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
- 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 doses and if the drug is misused or abused.
- Abuse or misuse of BELBUCA™ by swallowing may cause choking,
overdose, and death.
- Opioid agonists such as BELBUCA™ are sought by drug abusers and
people with addiction disorders and are subject to criminal
diversion. Strategies to reduce the risk include prescribing the
drug in the smallest appropriate quantity and advising the patient
on the proper disposal of unused drug.
- Contact a local state professional licensing board or state
controlled substances authority for information on how to prevent
and detect abuse or diversion of this product.
- BELBUCA™ should be prescribed only by healthcare professionals
who are knowledgeable in the use of potent opioids for the
management of chronic pain. Education and training programs that
meet FDA requirements are offered by accredited CME/CE providers,
and are available to prescribers of extended-release opioids at no
or nominal cost. A list of these programs can be found at
www.er-la-opioidREMS.com or by calling 1-800-503-0784. An
FDA-approved patient counseling document for healthcare providers
containing important safety information regarding the safe use,
storage, and disposal of extended-release opioids can be obtained
or downloaded at www.er-la-opioidREMS.com.
Life-Threatening Respiratory Depression
- Serious, life-threatening, or fatal respiratory depression has
been reported with the use of buprenorphine, even when used as
recommended. Respiratory depression, from opioid use, if not
immediately recognized and treated, may lead to respiratory arrest
and death. Management of respiratory depression may include close
observation, supportive measures, and use of opioid antagonists,
depending on the patient's clinical status.
- While serious, life-threatening or fatal respiratory depression
can occur at any time during the use of BELBUCA™, the risk is
greatest during initiation of therapy or following a dose increase.
Closely monitor patients for respiratory depression when initiating
therapy with BELBUCA™ and following dose increases.
- To reduce the risk of respiratory depression, proper dosing and
titration of BELBUCA™ are essential. Overestimating the dose of
BELBUCA™ when converting patients from another opioid product may
result in fatal overdose with the first dose.
- Accidental exposure to BELBUCA™, especially in children, can
result in respiratory depression and death due to an overdose of
buprenorphine.
Neonatal Opioid Withdrawal Syndrome
- Prolonged use of BELBUCA™ during pregnancy can result in
withdrawal signs in the neonate. Neonatal opioid withdrawal
syndrome, unlike opioid withdrawal syndrome in adults, 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.
- Neonatal opioid withdrawal syndrome presents as irritability,
hyperactivity and abnormal sleep pattern, high-pitched cry, tremor,
vomiting, diarrhea, failure to gain weight; and there have been
reports of convulsions, apnea, respiratory depression, and
bradycardia. The onset, duration, and severity of neonatal opioid
withdrawal syndrome vary based on the specific opioid used,
duration of use, timing and amount of last maternal use, and rate
of elimination of the drug by the newborn.
Risks due to Interactions with Central Nervous System
Depressants
- Hypotension, profound sedation, coma, or respiratory depression
may result if BELBUCA™ is used concomitantly with alcohol or other
CNS depressants (eg, sedatives, anxiolytics, hypnotics,
neuroleptics, other opioids).
- When considering the use of BELBUCA™ in a patient taking a CNS
depressant, assess the duration of use of the CNS depressant and
the patient's response, including the degree of tolerance that has
developed to CNS depression. Additionally, evaluate the patient's
use of alcohol or illicit drugs that cause CNS depression. If the
decision to begin therapy with BELBUCA™ is made, start with a lower
dosage of BELBUCA™, monitor patients for signs of sedation,
respiratory depression, and hypotension, and consider using a lower
dosage of the concomitant CNS depressant.
Risk of Life-Threatening Respiratory Depression in Elderly,
Cachectic, and Debilitated Patients
- Monitor elderly, cachectic, or debilitated patients closely,
particularly when initiating and titrating BELBUCA™ and when
BELBUCA™ is given concomitantly with other drugs that depress
respiration. Life-threatening respiratory depression is more likely
to occur in these patients, as they may have altered
pharmacokinetics or altered clearance compared with younger,
healthier patients.
Risk of Apnea in Patients with Chronic Pulmonary
Disease
- BELBUCA™-treated patients with significant chronic obstructive
pulmonary disease or cor pulmonale, and those with substantially
decreased respiratory reserve, hypoxia, hypercapnia, or preexisting
respiratory depression are at increased risk of decreased
respiratory drive, including apnea, even at recommended dosages of
BELBUCA™. Therefore, closely monitor these patients, especially
when initiating and titrating BELBUCA™. Alternatively, consider the
use of alternative non-opioid analgesics in these patients.
