Long-term revenue potential of over $75 million
for NME with IP protection through 2031
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.
Please see accompanying Full Prescribing
Information including Medication Guide for Symproic or
visit
www.symproic.com/pi.
References:
- Sehgal N, Colson J, Smith HS. Chronic pain treatment with
opioid analgesics: benefits versus harms of long-term therapy.
Expert Rev Neurother. 2013;13:1201-1220.
- Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe
GM. Emerging treatments in neurogastroenterology: a
multidisciplinary working group consensus statement on
opioid-induced constipation. Neurogastroenterol Motil. 2014;26:
1386-1395.
- Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic
noncancer pain: systematic review of efficacy and safety. Pain.
2004;112:372–80.
- Cook SF, Lanza L, Zhou X, et al. Gastrointestinal side effects
in chronic opioid users: results from a population based
survey.Aliment Pharmacol Ther. 2008;27(12):1224-1232.
- Brown RT, Zuelsdorff M, Fleming M. Adverse effects and
cognitive function among primary care patients taking opioids for
chronic nonmalignant pain. J Opioid Manag. 2006;2(3):137–146.
- Tuteja AK, Biskupiak J, Stoddard GJ, Lipman AG. Opioid induced
bowel disorders and narcotic bowel syndrome in patients with
chronic non-cancer pain. Neurogastroenterol Motil.
2010;22(4):424-430.
IMPORTANT SAFETY INFORMATION ABOUT BELBUCA®
BELBUCA® (buprenorphine buccal film), CIII 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 (e.g., 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.
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID
WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES AND OTHER CNS DEPRESSANTS
Addiction, Abuse, and
MisuseBELBUCA® exposes patients and other
users to the risks of opioid addiction, abuse, and misuse, which
can lead to overdose and death. Assess patient’s risk prior to
prescribing BELBUCA®, and monitor patients regularly for these
behaviors and conditions. Risk Evaluation and
Mitigation Strategy (REMS)To ensure that the
benefits of opioid analgesics outweigh the risks of addiction,
abuse, and misuse, the FDA has required a REMS for these products.
Under the requirements of the REMS, drug companies with approved
opioid analgesic products must make REMS-compliant education
programs available to healthcare providers. Healthcare providers
are strongly encouraged to
- complete a REMS-compliant education
program,
- counsel patients and/or their caregivers, with every
prescription, on safe use, serious risks, storage, and disposal of
these products,
- emphasize to patients and their caregivers the
importance of reading the Medication Guide every time it is
provided by their pharmacist, and
- consider other tools to improve patient, household, and
community safety.
Life-Threatening Respiratory
DepressionSerious, 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. Accidental
ExposureAccidental exposure to even one dose of
BELBUCA®, especially by children, can result in a fatal overdose of
buprenorphine. Neonatal Opioid Withdrawal
SyndromeProlonged 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. Risks from Concomitant Use with
Benzodiazepines or Other CNS
DepressantsConcomitant use of opioids with
benzodiazepines or other central nervous system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death. Reserve concomitant prescribing for
use in patients for whom alternative treatment options are
inadequate; limit dosages and durations to the minimum required;
and follow patients for signs and symptoms of respiratory
depression and sedation. |
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; and hypersensitivity (e.g., anaphylaxis)
to buprenorphine.
BELBUCA® contains buprenorphine, a Schedule III
controlled substance. As an opioid, BELBUCA® exposes users to the
risks of addiction, abuse, and 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.
Potential serious adverse events caused by
opioids include addiction, abuse, and misuse; life-threatening
respiratory depression; neonatal opioid withdrawal syndrome; risks
due to interactions with benzodiazepines or other central nervous
system depressants; risk of life-threatening respiratory depression
in patients with chronic pulmonary disease or in elderly,
cachectic, or debilitated patients; adrenal insufficiency; QTc
prolongation; severe hypotension; risks of use in patients with
increased intracranial pressure, brain tumors, head injury, or
impaired consciousness; 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.
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.
For full Prescribing Information, including Boxed
Warning, visit www.belbuca.com.
To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery
Sciences International, Inc. at 1-800-469-0261 or FDA at
1-800-FDA-1088 or www.fda.gov/safety/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/).
CAUTIONARY NOTE ON FORWARD-LOOKING
STATEMENTS
This press release, the presentation described
herein, and any statements of employees, representatives, and
partners of BioDelivery Sciences International,
Inc. ("BDSI") 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 BDSI'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 BDSI's management and are subject
to significant risks and uncertainties, including those detailed in
the BDSI's filings with the Securities and Exchange
Commission.
Actual results (including, without limitation,
the anticipated benefits to the Company related to the preferred
access to additional commercial lives as described herein) may
differ significantly from those set forth or implied 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 BDSI's
control). BDSI 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.
© 2019 BioDelivery Sciences International,
Inc. All rights reserved.
Contacts
Mary Coleman
Vice President, Investor Relations
BioDelivery Sciences International, Inc.
919-582-9050
mcoleman@bdsi.com
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