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.
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Interim Report
Camurus Q1 2019
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