Press Release
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`EX-99.1 2 d740613dex991.htm PRESS RELEASE
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`
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`Exhibit 99.1
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`BioDelivery Sciences Receives FDA Approval for
`BUNAVAIL™ (buprenorphine and naloxone) Buccal Film
`for the Maintenance Treatment of Opioid Dependence
`
`First and Only FDA-Approved Buccal Film Formulation of Buprenorphine and Naloxone
`to Compete in the $1.7 Billion and Growing U.S. Opioid Dependence Market
`
`Late Third Quarter 2014 Launch Anticipated, Utilizing Dedicated Sales Force
`
`Launch Plans to Be Discussed in Late Summer Investor Briefing
`
`RALEIGH, NC – June 6, 2014 — BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) received approval of the New Drug
`Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).
`BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include
`counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.
`
`BUNAVAIL was designed using BDSI’s advanced drug delivery technology, BioErodible MucoAdhesive (BEMA®), allowing for the efficient
`and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under
`the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared
`to Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct
`result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may
`help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.
`
`BUNAVAIL is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. The ability of
`BUNAVAIL to stick on the inside of the cheek, unlike sublingual products that need to be kept in place under the tongue until they dissolve,
`allows patients to talk, swallow and go about normal daily activities while the medication is being consistently absorbed.
`
`“BUNAVAIL is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence,” said Gregory
`Sullivan, M.D., principal investigator of the Phase 3 BUNAVAIL safety study and an addiction specialist and Medical Director of Parkway
`Medical Center in Birmingham, Alabama. “BUNAVAIL utilizes advanced drug delivery technology to fulfill an important need for treatment
`options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with
`sublingual administration and possibly help improve treatment compliance.”
`
`
`
`Dr. Sullivan continued, “BUNAVAIL was assessed in a Phase 3 clinical study in 249 patients who were converted from Suboxone sublingual
`tablet or film to BUNAVAIL. In this study, BUNAVAIL demonstrated favorable safety and efficacy in the maintenance treatment of opioid
`dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids
`over the 12-week period. The majority of patients who participated found BUNAVAIL easy to use and pleasant in taste. Additionally, prior to
`conversion to BUNAVAIL, about 40 percent of patients were experiencing constipation while receiving Suboxone tablet or film, a common
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`Press Release
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`problem with chronic opioid use, and more than two-thirds of these patients reported resolution of symptoms when they switched from Suboxone
`to BUNAVAIL.”
`
`“FDA’s approval of BUNAVAIL is another example of how we are creating products to help patients in their battle to overcome debilitating
`medical issues such as opioid dependence and is a tribute to the dedication and focus of our employees,” said Dr. Mark A. Sirgo, President and
`Chief Executive Officer of BDSI. “This is also a transformative event for BDSI, as we will be launching a product with our own dedicated sales
`force for the first time, which we believe will lead to significant value creation for our shareholders. We plan to share the details of our overall
`commercial plans later this summer as we approach the launch of BUNAVAIL. I am confident that the experience of the marketing and sales
`resources we have in place, we will have a positive launch and overall market reception for BUNAVAIL.”
`
`“Opioid addiction is a serious issue that can often be difficult to treat,” said Tim Lepak, President of the National Alliance of Advocates for
`Buprenorphine Treatment (NAABT). “People with opioid addiction face significant challenges in their efforts to rebuild their lives and achieve
`sustained addiction remission. It is important that patients have treatment options that are effective, safe and easy to use in order to provide them
`with their best chance for success. I believe people addicted to prescription opioids and heroin will welcome BUNAVAIL as a novel treatment
`option.”
`
`BUNAVAIL is the first mucoadhesive buccal film formulation of buprenorphine to compete directly with Suboxone sublingual film. In 2013, sales
`of Suboxone sublingual film increased to more than $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 14
`percent increase in prescriptions according to data from Symphony Health Solutions.
`
`BDSI plans to launch BUNAVAIL in late third quarter 2014 and anticipates peak sales potential of BUNAVAIL of up to $250 million in the U.S.
`BDSI will also begin entertaining commercial partnerships for BUNAVAIL outside of the U.S. In March 2014, BDSI announced it had entered
`into an agreement with Quintiles to support the launch of BUNAVAIL. Under terms of the agreement, Quintiles will provide a range of services to
`support the launch and subsequent commercialization of BUNAVAIL in the U.S., including recruiting and training a field sales force. In the U.S.,
`nearly 5,000 physicians are responsible for approximately 90 percent of prescriptions for buprenorphine products for the treatment of opioid
`dependence, according to recent data from Symphony Health Solutions.
`
`
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`Separately, BDSI has entered into an agreement with Ashfield Market Access to provide managed markets and trade support for BUNAVAIL.
`Ashfield Market Access, which is led by industry veterans including Steve Stefano, who led GlaxoSmithKline’s managed markets group for more
`than 20 years, will be responsible for executing a payer strategy aimed at maximizing patient access to BUNAVAIL.
