Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Camurus Interim Report January-March 2019


News provided by

Camurus AB

09 May, 2019, 11:17 GMT

Share this article

Share toX

Share this article

Share toX

STOCKHOLM, May 9, 2019 /PRNewswire/ --

"Initial sales of Buvidal® follows plan and we are expecting to see significant growth during the year"

Summary first quarter 2019 

  • Buvidal® launched as the first long-acting medicine for opioid dependence in the EU; with initial sales in Finland, the UK, Sweden, Germany and Denmark
  • Net revenues amounted to MSEK 18.5 (14.6), of which MSEK 11.0 (3.0) were from product sales
  • Enrollment completed in the DEBUT clinical study, comparing Buvidal® with daily treatment with sublingual buprenorphine/naloxone
  • Last patient last visit in the Phase 3 long-term extension study of CAM2038 for treatment of chronic pain
  • Phase 3 study protocol for CAM2029 in acromegaly finalized after alignment with the US FDA
  • Completed rights issue of MSEK 403

Significant event after the period 

  • Camurus' partner Braeburn initiated court proceedings to overturn a market exclusivity extending to 30 November 2020 and seek immediate market approval of Brixadi™ (the US trade name for Buvidal®) for the treatment of opioid use disorder in the US

Outlook for 2019 

  • Net revenues are expected to be in the region of MSEK 130–160*, with product sales of MSEK 70–90

* Forecast does not include possible milestone payments relating to Brixadi™ in the US

Financial summary first quarter 2019 

  •  Net Revenue MSEK 18.5 (14.6)- whereof product sales MSEK 11.0 (3.0)
  •  Operating result MSEK -84.4 (-46.4)
  •  Result for the period MSEK -67.6 (-36.3)
  •  Earnings per share SEK -1.50 (-0.97), before and after dilution
  •  Cash position MSEK 406.6 (266.6)

CEO statement

During the first quarter of 2019, we initiated the European launch of Buvidal®, our in-house developed, weekly and monthly depots for the treatment of opioid dependence. In our first launch market, Finland, an estimated 6% of patients with opioid dependence are receiving Buvidal® after its first 3 months of availability. Subsequently, we have launched Buvidal® in the UK, Sweden, Germany and Denmark, with a considerable interest in all markets and a positive response from healthcare providers and patients.

Positive start of EU launch

Following the launch of Buvidal®, patients in the EU have access to the first innovative long-acting medication for the treatment of opioid dependence, with individualized flexible weekly and monthly dosing. So far, around 500 patients have initiated treatment with Buvidal®, including new-to-treatment patients, and patients transferring from daily medication with sublingual buprenorphine and methadone. The majority of these patients are from Finland and Germany, while initial patient uptake in the UK, Sweden and Denmark, has, as expected, been less rapid due to the reimbursement and formulary listing processes. In Norway and Australia, we have submitted pricing and reimbursement applications and are expecting positive decisions and aim to start launches shortly thereafter. Initial sales of Buvidal® follows plan and with the positive feedback and engagement with stakeholders we are expecting to see significant growth during the year.

Large interest in Buvidal® in the criminal justice setting

Aside from very positive signals from healthcare providers, we have also seen a significant interest in our long-acting treatment solutions for use in custodial settings, where the unmet medical need of a safe and effective treatment alternative is significant. Several prisons in Germany have recently begun using Buvidal® for the treatment of patients with opioid dependence, with the expectation that our long-acting treatments will lead to improvement of outcomes and significant treatment efficiencies. Additionally, treatment with weekly and monthly Buvidal® may facilitate the transition to outpatient treatment protecting patients from the known risks of overdose and death during the first weeks of being released from prison. To further the understanding of the contribution Buvidal® can make in custodial settings a clinical UNLOC-T study comparing Buvidal® with methadone at eight prisons in New South Wales, Australia, is also progressing and initial results are expected in the fourth quarter of 2019. With a large unmet need and more than 100,000 individuals with opioid dependence in the EU and Australian prison systems combined, we see significant opportunities for Buvidal® in the criminal justice setting.

