Endo Health Solutions
) and partner
BioDelivery Sciences International
) recently provided an update on the development of their chronic
pain candidate BEMA Buprenorphine which is undergoing phase III
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The interim analyses, conducted by an independent
biostatistician, determined whether adjustments to the original
sample size were needed for the maintenance of appropriate study
power in order to find statistically significant differences
between BEMA Buprenorphine and placebo.
The companies stated that they have completed the interim
analyses of two phase III studies on the candidate. While one of
the studies involved opioid naive patients, the other evaluated
opioid experienced patients. The interim analysis of the study on
opioid naïve patients revealed that no adjustments in the sample
size were necessary and the original assumptions regarding sample
size were appropriate. With the interim analysis not revealing
the need for additional patients, the companies expect data from
the study in early 2014.
The interim analysis of the phase III study on opioid experienced
patients, however, revealed the need for additional patients to
be enrolled. Consequently, the companies do not expect the study
to be completed before mid-2014. However, U.S. approval for BEMA
buprenorphine is still expected to be sought in the second half
We remind investors that in Jan 2012, Endo Health inked a global
license and development agreement with BioDelivery Sciences
regarding BEMA buprenorphine. Per the terms of the deal, Endo
Health is responsible for the manufacturing, distribution and
commercialization of BEMA Buprenorphine on a worldwide basis.
While BioDelivery Sciences will be responsible for the
development of the candidate leading to the submission of the new
drug application to the FDA, Endo Health will submit the
marketing application to the U.S. regulatory body.
The successful development and subsequent commercialization of
BEMA Buprenorphine would be a big positive for Endo Health which
is struggling with its pain franchise with two of its lead
painkillers, Opana ER and Lidoderm facing/likely to face generic
competition. While sales of Opana ER are already on the decline
due to generic competition, Lidoderm will be facing the same from
) shortly. We note that the pain market boasts of big players
Endo Health currently carries a Zacks Rank #3 (Hold). Actavis
appears to be more attractive with a Zacks Rank #2 (Buy).