Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, AppDynamics Blog, Ian Goldsmith, Ed Featherston, Pat Romanski

News Feed Item

BioDelivery Sciences Provides an Update of Anticipated 2014 Milestones

BEMA Buprenorphine Phase 3 opioid naive study database lock imminent; triggers $10M milestone payment from Endo Pharmaceuticals

RALEIGH, N.C., Jan. 10, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced updates to the company's anticipated 2014 milestones for its product portfolio, including the imminent database lock for the Phase 3 clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in opioid naive subjects, with topline data expected late January or early February.

(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)

The database for the BEMA Buprenorphine Phase 3 clinical study in opioid naive patients with chronic pain is expected to be locked shortly by BDSI's partner, Endo Pharmaceuticals.  This event is expected to trigger a $10 million milestone payment from Endo per the licensing and development agreement signed in January 2012.  

In addition, based on recruitment rates in a second Phase 3 clinical study of BEMA Buprenorphine in an opioid experienced patient group, the database for this trial is anticipated to be locked by mid-2014, with results following shortly thereafter. 

BDSI also continues to develop the commercialization plans for the launch of BUNAVAIL for the maintenance treatment of opioid dependence.  As previously reported, the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014 for BUNAVAIL, which if approved is anticipated to launch late third quarter 2014.  BDSI estimates annual peak U.S. sales of BUNAVAIL of up to $250 million.

"This year will potentially provide two of the most significant value driving milestones that our company has ever experienced," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "We look forward to the results of our two Phase 3 studies for BEMA Buprenorphine for the treatment of chronic pain, which could potentially lead to an NDA submission late this year.  We are also extremely excited about the prospects of an NDA approval for BUNAVAIL this coming June with a launch shortly thereafter.  Finally, initiating enrollment in our Phase 3 program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy this quarter gives us our third exciting potential entry into the pain space."

Dr. Sirgo concluded, "Overall, this coming year will be an exceptionally exciting one for BDSI, and we look forward to the forthcoming milestones, which will be instrumental in enhancing the future value of the company."

Anticipated 2014 Milestones

BDSI expects to achieve the following key milestones in the upcoming year:

  • BEMA Buprenorphine Phase 3 data and additional milestone payments from Endo. In addition to the aforementioned opioid naive study database lock and subsequent milestone payment, BDSI expects to receive additional milestone payments upon the database lock of the opioid experienced study and the NDA filing.  BDSI anticipates the second database lock to occur in mid-year, and the potential filing of the NDA in late 2014.
  • Ongoing review and subsequent approval of the NDA for BUNAVAIL.  BDSI expects ongoing dialogue with the FDA in the review of the NDA for BUNAVAIL for the treatment of opioid dependence.  The review of the BUNAVAIL NDA is expected to be completed by June 7, 2014. 
  • Commercialization of BUNAVAIL in the U.S.  BDSI continues to evaluate its options for the commercialization of BUNAVAIL, including both partnering options as well as potentially leading efforts internally through the use of contract resources.  
  • Initiation of Phase 3 study for Clonidine Topical Gel.  BDSI plans to initiate a Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in the first quarter of 2014.   This study could complete enrollment in late 2014.
  • Re-launch of ONSOLIS.  BDSI continues to work closely with its commercial partner, Meda Pharmaceuticals, on plans for the reintroduction of ONSOLIS into the U.S. market for the management of breakthrough pain in opioid tolerant patients with cancer.  This is anticipated to take place in the second half of 2014.

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 currently consists of three products.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), 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, which is licensed on a worldwide basis to Endo Pharmaceuticals, is currently in Phase 3 development for the treatment of moderate to severe chronic pain.  Clonidine Topical Gel is expected to enter Phase 3 trials in 2014 for the treatment of painful diabetic neuropathy.

BUNAVAIL, a BEMA formulation of buprenorphine and naloxone, is currently under review by FDA for the maintenance treatment of opioid dependence.

