Interim report January-June 2017

Business highlights second quarter 2017 

• Completed clinical program for CAM2038 in opioid dependence.
• Positive clinical results from Phase 3 long-term safety study of CAM2038 in opioid dependence.
• Positive initial Phase 1a results for weekly setmelanotide FluidCrystal® under development for treatment of genetic obesity disease by Rhythm.
• Publication of clinical results for CAM2038 in JAMA Psychiatry and Journal of Substance Abuse Therapy.
• Four presentations about CAM2038 for treatment of opioid dependence at the CPDD Annual Meeting in Montreal, June 2017.
• Phase 2 results for CAM2029 in acromegaly and neuroendocrine tumours presented at ECE 2017 in Lisbon, May 2017.
• Maarten de Chateau, MD, PhD, appointed as Vice President, Medical Strategy & Innovation.

Financial summary second quarter 2017 

• Revenues MSEK 19,1 (25,8).
• Operating result MSEK -58,7 (-25,9).
• Result after tax MSEK -45,8 (-20,6).
• Earnings per share SEK -1,23 (-0,55), before and after dilution.
• Cash position MSEK 413,4 (549,0).

CEO comments 
Several important milestones were achieved during the second quarter. Our comprehensive clinical program has been completed, demonstrating robust efficacy and good safety profile of CAM2038 in opioid dependent individuals. Results from clinical studies were published in scientific journals and featured in four presentations at the College on Problem Drugs and Dependence 79th Annual Meeting held in Montreal in June.

In the completed 48-week Phase 3 safety study, 227 opioid dependent participants were dosed with CAM2038 across Europe, Australia, and the US. The study included both treatment seeking individuals and patients transferred from standard daily treatment with sublingual buprenorphine medications to CAM2038. The safety profile was good with no drug related serious or unexpected adverse events. Treatment effectiveness, as measured by the percentage illicit opioid-free patients and retention in treatment, was noticeable in both populations across the study. For treatment seeking individuals, the percentage of opioid-free patients increased by more than 60%. Clinically observed withdrawal symptom scores were insignificant in both groups (less than 2, scale 0-48) after the first treatment month. Patient satisfaction with the CAM2038 treatment was high, also compared to the pre-study treatment with daily sublingual buprenorphine.    

The evidence base for weekly and monthly CAM2038 as a potential new safe and effective treatment for opioid dependence has continued to grow. The interest from physicians and other stakeholders is noticeable; as reflected by the positive response to the four presentations of CAM2038 given at the College on Problem Drugs and Dependence in Montreal, June 17-22. Results from our opioid-blocking study were published in JAMA Psychiatry, the leading journal within Psychiatry. The study demonstrated rapid and effective blockade of opioid effects and suppression of withdrawal by CAM2038 from the first administered dose as well as during continued treatment. Thus, supporting the positioning of CAM2038 as stand-alone treatment, without the need for daily medications that may be diverted, misused and accidentally ingested by children.

With the successful completion of the clinical registration program, we now proceed to submitting our market approval applications to EMA and FDA per plan. Camurus is preparing for launch after an anticipated European approval mid-2018. We have continued to strengthen our European commercial organization with regional leadership, market access and medical affairs functions. Braeburn Pharmaceuticals is getting ready for an expected FDA approval and launch of CAM2038 in the first half of 2018.

In parallel, we and Braeburn Pharmaceuticals are working to expand the utility of CAM2038 to the treatment of chronic pain. A Phase 2 pharmacokinetic study in opioid dependent with chronic pain patients was just completed. The study demonstrated that repeated doses of weekly and monthly CAM2038 provided therapeutic buprenorphine plasma concentrations across the dosing intervals. Pain and withdrawal scores were both well maintained compared to pre-treatment with sublingual buprenorphine. A randomized pivotal Phase 3 study in opioid experienced patients with chronic low back pain is progressing, with study results expected early 2018. Results from a pharmacokinetic study of additional product candidates (CAM2047, CAM2048 and CAM2058) for treatment of nausea and post-operative pain, respectively, are expected the third quarter 2017. 

During the period, positive initial results were a from a Phase 1a single ascending dose study of a weekly setmelanotide FluidCrystal® depot under development for treatment of rare genetic obesity disorders by our partner Rhythm. The results were impressive according to Rhythm, meeting their criteria pharmacokinetics and tolerability for a weekly product. In the collaboration with Novartis for a long-acting octreotide (CAM2029) for treatment of acromegaly and neuroendocrine tumors, preparations for Phase 3 is progressing.

During the quarter, we strengthened our research and development team through the appointment of Maarten de Chateau, MD, PhD, as VP Medical Strategy & Innovation, with responsibility for expanding the early development pipeline.

We have had a productive first half of 2017 with important advances in several areas. Positive Phase 3 results and the successful completion of our clinical registration program for CAM2038 were important highlights. We are nearing the realization of our ambition to bring a new important treatment option for those patients suffering from the consequences of opioid dependence. I recognize the dedication and commitment of all our colleagues, investigators, and partners that enables us to achieve this.

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 13 July 2017.