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 momentum in the launch of Buvidal®


During the second quarter we reached several important business goals. The launch of Buvidal® for the treatment of opioid dependence was expanded and pricing and reimbursement approvals were obtained in key markets in the EU and Australia. A pivotal Phase 3 study of CAM2029 octreotide SC depot was initiated after IND acceptance by the FDA. In addition, positive results in a research collaboration with Ra Pharma for a new FluidCrystal® based long‐acting formulation of zilucoplan for the treatment of life threatening blood and tissue disorders resulted in a new license agreement,
signed after the period.

CEO STATEMENT

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



Buvidal® reaching new markets
We have continued our launch efforts in the first wave markets, Finland, Sweden, Denmark, Germany and the UK. The feedback from patients and healthcare professionals continues to be positive and inspiring, with numerous reports of how Buvidal® is transforming lives of individuals and families with opioid dependence. Additionally, our initial estimates suggest that treatment retention rates on Buvidal® are high – similar or better than in the Phase 3 long‐term safety study [1]. The number of patients in treatment with Buvidal® increased during the period from about 500 to 1,300, across more than 150 clinics. In our first market, Finland, Buvidal® already has a market share of more than 20% of buprenorphine treated patients and about 15% of all treated patients. As expected, the initial uptake has not been as fast on all markets, due to extended pricing and reimbursement processes. However, we made excellent progress during the quarter and received four positive reimbursement decisions from national authorities in key markets, including in Australia and Norway. In addition, more than 30 formularies in the UK have agreed to include Buvidal® on their listings, representing about one third of all patients with opioid dependence. Sales in other geographies continue to increase, with a high interest in both community and criminal justice settings. In addition, launch preparations have also progressed in the second and third wave markets. By the end of the year, we expect Buvidal® to be available on at least 10 markets, representing almost 400,000 patients in treatment for opioid dependence.

Approval status in the US and Israel
Early in the quarter, our partner Braeburn filed an action in the United States District Court for the District of Columbia (District Court), seeking to overturn the earlier decision by the US Food and Drug Administration (FDA) awarding a three‐year period of exclusivity to Sublocade™, which blocks approval of Brixadi™ monthly until November 30, 2020. The District Court held a hearing on the proceedings on July 15th, 2019, and a decision is expected later in the third quarter. A positive outcome at the District Court could potentially give patients in the US earlier access to Brixadi™ weekly and monthly depots for treatment of opioid use disorder. In Israel, our partner Medison was granted fast track (180 days) registration procedure for Buvidal® and is now on track for late 2019 approval.

Phase 3 publication in opioid dependence
In May 2019, detailed results from the global Phase 3 longterm safety study were published online in Addiction, showing long‐term safety, efficacy and high rates of patient satisfaction with Buvidal®. Clinical results with Buvidal® were also presented at multiple international scientific conferences: ASAM in Orlando, Florida, IOTOD in Frankfurt, Germany, Albatros Addiction Congress in Paris, France, and CPDD in San Antonio, Texas. The presentations included new analysis of Phase 3 data in patients using fentanyl, a growing problem around the world, showing improved outcomes with Buvidal® versus daily standard treatment with sublingual buprenorphine/naloxone. Additionally, two clinical studies of Buvidal® in outpatient and criminal justice settings respectively have been progressing according to plan. Initial results from both studies are expected in the fourth quarter.

Preparations for regulatory submission for CAM2038 in chronic pain
In the quarter, we also completed a 52‐week Phase 3 long‐term safety extension study of CAM2038 in patients with chronic pain. Data from the study, including pharmacokinetics, are currently being analyzed and the study report is being compiled. Pre‐submission meetings with regulatory authorities in the EU are planned during the autumn, followed by regulatory submissions in the first half of 2020. Based on the product profile and the positive results obtained in the pivotal Phase 3 study, we believe CAM2038 has a significant potential in the chronic pain area. With effective longacting pain relief and reduced risk of misuse, illegal diversion and overdosing, we believe that CAM2038 could become an effective, convenient and potentially safer treatment alternative for patients in need for strong opioid analgesics, such as morphine, oxycodone and fentanyl.

According to external assessments, one million patients in the seven largest global markets (7MM) are taking high doses of opioid analgesic drugs, morphine equivalent dose above 100 mg/day. About 2.5 million are estimated to be on doses above 50 mg/day.

Phase 3 entry with CAM2029 is a significant milestone for Camurus
Following the IND acceptance for entering Phase 3 with CAM2029 octreotide subcutaneous (SC) depot, Camurus now has two innovative product candidates in Phase 3 development, each addressing significant unmet medical needs and markets with large potential. With its ready‐for‐use design, enabling convenient once‐monthly dosing and enhanced plasma exposure, CAM2029 has an attractive target product profile with best‐in‐class potential on a global somatostatin analogue market currently worth more than $2.6 billion.

The start of the pivotal Phase 3 study of CAM2029 represents an important milestone for Camurus. We will enroll 78 patients in about 50 clinical sites in the US and Europe. The last patient in is expected mid‐2020. In parallel, we will also conduct a Phase 3 long‐term safety study in newly recruited patients and rollover patients from the pivotal study. Both studies are expected to be completed during 2021.

Progress in early pipeline and a new promising partnership with Ra Pharma
Aside from the late stage pipeline progress, we continued advancing our early stage programs, including initiating manufacturing of clinical batches of our CAM2043 weekly treprostinil depot for a planned Phase 2 start in H2 2019. Additionally, formulation optimization was performed for two new long‐acting peptide formulations targeting different endocrine disorders, which we plan to take into clinical development in 2020.

In the collaboration with Rhythm, a Phase 2 study of CAM4072, a weekly setmelanotide depot addressing rare genetic obesity disorders is ongoing, and expected to be completed by the end of the year. In parallel, manufacturing preparations are being conducted for a planned Phase 3 start in 2020.

After the quarter, following a successful feasibility study, we signed a license agreement with Ra Pharmaceuticals for a zilucoplan FluidCrystal® depot for the treatment of complement component 5 mediated disorders, including generalized myasthenia gravis and paroxysmal nocturnal hemoglobinuria. Under the agreement, Camurus will receive an upfront payment of $2 million and is eligible to receive up to $14.5 million in development milestones and other license payments, $55 million in sales milestones and a tiered single‐digit royalty on product sales related to the extended release FluidCrystal® formulation of zilucoplan.

Camurus well positioned for the second half of 2019
Camurus had a productive quarter with significant progress in the commercial business, start of a pivotal Phase 3 study of CAM2029, and a new FluidCrystal® partnership. With several positive pricing and reimbursement decisions and launch expansion to new markets, we have laid the foundation for a significantly increased patient access to Buvidal® in Europe and Australia. We see a significant commercial opportunity and an increasing external interest for CAM2029 in acromegaly, neuroendocrine tumors and other indications. In addition, we have growing pipeline of attractive product candidates in clinical development, addressing unmet needs of patients with severe and chronic disease. Together with an increasing number of products and technology partnerships, we expect a strong news flow and revenue growth in line our earlier guidance.

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