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