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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

Strong sales growth and raised revenue forecast for the full year 2020


CEO STATEMENT

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



During the second quarter, we continued to deliver strong growth in our markets in Europe and Australia resulting in an increase in our revenue and product sales forecast for the full year 2020. Quarterly product sales increased by 56% driven by high demand and increased access to Buvidal® for the treatment of opioid dependence. We received a positive decision on pricing and reimbursement for Buvidal in Sweden and extended our prescribing base in Australia. Furthermore, a legislative change in Austria meant that we could begin to launch Buvidal in this market in May. A request for final market approval of Brixadi™ (the US trade name for Buvidal) was submitted to the US FDA, with the date for the decision set for 1 December 2020. An advisory meeting was held regarding the market authorization application for Buvidal/CAM2038 for chronic pain in the EU, and our partner Rhythm received positive Phase 2 data for once-weekly setmelanotide FluidCrystal® in patients with severe genetic disorders of obesity.


Positive sales development and market expansion
During the second quarter, the positive development for Buvidal continued in our markets in Europe and Australia. Product sales totaled SEK 75.8 million, representing an increase of 56% compared to the previous quarter and 568% compared Q2 2019. By the end of June an estimated 9,500 patients were receiving treatment with Buvidal. In Finland and Norway, we continued to develop our market-leading position and in other European countries, including Sweden, Germany and UK, sales accelerated after success with
reimbursement and increased access to treatment. In Australia, the positive trend continued with strong sales and an expanded prescription base for Buvidal, which now also includes general practitioners, who account for around 75% of prescriptions for the treatment of opioid dependence.

Based on strong sales growth for Buvidal, in June we announced an increased revenue and product sales forecast for the full year 2020. The Covid-19 pandemic has had both a positive and a negative impact on our sales: whilst it has been a catalyst for the transition from daily medication to weekly and monthly Buvidal treatment in clinics with Buvidal experience, it has also limited access to healthcare professionals, which has delayed patient initiation on Buvidal in some markets.

Overall, sales of Buvidal continued to develop positively in existing markets and after a legislative change in Austria, we were able to begin to launch in this new market in May. With around 18,000 patients in opioid dependence treatment, Austria has approximately the same number of patients as Denmark, Norway and Sweden combined. During the quarter, we continued market preparations in second-wave countries, including Belgium, the Netherlands and Spain, strengthened by positive new data from our markets and recently completed clinical trials.

Compelling results from clinical trials of Buvidal against standard treatment
In June, results from the DEBUT and UNLOC-T studies were presented at the leading addiction meeting, the College on Problems of Drug Dependence (CPDD) Annual Scientific Meeting 2020. The clinical trials, which evaluated treatment with Buvidal against standard of care in outpatient and inpatient care in Australia, met both primary and secondary outcome measures.

The DEBUT study demonstrated significantly better patient reported satisfaction with Buvidal treatment compared to daily standard treatment. Patients receiving Buvidal also reported significantly higher satisfaction with treatment efficacy and convenience, as well as a significantly lower treatment burden and higher quality of life compared to daily standard treatment. The results further strengthen the already strong evidence base for Buvidal as the only long-acting treatment of opioid dependence that has documented superior treatment efficacy against daily standard treatment.

The UNLOC-T study investigated the use of Buvidal in seven prisons in New South Wales, Australia. The study showed a satisfactory safety profile with no severe side effects and no evidence of diversion of Buvidal was observed. Furthermore, treatment with Buvidal had significantly lower treatment costs compared to daily standard treatment, approximately one third of the cost of methadone therapy and one tenth of the cost of sublingual buprenorphine treatment. Since the study was completed, the uptake of Buvidal treatment has been rapid within the New South Wales prison system, with more than 500 patients receiving treatment with Buvidal within 3 months.

The UNLOC-T study has provided us with unique and valuable clinical and health economical data to communicate to healthcare providers and payers via scientific presentations and publications. We continue to build our evidence base with the recently started ARIDE study, which compares Buvidal to standard treatment with buprenorphine and methadone in over 420 opioid dependent patients in Germany. The goal is to continue to establish Buvidal as the evidence-based first choice in the treatment of opioid dependence.

Developments in North America and the rest of the world
In the US, a request for final market approval of Brixadi (the US trade name for Buvidal) was submitted to the FDA on 1 June 2020. The application was accepted and the date of approval (PDUFA date) was set for 1 December 2020. Later in June we announced that, following our issuance of a material breach notice on our US partner Braeburn Inc., Braeburn has initiated arbitration proceedings in England, under the parties’ license agreement. Through the arbitration Braeburn seeks a determination by the arbitral tribunal of whether the company is in such material breach of the license agreement. If the tribunal finds that Braeburn is in material breach, Camurus will be entitled (subject to a 60-day cure period) to terminate the agreement and regain all rights granted to Braeburn, including the company’s rights to Brixadi and other products in North America (including all regulatory filings). If the tribunal finds that Braeburn is not in material breach, the license agreement will remain in full force and effect. During the arbitration proceedings, which pursuant to the provisions of the license agreement are to be completed within 90 days from the appointment of a full arbitration panel, all of the parties’ respective rights and obligations under the license agreement remain in full force and effect, including Braeburn’s obligation to develop, register and commercialize Brixadi, as well as associated financial terms.

