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

Key milestones in opioid dependence and chronic pain


During the third quarter, we achieved significant milestones towards expected approvals of Buvidal® (CAM2038) for the treatment of opioid dependence. The positive CHMP opinion, the issuance of a PDUFA goal date by the FDA, and the soon-to-be completed regulatory review in Australia keeps us on track for approvals in key markets before year end. We also announced positive Phase 3 results for CAM2038 in patients with chronic pain and advanced other promising pipeline programs according to plan.

CEO STATEMENT

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



Excitement building for upcoming launches
In September we announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending approval of Buvidal for the treatment of opioid dependence in adults and adolescents from 16 years of age. A final decision on EU marketing authorization is expected from the European Commission later in November.

Once approved, Buvidal will be the first long-acting medicine available for the treatment of opioid dependence in Europe, where there are an estimated 1.3 million high-risk opioid users. By offering flexible weekly or monthly dosing options, we believe Buvidal will open the door for patients to improve their treatment outcomes and to live a more normal life – for example by eliminating the need for frequent, often daily, healthcare visits, which can be both burdensome and stigmatizing for people trying to rebuild their lives and engage in employment. Following the positive CHMP opinion for Buvidal, we have ramped up our commercial activities and are ready for launch in the first wave European markets, Germany, the UK and the Nordics, Q1 2019.

During this quarter we also established an Australian subsidiary, Camurus Pty Ltd, and appointed Ruari Macdonald as Business Unit Head. Ruari has extensive specialty pharma experience from GSK, Reckitt Benckiser, Eli Lilly and Mundipharma, including in the opioid dependence field.
In the US, the Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of 26 December 2018 for CAM2038. In preparation for the approval and launch of CAM2038, our partner Braeburn has worked intensively and strategically with key stakeholders, including payers and distributors, to ensure optimal patient access to this potentially ground-breaking treatment. With approximately 2.5 million people diagnosed with opioid use disorder, and 130 American lives lost daily to this escalating crisis, there is a great need for new and improved treatment options.

Effective and long-lasting relief from chronic pain
In September, we announced positive top-line Phase 3 results for CAM2038 in patients with chronic low-back pain. The study demonstrated that CAM2038 provides effective and long-acting relief from chronic pain in patients with a history of opioid pain treatment.

With depression, anxiety and drug dependence frequently linked to chronic pain, and the prevalence of chronic pain in Europe and the US at almost 20%, we know this is a major healthcare problem with huge costs to both the individual and society. Furthermore, we realize that treating patients with chronic pain who also have opioid dependence is particularly challenging. We have designed CAM2038 to provide durable, round-the-clock pain relief and to be a safer treatment alternative for this patient group, with the aim of addressing the risks of opioid tolerance development, dependence, misuse, diversion and overdose. We are currently evaluating the long-term safety of CAM2038 in an open label extension study. Thereafter, we will start to prepare marketing approval application to health authorities.

Preparing pivotal Phase 3 studies of CAM2029
During the third quarter, we finalized the design of the pivotal Phase 3 programs for CAM2029 for treatment of acromegaly and neuroendocrine tumors. The first study is planned to start during the second quarter 2019 after approval by the health authorities. With its patient friendly product design and potential for improved treatment outcomes, we believe CAM2029 could gain significant share of the long-acting somatostatin market with current global annual sales exceeding $2.6 billion.

Progressing clinical development of CAM2043
After reporting positive top-line results from a single-dose and repeated dose Phase 1 study of our long-acting treprostinil depot (CAM2043), we have initiated work with opinion leaders and clinical experts to design the pivotal clinical program for CAM2043
for the treatment of pulmonary arterial hypertension (PAH). Our goal is to conduct a clinical Phase 2 study in 2019 and thereafter initiate a pivotal Phase 3 study. Furthermore, we are investigating the use of CAM2043 in additional indications.

An update on our clinical pipeline will be provided at our Capital Markets Day in Stockholm on 11 December 2018.

We look forward to an exciting quarter as we move closer to the expected approvals and launch of Buvidal in key markets, which will transform the company as we evolve into commercial stage. These approvals will also contribute to the validation of our unique FluidCrystal® technology to drive future pipeline programs and business development. We believe Buvidal will play an important role in helping people struggling with opioid dependence to live better lives, and thereby contribute to curbing the global opioid crisis. I am proud of the achievements during the period, especially the significant efforts and commitment of our team that has driven this success.

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.

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.

  • 2018-12-10 Corporate Communication...
  • 2018-12-06 Supply Chain Coordinator
  • 2018-11-23 CEO & Management...
  • 2018-11-14 Drug Safety Manager/QPPV

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