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2016-05-18

Moberg Pharma: Moberg Pharma announces multiple patent approvals for MOB-015

STOCKHOLM, May 18th, 2016. Moberg Pharma AB (OMX: MOB) provided an
update on the intellectual property portfolio protecting MOB-015, the
Company's investigational topical treatment for onychomycosis (nail
fungus). Patents have recently been granted and Notice of Allowances
received in multiple territories worldwide. The patents granted are
expected to be in effect until 2032.

"These patents are exceptionally important to Moberg since they secure
IP rights for MOB-015 until at least 2032 in various markets
worldwide where we plan to sell or license this product, once
approved. They represent a strong addition to our portfolio which now
includes 12 issued patents and 27 pending patent applications
worldwide in four different patent families," said Peter Wolpert, CEO
of Moberg Pharma AB.

The patents granted include composition of matter claims for topical
formulations of antifungal allylamines (including terbinafine), as
well as methods of treatment claims for treating onychomycosis using
these novel formulations, enabling enhanced penetration of antifungal
allylamines into and through the nail.

Since February 2015, patents have been granted to Moberg in the U.S.,
Canada, Europe (EPO), Japan, Mexico, Singapore and South Africa.
Notices of Allowances have been issued in Australia, Israel and
Russia. Active applications are pending in several additional
territories, including Brazil, China, Hong Kong, Indonesia, India and
Korea.

Moberg is planning to initiate a Phase 3 program for MOB-015 in the
second half of 2016. In a recent Phase 2 study, MOB-015 demonstrated
delivery of high microgram levels of terbinafine into the nail, as
well as 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 that the majority of the patients treated
had severely affected nails - on average approximately 60% of the
nail plate was affected by the infection. Plasma levels of
terbinafine with MOB-015 were substantially lower than with oral
administration, reducing the risk of liver toxicities observed with
oral terbinafine.

About this information
Moberg Pharma discloses this information pursuant to the Swedish
Securities Markets Act and/or the Financial Instruments Trading Act.
The information was submitted for publication at 8:30 am (CET) on May
18th, 2016.

About MOB-015 and Onychomycosis
Approximately 10% of the general population suffer from onychomycosis
and a majority of those afflicted go untreated. The prescription
market is growing rapidly after the recent introduction of new
topical treatments in North America and Japan. Moberg Pharma expects
the U.S. market alone to exceed $2 billion by 2020 and estimates the
peak sales potential for MOB-015 to be in the range of $250-$500
million.

MOB-015 is an internally developed topical formulation of terbinafine
building on Moberg Pharma's experience from its leading OTC product
Kerasal Nail®. Oral terbinafine is the gold standard for treating
onychomycosis, but associated with safety issues including drug
interactions and liver injury. 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.

For additional information contact:
Peter Wolpert, CEO, Telephone: +46 707 35 71 35, E-mail:
peter.wolpert@mobergpharma.se

Kjell Rensfeldt, VP R&D, Telephone: +46 707 12 4532, E-mail:
kjell.rensfeldt@mobergpharma.se

About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical
company with OTC sales operations in the U.S. and a distributor
network in more than 40 countries. The company's portfolio includes
the OTC brands Kerasal®, Kerasal Nail®, Balmex®, Domeboro®. Kerasal
Nail®(Emtrix®or Nalox™ in certain markets) is a leading OTC treatment
of nail disorders in the U.S., Canada and several EU markets and is
currently being launched in Southeast Asia. The company is growing
organically as well as through acquisitions. Internal development
programs focuses on innovative drug delivery of proven compounds and
include two clinical stage assets, MOB-015 (onychomycosis) and BUPI
(pain management in oral mucositis). Moberg Pharma has offices in
Stockholm and New Jersey and the company's shares are listed on the
Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX:
MOB).

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http://news.cision.com/moberg-pharma/r/moberg-pharma-announces-multiple-...
http://mb.cision.com/Main/1662/2011198/516931.pdf

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