PRINCETON, N.J.
and MONTREAL, Feb. 1, 2016
/PRNewswire/ -- Braeburn Pharmaceuticals, Inc. ("Braeburn")
and Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading
Canadian specialty pharmaceutical company, announced today that
they have entered into an agreement whereby Knight received the
exclusive rights to commercialize PROBUPHINE® in Canada. PROBUPHINE® is an investigational
subdermal implant designed to deliver buprenorphine continuously
for six months following a single treatment, promoting patient
compliance and retention as well as helping to prevent accidental
paediatric exposure. Under the terms of this sublicense agreement,
Knight will also handle all ongoing regulatory and commercial
activities for PROBUPHINE® in Canada.
"According to the Canadian Drug Policy Coalition, overdose
deaths from opioids have risen sharply in Canada and now account for approximately half
of all drug related deaths in the country," said Behshad
Sheldon, President and CEO of Braeburn. "Partnering with Knight
Therapeutics is another step in our vision to making a lasting
impact on how this chronic disease is treated in North America."
"We are pleased that we can be instrumental in bringing
PROBUPHINE® to Canada," said
Jonathan Ross Goodman, President and
Chief Executive Officer of Knight. "Once approved by Health Canada,
PROBUPHINE® will be the first product to offer treatment for opioid
addiction for six months following a single treatment. This
innovative product has the potential to address an important unmet
need for opioid dependent patients."
About PROBUPHINE®
Probuphine is an investigational
subdermal implant designed to deliver buprenorphine continuously
for six months following a single treatment, and to promote patient
compliance and retention. Buprenorphine, which is the active
ingredient in multiple approved drug products for the treatment of
opioid dependence, is currently available in sublingual and buccal
formulations that require self-administration by patients on a
daily basis.
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.
Titan licensed the rights to commercialize Probuphine in the U.S.
and Canada in 2012.
The efficacy and safety of Probuphine has previously been
studied in several clinical studies. The most recent study enrolled
177 subjects who were randomized to receive either the Probuphine
implants or sublingual tablets, for a treatment period of six
months. Subjects in one group received four Probuphine implants
plus daily placebo sublingual tablets. A second group received four
placebo implants plus daily sublingual buprenorphine/naloxone
tablets (≤8mg/day).
The study met its primary objective of showing non-inferiority
based on comparison of the proportion of treatment responders in
each treatment arm. A responder was defined as having at least four
out of six months free of illicit opiates based on urine testing
and subject self-report. Additional analyses consistently
demonstrated that Probuphine was non-inferior to sublingual
buprenorphine/naloxone arm.
About Braeburn Pharmaceuticals, Inc.
Braeburn, an
Apple Tree Partners company, is a pill-free pharmaceutical company
delivering precision medicine in neuroscience. In September
2015, the U.S. Food and Drug Administration (FDA) accepted for
review Braeburn's New Drug Application for its lead candidate,
Probuphine®, a six-month buprenorphine implant for treatment of
opioid addiction. On January 12, 2016
the FDA Psychopharmacologic Drugs Advisory Committee recommended
approval by a vote of 12 to 5. The agency has set
February 27, 2016 as the target date
for action.
Long-acting therapeutic treatment options can be essential to
improving patient outcomes and facilitating recovery in these
conditions, which are often complicated by stigma and present
significant public health challenges. 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. Candidates
include: Probuphine®, a six-month buprenorphine implant for
treatment of opioid addiction; CAM2038, weekly and monthly
subcutaneous injection depot formulations of buprenorphine for
treatment of opioid addiction and pain; a risperidone six-month
implant for treatment of schizophrenia; and a novel molecule,
ATI-9242, for treatment of 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.gud-knight.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 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,
2014. 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.
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@gud-knight.com
Website: www.gud-knight.com
Braeburn Pharmaceuticals, Inc.
Sherry Feldberg
MSLGROUP Boston
781-684-0770
braeburnpharma@mslgroup.com
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SOURCE Braeburn Pharmaceuticals, Inc.