RALEIGH, N.C., April 10, 2019 (GLOBE NEWSWIRE) -- 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.
ABOUT SYMPROIC
Symproic® (naldemedine) tablets 0.2 mg is indicated for the treatment of OIC in adult patients 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® was made available to patients in the U.S. in October 2017.
IMPORTANT SAFETY INFORMATION ABOUT SYMPROIC®
CONTRAINDICATIONS
Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
Patients with a history of a hypersensitivity reaction to Symproic. Reactions have included bronchospasm and rash.
WARNINGS AND PRECAUTIONS
Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with Symproic.
Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using Symproic in such patients. Monitor for symptoms of opioid withdrawal in such patients.
DRUG INTERACTIONS
Avoid use with strong CYP3A inducers (e.g., rifampin) because they may reduce the efficacy of Symproic.
Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase Symproic concentrations. Monitor for potential adverse reactions.
Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.
USE IN SPECIFIC POPULATIONS
Symproic crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Symproic should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Avoid use in patients with severe hepatic impairment. No dose adjustment of Symproic is required in patients with mild or moderate hepatic impairment.
ADVERSE REACTIONS
The most common adverse reactions with Symproic as compared to placebo in clinical trials were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).
In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for Symproic and 1% (3/546) for placebo. In Study 3 (52-week data), the incidence was 3% (20/621) for Symproic and 1% (9/619) for placebo.
To report suspected Adverse Reactions, contact Shionogi at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI's marketed products and those in development address serious and debilitating conditions such as chronic pain, breakthrough cancer pain, and opioid dependence. For more information, please visit us at www.bdsi.com or follow us on Facebook.com/BioDeliverySI or Twitter BDSI@BioDeliverySI.
ABOUT SHIONOGI
Shionogi & Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of supplying the best possible medicine to protect the health and wellbeing of the patients it serves. Shionogi Inc., the US- based subsidiary of Shionogi & Co., Ltd., continues this focus on the development and commercialization of high quality medicines that protect the health and well-being of the patients it serves. The company currently markets products in several therapeutic areas including anti-infectives, pain, cardiovascular diseases and gastroenterology. Its pipeline is focused on infectious disease, pain, CNS and oncology. For more information on Shionogi Inc., visit www.shionogi.com (https://www.shionogi.com/). For more information on Shionogi & Co., Ltd., visit www.shionogi.co.jp/en (http://shionogi.co.jp/en/).
