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

High demand for treatment with Buvidal®


CEO STATEMENT

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



Camurus started 2020 with strong growth in revenue driven by increasing demand for weekly and monthly Buvidal. We saw a 90 percent increase in the number of patients receiving treatment in the quarter. Buvidal is now the market leader in both Finland and Norway, with the strongest growth occurring in Australia. This positive trend in all markets was partly catalyzed by the ongoing Covid-19 pandemic, as treatment providers recognized the benefits Buvidal offers in terms of reducing the treatment burden for both patients and healthcare professionals in a hard-pressed healthcare sector. During this quarter, we continued to improve the availability of Buvidal in our markets. The Australian regulatory agency extended access, allowing GPs – who treat the majority of patients with opioid dependence – to prescribe Buvidal. In Germany and Austria, renumeration and legislative changes were put forward to facilitate access to long-acting medications.


Individualized long-acting treatment gaining ground
Camurus started 2020 with a 60% increase in product sales compared to previous quarters – and a 340% increase compared to the first quarter of 2019. Sales of Buvidal in the first quarter of 2020 were SEK 48.6 million with total revenue of SEK 49.3 million. Less than a year after launch, sales are on a positive upward trend in all launch markets in Europe, and Buvidal is the market leader in both Finland and Norway. Australia is currently the fastest growing market with approximately 3,000 patients in treatment with Buvidal 6 months after its launch. This success has been driven by our skilled commercial and medical teams, together with the positive results and experiences from research collaborations and clinical studies conducted in partnership with clinical experts and authorities in Australia. In total, more than 7,500 patients were treated with Buvidal at the end of the quarter – which is nearly a 90% increase over the fourth quarter of 2019. Our flexible manufacturing operation has adapted quickly to the increasing demand for Buvidal ensuring appropriate licenses and deliveries are in place without any major disruption to supply in our markets. In the beginning of April, we announced high demand for Buvidal and that we expect revenues to reach the higher end of guidance.

During the quarter, we continued to work to improve access to Buvidal. In Australia, the results from a 6-month trial period of Buvidal in commercial use was reported by the pharmaceutical authority, the Therapeutic Goods Administration (TGA), and the authority extended prescribing from opioid dependence specialists to also include general practitioners, who treat the majority of Australia’s patients with opioid dependence. In Germany, as of 1 April 2020, the remuneration system for physicians has been modified to improve access to new treatment options, including long-acting injectables. In Austria, a change in legislation is ongoing that will allow Buvidal to be available to patients in Q2 2020. With approximately 18,000 people in treatment for opioid dependence, Austria has as many patients in treatment as in all the Scandinavian countries together. In the UK, the Health Minister in Wales expressed support for the treatment of opioid dependent patients with long-acting buprenorphine during the ongoing Covid-19 crisis. In Norway, clinics have established outreach services to allow access to Buvidal for patients faced with the risk of coronavirus infection if attending the clinics on public transport. In this context, long-term injections offer benefits for both patients and healthcare professionals. Finally, in different parts of Europe and Australia, important initiatives have been taken to improve access to treatment for vulnerable patient groups, including the homeless and patients in the criminal justice system.

Regulatory and clinical progress with Buvidal
During the first quarter, a market authorization application for Buvidal was submitted to the Swiss Agency for Therapeutic Products (Swissmedic).

The DEBUT and UNLOC-T study reports were completed during the quarter. DEBUT is the first randomized open label trial comparing patient-reported outcomes for a long-acting buprenorphine injection with daily sublingual buprenorphine standard of care. As previously announced, the study demonstrated statistically improved treatment effect, meeting the primary and several secondary patient reported endpoints, which further strengthen the scientific evidence base for Buvidal to become the future standard of care for patients with opioid dependence. The UNLOC-T study evaluated treatment with Buvidal compared to methadone in seven prisons in New South Wales, Australia. During the quarter, the results from both studies have been accepted for presentation at the leading addiction meeting, the College on Problems of Drug Dependence (CPDD), to be held virtually in June 2020.

An investigator initiated, prospective, observational study (ARIDE) began during the quarter. ARIDE will evaluate treatment with Buvidal compared to daily buprenorphine or methadone standard of care. The study will be coordinated by scientists at the Center of Interdisciplinary Addiction Research at Hamburg University, Germany. The study is expected to run for 2 years and recruit 426 outpatients, with results adding to the already extensive scientific evidence base for Buvidal.

