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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

Positive second quarter and opportunity
for market approval in the US


CEO STATEMENT

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



Camurus had a productive second quarter with increasing revenues, new regulatory approvals, progress in the development portfolio, and the publication of strong data in leading scientific journals. Product sales increased by 80% compared to the same quarter in 2020, and 10% compared to the first quarter of this year. The increase was weaker than expected, due to the continued impact of the COVID-19 pandemic on our markets in Europe and Australia. We expect to return to planned growth in the second half of the year as restrictions ease and Buvidal is launched in new markets. In the US, we are now looking forward to the possibility of Brixadi becoming available to US patients by the end of the year after the FDA set a target date for approval to December 15, 2021.


Camurus’ total revenues during the second quarter increased to SEK 138 million and operating result was SEK -60 million. Operating expenses increased with 75% compared to previous year, linked to the progress of our registration programs of CAM2029 in acromegaly, neuroendocrine tumors and polycystic liver disease. For the interim period January-June, revenues amounted to SEK 264 million and operating result to SEK -86 million, an improvement of 14% compared to 2020.

With increasing product sales and further significant revenue opportunities in the near future, as well as a cash balance of SEK 422 million, we have a strong base to achieve our strategic goals for growth and to bring new drug candidates in our research portfolio to the market.

Continued growth of product sales – limited by the effects of the COVID-19 pandemic
Product sales during the second quarter were SEK 137 million, an increase of 80% compared with a strong second quarter in 2020.

During the second quarter, we saw good sales growth in established markets that were spared from significant consequences of the COVID-19 pandemic, while a temporary slowdown was seen in markets where closures and restrictions hindered direct contacts with prescribers and healthcare professionals, and patients access to clinics for new initiations were limited. The pandemic has also led to protracted processes for pricing and reimbursement and the granting of various approvals, which has pushed launches for example in the Netherlands and Switzerland from the second to the third quarter.

With over 19,000 patients estimated in treatment with Buvidal at the end of the quarter, we have established a leading market position among long-term buprenorphine treatments in just over 2 years. The average market share of total number of patients in opioid dependence treatment in our existing markets is about 5%, ranging from approximately 2% in Germany and the UK, to between 10-20% in Scandinavia and Australia. In Finland, the patient share is now over 60% and more patients are getting access to treatment, driven by Buvidal.

In addition, during the quarter we prepared for launch of Buvidal in further seven European markets, including France, Switzerland and Benelux, which together have around 220,000 patients in opioid dependence treatment.1

Regulatory approvals and strengthened evidence base for Buvidal
During the quarter, we continued our efforts to establish Buvidal as evidence-based first choice for individualized treatment of opioid dependence. We received market approval for a higher 160mg dose of Buvidal in Australia, the EU and UK, which will start to be introduced on our markets during the third quarter. In Australia, an extension of the indication for Buvidal was also approved which allows direct initiation of treatment with Buvidal without the need for stabilization with daily dosed sublingual buprenorphine – as it is currently indicated in the EU.

The scientific evidence base for Buvidal was further strengthened with new publications in leading scientific journals. Results from the randomized, controlled DEBUT study published in JAMA Network Open showed significantly higher patient-reported satisfaction and quality of life with Buvidal compared to standard daily treatment. The UNLOC-T study, which was published in the leading addiction journal Addiction, showed positive treatment results and the benefits of using Buvidal in custodial setting.2,3

We have seen growing interest in Buvidal from governments, policy makers and media resulting in new initiatives and increased funding for innovative and “game-changing” treatments for opioid dependence. These have received wide coverage in published reports and in national and regional news.

Brixadi on its way to the US market
Important and welcome news during the quarter was the announcement that our US licensee Braeburn has submitted an updated New Drug Application (NDA) for market approval for Brixadi (the US tradename for Buvidal) to the Food and Drug Administration (FDA). The authority announced shortly afterwards that the filing had been accepted with a Prescription Drug User Fee Act (PDUFA) set for December 15, 2021.

