Diamyd Medical’s patent protection extended to 2032 in pivotal decision

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) informs that The
Regents of the University of California on behalf of its Los Angeles Campus
(UCLA) has been granted another key US patent for its GAD65 technology on which
the Diamyd® diabetes vaccine is based. The term of the new patent runs into
2032, which is approximately 10 years longer than current US patents. Diamyd
Medical is the exclusive licensee to the new patent.
The Diamyd® diabetes vaccine is an Antigen Based Therapy (ABT) under development
for the treatment and prevention of autoimmune diabetes. The active substance is
glutamic acid decarboxylase isoform 65 kDa (GAD65). Diamyd® has been used in
trials totaling more than one thousand patients with an excellent safety
profile. Diamyd® has shown an overall 16% efficacy (p=0.10) versus placebo in
preserving endogenous insulin secretion in a Phase III trial with children and
adolescents recently diagnosed with type 1 diabetes. The diabetes vaccine is
currently being further developed as an ABT in six approved clinical trials in
combination with other therapeutic agents. Diamyd® is easy to administer in any
clinical setting.

The new patent was issued after a pivotal decision by the United States Patent
and Trademark Office on January 6, 2015. The patent application was filed before
June 8, 1995, when the patent rules included that the patent term is 17 years
from issuance. Expiration date will therefore be January 6, 2032. The new patent
is of central importance to Diamyd Medical’s GAD65 patent estate as it protects
the use of GAD65 for treatment of autoimmune disease including diabetes.

“Long development times often result in short remaining patent protection once a
product reaches the market, and this is an important parameter when
pharmaceutical companies look for products that may pay off long term,” says
Anders Essen-Möller, Chairman of the Board of Diamyd Medical. “In our case, with
more than 15 years of development, including rather large studies, Diamyd® has
shown a certain effect and a good safety profile. That this development project
now has been granted renewed patent protection, as if Diamyd® was a product for
which development was just about to begin, is unique and will result in an
increased interest.”

Over the last years, it has become apparent that the autoimmune process that
causes type 1 diabetes must be attacked from several angles simultaneously
through the combination of at least two drugs in which an Antigen Based Therapy
(ABT) is considered a critical component. Diamyd® is the furthest developed ABT
for type 1 diabetes worldwide.

In type 1 diabetes the immune system attacks the patients’ own insulin-producing
beta cells. By analyzing markers in the blood, it is possible to identify
persons in whom this autoimmune process is ongoing, although clinical symptoms
of diabetes have not yet been established. When clinical symptoms present,
patients must be treated daily, for the rest of their lives, with insulin to
sustain life. Finding a cure is of major importance for the world’s healthcare
systems and for the well-being of patients. The annual market for an easy-to-use
therapeutic is estimated at several billion dollars.

About the Diamyd® diabetes vaccine
Diamyd® is being developed with the objective of preventing, delaying or
stopping the autoimmune attack on beta cells in type 1 diabetes and other forms
of autoimmune diabetes and thus preserve the body’s own ability to produce
insulin. Ongoing development work is aimed at enhancing the efficacy of the
treatment by combining Diamyd® with other agents and to treat earlier in the
disease process. New approaches are being evaluated in several clinical studies
together with different teams of researchers. Today, two researcher-initiated
clinical studies with Diamyd® are ongoing and an additional four are being
launched.

  · DIABGAD-1. A placebo-controlled study, where Diamyd® is being tested in
combination with ibuprofen and vitamin D. The study comprises a total of 64
patients between the ages of 10 and 18 recently diagnosed with type 1 diabetes,
and will continue for a total of 30 months. The aim of the combination treatment
is to preserve the body’s residual capacity to produce insulin. All of the
participants have been enrolled in the study and the initial six-month results,
focusing on immunological markers, are expected to be presented in the beginning
of 2015. The study runs at nine clinics in Sweden and is led by Professor Johnny
Ludvigsson at Linköping University.

  · DIAPREV-IT. A placebo-controlled study, where Diamyd® is being tested in
children with early stages of type 1 diabetes, meaning that they have been found
to have an ongoing autoimmune process but do not yet have any clinical symptoms
of diabetes. A total of 50 participants from the age of four have been enrolled
in the study, which will last for five years. The aim of the study is to
evaluate whether Diamyd® can delay or prevent the participants from presenting
with type 1 diabetes. The study is taking place in Sweden led by Dr. Helena
Elding Larsson at Lund University. Results are expected at the end of 2016.

  · DIAMYD®/GABA. A placebo-controlled study, where Diamyd® is being tested in
combination with GABA. The study will comprise 75 patients between the ages of 4
and 18 recently diagnosed with type 1 diabetes, and will continue for a total of
12 months. The aim of the combination treatment is to preserve the body’s
residual capacity to produce insulin. The study is taking place in the US led by
Professor Kenneth McCormick at the University of Alabama at Birmingham and is in
the start-up phase.

  · DIAPREV-IT 2. A placebo-controlled study, where Diamyd® is being tested in
combination with vitamin D in children with early stages type 1 diabetes,
meaning that they have been found to have an ongoing autoimmune process but do
not yet have any clinical symptoms of diabetes. A total of 80 participants
between the ages of 4 and 18 will be enrolled in the study, which will last for
five years. The aim of the study is to evaluate whether Diamyd® can delay or
prevent the participants from presenting with type 1 diabetes. The study is
taking place in Sweden led by Dr. Helena Elding Larsson and is in the start-up
phase.

  · DIAGNODE. An open label study, where Diamyd® is administered directly into
lymph nodes in combination with treatment with vitamin D. The study will
comprise five patients between the ages of 18 and 30 who have been newly
diagnosed with type 1 diabetes, and will continue for a total of 30 months. The
aim of the study is to evaluate the safety of the combination treatment and the
effect on the immune system and the patients’ insulin producing capacity. The
study is taking place in Sweden led by Professor Johnny Ludvigsson and is in the
start-up phase.

  · EDCR IIa. An open label study, where Diamyd® is combined with etanercept and
vitamin D. The study will comprise 20 patients between the ages of 8 and 18 who
have been newly diagnosed with type 1 diabetes, and will continue for a total of
30 months. The aim of the study is to evaluate the safety of the combination
treatment and the effect on the immune system and the patients’ insulin
producing capacity. The study is taking place in Sweden led by Professor Johnny
Ludvigsson and is in the start-up phase.

About Diamyd Medical
Diamyd Medical is dedicated to fighting type 1 diabetes and to working toward a
cure for the disease. Its projects include development of combination regimens
with the GAD-based Diamyd® diabetes vaccine for arresting the successive
destruction of insulin-producing beta cells. Diamyd Medical has an exclusive
license to patent rights held by the UCLA related to the GAD molecule. The
company has also an exclusive license from UCLA for GABA for the treatment of
diabetes and other inflammation-related conditions.

Diamyd Medical is a shareholder in the stem cell company Cellaviva AB, which is
establishing a Swedish commercial bank for private family saving of stem cells
in umbilical cord blood and other sources of stem cells. Stem cells are expected
to be used in Personalized Regenerative Medicine (PRM), for example, to restore
beta cell mass in diabetes patients where autoimmunity has been arrested. Diamyd
Medical also has an ownership stake in the US medical technology company
Companion Medical, Inc., and a minor shareholding and other financial interests
in the US gene therapy company Periphagen Holdings, Inc.

Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, Chairman, Phone: +46 70 55 10 679. E-mail: anders.essen
-moller@diamyd.com
Diamyd Medical AB (publ).
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68.
E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.