STOCKHOLM, Sept. 30, 2019 /PRNewswire/ -- Moberg Pharma
AB (OMX: MOB) has signed an exclusive license agreement with Taisho
Pharmaceutical Co., Ltd for development, registration and
commercialization of MOB-015 in Japan. Under the agreement, Moberg Pharma is
eligible to receive milestones of up to USD
50 million contingent on development and commercial
success, as well as supply fees including royalties.
Moberg Pharma has entered into a license agreement granting
Taisho Pharmaceutical Co., Ltd exclusive Japanese rights to
MOB-015, a new topical treatment of onychomycosis based on Moberg's
patented proprietary formulation of terbinafine. Taisho will fund
and conduct the development and registration activities in
Japan, and will be marketing,
distributing and selling MOB-015 in Japan upon completion of registration.
"We are excited to partner with Taisho for the large and
growing Japanese onychomycosis market, contributing to our vision
of making MOB-015 the leading nail fungus treatment worldwide,"
says Anna Ljung, CEO of Moberg
Pharma.
"This is the third major agreement for MOB-015 and further
validates the significant market potential for our lead asset and
the focused commercialization preparations by our team," says
Peter Wolpert, Executive Chairman of
Moberg Pharma.
Under the terms of the license agreement, Moberg Pharma provides
supply for the product and provides Taisho with know-how and
documentation from its international development
program. Moberg Pharma is eligible to receive up to
approximately USD 50 million in
milestone payments, including USD 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.
According to Moberg Pharma's market intelligence, the Japanese
market for branded prescription drugs for onychomycosis amounted to
$290 million in 2018, growing at more
than 8
percent.
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:
Peter Wolpert, Executive Chairman,
phone: US: +1-908-432-2203, e-mail:
peter.wolpert@mobergpharma.se
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 persons set out above, at 6.00
p.m. CET on September 30th,
2019.
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Moberg Pharma and
Taisho sign exclusive license agreement for MOB-015 in
Japan
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