BDSI's headquarters is located in Raleigh, North Carolina.  For more information, visit www.bdsi.com.

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.

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 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 2014 initiatives 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 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.

SOURCE BioDelivery Sciences International, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
NuoDB just introduced the Swifts 2.1 Release. In this demo at 15th Cloud Expo, Seth Proctor, CTO of NuoDB, Inc., discussed why scaling databases in the cloud is challenging, why building your application on top of the infrastructure that is designed with this in mind makes a difference, and what you can do with NuoDB that simplifies your programming model, your operations model.
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focu...
Hovhannes Avoyan, CEO of Monitis, Inc., a provider of on-demand systems management and monitoring software to 50,000 users spanning small businesses and Fortune 500 companies, has surpassed 1.5 million page views on the SYS-CON family of online magazines, which includes Cloud Computing Journal, DevOps Journal, Internet of Things Journal, and Big Data Journal. His home page at SYS-CON can be found at Montis.SYS-CON.com
As enterprises look to take advantage of the cloud, they need to understand the importance of safeguarding their confidential and sensitive data in cloud environments. Enterprises must protect their data from (i) system administrators who don't need to see the data in the clear and (ii) adversaries who become system administrators from stolen credentials. In short, enterprises must take control of their data: The best way to do this is by using advanced encryption, centralized key management and...
Leysin American School is an exclusive, private boarding school located in Leysin, Switzerland. Leysin selected an OpenStack-powered, private cloud as a service to manage multiple applications and provide development environments for students across the institution. Seeking to meet rigid data sovereignty and data integrity requirements while offering flexible, on-demand cloud resources to users, Leysin identified OpenStack as the clear choice to round out the school's cloud strategy. Additional...
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, has been named "Silver Sponsor" of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York, NY. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make sm...
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, will explain the best practices of continuous testing at high scale, which is r...
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
What are the benefits of using an enterprise-grade orchestration platform? In their session at 15th Cloud Expo, Nate Gordon, Director of Technology at Appcore, and Kedar Poduri, Senior Director of Product Management at Citrix Systems, took a closer look at the architectural design factors needed to support diverse workloads and how to run these workloads efficiently as a service provider. They also discussed how to deploy private cloud environments in 15 minutes or less.
Move from reactive to proactive cloud management in a heterogeneous cloud infrastructure. In his session at 16th Cloud Expo, Manoj Khabe, Innovative Solution-Focused Transformation Leader at Vicom Computer Services, Inc., will show how to replace a help desk-centric approach with an ITIL-based service model and service-centric CMDB that’s tightly integrated with an event and incident management platform. Learn how to expand the scope of operations management to service management. He will al...
SYS-CON Events announced today Arista Networks will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Arista Networks was founded to deliver software-driven cloud networking solutions for large data center and computing environments. Arista’s award-winning 10/40/100GbE switches redefine scalability, robustness, and price-performance, with over 3,000 customers and more than three million cloud networking ports depl...
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS soluti...
The DevOps Institute (DOI) launched on Monday with the mission of serving as the premier source for aligning industry standard quality DevOps training and examination services for enterprise IT. The Institute is led by a Board of Regents who will oversee DOI’s offerings in an effort to codify and promote DevOps’ best practices and standards that enable enterprise IT to deliver more value faster to their customers. The initial Board of Regents includes Gene Kim, Lori MacVittie, Sanjeev Sharma, ...
In his session at DevOps Summit, Andrei Yurkevich, CTO at Altoros, provided an overview of all the benefits and opportunities, as well as drawbacks of deploying Cloud Foundry PaaS with Juju and compared it to BOSH. Discover the features that overlap, and understand what Juju Charm is, what it is not, where you use one or the other or where you use both BOSH and Juju Charms together. Andrei Yurkevich is Cloud Foundry protagonist and CTO at Altoros. Under his supervision, the Altoros engineering ...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water,...