Focus and fresh efforts
During the past fiscal year, a new exciting chapter started for Diamyd Medical and our shareholders. We shall now go on to exploit the assets which have been built up in the Company over many years and advance through smart drug development and by seizing new business opportunities that arise in the field of diabetes.
It’s just over half a year ago that the subsidiary Diamyd Therapeutics AB was spun off from its longstanding listed parent company, now Mertiva AB, and distributed to the shareholders together with the diabetes operations and SEK 50 million. At the same time Diamyd Therapeutics assumed the name Diamyd Medical and was listed on NASDAQ OMX First North.
Dedication and focus
Diamyd Medical is today a dedicated diabetes company and we continue to work according to the vision that there is a cure for type 1 diabetes. Despite intense research in the field there is still no treatment that effectively intervenes in the autoimmune process that causes type 1 diabetes and LADA, the autoimmune forms of diabetes. Our work is therefore as important as ever.
Our primary development project, the diabetes vaccine Diamyd® and the active substance GAD have, according to many experts, the potential to become a key piece of the puzzle of a future solution to prevent, treat and cure type 1 diabetes and other forms of autoimmune diabetes. Our goal is to commercialize the diabetes vaccine for it to become part of the standard treatment of type 1 diabetes and LADA.
The Company’s strategy comprises three areas in which we work actively; continued development of the diabetes vaccine Diamyd® by enhancing the effect through various approaches, building successful alliances with industrial partners to ensure financing of the development towards market approval, and to expand the diabetes operations through acquisitions and inlicensing.
New approaches with the diabetes vaccine
The predominant hypothesis among diabetes researchers today is that the key to successfully treating type 1 diabetes is to simultaneously attack the disease from several angles by combining different therapeutics or by providing treatment earlier in the disease process, before onset of the disease. Many, perhaps most, leading scientists also argue that future treatment of type 1 diabetes must involve a so-called auto-antigen, like GAD, to in the long term stop the immune system’s attack on the cells in the body that produce insulin, the so-called beta cells.
The main approaches of our ongoing development work is therefore to test Diamyd® in combination with other drugs to enhance the beta cell preserving effect the diabetes vaccine has demonstrated in previous studies, as well as providing Diamyd® as a preventative treatment and thereby try to stop the onset of type 1 diabetes and other autoimmune diabetes altogether.
Collaboration creates opportunities
Two parallel Phase II studies are ongoing, a prevention study which started already in 2009, and a combination study which was launched in early 2013. Both studies are researcher-initiated which means that they are managed and funded by external researchers while Diamyd Medical provides the study drug and is entitled to utilize the study results. We expect to have results from both of the clinical studies in 2015.
By working with externally funded research groups we can test more treatment alternatives and a larger number of hypotheses than if we were to conduct and finance all studies with the diabetes vaccine ourselves. We are continuously having discussions with various academic research groups to start additional pilot studies. Our aim is to within three years have three additional clinical studies with the diabetes vaccine underway besides the two that are ongoing today. That the diabetes vaccine has a favorable safety profile is a great advantage for us in the efforts to bring about new studies.
Established manufacturing process
To be able to establish additional clinical pilot studies it is crucial to have enough fresh diabetes vaccine available. An important part of our work during the past year has therefore been to produce a new batch of the diabetes vaccine, which was done this September. We expect that the new vials with the diabetes vaccine Diamyd® will be released for use in clinical trials in late autumn 2013.
To develop an efficient manufacturing process that meets all regulatory requirements is an extensive and costly effort that takes many years and is conducted in parallel with the clinical development. Diamyd Medical has a well-established manufacturing process in place for Diamyd®, which represents a great value. The manufacturing process has been developed and refined over many years, and major development work was carried out together with Johnson & Johnson in 2010/2011 to make the production apparatus ready for commercial launch.
Opportunistic business development
In order to expand our business, we are working hard to identify and evaluate new opportunities for collaborations and deals in the field of diabetes. We leverage our expertise and worldwide network within diabetes and immunology to find attractive new business opportunities and to be ready to act when synergies and opportunities arise. We are opportunistic in our business development efforts and are looking at both new development projects and marketed diabetes products, as well as smaller companies with an interesting product or project portfolio.
As a first step in expanding our business, we concluded an exclusive license with UCLA during the spring of 2013 regarding a patent application for the specific combination therapy of GAD plus the endogenous substance GABA, which has shown promising results in preclinical studies. The license also includes the rights for the therapeutic use of GABA in connection with diabetes and other inflammatory disorders.
Diamyd Medical is a strong brand name in the diabetes world. We have a strong track record of pursuing cost-effective drug development and concluding commercial agreements with favorable terms. With the ongoing business development activities and increased efforts in the development of the diabetes vaccine, we are ready to grow and find markets for our development projects and products. I hope you will accompany us when we now have embarked on a new chapter in the history of Diamyd Medical.
Stockholm, October 31, 2013
CEO Diamyd Medical AB (publ)