Camurus Interim Report January-March 2016


“We are in a strong growth phase and on track to deliver on all our key
objectives for this year.”
Business highlights first quarter 2016

  · Recruitment goals reached in two Phase 3 trials of CAM2038 for opioid
dependence treatment.
  · Start of Phase 2 study of CAM2038 in patients with chronic pain.
  · Completion of Phase 2 study of CAM2029 in two patient groups with acromegaly
or neuroendocrine tumors.
  · Completion of Phase 1 study of CAM4071 in healthy volunteers.
  · Clinical development supporting toxicology studies initiated for two new
product candidates after completed formulation development and assessment
  · License agreement signed with Rhythm Inc. for long-acting FluidCrystal®
setmelanotide under development for rare genetic obesity disorders.

Significant events after the reporting period

  · Positive results from a Phase 2 study of the blockade of opioid effects by
CAM2038 in patients with opioid dependence.

Financial summary first quarter 2016

  · Revenues MSEK 20.2 (58.6).
  · Operating result MSEK -24.9 (13.1).
  · Result after tax MSEK -19.4 (10.2).
  · Earnings per share SEK -0.52 (0.41).
  · Cash position MSEK 571.9 (116.4).

CEO comments
We have had strong start of the year with positive preclinical assessments of
new promising drug candidates, initiation of the build-up of our commercial
organization in Europe, and completed recruitment of more than 600 patients in
two ongoing Phase 3 trials of our long-acting buprenorphine products for
treatment of opioid dependence.

The development of CAM2038 is well-timed, as problems associated with opioid
dependence continue to mount. In the US, opioid dependence has reached epidemic
proportions. Its’ devastating consequences are getting high attention with daily
news headlines and commentaries by leading politicians. The situation is serious
and untenable from both humanitarian and socioeconomic perspectives. There is
consensus about the need to reduce the stigma of opioid addiction and recognize
this condition as a chronic disease that must be treated using evidence based
approaches.

Our success in enrolling more than 600 patients in two Phase 3 trials in the US,
Europe and Australia in just three months, speaks to the high unmet need in this
underserved patient population. With this positive progress, we are looking
forward to completing the ongoing trials and receiving Phase 3 efficacy results
in Q4 2016. In this context, the recently announced positive results from our
Phase 2 opioid challenge study and the continued successful collaboration with
Braeburn Pharmaceuticals is noteworthy.

Besides opioid dependence, CAM2038 is also being developed for the treatment of
chronic pain. During Q1, we initiated a Phase 2 study in patients with chronic
pain, set to deliver results in Q4 2016. We are enthusiastic about the prospects
of CAM2038 for treatment of chronic pain, with the potential for round-the-clock
pain relief combined with minimal risks of misuse, abuse and diversion.

In our partnership with Novartis, we recently completed a Phase 2 trial of our
long-acting octreotide product, CAM2029, in patients with acromegaly and
neuroendocrine tumors. Results are expected late Q2 2016. The partnership with
Novartis continues to develop well, with high activity in preparing the start of
Phase 3 trials.

In the late stage pipeline, we have also recently completed a Phase 2 study of
product candidate CAM2032 for treatment of prostate cancer. Top-line results
from this trial are expected during the Q2 2016.

We are also progressing with promising new product developments and bridging
toxicology studies with two promising candidates were recently initiated.
Clinical development of a first prioritized product candidate is planned to
start during Q4 2016.

Several collaborations projects are also ongoing with international
pharmaceutical and biotech companies. As an example, a new license agreement was
signed with the US biotech Rhythm Inc. in January for the development and
commercialization of a once-weekly formulation of setmelanotide for treatment of
genetic obesity disorders. Shortly after the agreement, Rhythm received a
Breakthrough Therapy designation for setmelanotide by US FDA.

We are in a strong growth phase and on track to deliver on all key objectives
for this year:

 1. Carry through the clinical registration program for CAM2038 for treatment of
opioid dependence.
 2. Initiate the build-up of our European commercial organization for the
marketing of CAM2038.
 3. Continue the pivotal clinical program for CAM2038 in the second indication,
chronic pain.
 4. Complete the preparations of Phase 3 trials of CAM2029.
 5. Expand our pipeline with a new drug candidate in clinical development.

I look forward to an exciting and productive first year as a publicly listed
company, creating significant value growth through our business operations and
in our development pipeline.

Fredrik Tiberg
President and CEO

For more information:
Fredrik Tiberg, President and 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

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 07.00 a.m. on 17
May 2016.

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