Endo Health Solutions
) and partner
BioDelivery Sciences International
) announced positive top-line results from a phase III study on
their chronic pain candidate, BEMA buprenorphine in opioid naïve
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Results from the study showed treatment with BEMA buprenorphine
provided significantly greater relief from chronic pain relief in
comparison to placebo. The companies intend to provide further
updates on their BEMA buprenorphine chronic pain program in
The positive outcome and the locking of the database from the
phase III study have triggered a $10 million milestone payment
for BioDelivery Sciences from Endo. Endo will pay another $10
million on the completion of the opioid experienced phase III
study, the locking of database of which is expected before
mid-2014. The successful completion of the second phase III study
will lead to a New Drug Application (NDA) submission late this
We remind investors that in Jan 2012, Endo inked a global license
and development agreement with BioDelivery Sciences regarding
BEMA buprenorphine. Per the terms of the deal, Endo 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 NDA
to the FDA, Endo Health will submit the marketing application to
the U.S. regulatory body.
We are encouraged by the positive top-line results from the first
phase III study. 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.
Endo Health currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
). Both stocks carry a Zacks Rank #1 (Strong Buy).