How an FDA Approval Changes the Game for Endo and BioDelivery Sciences

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Early Monday morning, Endo International PLC (NASDAQ: ENDP), in conjunction with BioDelivery Sciences International Inc. (NASDAQ: BDSI), announced that the U.S. Food and Drug Administration (FDA) approved their long-term opioid treatment, Belbuca. This drug is intended for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term treatment for which alternative treatment options are inadequate.

As a result of this approval, Endo now owes a milestone payment of $50 million to BioDelivery Sciences, pursuant to their 2012 worldwide license and development agreement for the commercialization of Belbuca.

Based on current operations and forecasts, BioDelivery Sciences estimates that this milestone payment will provide it with sufficient capital to operate its business through roughly the middle of 2017.

Dr. Andrew Finn, Executive Vice President of Product Development at BioDelivery Sciences, said:

Belbuca will provide a novel, alternative treatment option for millions of people suffering with chronic pain. Clinical trials demonstrated that twice daily administration of Belbuca was well tolerated and controlled moderate to severe chronic pain. Belbuca will also provide healthcare practitioners and their patients with a new buprenorphine treatment option. Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics.

Dr. Mark A. Sirgo, president and CEO of BDSI, said:

The FDA approval of Belbuca is a major milestone for BDSI and a tribute to the exceptional working relationship between the teams at Endo and BDSI. I want to thank all of our employees at BDSI for achieving our third product approval.

Shares of Endo closed Friday up 10% at $56.60, with a consensus analyst price target of $93.47 and a 52-week trading range of $46.66 to $96.58. In early trading indications on Monday, shares were down 1.5% at $55.75.

Shares of BDSI closed Friday up 1.9% at $5.28. The consensus price target is $17.20, and the 52-week trading range is $4.66 to $18.33. In early trading indications, shares were up 17.4% at $6.20.

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