Bristol-Myers Squibb Company
(
BMY
) and partner
AstraZeneca
(
AZN
) recently presented data from a late-stage study which evaluated
their candidate dapagliflozin in adults suffering from type II
diabetes over 48 weeks.
Data from the randomized, parallel-group, double-blind,
placebo-controlled study revealed that treatment with the
combination of dapagliflozin and glimepiride resulted in similar
reduction in blood sugar levels over 48 weeks as was observed over
24 weeks. Results from the 24-week study were presented in
2010.
The study was extended by 24 weeks to evaluate the maintenance
of efficacy, as well as safety and tolerability of the combination
of dapagliflozin and glimepiride, over 48 weeks, in type II
diabetes patients versus placebo and glimepiride.
Patients treated with the combination of dapagliflozin and
glimepiride also demonstrated reductions in fasting plasma glucose
levels, post-prandial glucose and total body weight over 48
weeks.
We remind investors that dapagliflozin is currently under review
both in the EU as well as in the US for the treatment of type II
diabetes. Originally, the US Food and Drug Administration (FDA) was
scheduled to decide on the fate of dapagliflozin by October 28,
2011 (action date). However, the action date was pushed back to
January 28, 2012 since the agency needed more time to review the
additional data demanded by it.
We note that dapagliflozin would target a highly lucrative
diabetes market on approval. The market offers significant
commercial potential. Moreover, the incidence of diabetes is
on the rise, thanks to the rise in the aging population and also
obesity.
So far in 2011, it is estimated that approximately 365 million
people aged between 20 - 79 years have been affected by diabetes
across the globe. The affected population is expected to exceed 550
million by 2030. Type II diabetes accounts for bulk of the diabetes
cases diagnosed.
However, dapagliflozin would face competition from big players
like
Merck & Co.
(
MRK
) and
Novo Nordisk
(
NVO
). Moreover, other therapies for type II diabetes are under
development. Consequently, we prefer to remain on the sidelines
with a Neutral view on the stock until dapagliflozin gets approved
and starts delivering. The stock carries a Zacks #3 Rank
(short-term "Hold" rating) in the short- run.
BRISTOL-MYERS (
BMY
): Free Stock Analysis Report
MERCK & CO INC (
MRK
): Free Stock Analysis Report
NOVO-NORDISK AS (
NVO
): Free Stock Analysis Report
Zacks Investment
Research