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FDA Approval of BELBUCA™ (CIII) (Buprenorphine HCl) Buccal Film for Chronic Pain Triggers Milestone Payment of $50 Million to BioDelivery Sciences from Partner Endo Pharmaceuticals

RALEIGH, N.C., Oct. 26, 2015 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) and its partner Endo Pharmaceuticals Inc. (Endo), a subsidiary of Endo International plc (ENDP) (ENL.TO), announced earlier today that the U.S. Food and Drug Administration (FDA) approved BELBUCA™ (CIII) (buprenorphine HCl) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. FDA approval of BELBUCA has triggered a milestone payment to BDSI from Endo of $50 million pursuant to the 2012 worldwide license and development agreement between BDSI and Endo for the development and commercialization of BELBUCA.

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It is anticipated that BELBUCA may become commercially available in the U.S. during the first quarter of 2016, which may trigger additional milestone payments from Endo in the future if certain sales milestones are met. BDSI may also be entitled to receive tiered royalties on net sales of BELBUCA that start in the mid-teens.

Based on current operations and forecasts, BDSI estimates that the $50 million dollar milestone payment from Endo, when combined with current cash on hand, provides BDSI with sufficient capital to operate its business to approximately the middle of 2017.

"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," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.

"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," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.

Dr. Niraj Vasisht, Senior Vice President of Product Development and Chief Technical Officer at BDSI added, "Our patented BEMA delivery technology has enabled efficient and effective delivery of buprenorphine across the buccal mucosa and the seven approved dosages of BELBUCA will allow physicians to individualize titration and treatment based on the patient's analgesic needs."

INDICATION
BELBUCA™ (buprenorphine) buccal film 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.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA™ for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • BELBUCA™ is not indicated as an as-needed (prn) analgesic.

IMPORTANT SAFETY INFORMATION about BELBUCA™

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse
BELBUCA™ exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing BELBUCA™, and monitor patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA™. Monitor for respiratory depression, especially during initiation of BELBUCA™ or following a dose increase. Misuse or abuse of BELBUCA™ by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.

Accidental Exposure
Accidental exposure to even one dose of BELBUCA™, especially by children, can result in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal Syndrome
Prolonged use of BELBUCA™ during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

CONTRAINDICATIONS

BELBUCA™ is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity (eg, anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse

  • BELBUCA™ contains buprenorphine, a Schedule III controlled substance. As an opioid, BELBUCA™ exposes users to the risks of addiction, abuse, and misuse.
  • Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing BELBUCA™, and monitor all patients receiving BELBUCA™ for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed BELBUCA™, but use in such patients necessitates intensive counseling about the risks and proper use of BELBUCA™, along with intensive monitoring for signs of addiction, abuse, or misuse.
  • Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BELBUCA™ and in those who obtain the drug illicitly. Addiction can occur at recommended...

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