Braeburn Pharmaceuticals and Camurus Enroll First Patients in a Phase 3 Efficacy Trial of CAM2038 for treatment of Chronic Low Back Pain

Princeton, New Jersey and Lund, Sweden — 29 September 2016 — Braeburn
Pharmaceuticals and Camurus announce that the first patients have been enrolled
in the randomized, double blind, placebo controlled Phase 3 efficacy and safety
trial of CAM2038 in patients with moderate to severe chronic low back pain that
are currently being treated with opioids. CAM2038 is a long-acting injectable
medication with flexible dosing designed for either weekly or monthly
administration. The results of this study will demonstrate whether CAM2038 can
provide around-the-clock pain relief. The current standard of care for treatment
of chronic pain is oral opioids, usually taken multiple times a day.

“The Phase 3 trial is unique as it is the first time a subcutaneous long-acting
depot has been investigated in a pivotal trial for treatment of chronic pain.
The trial will provide essential insights into the efficacy and safety of
CAM2038 for treating a patient population that currently has few treatment
choices,” said Fredrik Tiberg, President and CEO of Camurus. “The study
represents an important expansion of our current development program for
CAM2038, targeting both addiction and pain indications.”

Moderate to severe chronic pain is a serious condition that affects
approximately 200 million adults in the United States and Europe, having a
profound impact on the quality of life of affected patients and contributing
substantially to lost productivity and morbidity, mortality, disability, and
demands on the health care system. In the US alone, chronic pain is estimated to
cost the nation $560-635 billion annually, exceeding the estimated cost of heart
disease ($309 billion), cancer ($243 billion) and diabetes ($188 billion).
(Gaskin DJ, Richard, P; The economic costs of pain in the United States. J Pain
2012, 13:715-724)

 “The effectiveness of opioids for pain, on one hand, and the potential for
their misuse, on the other, has created a dilemma for medical professionals.
Patients in chronic pain require these medications,” according to Behshad
Sheldon, President and CEO of Braeburn Pharmaceuticals. “Doctors are walking a
tightrope as they work to treat their patients suffering chronic pain at the
time of a full-blown epidemic of opioid addiction, one of the most significant
public health crises facing our nation. Our vision in developing CAM2038 is to
provide doctors with effective, long-acting alternatives to currently available
pain medications which, since they are administered by healthcare providers,
cannot be diverted, misused, or abused.”

"There is a high need for new and better treatment alternatives for millions of
patients suffering from chronic pain,” said Jeffrey D. Wayne, MD, investigator
and pain specialist, California. "The study is evaluating long-acting depot
formulations of buprenorphine in patients that despite treatment with high doses
of daily opioid medications have received inadequate pain relief. In addition to
potentially improving treatment outcomes for these patients, these innovative
formulations should have a significant positive impact on the growing healthcare
crisis of opioid abuse, overdoses and diversion.”

About the Phase 3 trial
The Phase 3 trial utilizes an enriched-enrollment, randomized withdrawal (EERW)
design and will enroll patients ages 18 to 75 years with moderate to severe non
-neuropathic chronic low back pain. These patients have been treated with
opioids and have not received adequate pain relief. The study includes an open
-label, dose titration period followed by a randomized, double-blind, placebo
-controlled 12-week treatment period. During the open-label titration phase,
study participants will be titrated with weekly CAM2038 until the pain is
controlled. Patients who achieve the desired control will then be randomized on
a 1:1 basis to either weekly or monthly analgesic doses of CAM2038 or to placebo
during the double-blind 12-week treatment period. A total of 170 patients will
be randomized to each arm. The primary endpoint of the study is a change in pain
as measured by the change in a patient's weekly pain score from baseline to week
12 of the randomized, double-blind treatment period. For further information,
see www.clinicaltrials.gov.

About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial stage
pharmaceutical company focused on long-acting therapeutic treatment options that
are 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 CAM2038,
weekly and monthly subcutaneous injection depot formulations of buprenorphine,
being investigated in opioid addiction and pain, and a risperidone six-month
implant being investigated in schizophrenia. More information on Braeburn can be
found at www.braeburnpharmaceuticals.com.

About CAM2038
CAM2038 are buprenorphine subcutaneous injection products in late stage clinical
development for the treatment of opioid addiction and pain. Once-weekly and once
-monthly formulations have been developed, each with multiple doses, to allow
individualized treatment of patients suffering from moderate to severe chronic
pain as well as for maintenance treatment of opioid use disorder. 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. Up to now, the CAM2038 products have been evaluated in four
completed Phase 1/2 clinical trials. Four additional clinical studies are
ongoing, including two Phase 3 trials in patients with opioid use disorder and
one recently started Phase 3 chronic pain study. So far, more than 900 subjects
have been enrolled in clinical trials designed to evaluate CAM2038.

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
fredrik.tiberg@camurus.com

Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
ir@camurus.com

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

The information was submitted for publication at 08.00 a.m. on 30 September
2016.