“Following the positive CHMP opinion for Buvidal®, we have ramped up our commercial activities and are ready for launch in the first wave European markets”
Business highlights third quarter 2018
- CHMP adopted positive opinion recommending European approval of Buvidal® (CAM2038) for treatment of opioid dependence
- Regional teams established on the first wave European markets
- FDA issued 26 December 2018 as PDUFA target date for US approval of CAM2038
- Positive top-line Phase 3 results announced from pivotal study of CAM2038 for the treatment of chronic pain
- Successful transfer of CAM2029 from Novartis to Camurus and finalized design of the pivotal Phase 3 program
- Scientific abstracts accepted for presentation at: International Society for Addiction Medicine (ISAM) conference in Busan, South Korea, 3-6 November 2018, and at Society for the Study of Addiction (SSA) conference in Newcastle, UK, 8-9 November 2018
Financial summary third quarter 2018
- Net sales MSEK 19.6 (12.5).
- Operating result MSEK -56.4 (-67.1).
- Result after tax MSEK -43.8 (-52.3).
- Earnings per share SEK -1.14 (-1.40), before and after dilution.
- Cash position MSEK 216.3 (369.7).
During the third quarter, we achieved significant milestones towards expected approvals of Buvidal® (CAM2038) for the treatment of opioid dependence. The positive CHMP opinion, the issuance of a PDUFA goal date by the FDA, and the soon-to-be completed regulatory review in Australia keeps us on track for approvals in key markets before year end. We also announced positive Phase 3 results for CAM2038 in patients with chronic pain and advanced other promising pipeline programs according to plan.
Excitement building for upcoming launches
In September we announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending approval of Buvidal for the treatment of opioid dependence in adults and adolescents from 16 years of age. A final decision on EU marketing authorization is expected from the European Commission later in November.
Once approved, Buvidal will be the first long-acting medicine available for the treatment of opioid dependence in Europe, where there are an estimated 1.3 million high-risk opioid users. By offering flexible weekly or monthly dosing options, we believe Buvidal will open the door for patients to improve their treatment outcomes and to live a more normal life – for example by eliminating the need for frequent, often daily, healthcare visits, which can be both burdensome and stigmatizing for people trying to rebuild their lives and engage in employment. Following the positive CHMP opinion for Buvidal, we have ramped up our commercial activities and are ready for launch in the first wave European markets, Germany, the UK and the Nordics, Q1 2019.
During this quarter we also established an Australian subsidiary, Camurus Pty Ltd, and appointed Ruari Macdonald as Business Unit Head. Ruari has extensive specialty pharma experience from GSK, Reckitt Benckiser, Eli Lilly and Mundipharma, including in the opioid dependence field.
In the US, the Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of 26 December 2018 for CAM2038. In preparation for the approval and launch of CAM2038, our partner Braeburn has worked intensively and strategically with key stakeholders, including payers and distributors, to ensure optimal patient access to this potentially ground-breaking treatment. With approximately 2.5 million people diagnosed with opioid use disorder, and 130 American lives lost daily to this escalating crisis, there is a great need for new and improved treatment options.
Effective and long-lasting relief from chronic pain
In September, we announced positive top-line Phase 3 results for CAM2038 in patients with chronic low-back pain. The study demonstrated that CAM2038 provides effective and long-acting relief from chronic pain in patients with a history of opioid pain treatment.
With depression, anxiety and drug dependence frequently linked to chronic pain, and the prevalence of chronic pain in Europe and the US at almost 20%, we know this is a major healthcare problem with huge costs to both the individual and society. Furthermore, we realize that treating patients with chronic pain who also have opioid dependence is particularly challenging. We have designed CAM2038 to provide durable, round-the-clock pain relief and to be a safer treatment alternative for this patient group, with the aim of addressing the risks of opioid tolerance development, dependence, misuse, diversion and overdose. We are currently evaluating the long-term safety of CAM2038 in an open label extension study. Thereafter, we will start to prepare marketing approval application to health authorities.
Preparing pivotal Phase 3 studies of CAM2029
During the third quarter, we finalized the design of the pivotal Phase 3 programs for CAM2029 for treatment of acromegaly and neuroendocrine tumors. The first study is planned to start during the second quarter 2019 after approval by the health authorities. With its patient friendly product design and potential for improved treatment outcomes, we believe CAM2029 could gain significant share of the long-acting somatostatin market with current global annual sales exceeding $2.6 billion.
Progressing clinical development of CAM2043
After reporting positive top-line results from a single-dose and repeated dose Phase 1 study of our long-acting treprostinil depot (CAM2043), we have initiated work with opinion leaders and clinical experts to design the pivotal clinical program for CAM2043 for the treatment of pulmonary arterial hypertension (PAH). Our goal is to conduct a clinical Phase 2 study in 2019 and thereafter initiate a pivotal Phase 3 study. Furthermore, we are investigating the use of CAM2043 in additional indications.
An update on our clinical pipeline will be provided at our Capital Markets Day in Stockholm on 11 December 2018.
We look forward to an exciting quarter as we move closer to the expected approvals and launch of Buvidal in key markets, which will transform the company as we evolve into commercial stage. These approvals will also contribute to the validation of our unique FluidCrystal® technology to drive future pipeline programs and business development. We believe Buvidal will play an important role in helping people struggling with opioid dependence to live better lives, and thereby contribute to curbing the global opioid crisis. I am proud of the achievements during the period, especially the significant efforts and commitment of our team that has driven this success.
President and CEO
For more information:
Fredrik Tiberg, CEO and Head of Research
Tel. +46 (0)46 286 46 92
This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 07.00 AM CET on 25 October 2018.