Interim Report January-September 2017
“The FDA has set a PDUFA target action date for CAM2038 of January 19, 2018. If approved, this would trigger a US commercial launch early next year.”
Business highlights third quarter 2017
- NDA submission to FDA for CAM2038 weekly and monthly buprenorphine depots for treatment of opioid dependence.
- MAA submission to EMA for CAM2038.
- CAM2038 NDA acceptance with Priority Review by FDA.
- CAM2038 MAA validation by EMA.
- CAM2043 IND submission to FDA.
- Phase 3 long-term safety extension study of CAM2038 initiated in patients with chronic non-cancer pain patients.
- Phase 1 study completed for CAM2047 and CAM2048/58 for CINV and postoperative pain, respectively
- Three abstracts accepted for oral presentations at ISAM Annual Meeting in Abu Dhabi, October 26-29.
Financial summary third quarter 2017
- Revenues MSEK 12.5 (30.5).
- Operating result MSEK -67.1 (-16.6).
- Result after tax MSEK -52.3 (-13.2).
- Earnings per share SEK -1.40 (-0.35),
- before and after dilution.
- Cash position MSEK 369.7 (518.2).
Excellent business progress was made in Q3. The FDA and EMA both formally accepted our submissions for marketing approvals for weekly and monthly buprenorphine depots (CAM2038) for the treatment of opioid use disorder and dependence. In addition, our New Drug Application (NDA) was granted Priority Review by the FDA. Thus, CAM2038 may be approved in the US in January 2018, with a European decision expected later in the year.
Together with our US partner Braeburn Pharmaceuticals, we are continuing preparations for the anticipated 2018 launches of CAM2038. Approximately 4 million individuals in the US and Europe are diagnosed with opioid dependence. The opioid crisis is continuing to escalate in the US, with an estimated 100 opioid overdose deaths each day. The Trump administration is expected to formally declare the opioid epidemic a national emergency this week. There is a clear need of new treatment options and, if approved, our weekly and monthly CAM2038 depots could be a new paradigm in opioid dependence treatment and reduce the burden and risks of current daily medications.
The FDA is convening a meeting of the Psychopharmacologic Drugs and the Drug Safety and Risk Management Advisory Committee for independent expert advice on the CAM2038 NDA. We look forward to sharing and discussing our data with the Advisory Committee on November 1, 2017. The FDA has set a PDUFA target action date for CAM2038 of January 19, 2018. If approved, this would trigger a US commercial launch early next year.
In anticipation of forthcoming US and European approvals we are continuing to build our commercial organization. Camurus now has presence in key European markets, including the UK, Germany, France and the Nordics. The regional teams have cross-functional expertise, delivering on pre-commercialization plans with the focus on distribution, market access, marketing and medical affairs.
Highlights from the clinical development of CAM2038 have been published in leading scientific journals and accepted for presentation at scientific conferences. Only this week (Oct 26-29), three oral presentations of CAM2038 phase 2 and phase 3 study results will be given at the Annual Meeting of the International Society of Addiction Medicine (ISAM) in Abu Dhabi. Camurus is also arranging an educational symposium at this meeting, featuring presentations by leading international experts in opioid addiction.
Alongside the significant efforts towards CAM2038 approvals and commercial readiness, we have also worked intensively to advance other development programs:
- CAM2038 for the treatment of chronic pain. In addition to completing recruitment to the Phase 3 efficacy study, a long-term safety extension study has been initiated. Top-line results from the efficacy study are expected in the Q1, 2018, while the long-term safety results will be available second half of 2018.
- CAM2029 for the treatment of acromegaly and neuroendocrine tumours. The start of Phase 3 trials has been postponed in order to evaluate new study designs recently suggested by health authorities, and to conduct additional manufacturing and packaging activities. Discussions with US FDA anticipated for early 2018 may result in an earlier study completion compared with current designs.
- Weekly setmelanotide (CAM4072) for the treatment of rare genetic disorders of obesity. During Q3, Rhythm completed a successful IPO on the NASDAQ Global Market to support rapid development of setmelanotide for rare genetic obesity disorders, expand indications and commercialize in the US and other core markets. Final results from the ongoing Phase 1 study, including repeated dosing, are expected in Q4 2017.
- CAM2047, CAM2048 and CAM2058 for the treatment of chemotherapy induced nausea and vomiting and post-operative pain. Phase I studies were completed and topline results agree with our pharmacokinetic and tolerability target profiles for these products.
- CAM2043 for the treatment of pulmonary arterial hypertension. An Investigational New Drug application was submitted for CAM2043 and we plan to start the first clinical trial in Q4 2017.
Camurus’ financial results are in line with our plan, with significant investments in R&D and build-up of our commercial organization for a 2018 European launch of CAM2038. We have a solid financial position with 370 MSEK in cash and the potential for significant near-term development milestone payments following NDA approval of CAM2038.
We have an exciting period ahead of us with an expected strong news flow, including the outcome of next weeks’ FDA Advisory Committee meeting as well as progress in our clinical pipeline.
President and CEO
For more information:
Fredrik Tiberg, CEO and Head of Research
Tel. +46 (0)46 286 46 92
Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 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 26 October 2017.