Positive Results on Endo/BDSI Candidate


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).

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