In the first quarter of 2019 we completed enrollment in the DEBUT outpatient clinical study comparing Buvidal® with daily standard-of-care with sublingual buprenorphine/naloxone. Results are expected during the fourth quarter.

A detailed subgroup analysis of fentanyl users in the pivotal Phase 3 study of Buvidal® compared to sublingual buprenorphine/naloxone was also conducted. The results, showing improved outcomes and less illicit opioid use in patients treated with Buvidal®, were presented by Professor Edward Nunes, Columbia Medical School at the American Society of Addiction Medicine 50th Annual Meeting in Orlando, and generated significant interest.

Court proceedings initiated in the US

After the first quarter, our partner Braeburn filed an action in federal district court for the District of Columbia, seeking to overturn the market exclusivity extending to 30 November 2020 granted by the US Food and Drug Administration (FDA) to Sublocade™, and seeking immediate approval of Brixadi™. A court decision is expected during the third quarter of 2019.

Continued investment in the product pipeline

The last patients in the 52-week Phase 3 long-term safety extension study of CAM2038 in patients with chronic pain completed their treatment during the first quarter of 2019. After closing of the database and compiling of results and the study report, we will meet with European regulatory authorities to discuss the regulatory submission for CAM2038 for the treatment of chronic pain. We plan to submit in the EU during the first half of 2020.

Another important milestone for us is the start of the Phase 3 program for our subcutaneous octreotide, CAM2029, being developed for the treatment of acromegaly and neuroendocrine tumors (NET). CAM2029 has been designed for easy self-administration and optimization of treatment effects for these chronic diseases. During the first quarter, we initiated manufacturing and finalized the pivotal Phase 3 study protocol after alignment of study details with the FDA. Clinical trial applications are submitted in the US and a number of national regulatory authorities in Europe. The goal is to start treatment in the Phase 3 study of CAM2029 at the beginning of the third quarter of 2019.

We also continued to work on the development of a Phase 2 study of CAM2043 (treprostinil), for the treatment of pulmonary arterial hypertension (PAH) and systemic sclerosis and aim to initiate Phase 2 clinical trials in patients towards the end of the year. Additionally, activities continued in other internal projects as well as in our partnerships, including with Braeburn, Rhythm and Solasia.

To secure financing of prioritized development projects and for the launch of Buvidal® in Europe and Australia, we completed a rights issue of SEK 403 million before issue costs towards the end of the quarter.

Focus on launches and growth

Our key objective for 2019 is to give patients in Europe and Australia rapid access to treatment with Buvidal®. Based on the high unmet medical need in opioid dependence and the positive feedback on treatment with Buvidal® from both patients and healthcare providers, we expect to see significant sales and growth over the year. This ambition is supported by a strong commercial organization with fully operational regional teams in Germany, the UK, the Nordics and Australia, and with local presence in France, Spain and Italy. With the significant opportunity presented by Buvidal® in opioid dependence, alongside expected development milestones in our pipeline of innovative products and our partnerships, I believe the 2019 outlook for Camurus is optimistic and will enable us to deliver strong growth and value for patients and shareholders.

Fredrik Tiberg
President and CEO

For more information:
Fredrik Tiberg, CEO and Head of Research
Tel. +46(0)46-286-46-92
fredrik.tiberg@camurus.com   

Fredrik Joabsson, Chief Business Development Officer
Tel. +46(0)70-776-17-37
ir@camurus.com 

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, 1.00 PM CET on 9 May 2019.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/camurus-ab/r/camurus-interim-report-january-march-2019,c2807909

The following files are available for download:

https://mb.cision.com/Main/13456/2807909/1040684.pdf

Interim Report Camurus Q1 2019

Modal title

Also from this source

Camurus' Oczyesa® receives marketing authorization for treatment of acromegaly in the EU

Camurus (NASDAQ STO: CAMX) today announced that the European Commission (EC) has granted Oczyesa®, octreotide subcutaneous depot, marketing...

Camurus' POSITANO study shows treatment effects with CAM2029 in polycystic liver disease patients

Camurus (NASDAQ STO: CAMX) today announced topline results from the 12-month, randomized, double-blind, placebo-controlled POSITANO Phase 2b study...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Earnings

Earnings

Earnings

Earnings

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.