`
`BDSI will be providing additional information regarding the FDA approval of BUNAVAIL and commercialization plans in the upcoming weeks.
`BDSI will be presenting on Wednesday, June 11 at 3:20 PM Central Time (4:20 PM Eastern Time) at the 34th Annual William Blair Growth Stock
`Conference in Chicago which will be webcast live and can be accessed at www.bdsi.com. BDSI also plans to hold an analyst and investor update
`meeting later in the summer to provide additional insight into plans for the late third quarter launch of BUNAVAIL.
`
`About BioDelivery Sciences International
`BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented
`drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven
`therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.
`
`BDSI’s pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery
`technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan
`(where it will be marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial
`rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha
`Pharmaceutical Co.).
`
`BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to
`Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.
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`BDSI’s approved product for the maintenance treatment of opioid dependence is BUNAVAIL, which was approved by the FDA in June 2014 and
`is expected to be commercially launched during late third quarter 2014.
`
`BDSI’s headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.
`About Opioid Dependence
`Opioid dependence is a significant and undertreated condition in the U.S., with over two million people dependent on opioids in 2012 according to
`the National Institute on Drug Abuse (NIDA).
`
`
`
`Suboxone, which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a
`result, currently generates annual sales of more than $1.3 billion according to data from Symphony Health Solutions. According to the World
`Health Organization, opioid dependence is a complex health condition that often requires long-term treatment and care. The treatment of opioid
`dependence is important to reduce its health and social consequences and to improve the well-being and social functioning of people affected. The
`main objectives of treating and rehabilitating persons with opioid dependence are to reduce dependence on illicit drugs; to reduce the morbidity and
`mortality caused by the use of illicit opioids, or associated with their use, such as infectious diseases; to improve physical and psychological health;
`to reduce criminal behavior; to facilitate reintegration into the workforce and education system and to improve social functioning. The
`achievement of a drug free state is the ideal and ultimate objective.
`
`About BUNAVAIL
`INDICATION
`BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) is indicated for the maintenance treatment of opioid dependence and should be used
`as part of a complete treatment plan to include counseling and psychosocial support.
`
`Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).
`
`
`IMPORTANT SAFETY INFORMATION
`Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child
`may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.
`
`Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been
`reported.
`
`Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience
`withdrawal symptoms.
`
`Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.
`
`BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between
`physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with
`uncomfortable withdrawal symptoms because your body has become used to this medicine.
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`Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in
`a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that
`may be different than other buprenorphine-containing medicines you may have been taking.
`
`BUNAVAIL can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in
`combination with benzodiazepines, sedatives, tranquilizers or alcohol. You should not drink alcohol while taking BUNAVAIL, as this can lead to
`loss of consciousness or even death.
`
`Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension (‘dizzy spells’) in
`ambulatory individuals.
`
`Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in
`sleep (insomnia), fatigue and sleepiness.
`
`Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea,
`anxiety, sleep problems, and cravings.
`
`BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit. Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL
`to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law. BUNAVAIL is not recommended in
`patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic
`impairment.
`
`Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL,
`tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.
`
`Before taking BUNAVAIL, talk to your doctor if you are breast-feeding or plan to breast-feed your baby. BUNAVAIL can pass into your breast
`milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way
`to feed your baby if you are taking BUNAVAIL.
`
`This is not a complete list of potential adverse events associated with BUNAVAIL Buccal Film. Please see full Prescribing Information for a
`complete list.
`
`To report negative side effects associated with taking BUNAVAIL Buccal Film, please call 1-800-469-0261. You are encouraged to report
`negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
`
`For more information, please see full Prescribing Information and Medication Guide for BUNAVAIL™ Buccal Film (CIII).
`
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`Cautionary Note on Forward-Looking Statements
`This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto
`(including, without limitation, at the presentations described herein) 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,
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`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 marketing and sales
`efforts for, and revenue generated from, BUNAVAIL) 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 events or otherwise, except as required by applicable law.
`
`Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product
`analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.
`
`BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are
`trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™
`is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYLTM is a trademark owned by TTY Biopharm. All other trademarks and
`tradenames are owned by their respective owners.
`
`© BioDelivery Sciences International, Inc. All rights reserved
`
`For further information:
`
`Investors:
`Brian Korb
`Senior Vice President
`The Trout Group LLC
`(646) 378-2923
`bkorb@troutgroup.com
`
`Al Medwar
`Vice President, Marketing and Corporate Development
`
`
`
`
`BioDelivery Sciences International, Inc.
`919-582-9050
`amedwar@bdsi.com
`
`Media:
`Susan Forman/Laura Radocaj
`Dian Griesel Int’l.
`212-825-3210
`sforman@dgicomm.com
`lradocaj@dgicomm.com
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