ÜBER CAMURUS

Bessere Behandlungen ermöglichen


Camurus entwickelt und vermarktet innovative und lang wirksame Medikamente zur Behandlung schwerer und chronischer Erkrankungen, einschließlich Opioidabhängigkeit, Schmerzen, Krebs und endokriner Erkrankungen. Neu entwickelte Arzneimittel auf Basis unserer firmeneigenen FluidCrystal® Technologie zur Wirkstoffapplikation sollen zu Verbesserungen der Lebensqualität, von Behandlungsergebnissen und Ressourcenauslastung führen. Camurus ist an der Nasdaq Stockholm unter dem Ticker „CAMX“ notiert.

In Deutschland wird die Camurus AB
durch die Camurus GmbH vertreten:
Carl-Reuther-Str. 1
68305 Mannheim

 

ÜBER CAMURUS

Bessere Behandlungen ermöglichen


Camurus entwickelt und vermarktet innovative und lang wirksame Medikamente zur Behandlung schwerer und chronischer Erkrankungen, einschließlich Opioidabhängigkeit, Schmerzen, Krebs und endokriner Erkrankungen. Neu entwickelte Arzneimittel auf Basis unserer firmeneigenen FluidCrystal® Technologie zur Wirkstoffapplikation sollen zu Verbesserungen der Lebensqualität, von Behandlungsergebnissen und Ressourcenauslastung führen. Camurus ist an der Nasdaq Stockholm unter dem Ticker „CAMX“ notiert.

In Deutschland wird die Camurus AB
durch die Camurus GmbH vertreten:
Carl-Reuther-Str. 1
68305 Mannheim

CEO STATEMENT

Stable growth and positive development
during the third quarter


CEO STATEMENT

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



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.
 

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


Aufsichtsrat


Verhaltenskodex


 

Karriere


Bei Camurus legen wir Wert auf Vielfalt, Gleichberechtigung und Verantwortung. Wir sind ein dynamisches Unternehmen mit einem gemeinsamen Wachstumsziel und einer innovativen und kooperativen Kultur. Unser Hauptsitz ist in Lund, Schweden. Dort befinden sich auch unsere hochmodernen Labors.

Das Know-how, die Innovationskraft und das Fachwissen unserer Mitarbeiter sind ein wesentlicher Bestandteil unseres anhaltenden Erfolgs. Engagement, Wissen und Kreativität sind entscheidend, um unser Ziel zu erreichen: Wir möchten den Patienten und der Gesellschaft neue und verbesserte Behandlungsmöglichkeiten für schwere und chronische Krankheiten anbieten. Die meisten Camurus-Mitarbeiter arbeiten in der Forschung und Entwicklung und haben einen Hochschulabschluss. Durch aktiven Wissenstransfer in unserem internationalen Netzwerk und intensive Kooperationen mit Hochschulen und Industriepartnern entwickeln wir unser Business und umfassendes Know-how kontinuierlich weiter. Camurus bietet eine dynamische und spannende Arbeitsumgebung. Unsere engagierten Experten verfügen über herausragende Fähigkeiten in vielen Forschungsbereichen.

Offene Stellen

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