BioDelivery Sciences (BDSI) Acquires U.S. Commercial Rights to Symproic

BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain, today announced that it has entered into an exclusive licensing agreement with Shionogi, Inc., to commercialize Symproic® (naldemedine) tablets 0.2 mg in the United States and Puerto Rico effective immediately. Symproic is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Symproic is a comprehensively studied OIC product with seven global Phase III clinical trials and received the highest category of endorsement from the American Gastroenterological Association in patients with laxative-refractory OIC.

It is estimated that approximately 40% - 60% of adults with chronic non-cancer pain on non-buprenorphine based opioid therapy will experience OIC, making it one of the most commonly reported side effects in this patient population and can significantly interfere with the appropriate management of chronic pain. Symproic has the potential to become a leading therapy option for OIC given its proven clinical profile and differentiation.

“We are very excited to add Symproic to our commercial portfolio of highly differentiated products for patients suffering from chronic pain and its associated conditions,” stated Herm Cukier, CEO of BDSI. “The product fits very synergistically both strategically and operationally with BELBUCA® (buprenorphine buccal film) CIII, enabling us to leverage our existing commercial organization and capabilities. We are confident Symproic has the potential to become a leading treatment option for OIC and expect to see an accretive contribution to cash flow in the first half of 2020.”

Under the terms of the agreement, BDSI will pay Shionogi, Inc., an initial payment of $20 million and an additional $10 million in six months. In addition, Shionogi is eligible to receive tiered royalty payments based on Net Sales of Symproic.

With the addition of Symproic, the company expects the long-term net sales potential of its product portfolio to be in the range of $325 - $400 million. Additionally, the company has reaffirmed its expectation to become operating cash flow positive by the end of 2019.

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