The Diamyd story

From research to results

Diamyd Medical is a true success story. In 1994 the company licenses the rights to GAD - the active substance in the Diamyd® diabetes vaccine. During the late 1990s, a large number of preclinical studies are conducted to ensure the substance's safety and efficacy. Studies in models of autoimmune diabetes indicate that the substance is safe and can stop or prevent the immune system from attacking the insulin-producing cells.

At the turn of the millennium, it is time to take the major step of testing the vaccine on human subjects. Within a few years, a Phase I safety study is conducted on healthy volunteers, and a Phase II study is conducted on patients with LADA (Latent Autoimmune Diabetes in Adults). This is done both to see whether the vaccine is safe and has the desired efficacy in humans, and to determine the optimal dosage. Both studies show positive and desirable results.

In the following years Diamyd Medical conducts two additional Phase II studies, one on adult LADA patients and the other on children and adolescents with type 1 diabetes. Diamyd Medical successfully completes the Phase II study in type 1 diabetes, and can demonstrate that the vaccine has slowed the autoimmune attack in the children and adolescents who were part of the study. Based on these results, in 2008, the company receives approval from the US FDA (Food and Drug Administration) and several European regulatory agencies to begin the decisive Phase III studies in type 1 diabetes. In 2009 the studies are ongoing in nine European countries and in the US.

In 2005 Diamyd acquires the operations in the American company Nurel Therapeutics Inc., whose gene therapy research becomes the foundation for Diamyd Inc., a subsidiary of Diamyd Medical. In addition to research on the patented NTDDS platform, Diamyd Inc. is also managing the production of GAD, the active substance in the Diamyd® vaccine.

At the end of 2007, the company founder and CEO Anders Essen-Möller, who has been successfully running the company with a clear vision since its inception, takes over as the company Chairman, and Diamyd Medical comes under new operational management. Elisabeth Lindner, with longstanding experience in the pharmaceutical industry, takes over as President and CEO. In addition the organization is strengthened in the business development and information areas, while the clinical trials department is expanded to manage the extensive Phase III programs under way in both Europe and the US.

A directed new share issue in 2008 strengthens the company's financial position and enables Diamyd Medical to continue the development of the Diamyd® diabetes vaccine under its own direction. The two products; Diamyd® for type 1 diabetes and Diamyd® for LADA, are developed separately for the two different types of autoimmune diabetes, which form the foundation for future agreements concerning partnerships, collaboration or licensing of the products.

The development from preclinical studies to clinical Phase III trials has been performed at a very low cost by industry standards. Since the beginning of 1994 Diamyd Medical has raised SEK 435 million through several issues. By way of comparison it generally costs SEK 8 billion to develop a biotechnology product from the research stage to a market-ready pharmaceutical product.

With the Diamyd® vaccine in Phase III and several development projects with the NTDDS technology related to diabetes complications, Diamyd Medical has grown into a genuine diabetes company. The company's opportunities and potential have grown, and the business can expand in several different areas through new research as well as through acquisitions and partnership agreements.

By concentrating on the important Phase III studies while at the same time building a professional company, Diamyd Medical is caring for both its product development and its future business.

Diamyd has taken the final preparatory step from a research company to a diabetes company.