo, the immune checkpoint inhibitor at $1.6 billion last quarter. The effect of one more blockbuster on its list could be significant, and this new TYK2 drug could achieve that by the middle of next decade.
Bristol-Myers will need another blockbuster to keep trending higher, its stock being stuck in a rut for four years now. Phase III registrational trials for BMS-986165 are now enrolling, scheduled for completion by mid 2020.
Depending on how you want to categorize its mechanism of action exactly, BMS-986165 could be considered the first TYK2 inhibitor on the market if approved. TYK2 is a specific type of receptor in the Janus kinase (JAK) family and there are other JAK drugs available like Incyte's (INCY) Jakafi already approved, so there is debate as to whether this would be the first of its kind. In any case, while we may not be looking at the next Humira exactly, we could be looking at something of a similar order over time, and with a much longer patent shield.
Disclosure: No positions.
This article first appeared on GuruFocus.
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