Moberg Pharma announces approvals to start Phase 3 study for MOB-015 in U.S. and Canada


STOCKHOLM, August 10, 2016. Moberg Pharma AB (OMX:MOB) today announced that the
U.S. Food and Drug Administration (FDA) has approved the Company’s
Investigational New Drug (IND) application and that a No Objection Letter has
been received from Health Canada to begin its Phase 3 trial for MOB-015 in the
treatment of onychomycosis.
This allows Moberg Pharma to start enrolling patients in the U.S. and Canada
pending approval from the Institutional Review Board (IRB/independent ethics
committee). The approvals concern a randomized, multicenter, vehicle-controlled
Phase 3 study. The patients will be evaluated over 52 weeks and the primary
endpoint will be the proportion of patients achieving complete cure of their
target nail. The company expects to start enrollment in the third quarter of
this year.

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 person set out above, at 8.30 CET
on August 10, 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 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.
For additional information contact:
Peter Wolpert, CEO, Phone: +46 707 35 71 35, E-mail:
peter.wolpert@mobergpharma.se
Kjell Rensfeldt, VP R&D, Phone: +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®, NewSkin®, Domeboro®, Fiber Choice® and PediaCare®. 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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