PR Newswire
RALEIGH, N.C., Dec. 8, 2016
RALEIGH, N.C., Dec. 8, 2016 /PRNewswire/ --BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has entered into an agreement with Endo Pharmaceuticals, Inc. (Endo) terminating their licensing of rights for BELBUCA™ (buprenorphine) buccal film. This transaction follows a strategic decision made by Endo regarding their U.S. branded pain business.
As a result of the agreement, the world-wide rights to BELBUCA will be transferred back to BDSI. While specific financial terms of the agreement have not been disclosed, the total cost of the transaction to BDSI will not materially impact BDSI's cash flow going forward. Furthermore, BDSI will not be responsible for future royalties or milestone payments to Endo, and Endo will not be obligated to any future milestone payments to BDSI. The agreement goes into effect on January 6, 2017.
The return of BELBUCA immediately adds additional topline revenue and is expected to be accretive by improving BDSI's net income and earnings per share in 2017. The recent annual run-rate for BELBUCA gross sales exceeds $27 million based on the most recent available monthly sales data.
"We respect Endo's strategic decision regarding its U.S. branded pain portfolio and appreciate its role in bringing BELBUCA to the market," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "While this change in direction is not what we originally envisioned for BELBUCA, Endo has laid a significant foundation for BELBUCA, and in so doing, has created a significant opportunity for BDSI. We recognize the hard work put forth by both companies since we entered our licensing and development agreement in 2012, and we appreciate the exceptional working relationship that has existed. We look forward to Endo's support behind the upcoming transition."
While BDSI plans to provide additional details on its commercial plans for BELBUCA at an event in late January, significant physician targeting work has identified the early and most likely adopters of BELBUCA. BDSI will initially leverage its existing sales force and capitalize on commercial synergies with BUNAVAIL for a focused commercial approach targeting identified healthcare providers which BDSI believes creates the potential to incrementally grow BELBUCA sales without the requirement of significant resources. BDSI will also explore other options for longer-term growth for BELBUCA both within and ex-U.S.
Given the greater long-term commercial and profitability opportunities with BELBUCA, BDSI will transition its primary commercial emphasis to BELBUCA while BUNAVAIL efforts will be limited to current BUNAVAIL prescribers and on driving sales from upcoming and future managed care contracts.
Dr. Sirgo concluded, "We believe BELBUCA is well positioned to provide healthcare providers and their patients a responsible solution for the treatment of chronic pain while also addressing the widespread concerns over the growing problem of opioid abuse, addiction and overdose in this country. BELBUCA provides important patient benefits and is well differentiated from other opioids. And as such, we believe BELBUCA has promising growth potential and the ability to add tremendous value to our company."
BDSI will hold a webcast and conference call on Thursday, December 8th at 8:00 AM to further discuss the transaction and BDSI's initial plans for BELBUCA.
Conference Call & Webcast
Thursday, December 8th @ 8:00 am Eastern Time
Domestic: 888-264-8945
International: 913-312-1448
Conference ID: 3258085
Webcast: http://public.viavid.com/index.php?id=122204
Replay Dial-In Numbers (Available through December 22nd):
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 3258085
HCP IMPORTANT SAFETY INFORMATION FOR BELBUCA™
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
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:
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Risks due to Interactions with Central Nervous System Depressants
Risk of Life-Threatening Respiratory Depression in Elderly, Cachectic, and Debilitated Patients
Risk of Apnea in Patients with Chronic Pulmonary Disease
QTc Prolongation
Severe Hypotension
Risks of Use in Patients with Head Injury or Increased Intracranial Pressure
Hepatotoxicity
Risk of Overdose in Patients With Moderate or Severe Hepatic Impairment
Anaphylactic/Allergic Reactions
Risk of Use in Patients with Gastrointestinal Conditions
Increased Risk of Seizures in Patients with Seizure Disorders
Risks of Use in Cancer Patients with Oral Mucositis
Risks of Driving and Operating Machinery
ADVERSE REACTIONS
Please see full Prescribing Information, including Boxed Warning and Medication Guide for BELBUCA™.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. 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 development strategy focuses on the utilization of the FDA's 505(b)(2) approval process. This regulatory pathway creates the potential for more timely and efficient approval of new formulations of previously approved therapeutics.
BDSI's area of focus is the development and commercialization of products in the areas of pain management and addiction. These are areas where BDSI believes its drug delivery technologies and products can best be applied to address critical unmet medical needs. BDSI's marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid dependence. BDSI's headquarters is in Raleigh, North Carolina.
For more information, please visit or follow us:
Internet: www.bdsi.com
Facebook: Facebook.com/BioDeliverySI
Twitter: @BioDeliverySI
BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is marketed in the U.S. by BioDelivery Sciences. BELBUCA® (buprenorphine) buccal film (CIII) is commercialized in the U.S. by Endo Pharmaceuticals through January 8, 2017, pursuant to the worldwide licensing and development agreement between BDSI and Endo. ONSOLIS® (fentanyl buccal soluble film) (CII) is licensed in the U.S. to Collegium Pharmaceutical pursuant to the U.S. licensing and development agreement between BDSI and Collegium. For full prescribing information and important safety information on BDSI products, including BOXED WARNINGS for ONSOLIS, please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261. For full prescribing and safety information on BELBUCA, please visit www.belbuca.com.
Cautionary Note on Forward-Looking Statements
This press release, the conference call described herein, and any statements of employees, representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's reacquisition of, and commercialization efforts for BELBUCA as described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
BDSI®, BEMA®, ONSOLIS® and BUNAVAIL® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences and BUNAVAIL logos are trademarks owned by BioDelivery Sciences International, Inc. BELBUCA® is a trademark currently owned by Endo Pharmaceuticals. All other trademarks and tradenames are owned by their respective owners.
© 2016 BioDelivery Sciences International, Inc. All rights reserved.
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SOURCE BioDelivery Sciences International, Inc.
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