Endo International has entered into an agreement with its partner, BioDelivery Sciences International (BDSI), a Raleigh, North Carolina-based specialty pharmaceutical company focused on pain and addiction, to return the pain-treatment product, Belbuca (buprenorphine) buccal film, to BDSI. As a result of this, Endo has also announced that it is eliminating its 375-member US branded pain-sales field force.

Financial terms of the agreement were not disclosed and are not material to Endo. Endo will not have any future royalty or milestone payments to BDSI, and BDSI is not obligated for any future royalty payments to Endo. The two companies had entered a licensing and development agreement for buprenorphine in January 2012, which was worth up to $180 million if all milestones were met.

With the return of Belbuca to BDSI, Endo believes it no longer requires field sales promotion and, as a result, is eliminating its branded pain-sales field force, which consisted of both full-time employees and contract sales representatives as well as internal support to the promoted pain business unit. Endo will focus efforts and resources more fully on its core US branded assets, including Xiaflex (collagenase clostridium histolyticum), which is indicated for treating adults with Dupuytren’s contracture with a palpable cord, and its cellulite development program. Endo’s legacy pain portfolio products, including Opana ER (oxymorphone hydrochloride extended release) and Percocet (acetaminophen; oxycodone hydrochloride), among others will be managed as mature brands.

Endo’s strategic actions are expected to result in restructuring charges of approximately $62 million, including a $40 million non-cash intangible asset impairment charge, and are expected to provide approximately $90 million to $100 million in annual run rate pre-tax gross cost savings in 2017. Endo anticipates a portion of these cost savings will be redeployed in 2017 to support its core franchises, including the pursuit of the development and approval of Xiaflex for cellulite following a recent announcement of positive Phase IIb data.

Belbuca buccal film is a buprenorphine formulation developed with a dissolving film that is absorbed through the inner lining of the cheek. The product is indicated 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.

Source: Endo International