BioDelivery Sciences Provides an Update of Anticipated 2014 Milestones

    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

BUNAVAIL PDUFA date June 7, 2014 - launch anticipated late third quarter

Clonidine Topical Gel Phase 3 program enrollment anticipated to begin first

PR Newswire

RALEIGH, N.C., Jan. 10, 2014

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.


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:

  oBEMA 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.
  oOngoing 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.
  oCommercialization 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.
  oInitiation 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.
  oRe-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

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. PAINKYL^TM is a trademark owned by TTY
Biopharm. All other trademarks and tradenames are owned by their respective

© 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.

Contact: Brian Korb, Senior Vice President, The Trout Group LLC, (646)
378-2923,; Al Medwar, Vice President, Marketing and
Corporate Development, BioDelivery Sciences International, Inc., 919-582-9050,
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