Bristol-Myers Squibb Advances in Rheumatoid Arthritis and Cancer

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Bristol-Myers Squibb (NYSE: BMY  ) reported positive results for its little-known rheumatoid arthritis agent clazakizumab this week. Scientists found that clazakizumab in combination with generic methotrexate had better efficacy in reducing symptoms over methotrexate alone, and comparable or better results compared with AbbVie's (NYSE: ABBV  ) rheumatoid arthritis blockbuster Humira (adalimumab).

This is great news for Bristol, whose No. 1 drug, Plavix, has been under serious competition from generics since its patent expiry in May 2012. The platelet aggregation inhibitor, often used prophylactically against thrombosis (heart attack and stroke) was responsible for more than 33% of Bristol's total revenue the year prior to its patent expiry. The story becomes more dim this year as Plavix patents in the EU expire, exacerbating an already 65% decline in sales of Plavix.

Time is of the essence here, as Bristol's No. 2 drug, the antipsychotic Abilify, is also facing expiration of its U.S. patent and commercialization rights next year. Generic competition also is beginning for Bristol's hepatitis-B drug Baraclude, HIV therapies Sustiva and Reyataz, and cancer therapy Erbitux.

It is hardly "out with the old, in with the new" for Bristol, however. Eliquis, a blood thinner approved only last year, has yielded disappointing sales, far short of expected performance with sales of just $41 million.

Watch out, AbbVie?
Clazakizumab is a disease-modifying therapy that targets the inflammatory processes in rheumatoid arthritis, a chronic autoimmune disease most known for causing painful joint inflammation and deformity. Treatment is targeted with both pain-control and disease-modifying antirheumatic drugs, or DMARDs, the latter of which can mitigate the progression of the disease. Methotrexate is the most commonly used DMARD and usually first-line therapy, but has a nasty side effect profile as it is relatively non-specific. As such, targeted biological agents -- a class of drugs that include clazakizumab -- have been an interest for pharmaceutical development.

AbbVie's Humira and Roche's (NASDAQOTH: RHHBY  ) Actemra (tocilizumab) currently have prominent holds on that biologic therapies for biologics in rheumatoid arthritis. The most recent study of clazakizumab reported better efficacy at 24 weeks when used with methotrexate compared with Humira plus methotrexate. The study also showed a 23.3% remission rate for the methotrexate combination with clazakizumab versus a remission rate of only 8.5% with the Humira-methotrexate combo.

While Bristol's new agent would compete with both Humira and Actemra, Roche would face more direct competition. Actemra has few other uses besides rheumatoid arthritis and acts against the exact same target compound as clazakizumab. That's a $1.1 billion annually grossing pie that Bristol's drug would be chomping at.

Meanwhile, AbbVie's Humira both dominates the field of rheumatoid arthritis biologics and also actively enjoys efficacy in other ailments including psoriasis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and juvenile polyarticular arthritis. Rheumatoid arthritis often occurs in conjunction with those autoimmune ailments and, barring data indicating success of clazakizumab against those illnesses as well, providers may prefer to prescribe Humira for those patients with multiple rheumatologic diseases.

AbbVie may be in the more comfortable seat as far as competition against Humira, but it isn't sitting easy yet. It recently announced an $840 million partnership with Belgian company Ablynx to develop the next-generation rheumatoid arthritis drug. Currently, that agent is in phase 2 trials.

Coming down the pipeline
Clazakizumab is a lesser-known drug in Bristol's pipeline, and the announcement of its successful data came quick on the tail of a positive update on survival from its top prospect, PD-1 cancer agent nivolumab. Nivolumab had announced promising results in studies earlier this year, but announced an update last week of 24% two-year survival for non-small-cell lung cancer, a welcome improvement over a prior announcement of 14% two-year survival.

Both of these advances certainly will help make up the $10 billion expected loss in revenue from Bristol's expiring drugs. Nonetheless, Bristol beat estimates for earnings and sales for the third quarter. With a new drug application expected as early as next year for nivolumab and continued studies on clazakizumab, Bristol's future is bright.

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