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

Positive and eventful third quarter for Camurus


During the third quarter we markedly increased our revenues and the number of patients in treatment with Buvidal® in the EU and Australia. In the US, the federal district court for the District of Columbia ordered the FDA to reconsider “with deliberate speed” the application for final approval of Brixadi™. The pivotal program for CAM2029 was extended with a Phase 3 long-term safety study and in parallel an autoinjector development was started to further simplify self-administration. In addition, a license agreement was signed with Ra Pharmaceuticals for a long-acting zilucoplan to treat life-threatening blood and tissue disorders.

CEO STATEMENT

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



Market expansion and growing Buvidal® sales
In the third quarter, we saw continued growth in sales of Buvidal® for treatment of opioid dependence in the EU and Australia. Our revenues increased by 105 percent to 40.2 MSEK compared to the corresponding quarter 2018. Product sales increased by 73 percent to 19.5 million SEK compared to the previous quarter, while the total number of patients on Buvidal® increased from about 1300 to 2500. Progress continued on the initial launch markets in the Nordics, Germany and the UK. In our first to launch market, Finland, we achieved an impressive market share of about 30 percent of buprenorphine treated patients and about 20 percent of all patients receiving medication assisted treatment (MAT). The corresponding patient shares in Germany were three and one percent, respectively, indicating a significant growth potential for Buvidal®.
We delivered on the planned expansion into new geographies with the recent listings of Buvidal® for reimbursement in Norway, Australia, Scotland, Wales and Northern Ireland. This was highlighted by the announcement in August by the Minister for Health, Greg Hunt, that the Australian government will invest 40 million dollars to give patients access to Buvidal®, and an additional product, under a PBS listing. We have already seen good initial patient uptake in Norway and Australia and expect an accelerated growth as the awareness of Buvidal® continues to increase.
We are well advanced preparing for launches in the next wave markets that include Austria, Italy, Spain and Benelux. Importantly, the feedback from prescribers and patients continues to be very positive across all markets and we therefore look positively on the sales development in the fourth quarter and during 2020.

Positive court decision on US exclusivity
In July, Chief Judge Beryl A. Howell of the US District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating the FDA’s decision to deny approval of Brixadi™ Monthly and remanding the case to the agency; ordering the FDA to reconsider “with deliberate speed” the application for final approval of Brixadi™, raising our hopes that Brixadi™ will soon be available to patients with opioid dependence in the US. In parallel, a Citizen Petition was conducted to revoke the orphan drug designation of Sublocade™. We are pleased with FDA’s 7 November decision to grant Braeburn’s Citizen Petition, thereby eliminating the risk of further market exclusivities blocking Brixadi™ from the US market. Braeburn can now focus on preparing for launch in 2020 – paving the way for an effective, individualized, long-acting treatment of opioid use disorder accessible to US patients. In view of the July 22 district court ruling, we are surprised by FDA’s decision to uphold the tentative approval decision to 30 November 2020. However, we do not expect that this will have a significant impact on the market potential over time. Brixadi™ has a competitive product profile and Braeburn will be well prepared for the upcoming launch.

Growing scientific evidence base for Buvidal®
During the period, all patients completed the treatment phases in the clinical studies, DEBUT and UNLOC-T. DEBUT evaluated randomized treatment with Buvidal® versus sublingual buprenorphine/ naloxone in 120 outpatients in community treatment. UNLOC-T compared non-randomized treatment of Buvidal® versus methadone a total of 129 patients in eight minimum to maximum security prisons in New South Wales (NSW) and is sponsored by the NSW Ministry of Health. Based on the study experience, scale up is already initiated in NSW prisons. Results from the studies will be presented at leading conferences in early 2020, but significant interest has already been generated as the study design and background data has presented at scientific meetings and conferences. Overall, the awareness of and interest in Buvidal® is growing. This is partly due to an increasing visibility through presentations, special symposia and plenary lectures by addiction experts at different international scientific conferences, including Lisbon Addictions.

In parallel with growing the evidence base for Buvidal® progress, we have continued to advance our development pipeline of innovative medicines for treatment of other severe and chronic diseases.

Preparing for submission in chronic pain
We believe our long-acting buprenorphine depots, CAM2038, also has the potential to address unmet medical needs in the area of chronic pain, by combining an effective, round-the clock, long-acting pain relief with a reduced risk of misuse, illegal diversion and overdosing, During the third quarter, we have been preparing for health authority meetings to discuss the planned regulatory submissions planned in e.g. the EU during the first half of 2020.

Phase 3 program expanded for CAM2029
The pivotal Phase 3 program for our long-acting octreotide depot, CAM2029 for treatment of acromegaly, was during the quarter expanded with a 52-week Phase 3 study to assess the long-term safety of CAM2029 in both new patients and patients transferred over from the randomized 24 week efficacy study. These studies will include in total about 140 patients across about 55 clinics in the US and Europe. We currently expect recruitment to be completed during 2020, while efficacy results are expected in 2021. During quarter, we also completed design and study protocol development for the pivotal registration program of CAM2029 in patients with neuroendocrine tumors, NET, and are continuing to evaluate other potential indication areas. Third party market assessments performed during the quarter indicate a market potential for CAM2029 of up to 1,2 billion dollars per year acromegaly and NET, depending on final product presentation and supporting clinical data. In parallel with these assessments, we have initiated the development of an autoinjector for CAM2029, as a complement to the existing prefilled syringe presentation.

Growing pipeline with own programs, ongoing partnerships and new license agreements
During the period, we also advanced early stage clinical and preclinical programs. Phase 2 preparations for the treprostinil extended release depot, CAM2043, for treatment of pulmonary arterial hypertension and Reynaud’s phenomenon, is well advanced, but study starts has for internal capacity reasons been pushed to next year. In the collaboration with Rhythm, CAM4072 for the treatment of genetic obesity disorders, a Phase 2 study is currently ongoing and is expected to be completed during the first half of 2020. In August, Rhythm announced positive results from a pivotal Phase 3 study of daily dosed setmelanotide in patients with obesity caused by pro-opiomelanocortin (POMC) or leptin receptor (LEPR) deficiency. This was good news also for the weekly setmelanotide formulation, supporting both safety and efficacy.

During the quarter, we also signed a license agreement with Ra Pharmaceuticals for the development of a long-acting zilucoplan depot for treatment of generalized myasthenia gravis, immune-mediated necrotizing myopathy, and other tissue-based complement-mediated disorders. Preparations for start of clinical development during 2020 are ongoing. After the period, it was announced that the Belgian pharmaceutical company UCB has put a bid to acquire Ra Pharmaceuticals for 2.5 billion dollars.

Strong third quarter and positive outlook
During the third quarter, we continued the transformation of Camurus from a R&D focused company to a science lead pharmaceutical company with an own commercial infrastructure in the EU and Australia.
In the three quarters since the first commercial sale, I am proud of our excellent and dedicated teams and their significant achievements in establishing an efficient distribution chain and sales of Buvidal® across our markets in the EU and the Australia. Pricing and reimbursement has been successfully secured in our first wave markets, supported by a robust and growing scientific evidence base for Buvidal®. We have also initiated new reimbursement applications and initiated launch activities to make our innovative, long-acting treatments available to patients in the next wave markets. We have made excellent progress in our R&D programs and look forward to a strong and positive news flow during the coming quarters.

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 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