BioDelivery Sciences to Develop a Long-Acting Injectable Depot Formulation of Buprenorphine with Evonik for Use in Opioid Dependence and Pain

RALEIGH, N.C., Oct. 28, 2014-- BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) has entered into an exclusive agreement with Evonik Corporation to develop and commercialize a proprietary, injectable microparticle formulation of buprenorphine potentially capable of providing 30 days of continuous therapy following a single subcutaneous injection.

While BDSI plans to pursue an indication for the maintenance treatment of opioid dependence, the company has also secured the rights and plans to develop a product for the treatment of chronic pain in patients requiring continuous opioid therapy.  BDSI has also secured options to license Evonik-owned intellectual property related to these products.

It is estimated that approximately 2.5 million people in the U.S. are dependent on prescription opioids or heroin. Despite the availability of effective treatments, including BUNAVAIL (buprenorphine and naloxone) buccal film, challenges remain regarding patient adherence to long-term buprenorphine treatment, which is critical to successfully manage opioid dependence.

"Given our significant experience with buprenorphine in both opioid dependence and chronic pain, we believe this is an ideal opportunity for BDSI to extend our franchise in both of these areas as the need remains high," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI.  "We look forward to working closely with Evonik to expeditiously complete formulation development work and move the product into the clinic late next year.  Since this will be a 505(b)(2) development program, we believe there may be an opportunity to move toward an NDA submission for opioid dependence in approximately three years time." 

"Evonik is pleased to work with BDSI on the development of this novel long-acting buprenorphine product," said Dr. Jean-Luc Herbeaux, head of Evonik's Global Health Care Business Line. "With its broad range of competencies in API and drug delivery systems, Evonik strives to support customers in the development and launch of novel medical treatments.  Using our proprietary FormEZE® microparticle technology and Resomer® biomaterials, this pharmaceutical will be manufactured at our state-of-the-art facility in Birmingham, Alabama."

"The potential availability of a long-acting formulation of buprenorphine has the opportunity to significantly advance the treatment of opioid dependence and furthers our commitment to this underserved treatment area," said Dr. Mark A. Sirgo, President and Chief Executive Officer.  "Not only would a single monthly injection provide an opportunity to substantially improve adherence to buprenorphine treatment, which is a formidable problem for many patients, it could also help to eliminate the problem of diversion.  We also believe this will be an outstanding companion product to BUNAVAIL and, if approved, provides another product for our existing sales team."

As part of the agreement, BDSI will have the right to license the product(s) following the attainment of Phase I ready formulations.  At that point, Evonik could receive downstream payments for milestones related to regulatory filings and subsequent NDA approvals as well as product royalties.  Evonik has the exclusive rights to develop the formulation and manufacture the product(s).

About Evonik

Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik's corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.

Evonik is active in over 100 countries around the world. In fiscal 2013, more than 33,500 employees generated sales of around €12.7 billion and an operating profit (adjusted EBITDA) of about €2.0 billion.

For additional information about Evonik in North America, please visit our website: www.evonik.com/north-america.

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 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 particular 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 located in Raleigh, North Carolina. 

For more information visit www.bdsi.com.

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