ABOUT CAMURUS

Delivering better treatments


Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”.

 

ABOUT CAMURUS

Delivering better treatments


Camurus is committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”.

CEO STATEMENT

Positive market signals for Buvidal® in Europe


During the first quarter of 2019, we initiated the European launch of Buvidal®, our in-house developed, weekly and monthly depots for the treatment of opioid dependence. In our first launch market, Finland, an estimated 6% of patients with opioid dependence are receiving Buvidal® after its first 3 months of availability. Subsequently, we have launched Buvidal® in the UK, Sweden, Germany and Denmark, with a considerable interest in all markets and a positive response from healthcare providers and patients.

CEO STATEMENT

Phase 3 long-term study confirms safety and continuous treatment efficacy



Positive start of EU launch
Following the launch of Buvidal®, patients in the EU have access to the first innovative long-acting medication for the treatment of opioid dependence, with individualized flexible weekly and monthly dosing. So far, around 500 patients have initiated treatment with Buvidal®, including new-to-treatment patients, and patients transferring from daily medication with sublingual buprenorphine and methadone. The majority of these patients are from Finland and Germany, while initial patient uptake in the UK, Sweden and Denmark, has, as expected, been less rapid due to the reimbursement and formulary listing processes. In Norway and Australia, we have submitted pricing and reimbursement applications and are expecting positive decisions and aim to start launches shortly thereafter. Initial sales of Buvidal® follows plan and with the positive feedback and engagement with stakeholders we are expecting to see significant growth during the year.

Large interest in Buvidal® in the criminal justice setting
Aside from very positive signals from healthcare providers, we have also seen a significant interest in our long-acting treatment solutions for use in custodial settings, where the unmet medical need of a safe and effective treatment alternative is significant. Several prisons in Germany have recently begun using Buvidal® for the treatment of patients with opioid dependence, with the expectation that our long-acting treatments will lead to improvement of outcomes and significant treatment efficiencies. Additionally, treatment with weekly and monthly Buvidal® may facilitate the transition to outpatient treatment protecting patients from the known risks of overdose and death during the first weeks of being released from prison. To further the understanding of the contribution Buvidal® can make in custodial settings a clinical UNLOC-T study comparing Buvidal® with methadone at eight prisons in New South Wales, Australia, is also progressing and initial results are expected in the fourth quarter of 2019. With a large unmet need and more than 100,000 individuals with opioid dependence in the EU and Australian prison systems combined, we see significant opportunities for Buvidal® in the criminal justice setting.

In the first quarter of 2019 we completed enrollment in the DEBUT outpatient clinical study comparing Buvidal® with daily standard-of-care with sublingual buprenorphine/naloxone. Results are expected during the fourth quarter.

A detailed subgroup analysis of fentanyl users in the pivotal Phase 3 study of Buvidal® compared to sublingual buprenorphine/ naloxone was also conducted. The results, showing improved outcomes and less illicit opioid use in patients treated with Buvidal®, were presented by Professor Edward Nunes, Columbia Medical School at the American Society of Addiction Medicine 50th Annual Meeting in Orlando, and generated significant interest.

Court proceedings initiated in the US
After the first quarter, our partner Braeburn filed an action in federal district court for the District of Columbia, seeking to overturn the market exclusivity extending to 30 November 2020 granted by the US Food and Drug Administration (FDA) to Sublocade, and seeking immediate approval of Brixadi. A court decision is expected during the third quarter of 2019.

Continued investment in the product pipeline
The last patients in the 52-week Phase 3 long-term safety extension study of CAM2038 in patients with chronic pain completed their treatment during the first quarter of 2019. After closing of the database and compiling of results and the study report, we will meet with European regulatory authorities to discuss the regulatory submission for CAM2038 for the treatment of chronic pain. We plan to submit in the EU during the first half of 2020.

Another important milestone for us is the start of the Phase 3 program for our subcutaneous octreotide, CAM2029, being developed for the treatment of acromegaly and neuroendocrine tumors (NET). CAM2029 has been designed for easy self-administration and optimization of treatment effects for these chronic diseases. During the first quarter, we initiated manufacturing and finalized the pivotal Phase 3 study protocol after alignment of study details with the FDA. Clinical trial applications are submitted in the US and a number of national regulatory authorities in Europe. The goal is to start treatment in the Phase 3 study of CAM2029 at the beginning of the third quarter of 2019.

We also continued to work on the development of a Phase 2 study of CAM2043 (treprostinil), for the treatment of pulmonary arterial hypertension (PAH) and systemic sclerosis and aim to initiate Phase 2 clinical trials in patients towards the end of the year. Additionally, activities continued in other internal projects as well as in our partnerships, including with Braeburn, Rhythm and Solasia.

To secure financing of prioritized development projects and for the launch of Buvidal® in Europe and Australia, we completed a rights issue of SEK 403 million before issue costs towards the end of the quarter.

Focus on launches and growth
Our key objective for 2019 is to give patients in Europe and Australia rapid access to treatment with Buvidal®. Based on the high unmet medical need in opioid dependence and the positive feedback on treatment with Buvidal® from both patients and healthcare providers, we expect to see significant sales and growth over the year. This ambition is supported by a strong commercial organization with fully operational regional teams in Germany, the UK, the Nordics and Australia, and with local presence in France, Spain and Italy. With the significant opportunity presented by Buvidal® in opioid dependence, alongside expected development milestones in our pipeline of innovative products and our partnerships, I believe the 2019 outlook for Camurus is optimistic and will enable us to deliver strong growth and value for patients and shareholders.