The opioid crisis in the US appears to have been exacerbated by Covid-19. In May, a 42% increase in suspected drug overdoses was recorded, according to the Overdose Detection Mapping Application Program (ODMAP), a federal initiative that collects data from ambulance personnel, hospitals and police. This is of grave concern, given the nearly 50,000 annual deaths associated with opioid overdoses in the US prior to Covid-19. We will therefore do our utmost to enable US patients to access Buvidal as a much-needed new and effective treatment option as soon as possible. This commitment also applies to Canada, which with an estimated 420,000 opioid dependent people1 and rising overdose death rates is itself in the midst of an opioid crisis.

We also continue to work with our partners Medison and NewBridge Pharmaceuticals to introduce Buvidal in the Middle East and North Africa (MENA) with a focus on ongoing and planned registration processes. Furthermore, patients arebeing treated within the framework of early access programs.

In addition to opioid dependence, we are developing Buvidal/CAM2038 for the treatment of chronic pain. During the quarter, a scientific advice meeting was held with regulatory authorities for the planned submission of a market authorization application to EMA during the second half of 2020.

Phase 3 studies and a new clinical program for CAM2029
After the patient recruitment for our ongoing Phase 3 studies of CAM2029 (long-acting octreotide) for the treatment of acromegaly stalled due to Covid-19, it is gratifying to see that more and more clinical sites are opening up for recruitment again. In order to maximize progression of the development project, we have focused on activities that are less affected by the current Covid-19 situation, such as the development of an auto-injector for CAM2029 and preparation of pharmacokinetic studies. As announced earlier, we expect some delays to the acromegaly project, but expect to continue the registration-based Phase 3 study in 2021 and the long-term study in early 2022.

In parallel with the development of acromegaly, planning and preparation of a Phase 3 study of CAM2029 for the treatment of neuroendocrine tumors is underway, with a scheduled start in early 2021 following a final reconciliation of the protocol with regulatory authorities in the third quarter of 2020.

Market surveys of CAM2029 in other indicative areas, including polycystic liver disease (PLD), representing a subgroup of patients with autosomal dominant polycystic kidney disease (ADPKD), were also completed during the quarter. This is a rare and serious chronic condition with significant negative impact on patient well-being and quality of life. Today, there is no approved treatment for PLD, but results from previous clinical studies of somatostatin analogues in patients with PLD suggest that CAM2029 may be an effective treatment. Following a Board decision and a recently completed directed issue, we are in the process of starting the clinical development of CAM2029 for the treatment of PLD.

Finally, during the quarter a new patent was granted in the US, extending IP protection for CAM2029 to 2037.

Advances in the early pipeline and positive Phase 2 results
In addition to CAM2029, we continue to advance our early clinical programs in-house and with partners. In June, we announced positive results from a Phase 2 study of once-weekly setmelanotide, CAM4072, under development by our partner Rhythm Pharmaceuticals, for the treatment of rare genetic disorders of obesity. Results from the study in study participants with severe obesity showed that the treatment effect with the weekly product is comparable to that achieved with daily injections of setmelanotide – with the potential for improved convenience and compliance for patients. The next step is to discuss the path to market registration with the US FDA. In addition to setmelanotide, several development collaborations with international pharmaceutical companies continued during the quarter, including preparations for starting clinical studies of long-
acting zilucoplan developed by Ra Pharmaceuticals (part of UCB) for the treatment of complement factor C5-mediated diseases. In addition, business discussions are underway regarding our own product candidates.

Continued strong development and raised full year 2020 revenue prognosis
The second quarter has been both productive and eventful and Camurus has delivered strong sales development despite significant challenges during the Covid-19 pandemic. For the fourth quarter in a row, we saw Buvidal sales growth of more than 50%. In addition to the positive development in our own markets, we look forward to final approval of Brixadi in the US on 1 December and completing the arbitration process with Braeburn.

To increase our financial flexibility and enable further market expansion for Buvidal, the upscaling of our commercial production and an expansion of the clinical program for CAM2029, a directed share issue of 2 million shares, raising proceeds of approximately SEK 300 million, was implemented on 2 July. I would like to take this opportunity to thank current and future shareholders for your support and our employees for their achievements and our impressive results during the first half of 2020. We have created a strong foundation for continued success in 2020 and the years to come.

Fredrik Tiberg
President and CEO

References
1. Opportunity Analysis and Forecast to 2027. Global Data 2018

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