In addition to the NDA review process, several investigator-lead clinical trials are also underway in the US, which together will include over 2,000 patients and contribute to an increased knowledge of the value of our treatment in various clinical applications.

With an estimated two million individuals diagnosed with opioid dependence, approximately ten million people misusing opioids, and 60,000 annual overdose deaths related to opioides, there is an urgent need for effective opioid treatment in the US.4 The opioid crisis has escalated during the COVID-19 pandemic and the Biden Government has taken important initiatives to curb the crisis, including allocating USD 1.5 billion for the prevention and treatment of opioid dependence.

It is very gratifying that US patients, upon approval, will have access to a new effective treatment for opioid dependence which offers flexible weekly and monthly dosing that can be easily adapted to the individual’s own needs. Based on our experience from Europe and Australia and interactions with experts in the US, we believe that Brixadi has the potential to gain a significant share of the opioid dependence market in the US.

Registration application and continued Phase 3 studies
During the quarter, we continued to prepare the application for market authorization of CAM2038 for the treatment of chronic pain. The goal is to submit the application to the European Medicines Agency (EMA) in the fourth quarter with the possibility of market approval during the second half of 2022.

In parallel, patient recruitment and treatment continued in our two Phase 3 studies of octreotide subcutaneous depot, CAM2029, in patients with acromegaly. Topline results from both studies are expected in 2022.

Preparations were also completed for start of a pivotal Phase 3 study of CAM2029 for the treatment of neuroendocrine tumors, where we expect the first patients to be enrolled and start treatment after the summer.

In addition, we are in the process of completing a bridging pharmacokinetic study of CAM2029 which characterizes pharmacokinetics, pharmacodynamics, and tolerability when dosing with our newly developed injection pen (autoinjector) and the prefilled syringe. Topline results from the single-dose part of the study are expected in then second half of 2021.

The recruitment of patients in the Phase 2 study of CAM2043 for treatment of Raynaud’s phenomenon, expected to be completed later in the year, was also resumed.

Collaborative development projects, among others with Rhythm and UCB, continued to progress and we look forward to the start of the pivotal phase 3 program for setmelanotide weekly depot, CAM4072, for the treatment of patients with genetically determined obesity during the second half of the year.

Significant progress on key objectives
In the second quarter, Camurus made significant progress on key objectives with increasing revenues, new regulatory approvals, and a potential US market authorization in 2021.

Considering the challenging conditions in many of our markets , I am pleased with the results and proud of the commitment and goal-focused work done by our employees and partners to increase access to Buvidal. We are positive about the continued development and opportunity for accelerated growth during the second half of the year as we expect the impact of the pandemic to wane.

In addition, there are further significant opportunities for Buvidal in chronic pain, in our broad development portfolio and different partnerships.

The work of building Camurus’ organization continues and during the quarter we had the pleasure of welcoming new skilled and experienced employees to the company, including Arnaud Vesin as general manager for France and Mozhgan Dorkhan as medical director for endocrinology. Furthermore, receiving the Carnegie Sustainability Award was a positive recognition of our joint long-term commitment to patients and society.

Fredrik Tiberg
President and CEO

References

1. European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), European Drug Report 2021: Trends and Developments. Accessible on: https://www.emcdda.europa.eu/system/files/publications/13838/TDAT21001ENN.pdf
2. Lintzeris, N., et al. Patient-Reported Outcomes of Treatment of Opioid Dependence With Weekly and Monthly Subcutaneous Depot vs Daily Sublingual Buprenorphine. A Randomized Clinical Trial. JAMA Network Open. 2021;4(5):e219041. Doi:10.1001/jamanetworkopen.2021.9041. Accessible on: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779751.
3. Dunlop, A.J., et al. Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings. Addiction. 2021 Jun 29. doi: 10.1111/add.15627. Online ahead of print.
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