“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”, Fredrik Tiberg, President and CEO, says in his CEO comments.
Business highlights third quarter 2018
Financial summary third quarter 2018
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.
Camurus’ partner, Braeburn Inc., has initiated court proceedings foran approval of Brixadi (Buvidal® in the US) and to overturn the 3-year market exclusivity granted by the FDA to another product.Read more
New positive results from a Phase 3 study show that Camurus’ Buvidal® provides better treatment effect for fentanyl abuse, among other things, compared to other standard treatments as well as lower withdrawal and drug craving.Read more
Camurus’ rights issue of 403 MSEK has been oversubscribed. The rights issue was carried out to secure financing of the launch and marketing of Buvidal in Europe and Australia.Read more
Aimpoint has been awarded a large contract of USD 24 million from the U.S. Military for the FCS13-RE system for SAAB’s portable weapon system Carl-Gustaf (MAAWS) and to be used by the U.S. Army, U.S. Marine Corps and the U.S. Special Operations Command.Read more
Based on Aimpoint's red dot sight for fire arms, the company has developed a commercial VR platform, GAIM, which is now spun off to a separate company.Read more
In 1959, Gunnar Sandberg established ElektroSandberg and lay the foundation for what we now know as Sandberg Development.Read more
Camurus' has published their Full year report 2018.Read more
As of January 7 Mikael Samuelsson is the new CEO for GRANULDISK.Read more
During the summer it was decided to spin off operations focused on the decontamination of fire rescue equipment from GRANULDISK into a separate company - RESCUE Intellitech.Read more
In November 2019 Mats Marklund took office as CEO for SWATAB.Read more
Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company’s lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social and psychosocial support.Read more
Camurus receives EU approval for weekly and monthly Buvidal® (CAM2038) for opioid dependence. Buvidal® is the first long-acting medicine approved in the EU for the treatment of opioid dependence in adults and adolescents.Read more
“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”, Fredrik Tiberg, President and CEO, says in his CEO comments.Read more
AF Bostäder in Lund will open two new laundry rooms at Vildanden, a student housing, where the students can wash with super-clean water in a chemical-free process.Read more
Sandberg Development has decided to spin-off and concentrate the business within the subsidiary GRANULDISK’s product area SOLO Rescue.Read more
The family owned investment company Sandberg Development invests in SWATAB (SCANDINAVIAN WATER TECHNOLOGY AB). The investment implies a growth venture with an upscaling of the organization and production, which will be built in Sandberg Development’s premises in Malmö.Read more
Sandberg Development invests SEK 30 million in the Malmö-based water recycling technology Company Orbital Systems.Read more
In the beginning of November reconstruction work started at our office facilites at Jägershillgatan 15 in Malmö.Read more
As part of our business concept - "Investing in innovations with growth in focus" - Sandberg Development has, during the summer, invested in an unlisted development Company, ISEC AB.Read more
New data support long-term safety and efficacy of weekly and monthly subcutaneous buprenorphine depots in patients with opioid use disorder.Read more
On April 18, 2017 the purchase deed was signed and Sandberg Development is now the owner of the property.Read more
One year after the reconstruction work started, the new production facilities were completed in March 2017.Read more
In March 2016 reconstruction and extension work started at our premises on Jägershillgatan 15 in Malmö. The first part of the reconstruction work involves the production facilities.Read more
From 2015 Sandberg Development is a sponsor of Star for Life, an educational/motivational programme, the aim of which is to strengthen the self esteem of young people and to counter the spread of HIV/AIDS.Read more
On Thursday December 3, 2015, Camurus started its first day of trading on Nasdaq Stockholm. The share price increased considerably during the first day and Camurus is now the largest company in the biotechnology sector on Nasdaq StockholmRead more
Camurus announces initial public offering on Nasdaq Stockholm. The company plans a new shares issue to a value of SEK 500 million net - a market capitalization of appr. SEK 2 billion.Read more
On November 3, 2015, Sandberg Development received Mazars prize for sustainable business. Per Sandberg was present at the prize ceremony which took place in Malmö.Read more
As of August 25, 2015 Kent Bengtsson started working as CFO in Sandberg Development.Read more
GRANULDISK recently moved into new facilities in Malmö. The history behind the large-scale investment is strong growth in Sweden and Europe and increased demand, not least from Asia and the Middle East. The company has recruited about ten new employees and expects to recruit more in the longer run.Read more
In the wake of an extensive branding process, GS Development is changing its name to Sandberg Development AB. This process was initiated to clarify its communications so that they reflect the group’s focus on world-class innovations.Read more