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

First long-acting opioid dependence treatment launched in the EU


2018 was a breakthrough year for Camurus. Buvidal was approved as the first long-acting depot treatment of opioid dependence in the EU and Australia. With distribution, marketing and sales in place, the European launch was quickly initiated with the first patients receiving treatment already by mid-January 2019. Physician and patient feedback has been positive, which is encouraging as we continue the roll-out of Buvidal on new markets. Also gratifying during the year was the positive Phase 3 results for CAM2038 in chronic pain.

CEO STATEMENT

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



In November 2018, we announced that the European commission and Therapeutic Goods Administration had approved Buvidal as the first long-acting injection treatment for opioid dependence in the EU and Australia.

To bring an innovative drug candidate from idea to approved medicine is a challenging process and the approvals are monumental milestones in our company’s history. We are proud to be able to give patients with opioid dependence access to a muchneeded new treatment paradigm with a demonstrated potential to improve treatment outcomes and quality of life of patients by reducing the significant burdens and risks associated with current daily medications.

The approval of Buvidal is a major milestone for Camurus and an important validation of our innovative FluidCrystal® technology.

Science-led commercial-stage pharmaceutical company
During 2018, we have continued the transformation of Camurus from an R&D focused company to an integrated, science-led commercial company. We grew our organization and are now one hundred employees and twenty fulltime consultants working from our Lund headquarter and regional offices in Cambridge, Mannheim, Paris and Sydney. Half of our people are in the commercial organization working with market access, medical education, marketing and sales and receiving cross-functional support from our strong teams in R&D, manufacturing and supplies, HR and finance. Together we are working passionately to make Buvidal available to patients around the world.

Of the estimated 1.5 million high-risk heroin and opioid users in Europe and Australia, less than half receive opioid dependence treatment today. Based on our current estimates, approximately 740,000 persons with opioid dependence could benefit from treatment of opioid dependence with long-acting medications and at least 100,000 patients could be in treatment with Buvidal in five years.

By providing weekly and monthly dosing options, Buvidal can improve adherence, without the requirement of frequent, often daily, visits to treatment clinics which can be burdensome and socially stigmatizing.

Buvidal launched in Finland, Sweden and the UK
In January 2019, Buvidal was launched in Finland, Sweden and the UK. The initial feedback from treating physicians and patients has been very positive, which is encouraging as we continue to roll-out Buvidal in Europe and Australia.

Alongside our commercial activities, we are expanding the comprehensive clinical evidence-base for Buvidal. During the period, recruitment of patients was started in a clinical study in the custodial setting. The study, sponsored by the Government of New South Wales, is conducted in seven prisons and evaluates the treatment with Buvidal versus methadone. We also have a study of Buvidal versus sublingual buprenorphine in the outpatient setting ongoing with focus on patient satisfaction and quality of life outcomes. Both studies are recruiting well and expected to deliver topline results late 2019.

After announcing positive Phase 3 efficacy results in chronic pain during the third quarter, the clinical development of Buvidal (CAM2038) in this indication continued with the long-term safety extension study. Results are expected in the second quarter 2019 and will be followed by discussions with health authorities before submission of market authorization applications.

Tentative US approval of Brixadi™
In the US, our partner Braeburn received a tentative approval of Brixadi (the US trade name for Buvidal), signifying that all regulatory requirements for approval were fulfilled. However, final approval of the monthly product was blocked by a market exclusivity granted extending to November 2020. The unexpected broad scope of the market exclusivity was decided by the FDA at the time of the tentative approval of Brixadi. Given the magnitude of the opioid crisis in the US, it is imperative that Brixadi is available as soon as possible to allow patients access to a new treatment which fulfils critical unmet medical needs. Several paths to address the current situation and being pursued by Braeburn.

Fully underwritten rights issue
From a financial perspective, the tentative approval meant that the USD 35 million milestone payment expected from Braeburn after market approval of Brixadi in 2018 is delayed. In view of this, our Board of Directors has resolved to, subject to Extraordinary General Meeting approval, carry out a new share issue with preferential rights for the company’s shareholders to raise gross proceeds of approximately SEK 400 million.

The proceeds from the rights issue will be used to finance the launch and marketing of Buvidal in Europe and Australia, progress the clinical development of key pipeline programs, including Phase 3 studies of CAM2029 in acromegaly and neuroendocrine tumors, and other prioritized programs, such as a Phase 2 study of CAM2043 for treatment of pulmonary hypertension.

The rights issue is fully committed and underwritten by current shareholders and external guarantors. We are of course thankful to all our shareholders for their support and commitment.

We look forward to a productive 2019 as we continue to launch Buvidal in key markets and progress the development of our innovative therapies.

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.

  • 2019-02-08 Senior Accountant
  • 2018-12-20 Key Account Manager Stockholm/mid Sweden
  • 2018-12-12 Regulatory Affairs Manager
  • 2018-12-10 Corporate Communication Associate

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