Camurus AB: Interim Report January-June 2016

STOCKHOLM–(BUSINESS WIRE)–Regulatory News:

“Camurus continues to make good progress with positive results from
several clinical trials and a Phase 3 registration program in opioid
addiction nearing completion.”

Business highlights second quarter 2016

  • Positive results from Phase 2 study of the opioid blocking effect of
    CAM2038.
  • Positive results from Phase 2 study of CAM2032 for treatment of
    prostate cancer.
  • Patient recruitment completed in Phase 2 study of CAM2038 in patients
    with chronic pain.
  • Distribution and license agreement signed with R-Pharm US for episil®
    in the US.
  • Richard Jameson assumed role as Camurus´ Chief Commercial Officer and
    Peter Hilgert is recruited as General Manager, Central Europe.
  • Two new product candidates have been selected for clinical development.

Significant events after the reporting period

  • Positive results from Phase 2 study of CAM2029 in patients with
    neuroendocrine tumors and acromegaly, in our collaboration with
    Novartis.

Financial summary first quarter 2016

  • Revenues MSEK 25.8 (22.7).
  • Operating result before and after items affecting comparability MSEK
    -25.9 (-31.6) and MSEK -25.9 (-147.6), respectively.
  • Result after tax MSEK -20.6 (-115.2)
  • Earnings per share before and after dilution SEK -0.55 (-4.57).
  • Cash position MSEK 549.0 (136.3).

CEO comments

Camurus continues to make good progress with positive results from
several clinical trials and a Phase 3 registration program in opioid
addiction nearing completion. Top-line efficacy results are expected
during the fourth quarter. To prepare for the planned marketing approval
of CAM2038, we are building our European commercial organization under
the leadership of Richard Jameson who recently joined as Chief
Commercial Officer.

An important highlight during the period was the positive results from
our pivotal Phase 2 study of our long-acting buprenorphine (CAM2038) in
opioid dependent patients. The study showed that treatment with CAM2038
provided a rapid and sustained blockade of the patients’ drug liking
after challenges with intravenous hydromorphone injections. Together
with the long-acting duration of CAM2038, the study results indicate
that CAM2038 can be effective in protecting opioid dependent patients
against relapse and continued misuse and abuse of illicit opioids.
Confirmatory efficacy results are expected in the fourth quarter, after
completion of a 24-week, randomized, double blind, double dummy Phase 3
trial.

CAM2038 is also being developed as a treatment for pain. During the
period, enrollment was completed in an ongoing Phase 2 study in opioid
dependent patients suffering from chronic pain. Results are expected in
the fourth quarter.

In our collaboration with Novartis, we recently completed a Phase 2
study of long-acting octreotide FluidCrystal® formulation (CAM2029),
supporting its potential for treating patients with acromegaly or
neuroendocrine tumors (NETs). In the study CAM2029 provided long-acting
octreotide release with well-maintained control of symptoms and disease
biomarkers after switching from Sandostatin® LAR®. Furthermore, the
safety and local tolerability of CAM2029 was good, and consistent
between the two treatments. As a next step, we look forward to the start
of planned Phase 3 trials of CAM2029 by Novartis in 2017.

In June we also announced the positive topline results from a Phase 2
study of CAM2032 for treatment of prostate cancer. Data on
pharmacokinetics, pharmacodynamics and safety after repeated dosing of
CAM2032 confirm earlier positive results with the product. The
properties of CAM2032 with the option of self-administration by patients
make this a potentially interesting future treatment alternative for
patients with advanced prostate cancer. The further development of
CAM2032, including potential partnerships, is currently being evaluated.

In the early pipeline, we have successfully completed toxicology studies
for two promising new product candidates. GMP-manufacturing is currently
ongoing and start of clinical development of these candidates is planned
for the fourth quarter 2016. In parallel, we are continuing several
interesting early stage collaboration projects with international
pharmaceutical and biotech companies.

Importantly, we are also making good progress with the establishment of
our commercial organization, preparing for the European launch of
CAM2038 in opioid dependence. Richard Jameson has now assumed the role
as our Chief Commercial Officer and more recently Peter Hilgert has been
recruited as General Manager for Central Europe. Peter comes from a
position as General Manager for Grünenthal in France and has a wealth of
commercial experience from the pain therapeutic area, including recent
product launches. Like Richard, he has worked in a number of leading
roles across marketing and sales of specialty pharmaceuticals. I am
delighted to welcome them both into our team.

To ensure patients and physicians in Europe to access CAM2038 as soon as
possible after marketing approval, we have started to prepare for
translating the results from our extensive development program into
health-economic outcomes to support reimbursement. We will also work
closely with stakeholders with medical communications, scientific
exchange and educational programs to increase disease awareness and the
benefits of our new and potentially transformative treatment options.

Fredrik Tiberg
President and CEO

This information is information that Camurus AB is obliged to make
public pursuant to the EU Market Abuse Regulation and the Swedish
Securities Markets Act. The information was submitted for publication,
through the agency of the chief executive officer, 07.00 AM CET on 14
July 2016.

This information was brought to you by Cision http://news.cision.com

Contacts

Camurus AB
Fredrik Tiberg, +46 (0)46 286 46 92
CEO and Head of
Research
fredrik.tiberg@camurus.com
or
Rein
Piir, +46 (0)70 853 72 92
VP Investor Relations
ir@camurus.com