Navigation 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 MANAGEMENT TEAM BOARD OF DIRECTORS CAREER CEO STATEMENT THIRD QUARTER 2021 Stable growth and positive development during the third quarter Progress continued during the third quarter with the launch of a new Phase 3 study, granting of orphan drug designation for CAM2029 in the US, double-digit sales growth and improved results. COVID-19 has continued to put pressure on us, however, we see potential for accelerated growth as access to health care providers and patients improves and new markets are added. In December, we also await an important approval decision for Brixadi™ in the US. Sales of Buvidal during the third quarter were SEK 152 million, an increase of 61% compared to 2020 and 11% compared to the previous quarter. Given continued impacts of the pandemic and summer holidays in Europe, we are content with the result and especially pleased with the significant commitment and efforts by our commercial and medical teams. After a long period of full and partial lockdowns and other restrictions in our markets, we have been able to gradually resume direct contact with health care providers and other stakeholders and patient access to Buvidal continues to improve. Growth during the third quarter was concentrated in established markets where health care providers and patients have gained experience of Buvidal, while the planned expansion in new markets was impeded by various restrictions, delayed price and reimbursement decisions and postponed orders in distributor markets. However, following a positive health economic evaluation in France and reimbursement approval in Slovenia, we launched Buvidal in these two countries during the quarter. In addition, we are fully prepared for launches in another five markets during the year, which will strengthen the sales growth in 2022. Buvidal is now available in 17 countries and we estimate that approximately 21,000 patients are currently receiving our treatment. The response from patients, HCPs and policy makers continues to be very positive which further strengthens our view of the future potential for Buvidal. Despite this positive response and progress in our markets, we have increased sales at a slightly lower rate than expected during the first nine months of the year meaning that we have downgraded our forecast for sales and revenue for the full year. Full year operating result is expected in the lower end of previously communicated range (see report page 15). For clarification, this excludes potential milestone payments for approval of Brixadi in the US. We see the situation as improving and it does not affect our view of growth in 2022 or our long-term goal of more than 100,000 patients receiving Buvidal in Europe and Australia in 2026. Growing evidence and increased interest for Buvidal Buvidal has in a relatively short time since launch been establishedas a market-leading treatment for patients with opioid dependence in several markets. This has led to the availability of an increased amount of data from various registers, investigator-led studies and clinical practice. During the third quarter, additional positive data from the DEBUT study were published, which demonstrates reduced stigma, and time and cost savings for patients treated with Buvidal compared with daily medication.1 A publication from a trial-led study in Germany reported promising results regarding the transition of patients from treatment with methadone to Buvidal in the penitentiary.2 In addition, further publications, meeting abstracts, posters and presentations at scientific congresses have continued to strengthen the evidence-base for Buvidal and increase knowledge about treatment among HCPs and other stakeholders. Upcoming approval decision in the US An approval decision for Brixadi (the US tradename for Buvidal) is anticipated shortly in the US. The updated NDA application, which has priority review status, was accepted by the FDA in June this year with a target date for approval decision on 15 December 2021. We look forward to a positive decision from the FDA and to our licensing partner Braeburn launching Brixadi in the US and making this innovative treatment available to patients with opioid dependence. Even before its approval, several large investigator-led clinical studies are ongoing in the US.3-6 In addition to the US, registration processes for Buvidal are underway in a number of markets in the Middle East and North Africa, where several approval decisions are expected early next year. In Europe, we are also completing an application for an extended marketing authorization for Buvidal (CAM2038) to the treatment of chronic pain. We plan to submit the application to the EMA before the end of the year and a decision is expected by the end of 2022. Start of new Phase 3 study and orphan drug designation for CAM2029 We have an extensive ongoing registration programme for CAM2029, our subcutaneous octreotide depot. The programme focuses on three rare diseases and consists of two ongoing Phase 3 studies of CAM2029 for the treatment of acromegaly, a Phase 3 study in patients with neuroendocrine tumours of the gastrointestinal tract or pancreas (GEP-NET), and a planned Phase 2/3 study of the treatment of patients with polycystic liver disease (PLD). In addition, we are in the process of completing a Phase 1 study to bridge the gap between the CAM2029 pre-filled syringe and our newly developed pen, which is now being introduced in all ongoing Phase 3 programmes. During the third quarter, recruitment and treatment of patients continued in our acromegaly studies, and we plan to report top-line results in H2 2022. In addition, we have recently initiated the SORENTO study, a