BioDelivery Sciences Provides Business Review and Update in Conjunction with
Filing of First Quarter 2014 Financials
BUNAVAIL PDUFA date June 7, 2014; Pre-launch activities underway to support an
anticipated late Q3 2014 launch
BEMA Buprenorphine Phase 3 clinical trial results in opioid experienced
patients with chronic pain expected early July 2014
Clonidine Topical Gel for Painful Diabetic Neuropathy - first Phase 3 study
50% enrolled; Interim analysis expected in Q3 2014
$60 Million equity financing led by Federated Kaufmann in February solidified
Endo second data base lock $10 million milestone payment anticipated in June
RALEIGH, N.C., May 8, 2014
RALEIGH, N.C., May 8, 2014 /PRNewswire/ -- BioDelivery Sciences International,
Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form
10-Q for the quarter ended March 31, 2014 with the U.S. Securities and
Exchange Commission and, in connection therewith, is providing a review of
BDSI's recent achievements and an update on business operations and upcoming
milestones for 2014.
BDSI is expecting to hear from the U.S. Food and Drug Administration (FDA) on
its New Drug Application (NDA) for BUNAVAIL (buprenorphine and naloxone buccal
film) on or about June 7, 2014. Assuming BUNAVAIL is approved, BDSI intends
to launch BUNAVAIL, a proposed maintenance treatment for opioid dependence, in
the latter part of the third quarter of 2014. In March, BDSI announced that
it entered into an agreement with Quintiles to provide a range of services to
support the anticipated launch including the establishment of a sales team.
Separately, BDSI entered into an agreement with Ashfield Market Access, led
by former GSK veteran Steve Stefano, to provide managed markets and trade
support for BUNAVAIL.
As recently reported, data from clinical studies of BUNAVAIL were presented at
the American Society of Addiction Medicine (ASAM) 45th Annual
Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida. Four
posters were presented highlighting data from the clinical development
program, which included the pivotal bioequivalence study of BUNAVAIL compared
to Suboxone tablets. Also highlighted was a safety study conducted in 249
subjects undergoing maintenance treatment for opioid dependence with Suboxone
film or tablets who were converted to BUNAVAIL for 12 weeks. The posters are
accessible at www.bdsi.com.
On January 23, 2014, Endo Pharmaceuticals and BDSI announced positive top-line
results from its pivotal Phase 3 efficacy study of BEMA Buprenorphine in
opioid "naïve" subjects, and in conjunction with database lock, BDSI received
a milestone payment from Endo in the amount of $10 million. BEMA Buprenorphine
is being developed for the treatment of moderate to severe chronic pain in
patients requiring around-the-clock opioid therapy for an extended period of
time. Results of the second Phase 3 study, which was conducted in opioid
"experienced" patients, are anticipated in early July. If successful, an NDA
for an indication of the treatment of moderate to severe chronic pain would be
anticipated to be submitted in late 2014 or early 2015.
On April 3, 2014, BDSI announced the enrollment of the first patient in the
RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the
treatment of painful diabetic neuropathy (PDN). The Phase 3 trial is a
multicenter, randomized, double-blind, placebo-controlled study in 140
subjects to determine the efficacy and safety of Clonidine Topical Gel in the
treatment of pain associated with PDN. As of the beginning of May, over 50%
of subjects had been randomized in this trial with the interim analysis
anticipated to occur in the third quarter of 2014. The purpose of the interim
analysis is to confirm the assumptions regarding the study sample size and
allow for an adjustment in size if needed. Clonidine Topical Gel has the
opportunity to be the first topical product approved by FDA for the treatment
of PDN. As such, BDSI currently estimates annual peak sales potential for
this product in excess of $300 million.
In February 2014, BDSI closed a $60 million registered common stock financing
with a select group of institutional investors led by Federated Kaufmann.
This financing strengthened BDSI's balance sheet in front of its anticipated
2014-2015 activities, and at March 31, 2014, BDSI had $88.2 million in cash
compared to $23.2 million at December 31, 2013.
Research and development costs were $14.6 million in the first quarter of
2014, compared to a corresponding $12.0 million in the first quarter of 2013.
The current quarter increase in research and development expense was due
primarily to additional research and development costs associated with the
BEMA Buprenorphine for chronic pain late stage development program and the
initiation of the Clonidine Topical Gel Phase 3 program. Overall R&D costs
for 2014 will fall below 2013 levels.
"There has never been a more exciting time at BDSI as we move closer to the
PDUFA date of June 7^th and potential launch of BUNAVAIL this year, as well as
the data read out of our second pivotal trial for BEMA Buprenorphine for
chronic pain in early July," said Dr. Mark A. Sirgo, President and Chief
Executive Officer of BDSI. "As it relates to BUNAVAIL, opioid dependence has
unfortunately become a national epidemic and a clear need exists for new
treatment options. To help address this need, we are currently readying
launch plans for BUNAVAIL and have entered into agreements with Quintiles and
Ashfield Market Access to provide the services and infrastructure needed to
support our planned sales and managed markets activities. Additionally, we
are working aggressively with our commercial partner Endo to complete the
Phase 3 program and believe the market opportunity for BEMA Buprenorphine for
chronic pain continues to expand for a differentiated Schedule 3 opioid.
Furthermore, we are excited to have expanded our late-stage product pipeline
with the initiation of the Phase 3 clinical trial of Clonidine Topical Gel for
the treatment of painful diabetic neuropathy."
"With a strengthened balance sheet, BUNAVAIL approaching its PDUFA date, the
final pivotal study for BEMA Buprenorphine for chronic pain reporting out
mid-year and Clonidine Topical Gel in Phase 3, we believe BDSI has the
strongest potential in it's history to generate sustainable value for our
shareholders," concluded Dr. Sirgo.
Anticipated 2014 Milestones
BDSI is focusing its resources on achievement of the following key milestones:
oBUNAVAIL for Opioid Dependence. Given the PDUFA date of June 7, 2014, BDSI
is currently working on the execution of the sales, marketing and other
commercialization and product supply chain activities to support the
anticipated late third quarter 2014 launch of BUNAVAIL.
oBEMA Buprenorphine for Chronic Pain. BDSI anticipates the second database
lock from the Phase 3 trial for opioid experienced patients and subsequent
$10 million milestone payment from Endo to occur in mid-year 2014.
Assuming positive results, the potential filing of the NDA would be
expected to take place in late 2014 or early 2015.
oClonidine Topical Gel for Painful Diabetic Neuropathy. A Phase 3 study was
initiated earlier in 2014 with the potential for the planned interim
analysis during third quarter of this year.
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.
An NDA for BUNAVAIL, a BEMA formulation of buprenorphine in combination with
naloxone, is currently under review for the maintenance treatment of opioid
dependence and has a PDUFA date of June 7, 2014.
BDSI's headquarters is located in Raleigh, North Carolina. For more
information visit www.bdsi.com
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, 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 FDA's review of BUNAVAIL, the results of the Company's
commercial efforts for BUNAVAIL, and the results of the Company's clinical
trials for BEMA Buprenorphine and Clonidine Topical Gel) 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. PAINKYL^™ is a trademark owned by TTY
Biopharm. All other trademarks and tradenames are owned by their respective
© BioDelivery Sciences International, Inc. All rights reserved
SOURCE BioDelivery Sciences International, Inc.
Contact: Brian Korb, Senior Vice President, The Trout Group LLC, (646)
378-2923, firstname.lastname@example.org; Al Medwar, Vice President, Marketing and
Corporate Development, BioDelivery Sciences International, Inc., 919-582-9050,
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