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Bristol-Myers Squibb Company (BMY - Analyst Report) recently presented encouraging long-term data from a phase IIIb study (AMPLE: n=646) on its rheumatoid arthritis (RA) candidate Orencia. Results were presented at the annual meeting of the European Congress of Rheumatology held in Spain.
The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc.’s (ABBV - Analyst Report) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. The US Food and Drug Administration cleared the subcutaneous formulation of Orencia in 2011. Only the intravenous version was available prior to that.

According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie’s RA therapy. Data from the second year of the study was found to be non-inferior to the results obtained in the first year. We note that in the first year, the study met its primary endpoint as measured by non-inferiority of atleast 20% reduction in the disease symptoms. The measure is known as American College of Rheumatology (ACR) 20.

Moreover, 85% patients in the Orencia arm achieved radiographic non-progression at 2 years compared to 84% in the Humira arm. Furthermore, the overall safety profile was also found to be consistent across both cohorts.

We note that Orencia is marketed for treating adults suffering from moderate-to-severe RA, who have responded inadequately to one or more available therapies for the disease. Approval as a first-line therapy would boost Bristol-Myers’ top line further.

We believe that the encouraging long-term data on Orencia is good news for Bristol-Myers, which is looking to combat the loss of revenues due to the genericization of Plavix by introducing new products and signing deals/making acquisitions. Moreover, the threat of genericization looms over many other key drugs at Bristol-Myers.

Bristol-Myers carries a Zacks Rank # 3 (Hold). Companies such as Biogen Idec Inc. (BIIB - Analyst Report) and Jazz Pharmaceuticals Public Limited Company (JAZZ - Analyst Report) appear to be favorably placed with a Zacks Rank #1 (Strong Buy).

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