Endo/BioDelivery File Regulatory Application for Pain Drug

Zacks

Endo International’s (ENDP) subsidiary Endo Pharmaceuticals Inc. along with its partner BioDelivery Sciences International, Inc. (BDSI) announced the submission of a new drug application (NDA) to the FDA for buprenorphine HCl buccal film. The companies are looking to get buprenorphine HCL buccal film approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

We note that buprenorphine HCl buccal film is being developed using BioDelivery’s patented BioErodible MucoAdhesive (BEMA) drug delivery technology and will be commercialized through a global license and development agreement between Endo and BioDelivery.

Our Take

We are pleased with the pipeline progress at Endo. Endo has been struggling financially due to generic competition affecting its key painkillers Lidoderm (pain associated with post-herpetic neuralgia) and Opana ER (chronic severe pain). Approval of new drugs will not only help Endo to offset the impact of genericization with but will also help to diversify its portfolio.

In Oct 2014, Endo announced that it is set to acquire Auxilium Pharmaceuticals Inc. (AUXL) for $2.6 billion ($33.25 per share) in cash as well as stock. The acquisition is expected to close by the first half of 2015 and be immediately accretive to Endo’s earnings following the closure. With the addition of Auxilium Pharma’s products, Endo can diversify its business in areas like urology and orthopedics (read more: http://www.zacks.com/stock/news/149909/endo-to-buy-auxilium-for-26b-diversify-portfolio).

Endo carries Zacks Rank #2 (Buy), while BioDelivery is a Zacks Rank #4 (Sell) stock. A better-ranked stock in the health care space is Amgen Inc. (AMGN) sporting a Zacks Rank #1 (Strong Buy).

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