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 QUARTER 2021

Positive start of the year with high growth
and important progress in the pipeline


CEO STATEMENT

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



Camurus’ revenue increased strongly during the first quarter – by 156% compared to the first quarter of 2020. We successfully continued our work to make Buvidal available in new markets through its launch in Spain, a positive health economic decision in France, market approval in New Zealand and a recommendation for market approval of a new higher dose strength of Buvidal in the EU. Our Phase 3 studies of CAM2029 for the treatment of acromegaly advanced and we received acceptance from the FDA for a new Phase 3 study of CAM2029 for the treatment of neuroendocrine tumors. During the quarter, we also completed a scientific advice with FDA and aligned the Phase 2/3 clinical development program for CAM2029 for the treatment of polycystic liver disease.


Positive market development for Buvidal and new regulatory approvals
Camurus had an excellent start of 2021 with strong revenue growth, new regulatory approvals and progress in the pipeline. Sales during the quarter were clearly affected by restrictions and extensive closures in relation to the COVID-19 pandemic in several European countries but improved towards the end of the quarter as restrictions began to ease in some countries. Product sales were SEK 124 million, which corresponds to an increase of 156% compared with the same quarter in 2020 and 20% compared to the previous quarter. Approximately 18,000 patients were in treatment with Buvidal at the end of the quarter.

We continued to strengthen our position in markets where Buvidal has been established, such as the Nordic region, the UK and Australia, during the quarter. In markets were Buvidal launched more recently, like Austria and Belgium, sales development has continued to be positive but to a greater extent been affected by COVID-19. During the first quarter, we began the launch of Buvidal in Spain and we look forward to growing sales as regional permits and decisions begin to come into place. In France, we reached an important milestone when the Haute Autorité de Santé (HAS) made a positive health economic evaluation of Buvidal, which led us to begin preparations for a planned launch of Buvidal in the third quarter and the development of our commercial organization in France. COVID-19 has also delayed reimbursement decisions by country authorities; however, we are making good progress with accelerating launch preparations in Switzerland, the Netherlands and several other European countries.

Furthermore, we received an additional market approval, in New Zealand, and a recommendation for the approval of a new higher 160mg dose of Buvidal from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). A final approval from the European Commission is expected at the end of May, which will further increase the possibility of treating all patients with Buvidal. We also finalized the discussion with the Australian Therapeutic Goods Administration (TGA) regarding our regulatory application for Buvidal in Australia. The approval process has been very swift and on 3 May 2021, we announced the approval for a new Buvidal Monthly 160mg dose along other important label updates, including direct treatment initiation with Buvidal Weekly. In addition, several regulatory applications for Buvidal are under review, e.g. in the Middle East.

In the US, we are awaiting notification from our partner Braeburn that all questions that the Food and Drug Administration (FDA) raised in their Complete Response Letter of December 1, 2020 have been dealt with. We are also awaiting notification of the resubmission of the updated drug application, NDA, for Brixadi™ (the trademark for Buvidal in the US). We continue to expect a decision for final approval of Brixadi in the second half of 2021, which after repeated delays is long-awaited – not least given the enormous need for treatment in the US and the increasingly large number of opioid overdoses occurring during the COVID-19 pandemic. The Biden administration has recognized the enormous challenge that the opioid epidemic represents and has recently initiated a rescue plan, a USD 1.5 billion dollars grant, for substance abuse prevention and treatment.

Several investigator-led clinical trials of Buvidal are currently ongoing in the US, Europe and Australia. Together, they will include over 2,000 patients and contribute to an increased knowledge of the value of Buvidal in various clinical applications in different treatment environments, such as emergency, outpatient and prison care.

We have seen that the introduction of Buvidal has contributed to increased interest in treatment among patients that previously, for different reasons, chose not to enter treatment of their opioid dependence. This is illustrated by two recent scientific publications which highlight the possibilities with Buvidal in vulnerable and diffiucult to treat patient groups.1,2 Real world experience with Buvidal continues to be very positive across treatment groups, settings, and geographies.