QTc Prolongation
- BELBUCA™ has been observed to prolong the QTc interval in some
subjects participating in clinical trials. Consider these
observations in clinical decisions when prescribing BELBUCA™ to
patients with hypokalemia, hypomagnesemia, or clinically unstable
cardiac disease, including unstable atrial fibrillation,
symptomatic bradycardia, unstable congestive heart failure, or
active myocardial ischemia. Periodic electrocardiographic (ECG)
monitoring is recommended in these patients. Avoid the use of
BELBUCA™ in patients with a history of Long QT Syndrome or an
immediate family member with this condition or those taking Class
IA antiarrhythmic medications (e.g., quinidine, procainamide,
disopyramide) or Class III antiarrhythmic medications (e.g.,
sotalol, amiodarone, dofetilide), or other medications that prolong
the QT interval.
Severe Hypotension
- BELBUCA™ may cause severe hypotension, including orthostatic
hypotension and syncope, in ambulatory patients. There is an
increased risk in patients whose ability to maintain blood pressure
has already been compromised by a reduced blood volume or
concurrent administration of certain CNS depressant drugs (eg,
phenothiazines or general anesthetics). Monitor these patients for
signs of hypotension after initiating or titrating the dose of
BELBUCA™. Avoid the use of BELBUCA™ in patients with
circulatory shock, because BELBUCA™ may cause vasodilation that can
further reduce cardiac output and blood pressure.
Risks of Use in Patients with Head Injury or Increased
Intracranial Pressure
- In patients who may be susceptible to the intracranial effects
of CO2 retention (e.g., those with evidence of increased
intracranial pressure or brain tumors), BELBUCA™ may reduce
respiratory drive, and the resultant CO2 retention can
further increase intracranial pressure. Monitor such patients for
signs of sedation and respiratory depression, particularly when
initiating therapy with BELBUCA™.
- Opioids may also obscure the clinical course in a patient with
a head injury. Avoid the use of BELBUCA™ in patients with impaired
consciousness or coma.
Hepatotoxicity
- Cases of cytolytic hepatitis and hepatitis with jaundice have
been observed in individuals receiving sublingual formulations of
buprenorphine for the treatment of opioid dependence, both in
clinical trials and in post-marketing adverse events reports. For
patients at increased risk of hepatoxicity (e.g., patients with a
history of excessive alcohol intake, intravenous drug abuse or
liver disease), obtain baseline liver enzyme levels and monitor
periodically during treatment with BELBUCA™.
Risk of Overdose in Patients With Moderate or Severe Hepatic
Impairment
- In a pharmacokinetic study of subjects dosed with buprenorphine
sublingual tablets, buprenorphine plasma levels were found to be
higher and the half-life was found to be longer in subjects with
moderate and severe hepatic impairment but not in subjects with
mild hepatic impairment. For patients with severe hepatic
impairment, a dose adjustment is recommended, and patients with
moderate or severe hepatic impairment should be monitored for signs
and symptoms of toxicity or overdose caused by increased levels of
buprenorphine.
Anaphylactic/Allergic Reactions
- Cases of acute and chronic hypersensitivity to buprenorphine
have been reported both in clinical trials and in post-marketing
experience. The most common signs and symptoms include rashes,
hives, and pruritus. Cases of bronchospasm, angioneurotic edema,
and anaphylactic shock have been reported.
Risk of Use in Patients with Gastrointestinal
Conditions
- BELBUCA™ may cause spasm of the sphincter of Oddi. Opioids may
cause increases in the serum amylase. Monitor patients with biliary
tract disease, including acute pancreatitis, for worsening
symptoms.
Increased Risk of Seizures in Patients with Seizure
Disorders
- Buprenorphine may increase the frequency of seizures in
patients with seizure disorders and may increase the risk of
seizures occurring in other clinical settings associated with
seizures. Monitor patients with a history of seizure disorders for
worsened seizure control during BELBUCA™ therapy.
Risks of Use in Cancer Patients with Oral Mucositis
- Cancer patients with oral mucositis may absorb buprenorphine
more rapidly than intended and are likely to experience transiently
higher plasma levels of the opioid. A dose reduction is recommended
in these patients. Monitor carefully for signs and symptoms of
toxicity or overdose caused by increased levels of
buprenorphine.
Risks of Driving and Operating Machinery
- BELBUCA™ may impair the mental and physical abilities needed to
perform potentially hazardous activities such as driving a car or
operating machinery. Warn patients not to drive or operate
dangerous machinery unless they are tolerant to side effects of
BELBUCA™ and know how they will react to the medication.
ADVERSE REACTIONS
- The most common adverse reactions (≥5%) reported by patients
treated with BELBUCA™ in the clinical trials were nausea,
constipation, headache, vomiting, fatigue, dizziness, somnolence,
diarrhea, dry mouth, and upper respiratory tract infection.
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.
Logo -
http://photos.prnewswire.com/prnh/20110217/CL49801LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/biodelivery-sciences-reacquires-license-to-belbuca-from-endo-pharmaceuticals-300375132.html
SOURCE BioDelivery Sciences International, Inc.