randomized, activecontrolled study of CAM2029 for the treatment of patients with GEP-NET. The study aims to demonstrate improved progression-free survival when treated with CAM2029 compared to standard medical treatment with first-generation longacting somatostatin analogues.7 The study is estimated to include more than 300 patients with advanced and welldifferentiated tumours at approximately 90 clinical sites in North America and Europe. Screening of patients has begun, and the study is expected to be fully recruited in 2022. Overall results regarding primary and secondary outcome measures of efficacy and safety are expected in 2024. CAM2029 is also being developed for the treatment of PLD – a rare disease caused by the formation of multiple cysts in the liver, which can lead to severe symptoms and reduced quality of life and where there is a large medical unmet need and no approved medical treatment. During the third quarter, the FDA granted CAM2029 orphan drug designation for PLD as well as approval for the start of a registration-based Phase 2/3 study, with planned study start early next year. As part of the preparations, we have, based on input from the FDA, developed a new tool to measure patient-reported treatment results that will be part of the clinical study. Phase 3 studies of CAM4072 in patients with genetic obesity disease Our collaboration with Rhythm Pharmaceuticals is progressing according to plan with the goal of documenting and registering CAM4072, a weekly preparation of setmelanotide for the treatment of various genetically determined obesity diseases, including Bardet-Biedl syndrome (BBS), which is characterized by obesity, visual impairment and other morbidities. Rhythm has announced that it plans to launch two randomized Phase 3 trials of CAM4072 for the treatment of BBS – one study in patients previously treated with daily injections and one in untreated individuals. The first patients are expected to be recruited before the end of the year. Strong base for continued growth and value creation Camurus had a solid third quarter with continued progress in our development pipeline, double-digit quarterly sales growth and strong results development. We ended the quarter with a strong cash position and foundation to execute on our long-term strategy for growth and market expansion, to bring new product candidates to the market, and expect to achieve profitability from 2022. Since 2019, we have successfully launched our first drug Buvidal across Europe and Australia, strengthened the scientific evidence-base and built an effective commercial infrastructure consisting of committed and knowledgeable employees with a strong foundation in our values and with improved treatment outcomes and patients’ quality of life in clear focus. During the third quarter, we welcomed new highly qualified employees to Camurus, including our commercial and medical teams, and recruited a new head of global market access. We announced that our CFO Eva Pinotti-Lindqvist, after seven successful years in the company, had decided to leave her position after handing over to a new CFO – and in October we announced that Jon U. Garay Alonso will take over as CFO and join Camurus’ management team on 1 February 2022. We believe we are well prepared as we enter the next phase of Camurus’ development, with a clear focus on growth and international expansion, new approvals and product launches in pain and rare diseases, as well as increased activity in business development. In addition to our own activities, we look forward to new advances in our partnerships in the near future, with a final approval decision from the FDA and Braeburn’s launch of Brixadi in the US as eagerly awaited highlights. Fredrik Tiberg President and CEO References 1. Barnett A., et al. Tracing the affordances of longacting injectable depot buprenorphine: A qualitative study of patients’ experiences in Australia. Drug Alcohol Depend. 227: 108959, 2021. 2. Soyka M., et al. Transition from methadone to subcutaneous buprenorphine depot in patients with opioid use disorder in custodial setting – a case series. Am J Drug Alcohol Abuse. 47: 599-604, 2021. 3. Seval N., et al. Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder Contemp Clin Trials. 2021; 105:106394. 4. Gordon MS, et al. A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail. J Subst Abuse Treat. 128:108241, 2021. 5. D’Onofrio G., et al. The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation. Contemp Clin Trials. 104: 106359, 2021 6. Winhusen T., et al. Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparingextended-release and daily buprenorphine formulations. Contemp Clin Trials. 93:106014, 2020. 7. A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (SORENTO). www.clinicaltrials.gov (NCT05050942).4. CDC, Centers for Disease Control and Prevention, Provisional Drug Overdose Death Counts. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm. Management team Fredrik Tiberg Eva Pinotti-Lindqvist Richard Jameson Agneta Svedberg Andrew McLean Annette Mattsson Fredrik Joabsson Maria Lundqvist Peter Hjelmström Torsten Malmström Board of directors Per Olof Wallström Behshad Sheldon Fredrik Tiberg Hege Hellstrom Jakob Lindberg Kerstin Valinder Strinnholm Ole Vahlgren Code of conduct Valid from 5 July 2021, adopted at a board meeting on 3 June 2021 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 E-mail addresses General enquiries: info@camurus.com Business Development: busdev@camurus.com Media: media@camurus.com Investor Relations: ir@camurus.com ABOUT CAMURUS PRESENTATIONS PIPELINE PRODUCTS TECHNOLOGIES INVESTORS CAREER LEGAL NOTICE PRIVACY CONTACT IR CONTACT By continuing to use the site, you agree to the use of cookies. more information Accept