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

Strong finish to launch year for Buvidal®


The successful launch of Buvidal® in first wave markets in the EU and Australia continued during the fourth quarter, delivering strong double-digit sales growth. The very positive feedback received from patients was reflected in topline results from the DEBUT clinical study, which demonstrated superior patient reported outcomes with Buvidal compared to buprenorphine standard of care. In the US, the FDA approved a Citizen Petition which enables Brixadi™ to enter the market from 1 December 2020. Finally, we took important steps to advance our pipeline of innovative therapies and raised SEK 300 million for Phase 3 development in neuroendocrine tumors and premarketing activities in chronic pain.

CEO STATEMENT

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



Growing Buvidal sales
During the quarter, we saw a continued robust growth of Buvidal sales in the first wave launch markets in the EU and Australia. Product sales grew by 55% compared to the previous quarter to SEK 30.3 million. Full year product sales were SEK 72.1 million, meeting our 2019 guidance, although at the lower end due to unforeseen external delays in legislation changes and market access processes. Total revenues were SEK 35.0 million for the quarter and SEK 105.6 million for the year.

We are pleased with our first year as a commercial stage pharmaceutical company with an own marketing and sales organization. Buvidal was launched in seven countries and the feedback from patients and healthcare professionals have throughout been very positive, which is an important source of inspiration for all of us working at Camurus. In Finland, our first launch market, Buvidal is already the market leader with a 45% year-end share of buprenorphine patients, and 30% of all medication assisted treatment (MAT) patients. After receiving pricing and reimbursement, similar rapid growth was seen in Norway and Australia, while sales in other markets developed at more modest rates but are gaining momentum access limitations and other momentary hurdles are being addressed. At the end of the year around 4,000 patients were in treatment with Buvidal – a 60% increase compared to the end of the third quarter. In 2020, we anticipate Buvidal sales in the range of SEK 240–280 million.

During the fourth quarter we entered a strategic partnership with NewBridge Pharmaceuticals for the commercialization of Buvidal across 12 countries in the Middle East and North Africa (MENA). NewBridge has a strong presence in the region, with local and regional regulatory and medical expertise, an established marketing and sales organization, and a broad pharmaceuticals portfolio in neurology, immunology, and oncology. We look forward to a rewarding collaboration to make Buvidal available to the many patients living with opioid dependence in MENA.

Superior treatment outcomes in DEBUT study
Positive results from the DEBUT clinical study, assessing treatment with Buvidal versus daily sublingual buprenorphine in 120 Australian patients with opioid dependence, were announced during the fourth quarter. This is to our knowledge the first randomized, controlled trial comparing patient reported outcomes (PROs) between a long-acting buprenorphine injection and standard of care in a head-to-head study. Buvidal met the primary endpoint and demonstrated superior patient satisfaction and significant improvements in treatment burden, quality of life and other secondary endpoints compared to standard of care. This is in agreement with earlier published results from our Phase 3 long-term safety study and the positive anecdotal feedback from patients and physicians using Buvidal in real life clinical settings.

In parallel, the core part of the UNLOCT study, comparing weekly and monthly Buvidal to oral methadone in seven prisons in New South Wales, Australia, was completed. Positive preliminary results were presented at the Lisbon Addiction Conference in October 2019 alongside oral and plenary presentations and workshops about Buvidal in the outpatient setting. During 2020 we will continue our high activity at international conferences and publication of new study data for Buvidal in leading scientific journals.

Final approval and launch of Brixadi
The FDA’s decision on 6 November 2019 to grant Braeburn’s Citizen Petition and revoke the orphan designation for Sublocade™ removed the risk of any further exclusivity barriers and Brixadi is now on track for final NDA approval and launch in December 2020, with the possibility of an early launch of the weekly product. The market potential for Brixadi is very significant: with more than 2 million people diagnosed with opioid use disorder and about 1 million patients in MAT in the US, we estimate the US market potential for Brixadi to be approximately USD 600–1,200 million based on a 5–10% market share of buprenorphine patients.

Market authorization application and phase 3 studies
During the quarter preparations continued for the planned submission of an EU market authorization application in the second or third quarter of 2020 for CAM2038 for the treatment of chronic pain, with an anticipated approval in 2021. CAM2038 has a strong and competitive product profile and meets an important medical need for patients with chronic pain whose current treatment options are often limited to daily medication with strong opioids. We are currently conducting detailed market analysis to optimize product positioning and market access in our key markets. We estimate significant potential for CAM2038 in segments of the pain market, at the same magnitude as Buvidal for the treatment of opioid dependence.

During 2019 we started two global Phase 3 studies of our long-acting octreotide depot, CAM2029, for the treatment of acromegaly. The studies will in total include approximately 140 patients across 60 specialist clinics in the US and Europe and are expected to be fully recruited in 2020 with results in 2021. In parallel to these studies, where the investigational drug is administered as a prefilled syringe, we are developing an autoinjector to further simplify and enhance patient self-administration. A pharmacokinetic bridging study is planned to start during the year. Following the successful directed share issue in December 2019, we are also preparing for the start of the pivotal study program for CAM2029 in neuroendocrine tumors as well as in an additional indication where third-party assessments have confirmed the attractiveness and market potential of the CAM2029 product profile, which addresses significant unmet medical needs.

Early stage pipeline and partnerships
During the fourth quarter we submitted a clinical trial application for a Phase 2a study of our treprostinil weekly depot, CAM2043, in patients with Reynaud’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 clinical trial application was granted in January 2020 and the study is expected to start during the second quarter of 2020. In parallel, a Phase 2 study of CAM2043 for treatment of pulmonary arterial hypertension is being planned.

In the collaboration with Rhythm Pharmaceuticals, a weekly setmelanotide depot, CAM4072, for the treatment of genetic obesity disorders is being developed. A Phase 2 study is currently ongoing with more than 70 patients with obesity recruited to date. Results from the study, which is designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of CAM4072 after 3 months treatment, are expected in 2020. In parallel, manufacturing preparations for the start of the pivotal study program are ongoing.

In our new collaboration with Ra Pharmaceuticals on the development of a long-acting zilucoplan, preparations are ongoing for the start of clinical development during 2020. During the quarter, it was announced that the Belgian pharmaceutical company UCB has bid to acquire Ra. The acquisition is expected to be approved during the first quarter of 2020.

Strong fourth quarter lays the foundation for a successful 2020
Our achievements during the fourth quarter, including strong sales growth for Buvidal, improved access for patients, and preparations for launch in new markets, lay the foundation for a successful 2020. Our strategy for Buvidal focuses on increasing our market share, expanding sales to second and third wave markets, and establishing Buvidal as the evidence-based standard of care for the treatment of opioid dependence. In addition to developments on our own markets, we are looking forward to Brixadi becoming available to US patients as well as Buvidal approvals and launches on new markets in e.g. the MENA region. This quarter we also completed a directed share issue, raising SEK 300 million to secure further investments in our late-stage pipeline projects, including chronic pain and neuroendocrine tumors, as well as prioritized early stage projects. I would like to thank existing and new shareholders for your support during 2019 and our growing number of dedicated co-workers at Camurus. This was a pivotal year for Camurus and we are looking forward to a new year with strong growth and a positive news flow

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.

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