STOCKHOLM, June 28,
2023 /PRNewswire/ -- Moberg Pharma AB (OMX:
MOB) hereby announces that the Decentralized
Procedure has ended with a positive outcome and that MOB-015 is
recommended for national approval in 13 European countries for the
treatment of mild to moderate fungal infections of the nails in
adults.
- The approval in the European Union represents the first
marketing authorizations for Moberg Pharma´s new onychomycosis
treatment worldwide
- Approval is supported by two Phase 3 trials where MOB-015
demonstrated superior levels of mycological cure (76% vs up to 42%
for comparators), and a significantly better complete cure rate
compared to vehicle, without any serious adverse reactions
- MOB-015 is a topical formulation of terbinafine, enabling
effective concentrations of terbinafine to the nail and nail bed
while avoiding the risk of systemic exposure seen with oral
terbinafine use
The Decentralized Procedure includes the following
EU countries: Austria,
Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain
and Sweden. Next steps include
national implementation in each country and granting of marketing
authorizations including OTC-approvals when applicable. National
approvals are expected to follow during upcoming months and
timelines may vary between countries.
"We are excited about the MOB-015 program, with its
cutting-edge technology and the promising 76% mycological cure rate
shown in the clinical trials. It is a good fit for our
Canesten® brand, with potential to become a game changer
within onychomycosis,'' says Karen
Hackney, Bayer Consumer Health Head of R&D
Dermatology.
"We are incredible proud to bring a new efficacious treatment
option with a favorable safety profile to people living with
onychomycosis in Europe, an
important part of our vision of making MOB-015 the leading nail
fungus treatment worldwide," says Anna
Ljung, CEO of Moberg Pharma.
Our commercialization rollout will be a two-step process,
planned to start in our home market Scandinavia. We will initiate
launch as quickly as possible following national approval,
expecting to initiate launch preparations in Sweden before the end of the year. Exact
choice of countries will depend on time to national approval -
which may vary.
This early Scandinavian launch enables us to gain valuable
insights into consumer behaviour, collecting patient feedback and
provide user data to support direct to OTC/OTC-switches in more
countries. The launch in Scandinavia will take place in
collaboration with our partner Allderma, managed by the commercial
leaders which were responsible for the successful Nordic launch of
Nalox®, Moberg Pharma's first-generation nail fungus
product.
Step 2 of the launch will be a pan-European rollout together
with our partner Bayer, following the results in the ongoing North
American study. This as we believe it is likely that we will be
able to strengthen the product claims further, including a shorter
dosing regimen with the potential to deliver superior complete cure
rates. The timing is also driven by our need to secure sufficient
API for a pan-European launch.
Over the recent months we have had many interactions with
investigators in the ongoing North American trial, confirming the
enthusiasm of the physicians for the treatment and the progress in
the clinical study.
Our partner Bayer is a world leader in OTC fungus treatments
with the Canesten® brand, and we are excited to work
together on the pan-European launch. Our shared conviction is that
it is in the best interest of MOB-015's long term potential to
include the new data expected from the North American trial into
this launch.
Recruitment in the trial is expected to be completed before year
end, followed by expected topline results in the first quarter of
2025. Already now, Bayer is closely involved in the project and
will co-invest in development work such as packaging improvements
ahead of the pan-European launch.
Out of the two API manufacturers initially included in our
registration file, only one is approved at this timepoint, and the
one approved will stop its production of terbinafine later this
year. Short term we therefore have a limited supply of terbinafine
and are building as much API stock as possible. We expect to be
able to include the second API supplier within short post approval.
We are also looking for an additional API source and have
identified several possible suppliers to commence discussions to
secure long-term supply of terbinafine.
For additional information, please contact:
Anna Ljung, CEO, telephone:
+46 707 66 60 30, E-mail: anna.ljung@mobergpharma.se
About this information
This information is information that Moberg Pharma AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact person set out above, on June
28th, 2023, at 11.00 am
CEST.
About MOB-015 and Onychomycosis
Approximately 5-10% of the general population suffer from
onychomycosis and a majority of those afflicted go untreated. The
global market opportunity is significant with more than hundred
million patients worldwide and a clear demand for better products.
Moberg Pharma estimates the annual worldwide peak sales potential
for MOB-015 to be in the range of USD
250-500 million.
