“We are targeting marketing authorization approvals in all key markets in 2018”
Business highlights first quarter 2018
- Complete response letter (CRL) received by our partner Braeburn Pharmaceuticals from the FDA regarding the CAM2038 new drug application (NDA) for the treatment of opioid use disorder
- Type A Meeting Package submitted to the FDA regarding CRL request for additional information for the CAM2038 NDA
- CAM2038 marketing approval applications in EU and Australia progressed according to plan
- All patients completed treatment in the randomized Phase 3 study of CAM2038 in patients with chronic pain
- Notice of allowance received for CAM2029 patent applications from the US and Australian patent offices
- First clinical milestone achieved in collaboration with Rhythm Pharmaceuticals regarding the development of a weekly setmelanotide depot, CAM4072, for the treatment of genetic obesity disorders
- Single ascending dose part of Phase 1 clinical study of long-acting treprostinil, CAM2043, completed
- Company presentations at Biostock Live, Stockholm Corporate Finance Life Science Seminar, Cowen and Company 38th Annual Health Care Conference 2018, Carnegie Nordic Healthcare Seminar 2018
Significant events after the reporting period
- Camurus regains worldwide development and commercialization rights to CAM2029 and related product candidates from Novartis
Financial summary first quarter 2018
- Net sales MSEK 14.6 (17.2).
- Operating result MSEK -46.4 (-51.6).
- Result after tax MSEK -36.3 (-40.2).
- Earnings per share, before and after dilution SEK -0.97 (-1.08).
- Cash position MSEK 266.6 (463.8).
During the first quarter of 2018, we worked intensely to address the questions raised by the FDA in the CRL issued for CAM2038 for the treatment of opioid dependence. A briefing package has been submitted to the Agency detailing key parts of the response strategy for the resubmission of the NDA. Meanwhile, the regulatory review processes for CAM2038 continued to progress in Europe and Australia, and we are targeting marketing authorization approvals in all key markets in 2018.
Regulatory approvals and preparations for launch
In January 2018, our partner Braeburn Pharmaceuticals received a complete response letter (CRL) from the US Food and Drug Administration (FDA), requesting additional information for the US marketing approval of our weekly and monthly buprenorphine depots, CAM2038, for the treatment of opioid dependence. The work to answer the Agencies questions started immediately and we expect resubmission of the new drug application (NDA) for CAM2038 in Q2 2018. In parallel, our own marketing authorization applications in Europe and Australia progressed, with anticipated approval decisions in the fourth quarter of 2018.
CAM2038 has the potential to be the first approved long-acting treatment for opioid dependence in Europe and Australia. Preparations for launch, including the establishment of regional commercial teams, continue in full force. The interest in CAM2038 among patients, prescribers, payors and authorities is very encouraging. In addition to the strong data already established in the pivotal clinical studies, we are currently advancing new innovative partnerships to further demonstrate the clinical and health economic value of CAM2038 in opioid dependence treatment.
Phase 3 study in chronic pain under completion
During the first quarter of 2018, all subjects completed treatment in the randomized, controlled Phase 3 efficacy study of CAM2038 for the treatment of chronic lower back pain. Topline efficacy results from the study, which has an ongoing long-term safety extension for a broader patient population, are expected towards the end of the second quarter of 2018. Positive Phase 3 results will form the basis of the continued clinical development of CAM2048/58 for postoperative pain and nausea.
Camurus regains rights to CAM2029
During the quarter, manufacturing preparations for Phase 3 development of CAM2029 progressed well. We received notice of allowance of new patents from the US and Australian patent offices, which can further strengthen and extend the patent protection of CAM2029 until 2032 or beyond.
After the period, we announced that Camurus regains the global development and commercialization rights to CAM2029, and related assets, from Novartis. This represents an important business opportunity for Camurus, which is well aligned with our strategy of building a strong and profitable specialty pharmaceutical company.
Clinical milestone achieved in the collaboration with Rhythm
After the completion of the initial studies of a weekly setmelanotide depot for treatment of genetic obesity disorders under development by our partner Rhythm, Camurus received notice that the first clinical milestone in the collaboration had been achieved. Preparations for continued clinical studies in patients with rare genetic obesity disorders are ongoing.
Completion of single ascending dosing in clinical study of long-acting treprostinil
At the end of 2017, Camurus started a clinical Phase 1 study of a promising new product candidate – a long-acting treprostinil depot, CAM2043, for the treatment of pulmonary arterial hypertension (PAH). The first single ascending dose part of the study is now completed, and repeated dosing has been initiated. Topline pharmacokinetic and tolerability results from this study are expected in the second quarter of 2018. Further clinical development of CAM2043 is being prepared with the aim to start a pivotal registration program in 2019.
We continued to make good progress in our key development programs during the first quarter, and I anticipate a strong news flow during the remainder of the year, with results and highlights from our clinical studies, marketing authorization decisions, and potential launches of CAM2038 in key global markets.
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, 01.00 PM CET on 3 May 2018.