Business highlights fourth quarter 2016
- Positive pivotal phase 3 trial results received for long-acting buprenorphine, CAM2038, for treatment of opioid addiction.
- Start of Phase 1-trial of CAM2047, CAM2038 and CAM2058 for treatment of nausea and pain.
- Stage 1 of the establishment of Camurus´ European commercial organization and operational structure completed.
- Expansion of collaboration and license agreement with Braeburn Pharmaceuticals.
- Preclinical development program for CAM2043 for treatment of pulmonary arterial hypertension completed.
- Three presentations of long-acting buprenorphine, CAM2038, at ISAM annual meeting 2016 in Montreal.
- Capital Markets and R&D Day held at the Royal Swedish Engineering Academy in Stockholm.
Financial summary fourth quarter 2016
- Revenues MSEK 37.1 (36.3).
- Operating result before and after items affecting comparability MSEK -35.1 (-4.9) and MSEK -35.1 (‑40.4), respectively.
- Result after tax MSEK -27.8 (-31.9).
- Earnings per share SEK -0.75 (-1.05), before and after dilution.
- Cash position MSEK 508.6 (716.1).
Financial summary full year 2016
- Revenues MSEK 113.7 (154.8).
- Operating result before and after items affecting comparability MSEK -102.5 (-30.5) and MSEK -102.5 (-204.1) respectively.
- Result after tax MSEK -81.0 (-159.5)
- Earnings per share SEK -2.17 (-6.02), before and after dilution.
- Cash position MSEK 508.6 (716.1).
The final quarter of 2016 saw us achieve a major milestone for Camurus. Results from our completed Phase 3 study of CAM2038 in opioid dependence demonstrated significantly better treatment effect with our long-acting depots versus standard of care with daily sublingual tablets. With this achievement, we now initiated the work on the market approval applications for both the EMA and FDA.
Our long-acting buprenorphine depots, CAM2038, for treatment of opioid dependence, clearly fulfilled efficacy primary endpoints agreed with the European Medicines Agency (EMA) as well as US Food and Drug Administration (FDA). Additionally, secondary analyses demonstrated superior efficacy versus daily sublingual buprenorphine/naloxone tablets. These clear-cut, positive Phase 3 results are particularly impressive in the light of the randomized, controlled double blind, double dummy design, and with regard to the complex patient population that was included directly from the active opioid misuse. Approximately 70% of the 428 study participants were using heroin and more than half of them were injection opioid users. Most of them also used other illicit drugs, including cocaine, amphetamine and marijuana. This group is representative of patients starting their treatment of opioid dependency both in EU and the US.
Present daily treatment with buprenorphine or methadone has been clearly demonstrated to be effective in decreasing opioid misuse, reducing mortality and the spreading of infectious diseases. Unfortunately, these treatments have some significant limitations. These include poor treatment adherence, costs and stigma in connection to need of frequent clinic visits and supervised dosing, overdosing, as well as diversion and misuse. Using long-acting medications, these limitations can be significantly reduced, or even eliminated, as pointed out by Prof. Edward Nunes MD, PhD, Columbia University Medical School during his presentation at Camurus’ first Capital Markets and R&D Day in Stockholm, December 14, 2016. Combined with the documented treatment efficacy and favorable safety profile, our long-acting depot products have the potential to transform the treatment of opioid dependence and provide improvement to patients, healthcare providers and society. Process of filing market authorization and new drug applications for CAM2038 to the EMA and FDA mid 2017 are on track.
During the period, important advances were also made regarding commercial manufacturing as well as establishment of our commercial organization and operational structure in front of the planned launching of CAM2038 in Europe during 2018. We have been working closely with experts and stakeholders within the various national health systems, as well as performing health economic analyses and modelling. Initial results will be presented at the AMCP Managed Care Specialty Pharmacy Annual Meeting i Denver, Colorado in March 2017.
In our collaboration with Novartis, following the announcement of positive Phase 2 results for our subcutaneous long-acting octreotide depot, CAM2029, for treatment of acromegaly and neuroendocrine tumours (NET), a clinical study report has been completed during the quarter. Results will be presented at several conferences during the spring, including ENETS, Barcelona in March and at ENDO, Orlando in April. After completed preparations for GMP-manufacturing of the product during the quarter, GMP manufacturing is now initiated ahead of planned Phase 3 start later in the year.
In the collaboration with Rhythm regarding weekly setmelanotide FluidCrystal® investigational product for treatment of genetic obesity disease, GMP-manufacturing was successfully completed and preparations of a clinical trial are ongoing ahead of the start during 2017.
In our early development pipeline, we initiated a clinical pharmacokinetic study of new product candidates for treatment of pain as well as nausea and vomiting. Two of the programs are conducted with our US partner Braeburn Pharmaceuticals, after having expanded our license agreement during the period.
A new exciting program in our pipeline is a subcutaneous depot of treprostinil, CAM2043, for treatment of pulmonary arterial hypertension. PAH is a rare progressive lung and heart disease with a poor life expectancy of less than 3 years, if left untreated. Based on our preclinical results, we believe that CAM2043 has potential to significantly improve treatment versus available treatments. Presently treprostinil is administrated using continuous infusion, a complex procedure associated with significant and treatment limiting side-effects such as pain and serious infections. The PAH market exceeded USD 4 billion 2015, with treprostinil representing about 25%.
Our strong results delivered during the past year have resulted in an increased interest in Camurus and contributed to a positive development of the company value.
Behind the success is our team of fantastic coworkers, dedicated partners and clinical investigators, as well as their study teams. Warm thanks to you all!
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 16 February 2017.