MOB-015 is an in-house developed topical formulation of
terbinafine based on Moberg Pharma's experience from the leading
OTC product Kerasal Nail®/Emtrix®. Oral
terbinafine is currently the gold standard for treating
onychomycosis but associated with safety issues, including drug
interactions and liver damage. For many years, developing a topical
terbinafine treatment without the safety issues of oral terbinafine
has been highly desirable, but unsuccessful due to insufficient
delivery of the active substance through the nail.
A total of 953 subjects received MOB-015 in the clinical
development program across seven studies. Safety and efficacy were
investigated in two randomized, controlled, multicentre,
international Phase 3 studies in patients with toenail
onychomycosis. MOB-015 has shown to be superior to vehicle. At
week 12 mycological cure was shown in 42.8% of subjects in the
MOB-015 group, increasing to 75.6% at Week 52. The systemic
absorption of topical terbinafine is several orders of magnitude
lower than for orally administered terbinafine. The systemic
exposure to terbinafine has been assessed in a Phase 1 systemic
absorption study under maximal use conditions in subjects with
onychomycosis. The mean plasma terbinafine concentration after 4
weeks of treatment was approximately 2000 times lower than the mean
plasma level observed after oral administration of 250 mg
terbinafine once daily for 28 days. Therefore, systemic
bioavailability of terbinafine from topical application of
MOB-015 is considered negligible.
MOB-015 is currently being evaluated over 52 weeks in a
randomized, multicenter, controlled Phase 3 study, including in
total approximately 350 patients in the U.S. and Canada. The primary endpoint is the proportion
of patients achieving complete cure of their target nail.
Recruitment is expected to be completed before year end, followed
by expected topline results in the first quarter of 2025.
About Moberg Pharma,
www.mobergpharma.com
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused
on commercializing proprietary innovations based on drug delivery
of proven compounds. The Company's main asset, MOB-015, is a novel
topical treatment for onychomycosis. Data from phase 3 clinical
trials in more than 800 patients for MOB-015 indicate that the
product has the potential to become the future market leader in
onychomycosis. Moberg Pharma has agreements with commercial
partners in place in Europe and
Canada, among others, and the
Company's goal is to receive its first market approval and initiate
launch preparations of MOB-015 in 2023. Moberg Pharma is
headquartered in Stockholm and the
Company's shares are listed on the Small Cap list of the Nasdaq
Stockholm (OMX: MOB).
Forward-looking statements
This press release contains forward-looking statements related to
the Company's intentions, estimates or expectations with regard to
the Company's future results, financial position, liquidity,
development, outlook, estimated growth, strategies and
opportunities as well as the markets in which the Company is
active. Forward-looking statements are statements that do not refer
to historical facts and can be identified by the use of terms such
as "believes," "expects," "anticipates," "intends," "estimates,"
"will," "may," "implies," "should," "could" and, in each case,
their negative, or comparable terminology. The forward-looking
statements in this press release are based on various assumptions,
which in several cases are based on further assumptions. Although
the Company believes that the assumptions reflected in these
forward-looking statements are reasonable, there is no guarantee
that they will occur or that they are correct. Since these
assumptions are based on assumptions or estimates and involve risks
and uncertainties, actual results or outcomes, for many different
reasons, may differ materially from those what is stated in the
forward-looking statements. Due to such risks, uncertainties,
eventualities and other significant factors, actual events may
differ materially from the expectations that expressly or
implicitly are contained in this press release through the
forward-looking statements. The Company does not guarantee that the
assumptions which serve as a basis for the forward-looking
statements in this press release are correct, and each reader of
the press release should not rely on the forward-looking statements
in this press release. The information, opinions and
forward-looking statements that expressly or implicitly are stated
herein are provided only as of the date of this press release and
may change. Neither the Company nor any other party will review,
update, confirm or publicly announce any revision of any
forward-looking statement to reflect events that occur or
circumstances that arise with respect to the contents of this press
release, beyond what is required by law or Nasdaq Stockholm's rules
for issuers.
The following files are available for download:
https://mb.cision.com/Main/1662/3795758/2157682.pdf
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MOB-015 is recommended
for approval in EU
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SOURCE Moberg Pharma