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).

Attachments

05171498.pdf