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CEO Comments

Diamyd Medical tackles autoimmune type 1 diabetes on three fronts: drug development, stem cell technology and medical devices. During the last quarter, the Company has advanced its positions in all of these areas. In addition to efforts to identify partners for the diabetes vaccine Diamyd®, the following were also noteworthy: a) three new studies with the diabetes vaccine Diamyd® (DiAPREV-IT 2 , Diamyd®/GABA, and EDCR IIa) recruited their first patients; b) Diamyd®+vitamin D+ibuprofen has been well tolerated during the first six months’ treatment as part of the DIABGAD study (immunological results); c) additional shares were acquired in the stem cell company Cellaviva, and; d) more shares were purchased in the medical devices company Companion Medical. In addition, a private placement brought in SEK 15 million to Diamyd Medical.

Diamyd Medical sees many values in using resources to try to extend the life of and improve quality of life for people with type 1 diabetes. Type 1 diabetes is a life-long autoimmune disease, where the body’s own immune system breaks down the cells in the body that produce the vital hormone insulin. Each day, the blood sugar level is checked with frequent measurements and, each day, insulin must be added through injections or a pump to sustain life. Still, these patients risk severe complications from the disease, both in the short term and the long term. Type 1 diabetes is estimated to cost around SEK 100 billion annually in the US alone and, currently, there is no approved treatment in the market that can interrupt or prevent the autoimmune process. All things considered, this makes diabetes one of the greatest opportunities of our age, from both a humanitarian and a business perspective. New products in the diabetes field that improve conditions for patients have enormous financial potential.

The diabetes vaccine Diamyd® is, to the Company’s knowledge, ”first in class” in terms of antigen-based therapeutics being developed for type 1 diabetes. Diamyd® has demonstrated a good safety profile in studies with more than 1,000 participants. In a European phase III study conducted in nine countries with 334 newly diagnosed children, Diamyd® showed an efficacy of 16 percent (p=0.10) with regard to preserving the body’s capacity to produce insulin. Even small improvements in the ability to preserve the body’s ability to produce insulin are considered significant advances in protecting against complications later in life. The Company’s strategy is now, in various smaller studies, to combine the diabetes vaccine Diamyd® with other substances and devices with market approval with the aim of identifying a treatment that synergistically strengthens the efficacy of the diabetes vaccine. Three such studies are currently ongoing in which Diamyd® is being combined with substances such as GABA, etanercept, ibuprofen and vitamin D for children recently diagnosed with type 1 diabetes. In a fourth study with adult patients, Diamyd® is administered directly into lymph nodes, again in combination with treatment with vitamin D. Furthermore, two studies are ongoing with Diamyd® to evaluate whether it can prevent or delay type 1 diabetes in children who are at high risk of developing the disease.

Stem cell technology is advancing at a rapid pace. The Company’s commitment in this area builds on the vision of a combination treatment with tolerance induction for the insulin-producing beta cells, paired with treatment with autologous differentiated stem cells to replace lost beta cell mass that could finally mean a cure for type 1 diabetes. Diamyd Medical now owns 39 percent of the stem cell company Cellaviva and is open to additional collaborative undertakings in this and other areas to win the fight against type 1 diabetes.

Thank you for your interest.

Stockholm, July 1, 2015

Anders Essen-Möller
President and CEO Diamyd Medical AB (publ)

 

Diamyd Medical tackles autoimmune type 1 diabetes on three fronts: drug development, stem cell technology and medical devices.