PRINCETON, N.J. and
MONTREAL, June 13, 2017 /PRNewswire/ -- Braeburn
Pharmaceuticals, Inc. ("Braeburn") and Knight Therapeutics Inc.
(TSX: GUD) ("Knight"), a leading Canadian specialty pharmaceutical
company, announced today that Knight's New Drug Submission (NDS)
has been accepted for review by Health Canada for
Probuphine® (buprenorphine) implant for the
treatment of opioid drug dependence.
"Probuphine is a unique and innovative product that has
the potential to address an important unmet need for opioid
dependent patients in Canada,"
said Jonathan Ross Goodman, Chief
Executive Officer (CEO) of Knight. "With Probuphine, Knight is
continuing to advance its portfolio of opioid supportive
therapeutics, which includes Movantik®, a product for
opioid-induced constipation we in-licensed from AstraZeneca and
began commercializing in March of this year."
"Opioid addiction is an overwhelming public health
epidemic in North America.
Acceptance of the NDS in Canada is
another important milestone for Probuphine," said Mike Derkacz, President and CEO of
Braeburn.
"We look forward to working with Knight and Health Canada
to bring this important treatment option to Canadian
patients."
Knight and Braeburn signed an exclusive distribution and
sublicense agreement in February
2016, granting Knight the exclusive right to distribute
Probuphine in Canada.
About
PROBUPHINE®
Probuphine is the only
subdermal implant designed to deliver buprenorphine continuously
for six months following a single treatment.
Probuphine was developed using ProNeura™, the continuous
drug delivery system developed by Titan Pharmaceuticals, Inc.
("Titan") that consists of a small, solid implant made from a
mixture of ethylene-vinyl acetate (EVA) and a drug substance. The
resulting construct is a solid matrix that is placed subdermally,
normally in the upper arm in an outpatient office procedure, and
removed in a similar manner at the end of the treatment
period. Braeburn obtained U.S. Food and Drug Administration
("FDA") approval for Probuphine in May
2016 and became the first buprenorphine implant for the
long-term maintenance treatment of opioid addiction.
About Braeburn Pharmaceuticals
Inc.
Braeburn Pharmaceuticals, an Apple Tree
Partners company, is a commercial-stage pharmaceutical company
delivering individualized medicine in neuroscience. Long-acting
therapeutic treatment options can be essential to improving patient
outcomes and facilitating recovery in neurological and psychiatric
disorders, which are often complicated by stigma and present
significant public health challenges. Braeburn's commercial
product, Probuphine® (buprenorphine) implant was
approved by the FDA in May 2016.
Braeburn's investigational product pipeline consists of long-acting
implantable and injectable therapies for serious neurological and
psychiatric disorders, including opioid addiction, pain, and
schizophrenia. Braeburn's pipeline products are at various stages
of clinical development and include weekly and monthly CAM2038,
subcutaneous injection depot formulations of buprenorphine, being
investigated in opioid addiction and pain, BB0417
buprenorphine/granisetron injectable for acute pain, and BB0817,
six-month risperidone implant being investigated in schizophrenia.
More information on Braeburn can be found at
www.braeburnpharmaceuticals.com.
About Knight Therapeutics
Inc.
Knight Therapeutics Inc., headquartered in
Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing
innovative pharmaceutical products for the Canadian and select
international markets. Knight Therapeutics Inc.'s shares trade on
TSX under the symbol GUD. For more information about Knight
Therapeutics Inc., please visit the company's web site at
www.gudknight.com or www.sedar.com.
Forward-Looking Statement
This
document contains forward-looking statements for Knight
Therapeutics Inc. and its subsidiaries. These forward-looking
statements, by their nature, necessarily involve risks and
uncertainties that could cause actual results to differ materially
from those contemplated by the forward-looking statements. Knight
Therapeutics Inc. considers the assumptions on which these
forward-looking statements are based to be reasonable at the time
that they were prepared, but cautions the reader that these
assumptions regarding future events, many of which are beyond the
control of Knight Therapeutics Inc. and its subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could
cause actual results to differ materially from current
expectations, are discussed in Knight Therapeutics Inc.'s Annual
Report and in Knight Therapeutics Inc.'s Annual Information Form
for the year ended December 31, 2016.
Knight Therapeutics Inc. disclaims any intention or obligation to
update or revise any forward-looking statements whether as a result
of new information or future events, except as required by
law.
Probuphine Indication and Important Safety
Information
PROBUPHINE is indicated for the
maintenance treatment of opioid dependence in patients who have
achieved and sustained prolonged clinical stability on
low-to-moderate doses of a transmucosal buprenorphine-containing
product (i.e., doses of no more than 8 mg per day of Subutex or
Suboxone sublingual tablet or generic equivalent).
PROBUPHINE should be used as part of a complete treatment
program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to
treatment and patients who have not achieved and sustained
prolonged clinical stability, while being maintained on
buprenorphine 8 mg per day or less of a Subutex or Suboxone
sublingual tablet or generic equivalent.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and
NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and
Removal
Insertion and removal of PROBUPHINE are associated with
the risk of implant migration, protrusion, expulsion resulting from
the procedure. Rare but serious complications including nerve
damage and migration resulting in embolism and death may result
from improper insertion of drug implants inserted in the upper arm.
Additional complications may include local migration, protrusion
and expulsion. Incomplete insertions or infections may lead to
protrusion or expulsion.
Because of the risks associated with insertion and
removal, PROBUPHINE is available only through a restricted program
called the PROBUPHINE REMS Program. All Healthcare Providers must
successfully complete a live training program on the insertion and
removal procedures and become certified, prior to performing
insertions or prescribing PROBUPHINE implants. Patients must be
monitored to ensure that PROBUPHINE is removed by a healthcare
provider certified to perform insertions.
Please see the Important Safety Information in
the Package Insert for more information, which you can access
at:
http://probuphinerems.com/wp-content/uploads/2016/02/final-approved-pi.pdf
For further information, please
contact:
Knight Therapeutics Inc.
Jeffrey Kadanoff, P.Eng.,
MBA
Chief Financial Officer
Tel: 514-484-GUD1 (4831)
Fax: 514-481-4116
Email: info@gudknight.com
Website: www.gudknight.com
Braeburn Pharmaceuticals, Inc.
Sherry Feldberg
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com
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SOURCE Braeburn Pharmaceuticals, Inc.