Interim report January-June 2016

“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 second 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 the planned marketing approval in 2018, 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

For more information: 
Fredrik Tiberg, CEO and Head of Research
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 

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.