Positive Results on Endo/BDSI Candidate - Analyst Blog
January 24 2014 - 3:45PM
Zacks
Endo Health
Solutions (ENDP) and partner BioDelivery Sciences
International (BDSI) announced positive top-line results
from a phase III study on their chronic pain candidate, BEMA
buprenorphine in opioid naïve patients.
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
mid-2014.
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 year.
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 Actelion Ltd. (ALIOF)
and Affymetrix Inc. (AFFX). Both stocks carry a
Zacks Rank #1 (Strong Buy).
AFFYMETRIX INC (AFFX): Free Stock Analysis Report
ACTELION LTD (ALIOF): Get Free Report
BIODELIVERY SCI (BDSI): Free Stock Analysis Report
ENDO PHARMACEUT (ENDP): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Affymetrix (NASDAQ:AFFX)
Historical Stock Chart
From Sep 2024 to Oct 2024
Affymetrix (NASDAQ:AFFX)
Historical Stock Chart
From Oct 2023 to Oct 2024
Real-Time news about Affymetrix, Inc. (NASDAQ): 0 recent articles
More Affymetrix News Articles