“We made significant progress towards regulatory approvals for CAM2038 in the US, Europe and Australia”
Business highlights second quarter 2018
- NDA for CAM2038 resubmitted to FDA
- JAMA Internal Medicine published positive Phase 3 study results for CAM2038 for treatment of opioid use disorder
- Camurus regained exclusive worldwide rights to CAM2029 and related product candidates from Novartis
- Topline results announced from Phase 1 study of CAM2043 for the treatment PAH
- Directed share issue completed with proceeds of 102 MSEK
- Camurus and Medison entered into agreement for CAM2038 in Israel
- episil® oral liquid launched in Japan by Meiji Seika Pharma
- Company presentation at the H.C. Wainwright & Co. Global Life Sciences Conference, and Jefferies Global Healthcare Conference
- Clinical results for CAM2038 presented at the American Society for Addiction Medicine (ASAM) Annual Conference, Congrès International d’Addictologie de l’Albatros, and the College on Problem Drugs and Dependence (CPDD) Annual Scientific Meeting
- New patents issued for CAM2029 and CAM2038 in the US
Significant events after the reporting period
- FDA accepts complete response and issues user fee (PDUFA) goal date of December 26, 2018
Financial summary second quarter 2018
- Net sales MSEK 7.3 (19.1).
- Operating result MSEK -81.2 (-58.7).
- Result after tax MSEK -67.5 (-45.8).
- Earnings per share SEK -1.81 (-1.23), before and after dilution.
- Cash position MSEK 199.1 (413.4).
During the second quarter, we continued to progress approval processes for our weekly and monthly buprenorphine depots, CAM2038, for the treatment of opioid dependence, and intensified our launch preparations in Europe and Australia. We regained the worldwide rights to CAM2029 octreotide depot, received positive clinical results for CAM2043, and completed a directed share issue.
Progress in approval processes and launch readiness
During the second quarter, we made significant progress towards regulatory approvals of CAM2038 in the US, Europe and Australia. The New Drug Application (NDA) was resubmitted to the FDA by our US partner Braeburn. After the period, we were delighted to receive notice of the FDA’s acceptance of the complete response together with a PDUFA goal date of December 26, 2018. Market Authorization Application (MAA) review processes in the EU and Australia continued to advance, with expected approvals on all key markets in 2018.
Results from our randomized, double-blind, double-dummy, active-controlled Phase 3 study were published in JAMA Internal Medicine, demonstrating favorable clinical outcomes for CAM2038 versus current standard treatment with daily sublingual buprenorphine/naloxone in opioid dependent patients. This represents the first publication of Phase 3 study results for a long-acting buprenorphine injectable treatment. Clinical study results, including subgroup analyses of Phase 3 results in heroin and injection drug users, have also been presented at leading international scientific addiction conferences, showing statistically improved outcomes for key measures for CAM2038 versus daily sublingual buprenorphine/naloxone.
Launch preparations for CAM2038 continued to progress. In the US, Braeburn made significant advances in establishing an effective marketing, reimbursement and distribution model for CAM2038. Responses from payors and prescribers have been encouraging. In Europe, we have further strengthened our organization within marketing, medical affairs and market access, and our commercial teams have continued to execute on the regional go-to-market plans for CAM2038. In Australia, we recruited a business unit head with experience in the opioid dependence therapy area to build the organization and prepare for launch. Additionally, we initiated the expansion of our global distribution network to ensure access to treatment for patients outside EU and Australia and signed an agreement with Medison Pharma for commercialization of CAM2038 in Israel.
Conclusion of pivotal study in chronic pain
A randomized, placebo-controlled Phase 3 study of CAM2038 for the treatment of chronic low back pain was concluded in May 2018. Subsequently, our study teams have been preparing for database lock and unblinding of the study. Topline efficacy results are expected in the third quarter. Meanwhile, a long-term safety extension study of CAM2038 is ongoing, which is anticipated to be clinically completed towards the end 2018.
Preparing for CAM2029 Phase 3 studies
After regaining the exclusive worldwide rights to our CAM2029 octreotide depot and related products from Novartis, we have worked diligently to ensure a smooth transfer of the project and have also started to prepare for Phase 3 registration programs for CAM2029 in acromegaly and neuroendocrine tumors (NET). During the second half of 2018, we plan to complete ongoing manufacturing preparations for Phase 3 and engage with healthcare authorities in the EU and US to align clinical registration program updates. The market for long-acting somatostatin products, Sandostatin® LAR® and Somatuline® Autogel®, has shown steady growth for the past two decades with 2017 global sales exceeding USD 2.4 billion. Based on our product design advantages and positive clinical results from Phase 1 and 2 studies, we expect that CAM2029, if approved, could gain a significant market share and become an important catalyst for future growth and value creation for Camurus.
Promising Phase 1 results for CAM2043
In our early pipeline, we obtained topline results from the first clinical study of our weekly treprostinil depot, CAM2043, in development for treatment of pulmonary arterial hypertension (PAH). Based on the positive pharmacokinetic and tolerability results in healthy volunteers, we have started preparing the further clinical development of CAM2043 in collaboration with key opinion leaders and clinical experts.
Directed share issue completed
To support the commercialization of CAM2038 in Australia and the initiation of clinical development programs for CAM2029 and CAM2043, a directed share issue of approximately MSEK 102 was completed in June, securing these important activities up to the expected US approval and launch of CAM2038.
The second quarter has been intense and productive, during which our dedicated teams continued to deliver on key priorities. I am proud of the commitment of my coworkers and thankful for the many positive results that they have achieved. With the approvals of CAM2038, we will have the opportunity to positively impact the lives of hundreds of thousands of patients living with opioid dependence. In the longer term we aim to address important treatment needs in other patient groups with severe and chronic diseases.
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 17 July 2018.