Significant progress in our development pipeline and partnerships
During the quarter, we made excellent progress with our key pipeline programs. Our two pivotal Phase 3 studies of octreotide subcutaneous depot, CAM2029, in patients with acromegaly have continued during the quarter with the aim for the studies to be fully recruited during the third or fourth quarter of this year, depending on the COVID-19 pandemic. Many of our study clinics are still closed, but an increasing number are starting to reopen for recruitment again. During the quarter, we also received permission to start our Phase 3 study of CAM2029 for the treatment of patients with neuroendocrine tumors (NET). This is a randomized active controlled study of the efficacy and safety of CAM2029 in approximately 300 patients with NET. Our goal is to demonstrate a statistically improved treatment effect with CAM2029 compared to current standard treatment with Somatuline® Autogel® or Sandostatin® LAR®.

In addition to the Phase 3 programs, a Phase 1 clinical trial of CAM2029 in a pre-filled syringe with or without an autoinjector is ongoing. The study is progressing well; the first part of the study is expected to be completed during the second quarter. Thereafter, the second part will begin to characterize pharmacokinetics after repeated dosing of CAM2029. In addition to ongoing program within acromegaly and NET, we had a scientific advisory meeting with the FDA regarding the ongoing development of CAM2029 for the treatment of polycystic liver disease (PLD). PLD is a rare and potentially serious disease which consequences can be dyspnea, early satiety, negative impacts on patient’s body image, depression and poor quality of life. In the meeting with the Agency, we reached alignment on our ongoing development of patient reported outcomes measures for our planned registration studies and the design of the Phase 2/3 study that we are preparing to start in the second half of this year.

In addition to the activities for CAM2029, we have several ongoing development programs, both in-house and with partners, such as Rhythm and UCB. The Phase 2 clinical trial of CAM2043 in patients with Raynaud’s phenomenon was halted during the first quarter, pending the clinic’s permission to reopen after closure due to COVID-19. Patient recruitment has now resumed, and we expect that the study can be completed during the year. In collaboration with Rhythm, preparations are underway for a registration-based study of setmelanotide weekly depot (CAM4072) for the treatment of patients with genetically determined obesity disease. Rhythm plans to launch the Phase 3 program during the second half of 2021. In addition, our collaboration with UCB on the development of a long-acting zilucoplan for the treatment of generalized myasthenia gravis has progressed, as has our collaborations with other international pharmaceutical companies on early development projects based on our FluidCrystal® technology platform.

Continued investment in growth, market expansion and new long-acting medicines
Over the past 2 years, Camurus has successfully undergone a transformation from a purely research and development company to a fully integrated pharmaceutical company with its own commercial organization on two continents. During the first quarter, we continued to deliver on our goal of becoming a long-term profitable and fast-growing company by developing and marketing innovative long-acting medicines that significantly contribute to better treatment results and quality of life for patients with severe and chronic diseases.

Total revenues, product sales, and the financial result continued to improve during the first quarter, and we maintained our solid cash position. At this early stage of the year, our outlook for 2021 is unchanged and we continue to invest heavily in the development of our product portfolio and commercial platform for further growth and business expansion.

In this context, we are pleased to welcome Maria Lundqvist to Camurus as Head of HR and member of the management team. Maria brings more than 20 years of experience from the pharmaceutical industry and most recently came from a position as Head of HR for Teva Pharmaceuticals in the Nordic region.

After a positive first quarter, we continue to focus on our key goals of growth, market expansion and progressing our clinical studies and pipeline of innovative medicines towards market approval and launch.

Fredrik Tiberg
President and CEO

References
1. Weeks A, et al. Initial experience with subcutaneous depot buprenorphine in a medically supervised injecting facility. Drug Alcohol Rev. 2021; Online ahead of print https://doi.org/10.1111/dar.1329
2. Tay Wee Teck J, et al. Using Microdosing to Induct Patients Into a Long-Acting Injectable Buprenorphine Depot Medication in Low Threshold Community Settings: A Case Study. Front Pharmacol. 2021; Online ahead of print https://doi.org/10.3389/fphar.2021.631784

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 AB Ideon Science Park. SE-223 70 Lund, Sweden. Visiting address Ideongatan 1A. 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