STOCKHOLM, Oct. 21, 2019 /PRNewswire/ -- Moberg Pharma
AB (OMX: MOB) has signed a distribution agreement with
DongKoo Bio & Pharma Co., Ltd
for MOB-015 in the Republic of Korea. Under the agreement DongKoo
is granted exclusive rights to market and sell MOB-015 in the
Republic of Korea. Moberg Pharma assumes production and supply
responsibility.
DongKoo will conduct registration activities in the Republic of
Korea, and will be marketing, distributing and selling MOB-015 in
the Republic of Korea upon completion of registration.
"This is the fourth commercial agreement for MOB-015, this time
with the market leader in dermatology in Korea with excellent
coverage of the dermatology clinics. We look forward to work with
DongKoo and making MOB-015 available in Korea, contributing to our
vision of making MOB-015 the leading nail fungus treatment
worldwide", says Anna Ljung, CEO
of Moberg Pharma.
According to Moberg Pharma's market intelligence, the Korean market
for topical drugs for onychomycosis amounts to $40 million (rolling 12m ending June
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 previously
having developed and commercialized a leading OTC product for
onychomycosis. 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 more than 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 December 2019, followed by results in
Europe expected in the second
quarter of 2020.
Contact:
For additional information, please contact:
Anna Ljung, CEO, telephone:
+46 707 66 60 30, E-mail:
anna.ljung@mobergpharma.se
Peter Wolpert, Executive Chairman,
phone: US: +1 908 432 2203, e-mail:
peter.wolpert@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 persons set out above, at 7.00
a.m. CET on October 21st,
2019.
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Moberg Pharma and
DongKoo sign agreement for MOB-015 in the Republic of
Korea
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SOURCE Moberg Pharma