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

Launch preparations and positive pipeline development


During the second quarter, we continued to progress approval processes for our weekly and monthly buprenorphine depots, CAM2038, for the treatment of opioid dependence, and intensified our launch preparations in Europe and Australia. We regained the worldwide rights to CAM2029 octreotide depot, received positive clinical results for CAM2043, and completed a directed share issue.

CEO STATEMENT

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



Progress in approval processes and launch readiness
During the second quarter, we made significant progress towards regulatory approvals of CAM2038 in the US, Europe and Australia. The New Drug Application (NDA) was resubmitted to the FDA by our US partner Braeburn. After the period, we were delighted to receive notice of the FDA’s acceptance of the complete response together with a PDUFA goal date of December 26, 2018. Market Authorization Application (MAA) review processes in the EU and Australia continued to advance, with expected approvals on all key markets in 2018.
Results from our randomized, double-blind, double-dummy, active-controlled Phase 3 study were published in JAMA Internal Medicine, demonstrating favorable clinical outcomes for CAM2038 versus current standard treatment with daily sublingual buprenorphine/naloxone in opioid dependent patients. This represents the first publication of Phase 3 study results for a long-acting buprenorphine injectable treatment. Clinical study results, including subgroup analyses of Phase 3 results in heroin and injection drug users, have also been presented at leading international scientific addiction conferences, showing statistically improved outcomes for key measures for CAM2038 versus daily sublingual buprenorphine/naloxone.

Launch preparations for CAM2038 continued to progress. In the US, Braeburn made significant advances in establishing an effective marketing, reimbursement and distribution model for CAM2038. Responses from payors and prescribers have been encouraging. In Europe, we have further strengthened our organization within marketing, medical affairs and market access, and our commercial teams have continued to execute on the regional go-to-market plans for CAM2038. In Australia, we recruited a business unit head with experience in the opioid dependence therapy area to build the organization and prepare for launch. Additionally, we initiated the expansion of our global distribution network to ensure access to treatment for patients outside EU and Australia and signed an agreement with Medison Pharma for commercialization of CAM2038 in Israel.

Conclusion of pivotal study in chronic pain
A randomized, placebo-controlled Phase 3 study of CAM2038 for the treatment of chronic low back pain was concluded in May 2018. Subsequently, our study teams have been preparing for database lock and unblinding of the study. Topline efficacy results are expected in the third quarter. Meanwhile, a long-term safety extension study of CAM2038 is ongoing, which is anticipated to be clinically completed towards the end 2018.

Preparing for CAM2029 Phase 3 studies
After regaining the exclusive worldwide rights to our CAM2029 octreotide depot and related products from Novartis, we have worked diligently to ensure a smooth transfer of the project and have also started to prepare for Phase 3 registration programs for CAM2029 in acromegaly and neuroendocrine tumors (NET). During the second half of 2018, we plan to complete ongoing manufacturing preparations for Phase 3 and engage with healthcare authorities in the EU and US to align clinical registration program updates. The market for long-acting somatostatin products, Sandostatin® LAR® and Somatuline® Autogel®, has shown steady growth for the past two decades with 2017 global sales exceeding USD 2.4 billion. Based on our product design advantages and positive clinical results from Phase 1 and 2 studies, we expect that CAM2029, if approved, could gain a significant market share and become an important catalyst for future growth and value creation for Camurus.

Promising Phase 1 results for CAM2043
In our early pipeline, we obtained topline results from the first clinical study of our weekly treprostinil depot, CAM2043, in development for treatment of pulmonary arterial hypertension (PAH). Based on the positive pharmacokinetic and tolerability results in healthy volunteers, we have started preparing the further clinical development of CAM2043 in collaboration with key opinion leaders and clinical experts.

Directed share issue completed
To support the commercialization of CAM2038 in Australia and the initiation of clinical development programs for CAM2029 and CAM2043, a directed share issue of approximately MSEK 102 was completed in June, securing these important activities up to the expected US approval and launch of CAM2038.

The second quarter has been intense and productive, during which our dedicated teams continued to deliver on key priorities. I am proud of the commitment of my coworkers and thankful for the many positive results that they have achieved. With the approvals of CAM2038, we will have the opportunity to positively impact the lives of hundreds of thousands of patients living with opioid dependence. In the longer term we aim to address important treatment needs in other patient groups with severe and chronic diseases.

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.

  • 2018-10-05 Medical Science Liaison...

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