STOCKHOLM, Feb. 11, 2019 /PRNewswire/ -- Moberg Pharma AB
(OMX: MOB) has signed an exclusive license agreement with Bayer for
commercialization of MOB-015 in Europe. Under the agreement, Moberg Pharma is
eligible to receive up to EUR 50
million contingent on development and commercial
success, as well as supply fees including royalties.
Moberg Pharma has entered into a license agreement granting the
Consumer Health division of Bayer exclusive European rights to
MOB-015, a new topical treatment of onychomycosis based on Moberg's
patented proprietary formulation of terbinafine. Bayer will be
marketing, distributing and selling MOB-015 in Europe upon completion of Phase III clinical
development and registration.
"We are thrilled to partner with Bayer for the European
launch, as part of our vision of making MOB-015 the leading nail
fungus treatment worldwide. This is the second major agreement for
MOB-015 and a further validation of the significant market
potential for our asset," says Peter
Wolpert, Moberg Pharma's CEO.
Under the terms of the license agreement, Moberg Pharma will
finalize the ongoing Phase III program, complete registration in
Europe and provide supply for the
product. Moberg Pharma is eligible to receive up to
EUR 50 million in milestone payments,
including EUR 1.5 million paid at
signing. The majority of the milestone payments are contingent on
sales targets, with the balance contingent on development and
regulatory milestones. Moberg Pharma will also receive supply
fees including royalties.
"We are excited about the opportunity to partner with Moberg
and the potential to bring this cutting-edge technology to market
in order to advance one of our key categories,'' says
Heiko Petersen, Head of Bayer's
Global Category Business Unit Dermatology.
The European OTC market for onychomycosis drugs amounted to
EUR 192 million in 2017, growing at
2.6%
(Source: Nicholas Hall DB6
database, 2017 update, value in Euro @ MSP prices).
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 persons set out above, at 6.00
p.m. CET on February 11th,
2019.
About MOB-015 and Onychomycosis
Approximately 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 internally developed topical formulation of
terbinafine based on Moberg Pharma's experience from its 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.
In a previous phase 2 study, MOB-015 demonstrated delivery of
high microgram levels of terbinafine into the nail and through the
nail plate into the nail bed. Mycological cure of 54% and
significant clear nail growth was observed in patients who
completed the phase 2 study. The results are remarkable,
particularly when taking into account the severity of the nails
included in the study – on average approximately 60% of the nail
plate was affected by the infection. Plasma levels of terbinafine
with MOB-015 were substantially lower than after oral
administration, reducing the risk of liver toxicities observed with
oral terbinafine.
MOB-015 is currently being evaluated over 52 weeks in two
randomized, multicenter, controlled Phase 3 studies, including in
total approximately 800 patients in North
America and Europe. The
primary endpoint in both studies is the proportion of patients
achieving complete cure of their target nail. Topline results from
the North American study are expected in the fourth quarter of
2019, followed by results in Europe in 2020.
CONTACT:
For additional information, please contact:
Peter Wolpert, CEO, phone:
Sweden: +46-707-35-7135, US:
+1-908-432-2203, e-mail: peter.wolpert@mobergpharma.se
Eleonora Stern-Nejman, Investor
relations, phone: +46-701-76-22-42, e-mail:
eleonora.stern-nejman@mobergpharma.se
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Moberg Pharma and
Bayer sign exclusive license agreement for MOB-015 in
Europe
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SOURCE Moberg Pharma