) and partner
) presented encouraging data from a phase III study (n=447) which
compared the efficacy of their type II diabetes candidate,
dapagliflozin (10 mg), to placebo.
The study evaluated adults whose disease was inadequately
) Januvia either as a monotherapy or in combination with metformin.
Results from the multicenter, randomized, double-blind,
placebo-controlled, parallel-group 48 week (including an extension
period of 24 weeks) study were presented at the American Diabetes
Results from the study revealed that patients treated with the
dapagliflozin and Januvia (with or without metformin) combination
experienced a significant reduction in blood sugar levels compared
to those in the placebo plus Januvia (with or without metformin)
arm at the end of 24 weeks. Similar results were obtained at the
end of 48 weeks. Moreover, patients in the dapagliflozin arm also
experienced a significant reduction in their body weight and the
levels of fasting plasma glucose compared to those in the placebo
We note that dapagliflozin is one of the most interesting
candidates in Bristol-Myers' pipeline. The regulatory paths for
dapagliflozin have been quite diverse as far as approval in the US
and EU is concerned. While the candidate received a complete
response letter (CRL) in the US in January 2012, the Committee for
Medicinal Products for Human Use of the European Medicines Agency
(EMA) issued a positive opinion regarding the approval of
dapagliflozin in the EU in April 2012. Dapagliflozin will target
the highly lucrative type II diabetes market once approved.
Even though pleased with the positive data on dapagliflozin a,
we believe that investor focus will remain on how Bristol-Myers
fares following the US loss of exclusivity of its blockbuster blood
thinner Plavix on May 17, 2012.
Bristol-Myers has co-developed Plavix with
). The loss of exclusivity is likely to result in substantial
revenue losses for Bristol-Myers. Companies such as
Dr. Reddy's Laboratories
) have already launched their respective generic versions of the
Bristol-Myers is looking to combat the generic threat through
partnering deals and acquisitions. Apart from acquisitions and
partnership deals, Bristol-Myers is looking to introduce new
products to augment its product portfolio to combat the generic
threat. Bristol-Myers has met with a fair amount of success towards
achieving this objective. Many new products were launched/ approved
in 2011. We expect Bristol-Myers to continue introducing new
products throughout 2012.
We currently have a Neutral recommendation on Bristol-Myers. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
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