Moberg Pharma announces positive phase II data for BUPI

STOCKHOLM, January 11, 2016. Moberg Pharma AB (OMX: MOB) announces positive top
-line results from a phase II-study with BUPI for the treatment of pain due to
oral mucositis in patients with head and neck cancer. BUPI achieved a
statistically significant reduction in pain.
32 patients completed the phase II-study in which the efficacy of BUPI was
compared to standard treatment for pain in the oral cavity. The open clinical
study was conducted at two hospitals in Denmark.

The primary endpoint was a measurement of pain in the mouth or pharynx 60
minutes post administration of BUPI compared to the average pain during the day
for the control group. The group treated with BUPI had 23% reduction in pain
compared to the control group (VAS* 37.47 in BUPI vs. 48.94 in control,
p=0.0326). Both groups were allowed to use standard treatment options for pain
during the study. The control group was furthermore allowed to use locally
acting anesthetics for the oral cavity, in the form of a lidocaine gel. The
difference in the mouth (pharynx excluded) was even more pronounced. Treatment
with BUPI resulted in an additional pain reduction of 46% compared to standard
treatment (VAS 17.74 vs. 33.03, p=0.0027). No serious adverse events were
reported among the patients treated with BUPI.

Kjell Rensfeldt, VP Research and Development at Moberg Pharma,
commented:
”This study shows that BUPI provided additional pain reduction to levels below
VAS 40 in a patient population for which it is difficult to achieve adequate
pain relief. Developing a new formulation of bupivacaine, intended for self
-administration at home, requires a thorough evaluation of the safety profile of
the product. Moberg Pharma will now proceed with in-depth analyses of all other
data collected in this study, in order to guide further clinical development of
BUPI”.

* Pain evaluation with VAS (visual analogue scale) where VAS 0 = no pain and VAS
100 = worst imaginable pain.

About Oral Mucositis and BUPI
Oral mucositis (“OM)” is a painful inflammation and ulceration of the mucous
membranes lining the mouth. OM is a common and often debilitating complication
of cancer treatment which affects 80% of patients with head and neck cancer
receiving radiotherapy, almost all patients undergoing bone marrow
transplantation, and a wide range of patients receiving chemotherapy. OM makes
the patient less likely to comply with their cancer treatment, increases
mortality and morbidity and contributes to rising health care costs. In the
U.S., every year approximately 400 000 patients suffer from OM during cancer
therapy. The BUPI technology encompasses novel lozenge formulations of
bupivacaine, a local anesthetic with a well-established long acting effect,
currently available on the market for other indications as an injectable. A BUPI
lozenge is currently investigated in an ongoing clinical phase II study.

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 January 11, 2016.
For additional information contact:
Peter Wolpert, CEO, Telephone: +46 (0)70 - 735 7135, E-mail:
peter.wolpert@mobergpharma.se
Kjell Rensfeldt, VP R&D, Telephone: +46 (0)70 - 712 45 32, E-mail:
kjell.rensfeldt@mobergpharma.se
About Moberg Pharma
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®, Jointflex®, Vanquish®, and Fergon®. 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 phase II assets, MOB-015
(onychomycosis) and BUPI (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). For further
information, please visit: www.mobergpharma.com.