â€œWe are fully dedicated to achieving approvals for CAM2038 in Europe, Australia and the US during 2018, and the launch preparations for this much-needed treatment of opioid dependence are progressing according to plan.â€�
Business highlights fourth quarter 2017
- Recommendation of approval of CAM2038 NDA by the FDA Advisory Committees.
- Acceptance of CAM2038 MAA for review by the Australian TGA.
- All patients enrolled in Phase 3 efficacy and long-term safety extension study of CAM2038 in chronic pain
- Positive Phase 1 results after repeat dosing of weekly setmelanotide formulation, CAM4072, for treatment of genetic obesity disorders in collaboration with Rhythm.
- IND approval and first cohort treated in Phase 1 study of CAM2043 for treatment of pulmonary arterial hypertension.
- Presentations of Phase 3 results for CAM2038 at ISAM Annual Meeting in Abu Dhabi, UAE, AAAP Annual Meeting in San Diego, US, APSAD in Melbourne; ATHS meeting in Biarritz; and SSA meeting in Newcastle.
- Company presentations at Jefferies London Healthcare Conference 2017, London.
Financial summary fourth quarter 2017
- Revenues MSEK 5.5 (37.1).
- Operating result MSEK -66.1 (-35.1).
- Result after tax MSEK -52.2 (-27.8).
- Earnings per share SEK -1.40 (-0.75), before and after dilution.
- Cash position MSEK 314.5 (508.6).
Financial summary full year 2017
- Revenues MSEK 54.3 (113.7).
- Operating result MSEK -243.5 (-102.5).
- Result after tax MSEK -190.6 (-81.0).
- Earnings per share SEK -5.11 (-2.17), before and after dilution.
- Cash position MSEK 314.5 (508.6).
Highlights from the last quarter of 2017 include the FDA Advisory Committee recommendation for approval of CAM2038 for opioid dependence and the start of a new clinical program for treatment of pulmonary arterial hypertension.
Listening to the testimonies of patients that participated in our clinical studies of CAM2038 was a touching experience for me at the Advisory Committee meeting. Their stories of how CAM2038 had contributed to their recovery, and improved their self-esteem, without the stigma and disease reminders associated with daily sublingual medication, was a firm acknowledgement that we have developed a treatment with the potential to significantly improve lives. The positive response from so many patients and study investigators spurs us in our quest to make CAM2038 available on the market as quickly as possible.
During the final quarter of 2017 we were delighted to receive a positive FDA Advisory Committee recommendation for CAM2038. However, on the 19 January 2018, Braeburn Pharmaceuticals, our US partner for CAM2038, received a complete response letter from the FDA, requiring further information to the New Drug Application (NDA) for CAM2038. No additional clinical studies are required, and we are working with Braeburn to address the FDAâ€™s questions. While the complete response letter for CAM2038 was unexpected and disappointing, we do not believe this delay will significantly impact the future market potential for CAM2038.
Approval of CAM2038 in other markets progressed according to plan. The CAM2038 market approval application (MAA) submitted to the Australian Therapeutic Goods Administration (TGA) was accepted for review and is being processed alongside the European MAA. An opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use is expected in Q3 2018, and final approval decisions from both the EMA and TGA are anticipated in Q4 2018.
In preparation for the commercial launch of CAM2038, we are continuing to add experts to our regional teams in the UK, Germany, France, and the Nordics. In parallel, we are engaging with key opinion leaders and payors to demonstrate the value CAM2038 will bring to health economies and the wider society.
During Q4, Phase 3 results from our comprehensive clinical study program for CAM2038 for opioid dependence were presented by our study investigators at several leading international addiction conferences and regional meetings: ISAM Annual Meeting in Abu Dhabi, AAAP in San Diego, APSAD in Melbourne, ATHS in Biarritz, and SSA in Newcastle.
Aside from scientific and regulatory progress in the opioid dependence area, we also made progress with other important programs in Q4:
- CAM2038 for the treatment of chronic pain. The pivotal Phase 3 efficacy study is currently being completed and have been extended with a long-term safety study, which was fully enrolled during the quarter. Topline efficacy results are expected to be announced in Q2 2018, while long-term safety data are planned for Q4 2018.
- CAM2029 for the treatment of acromegaly and neuroendocrine tumors. The collaboration with Novartis is in full force. We plan to present updated timelines on the start of the Phase 3 program mid-2018.
- Weekly setmelanotide, CAM4072, for the treatment of rare genetic disorders of obesity. Following the successful completion of a single-dose study, Rhythm recently completed a repeat dose study of CAM4072. The formulation, based on our FluidCrystalÂ® technology, demonstrated tolerability and pharmacokinetics that support further clinical development.
- CAM2043 for the treatment of pulmonary arterial hypertension (PAH). An Investigational New Drug Application (IND) was submitted to the FDA and the first cohort was treated with our weekly treprostinil depot. Initial results from this study are expected during Q2 2018.
PAH is a rare and severe chronic disease of the heart and lungs. The current PAH market exceeds USD 5 billion globally, of which almost one quarter is treprostinil sales. A weekly subcutaneous depot could provide important patient benefits compared to current infusion products, which are associated with risks of serious infections, severe infusion site pain and which require a complex extracorporeal pump system.
Looking ahead, we can expect an exciting year as we and our partners continue to move our clinical pipeline forward. We are fully dedicated to achieving approvals for CAM2038 in Europe, Australia and the US during 2018, and the launch preparations for this much-needed treatment for opioid dependence are progressing according to plan. We are also anticipating positive Phase 3 results for a second indication of chronic pain, which, like opioid dependence, is an area with high unmet medical needs and significant market potential. In addition, results from several of our other clinical programs and collaborations are expected during the year, with the potential for further value creation and company growth.
President and CEO
For more information:
Fredrik Tiberg, CEO and Head of Research
Tel. +46 (0)46 286 46 92
Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
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 15 February 2018.
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