Fredrik Tiberg
President and CEO

We had a busy and productive first quarter with five ongoing clinical trials and several studies under initiation. The last patients completed treatment in the Phase 3 long-term safety study of CAM2038, weekly and monthly buprenorphine depots. New top-line Phase 3 results support the long-term safety and efficacy of CAM2038 in patients with opioid dependence. Having concluded pre-submission meetings with EMA and FDA, market approval applications for CAM2038 are now being finalized.


During the first quarter, we completed treatment of all patients in the open-label, long-term safety Phase 3 study of our weekly and monthly depots of buprenorphine together with our US partner Braeburn Pharmaceuticals. 228 patients in Europe, the U.S. and Australia were randomized in the study. Topline results demonstrated that the CAM2038 weekly and monthly depots were well tolerated and provided continuous treatment effect across the 48-week treatment period. Study retention was high, with 71% of patients completing the 48-week study treatment period.

After positive pre-submission meetings with the regulatory authorities (EMA and FDA), we are together with Braeburn Pharmaceuticals finalizing our market marketing authorization application and new drug applications (MAA and NDA) for submissions in mid-2017. The preparations for our anticipated 2018 launch of CAM2038 in Europe is well on-track, with the aim to provide patients rapid access to a new treatment alternative with the potential to improve both treatment outcomes and quality of life.

We are also working to expand the future indications for CAM2038 to treatment of chronic pain and expect to complete the ongoing pivotal Phase 3-study in patients with chronic low-back pain before the end of the year. During the period, a meeting was held with FDA regarding the product registration for chronic pain. There is a significant unmet medical need for new therapeutic options for treating chronic pain, highlighted by the current opioid crisis and issues of diversion, misuse, dependence and overdoses relating to the use of prescription opioids. CAM2038 may effectively address these problems and become an important treatment alternative, including for patients in need for higher doses of opioid analgesics and risks of dependence, and may also provide effective and long-acting pain relief.

In our collaboration with Novartis for our long-acting octreotide depot, CAM2029, for treatment of acromegaly and neuroendocrine tumours, GMP-manufacturing was performed during the period for Novartis’ planned start of Phase 3 studies later this year. Results from our previous Phase 2 study of CAM2029 in acromegaly and NET patients were presented at two scientific conferences; ENETS 2017 in Barcelona and ENDO 2017 in Orlando.

In the early clinical pipeline, treatment of the last cohorts is ongoing in the Phase 1 study of CAM2047 for treatment of chemotherapy-induced nausea and vomiting (CINV), and CAM2048 and CAM2058 for treatment of pain, nausea and vomiting. Study results are expected third quarter 2017. We are also preparing the start of the first clinical trial of our subcutaneous treprostinil depot, CAM2043, aiming at the development of a new treatment alternative for pulmonary arterial hypertension (PAH); a rare, serious and life-threatening condition affecting the lungs and heart.

Camurus is expanding with good prospects of further growth and continued value creation. This is reflected by an increasing interest from both pharmaceutical companies and the international investor community, for instance, in connection with our presentations and at J.P. Morgan and Cowen and Co. Annual Health Care Conferences earlier in the year.

In parallel with the advances in our product pipeline, we are also building our commercial organization for the anticipated launch of CAM2038 in 2018. To support the business expansion, we have strengthened the management team and organization with new functions and expertise. Urban Paulsson, with broad and international expertise from the pharmaceutical industry, was recently appointed as VP Corporate Development & General Counsel, and Cecilia Callmer, previously at Novo Nordisk and Ferring Pharmaceuticals, has taken the position as VP Human Resources.

We have had a good start of the year, with the recent announcement of positive Phase 3 results, and are now about to enter the registration phase with CAM2038. We are also having good progress in other clinical programs and look forward to a continued positive news flow during the year.

Fredrik Tiberg
President and CEO

Management team


Board of directors


Code of conduct


 

Career


At Camurus, we value diversity, equality, and responsibility. We are an agile organization with a shared ambition for growth and an innovative and collaborative culture. Our operations are conducted from the modern, state-of-the-art laboratories and offices at our headquarters in Lund, Sweden.

Camurus is a knowledge-based company, and the know-how, innovation, and expertise of our employees is an essential part of our continued success. Passion, knowledge, and creativity are vital for attaining our goal: to offer patients and society new and improved treatments for serious and chronic diseases. The vast majority of Camurus’ employees work in research and development and many of them hold advanced university degrees. Our business and comprehensive expertise are continually developed through an active transfer of knowledge throughout our international network and through intense collaborations with academia and industrial partners. Camurus is a dynamic and exciting workplace, populated by devoted experts with outstanding skills in many fields of research.

Vacant positions

Camurus is growing continuously and we recruit from time to time people with certain competencies. The skills and competencies we need depends on which part of our operations that expands. We currently do not accept unsolicited applications.

Vacant positions will be published here.

  • 2019-06-05 Research Scientist- Analytical Development
  • 2019-06-05 Drug Safety Manager / QPPV
  • 2019-04-23 Quality Assurance Manager
  • 2019-04-23 Clinical Program Manager/Clinical Trial Manager

Camurus AB Ideon Science Park. SE-223 70 Lund, Sweden. Visiting address Sölvegatan 41 A. 223 62 Lund, Sweden.
Phone: +46 46 286 57 30 Fax: +46 46 286 57 39 Email Addresses General enquiries: info@camurus.com
Business Development: busdev@camurus.com Media: media@camurus.com Investor Relations ir@camurus.com