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2016-10-19

Moberg Pharma: European Patent granted for BUPI

STOCKHOLM, October 19, 2016 -- Moberg Pharma AB (OMX: MOB) announced
that the European Patent Office (EPO) has issued Patent No. 2701681
which protects BUPI, currently in development for oral mucositis.

The new patent covers pharmaceutical compositions comprising a local
anesthetic, such as bupivacaine, for local administration to the
mouth or throat. The patent also protects lozenge formulations of a
local anesthetic for use in the treatment of oral mucositis in cancer
patients. This patent is expected to provide coverage through at
least 2031. Additional patent applications are pending in the United
States and Canada.

"This patent provides Moberg with important intellectual property
protection for BUPI, our lozenge formulation of bupivacaine for pain
management of oral mucositis in cancer patients," commented Peter
Wolpert, Moberg Pharma's CEO. "This issuance of this patent is an
important milestone for the BUPI development program and part of our
overall strategy to establish a broad portfolio of patent claims to
protect our proprietary products."

Earlier in 2016, the Company announced positive Phase 2 results with
BUPI in treating pain associated with oral mucositis in patients with
head and neck cancer undergoing radiotherapy. The primary endpoint
was met with high statistical significance. The Company is moving
forward with one Phase 3 trial to be conducted in Europe, co-funded
by a grant from Eurostars. A second Phase 3 study will be conducted
in India, financed by Moberg's partner Cadila Pharmaceuticals. The
agreement with Cadila in combination with the Eurostars grant means
that Moberg's investment for the BUPI phase 3 program is
substantially reduced.

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 October 19, 2016.

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 patent protected 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. In Phase 2, the group
treated with BUPI had 31% reduction in pain in mouth or pharynx
compared to standard pain treatment (p=0.0032). The difference
measured in the mouth only was even more pronounced - BUPI provided
50% additional pain reduction compared to standard treatment
(p=0.0002).

For additional information, please 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 as well as in several markets in EU and 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 (MOB.ST).

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http://news.cision.com/moberg-pharma/r/european-patent-granted-for-bupi,...
http://mb.cision.com/Main/1662/2103792/576738.pdf

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