Interim report January-September 2016

“All patients completed treatment in the pivotal Phase 3 opioid dependence trial and we are excited about receiving the study results. In parallel, we are preparing for submissions of marketing approval applications in Europe and the US during 2017.”

Business highlights third quarter 2016 

• Treatment of all patients completed in Phase 3 efficacy study of CAM2038 for treatment of opioid dependence.
• First patient enrolled in a Phase 3 trial of CAM2038 in patients with chronic back pain.
• Positive results received from Phase 2 study of CAM2029 in NET and acromegaly patients.
• Clinical trial application submitted for three new drug candidates for treatment of post-operative pain and/or nausea and vomiting. 

Significant events after the reporting period 

• Expansion of collaboration and license agreement with Braeburn Pharmaceuticals with new combination product CAM2058 for treatment of postoperative pain.

Financial summary third quarter 2016 

• Revenues MSEK 30.5 (37.2).
• Operating result before and after items affecting comparability MSEK -16.6 (-7.1) and MSEK -16.6 (-29.1), respectively.
• Result after tax MSEK -13.2 (-22.7).
• Earnings per share SEK -0.35 (-0.90), before and after dilution.
• Cash position MSEK 518.2 (112.3).

CEO comments 
Good progress was made during the third quarter. All patients completed treatment in the pivotal Phase 3 opioid dependence trial and we are excited about receiving the study results. In parallel, we are preparing for submissions of marketing approval applications in Europe and the US during 2017. Another highlight during the quarter was the initiation of a new Phase 3 trial of CAM2038 for treatment of chronic pain. This is an area with an unmet need for new, effective and safe treatment solutions that have reduced risks of misuse, overdosing and diversion.

Our extensive study program on CAM2038 led to the presentation of three scientific papers at the International Society for Addiction Medicine (ISAM) meeting in Montreal, October 20-22, 2016. Professor Sharon Walsh, MD/PhD, University of Kentucky, presented new data from a pivotal Phase 2 trial showing how CAM2038 blocks subjective opioid effects of randomized hydromorphone injections and discussed the relevance of the results for clinical practice. I presented data pharmacokinetics and safety of CAM2038 from Phase 1 trials in healthy volunteers under naltrexone blockade, while study design and protocol of the ongoing Phase 3 program were presented by Assoc. Professor Michelle Lofwall, MD, Medical Director of UK College of Medicine Straus Clinic, University of Kentucky. The presentations were timely, in advance of the forthcoming topline Phase 3 results. In parallel, preparations are ongoing for submissions of marketing approval applications for CAM2038 for treatment of opioid use disorder. We have also initiated a new Phase 3 trial of CAM2038 for treatment of chronic pain and thereby taken a first step towards expanding future indication areas for the product for pain. In general, we see a significant potential for innovative, effective and non-abusable pain treatments.

During the period, we announced positive results from a Phase 2 trial of our long-acting octreotide formulation CAM2029 for treatment of patients with neuroendocrine tumors (NET) or acromegaly. The product candidate was well tolerated and the treatment effects were comparable or better in some patients after switching from Sandostatin® LAR® to CAM2029. The results are promising and we are looking forward to Novartis initiating the Phase 3 trials in acromegaly and NET patients during 2017.

In the early pipeline, a clinical trial application has been submitted for a Phase 1 trial of three new product candidates - CAM2047, CAM2048 and CAM2058 - targeting indications of nausea and vomiting and/or postoperative pain. This study is designed to assess pharmacokinetics, pharmacodynamics and safety and will provide important insight and guidance for the further clinical development of these assets. After the period we announced the expansion of the collaboration and license agreement with Braeburn Pharmaceuticals for the further development and commercialization in North America of CAM2058, a combination product of buprenorphine and granisetron for treatment of postoperative pain, nausea and vomiting.

With regards to our ongoing early stage collaborations, we were pleased to note good progress by our partner Rhythm in relation to their development of setmelanotide for treatment of rare genetic obesity disease. In addition to the publication of promising Phase 2 data in New England Journal of Medicine, the investigational drug, setmelanotide, was during the period granted Breakthrough Therapy designation for POMS deficiency obesity and Orphan Designation for Prader-Willis Syndrome. In our collaboration of the development of a weekly semelanotide FluidCrystal®, final preparations for a first clinical study are being finalized.

We have also completed the initial stage of building our own commercial organization. Key leadership roles and specialist functions are now in place and I am delighted that in a short period we have established a strong core team of internationally experienced and entrepreneurial professionals and experts. Meanwhile, our partner Braeburn Pharmaceuticals has been expanding their US commercial footprint after the recent successful market approval of Probuphine® implant by the US FDA. Together, we have built a strong foundation for the planned approvals of CAM2038 in the US and Europe during 2018.

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 8 November 2016.