Bristol-Myers takes shot at Humira as arthritis drug aces Phase IIb

Bristol-Myers Squibb's little-discussed rheumatoid arthritis drug clazakizumab posted strong results in a mid-stage study, meeting its endpoints, notching promising remission data and stirring hopes that the treatment can compete with AbbVie's blockbuster Humira.

In a study on 418 patients, Bristol-Myers' ($BMY) clazakizumab combined with generic methotrexate reduced RA symptoms by 20% in about 78% of patients, far better than the 39.3% for methotrexate alone and roughly equal to the 76.3% of patients who benefited from Humira coupled with the generic. And clazakizumab's benefits only increased over time: By week 24, Bristol-Myers' drug combo reduced symptoms by 70% or more in 38.3% while the cocktail from AbbVie ($ABBV) did so for just 18.6%.

But where the drug really has a chance to differentiate itself is in remission rates, investigator Paul Emery said, and clazakizumab plus methotrexate posted 23.3% compared to Humira's 8.5% when similarly paired.

"There is a great need for additional disease-modifying therapies that can provide more patients with deep and sustainable remission, helping preserve function and limit further joint damage," Emery said in a statement. "Currently, less than 30% of RA patients experience sustained remission as defined by (American College of Rheumatology) criteria."

If those data are enough to convince the FDA, Bristol-Myers, despite its of-late focus on immuno-oncology, could end up with a contender in the multi-billion-dollar RA market, something the New York heavyweight could use as generics rend Plavix sales and the launch of Eliquis lags. And combined with its latest upbeat report on nivolumab, the company's shares shot up a hefty 6% Monday morning.

The drug, which Bristol-Myers licensed from Alder Biopharmaceuticals in 2009, is an anti-IL-6 monoclonal antibody, working to block pro-inflammatory cytokine and halt the effects of RA. Alder, a 2010 Fierce 15 winner, is due up to $1.1 billion in the deal, getting $85 million upfront and signing up for as much as $764 million in development milestones, $200 million in sales goals and a cut of royalties.

Aside from the behemoth Humira, clazakizumab would face stiff competition from Roche's ($RHHBY) Actemra, a drug with $1 billion in annual sales that targets the same cytokine, and AbbVie is forking out up to $840 million to Ablynx with its eye on an IL-6 therapy of its own, a drug now in Phase II.

- read the study results

Special Report: FierceBiotech's 2010 Fierce 15 | Alder Biopharmaceuticals

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