Preparations for the registration of weekly and monthly CAM2038 for the treatment of chronic pain in Europe continued.

Expansion to the US and Middle East
In the US, we look forward to a final market approval of Brixadi™ (the US trade name for Buvidal) 1 December 2020. The need for new effective treatments is immense in the US, with nearly 50,000 annual deaths caused by opioid overdose – the major cause of death in people under 50 years old.1 With more than two million people diagnosed with opioid dependence, the US represents the largest single market for opioid dependence in the world.2 Our partner Braeburn is preparing for the launch of Brixadi shortly after market approval. In the Middle East the first patients started treatment during the quarter, and we are now working with our partner NewBridge Pharmaceuticals to increase availability of Buvidal in the region.

Pivotal study program for long-acting subcutaneous octreotide
CAM2029 is a long-acting subcutaneous octreotide injection designed for easy self-administration, for the treatment of acromegaly and neuroendocrine tumors. During the quarter the ongoing Phase 3 studies in patients with acromegaly continued. However, due to Covid-19, the recruitment of new patients has temporarily stalled, which most likely will result in a delayed completion of enrollment in the ongoing studies. In mitigation, we have shifted our focus to other time critical activities – primarily the development of the CAM2029 autoinjector. Overall, we assess that Covid-19 will affect the acromegaly program timelines, but that this will be limited and clinical costs for the acromegaly program will shift forward.

During the period, we completed market assessments for potential additional indications of CAM2029. The results of these assessments are very positive and point to considerable medical needs and a significant sales potential for CAM2029 outside the prioritized areas in acromegaly and neuroendocrine tumors. Preparations for the start of pivotal studies of CAM2029 in one of these new indications, as well as in neuroendocrine tumors, are ongoing.

Early stage pipeline and partnerships
During the first quarter, our clinical trial application was granted for a Phase 2a study of our treprostinil weekly depot, CAM2043, in patients with Raynaud’s phenomenon; a rare and serious condition characterized by episodes of pallor followed by cyanosis of fingers or toes, which can be very painful and cause digital ulcers and dry necrosis. The study was expected to start during the second quarter of 2020 but, due to Covid-19, study initiation has been moved to the second half of 2020.

In collaboration with Rhythm Pharmaceuticals, a Phase 2 study of weekly setmelanotide, CAM4072, for the treatment of genetic obesity disorders, is under completion. The study, which has recruited more than 70 participants with obesity, is designed to evaluate the pharmacokinetics, pharmaco-dynamics and safety of CAM4072 after 3 months of treatment. Results are expected later in 2020. Manufacturing preparations for the start of the pivotal study program are ongoing.

During the quarter, preparations continued for the start of the clinical development of long-acting zilucoplan, CAM4083, developed in collaboration with our partner Ra Pharmaceuticals, for the treatment of complement C5 mediated diseases. In April 2020, the Belgian pharmaceutical company UCB completed the acquisition of Ra Pharmaceuticals.

In addition to collaborations with Rhythm and Ra Pharmaceuticals, we initiated two new research collaborations with international pharmaceutical companies. These collaborations will be communicated when we enter into relevant clinical development programs or with the announcement of license agreements.

Positive start of the year with strong growth and market expansion
We assess that the increasing demand for Buvidal in the EU and Australia in the first quarter will continue during the second quarter, supported by regulatory, renumeration, and legal changes, and our expansion into new markets. Due to Covid-19, this trend is reinforced by the need to decrease non-essential clinic visits and optimize the use of resources in strained healthcare systems. Covid-19 has presented us with significant challenges to ensure product supply and medical support for healthcare providers and patients. It is very gratifying to see how well our commercial and medical teams, and our robust and streamlined manufacturing and supply chain, has handled the situation.

For people suffering from chronic conditions, for whom lifelong medication has become a reality, there is much to be gained from improving treatments – in terms of efficacy and quality of life, but also in terms of how the treatments are administered – and this coronavirus pandemic has further highlighted the benefits of such long-acting treatments.

Overall, Camurus stands strong at a challenging and uncertain time.

Fredrik Tiberg
President and CEO

References
1. Centers for Disease Control and Prevention, https://www.cdc.gov/drugoverdose/index.html , Accessed on 2020-03-27.
2. Frazier at al, 2017, Journal of the American Medical Association

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