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2016-05-11

Camurus AB: Braeburn Pharmaceuticals and Camurus announce positive results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use disorder

Princeton, New Jersey and Lund, Sweden - 11 May 2016 - Braeburn
Pharmaceuticals and Camurus today announce top line results of a
multiple-dose, pivotal Phase 2 study assessing the blockade by
CAM2038 of subjective opioid effects of multiple randomized
hydromorphone challenges in adults with opioid use disorder.

A key objective of medication-assisted treatment for opioid use
disorder is to reduce or eliminate the use of illicit opioids. The
results from the present Phase 2 study demonstrate that CAM2038
blocks effectively the subjective effects of opioid challenges with
hydromorphone, including limiting drug liking.

"This study provides clinical proof of concept that CAM2038 will be an
effective treatment for opioid use disorder," said Behshad Sheldon,
President and CEO of Braeburn Pharmaceuticals, "The current opioid
crisis demands innovation, and CAM2038's novel technology is now one
step closer to providing physicians and patients with a different
approach to treating this deadly chronic disease."

The primary endpoint was met for both CAM2038 doses, demonstrating
blockade of the subjective effects of hydromorphone as measured by
the Drug-Liking Visual Analog Scale. Furthermore, CAM2038 was well
tolerated across the course of treatment.

"The study results show that CAM2038 provides rapid and extended
blockade of opioid effects," said Fredrik Tiberg, President and CEO
of Camurus. "The results also confirm the dose selection in the
current Phase 3 program and the potential of CAM2038 as a future
treatment alternative for patients with opioid use disorder, from
initiation to long-term maintenance."

"The current study demonstrated that weekly injections of CAM2038
produced significant and robust opioid blockade, a critical mechanism
of efficacy for medications treating opioid dependence. CAM2038 has
the potential to alter the current treatment paradigm for opioid
dependence." said Sharon Walsh, Ph.D.., Professor of Behavioral
Science and Director of the Center on Drug and Alcohol Research,
University of Kentucky, "Because of its long acting properties, CAM
2038 may decrease patient and physician burden, improve access to
treatment, and obviate public health concerns about illicit diversion
of buprenorphine."

"We were pleased to be involved in the development of CAM2038 and are
hopeful that it will serve as another safe and effective therapeutic
option for patients with opioid use disorder. The ability of CAM2038
to produce a long-lasting and robust blockade of
hydromorphone-induced Drug Liking is especially encouraging," said
Sandra D Comer, Ph.D, Professor of Neurobiology, Columbia University.
"Importantly, the fact that CAM2038 will be given in the clinic by
health providers should address concerns about diversion of
buprenorphine for illicit use. We feel that this medication, with its
ease of administration and flexible dosing capabilities, could
significantly improve management of patients."

About the Phase 2 Trial
The Phase 2 study was a three-center, randomized, double-blind,
inpatient study to evaluate the degree of subjective opioid blocking
efficacy of CAM2038 q1w in non-treatment-seeking participants with
moderate-to-severe opioid use disorder. After screening, participants
were randomized to different CAM2038 q1w once-weekly injections for
two weeks. During this period, four challenge sessions were conducted
with a randomized hydromorphone dose to determine subjective `liking'
score based on a visual analogue scale. Additional information on the
design of the trial can be found at www.clinicaltrials.gov.

About CAM2038
The investigational CAM2038 buprenorphine subcutaneous injection
products for treatment of opioid addiction are being developed as
once-weekly and once-monthly formulations, each with multiple doses,
to cover all phases of treatment from initiation through maintenance.
The CAM2038 products are designed for administration by healthcare
personnel to ensure proper delivery that minimizes the risks of
diversion, abuse, misuse, and accidental exposure. The CAM2038
products have been evaluated in three Phase 1/2 clinical trials,
which evaluated the safety and tolerability as well as
pharmacokinetic and pharmacodynamic properties of the products in a
total of 176 individuals (opioid-dependent patients and healthy
volunteers under naltrexone blockage). Four more trials, including
two Phase 3 studies, are currently ongoing. CAM2038 is also being
developed for treatment of chronic pain.

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a
pill-free pharmaceutical company delivering precision medicine in
neuroscience. In September 2015 the 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. The Agency set May 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.braeburnpharma.com.

About Camurus
Camurus is a Swedish research-based pharmaceutical company committed
to developing and commercialising innovative and differentiated
medicines for the treatment of severe and chronic conditions. New
drug products with best-in-class potential are conceived based on the
proprietary FluidCrystal® drug delivery technologies and an extensive
R&D expertise. Camurus' clinical pipeline includes products for
treatment of cancer, endocrine diseases, pain and addiction,
developed in-house and in collaboration with international
pharmaceutical companies. The company's share is listed on Nasdaq
Stockholm under the ticker "CAMX". For more information, visit
www.camurus.com.

Media contacts:
Fredrik Tiberg, President & CEO
Tel: +46 (0)46 286 46 92
ir@camurus.com

Sherry Feldberg
MSLGROUP Boston
+1 781 684 0770
braeburnpharma@mslgroup.com

The information in this press release is disclosed by Camurus AB in
accordance with the Swedish Securities Markets Act and/or the Swedish
Financial Instruments Trading Act. The information was submitted for
publication at 08.00 a.m. on 11 May 2016.

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http://news.cision.com/camurus-ab/r/braeburn-pharmaceuticals-and-camurus...
http://mb.cision.com/Main/13456/2006529/514017.pdf

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