Diamyd Medical AB
Budget
€10 — €0
EP Access
0
accredited persons
Staff
1
0.1 FTE
EU Grants
None
Mission & Goals
Diamyd Medical develops precision medicine therapies for the prevention and treatment of autoimmune diabetes. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. A facility for manufacturing of biological products is being set up in Umeå, Sweden. The primary purpose is the manufacture of recombinant GAD65, the active ingredient in the investigational medicine retogatein. The long-term goal for the facility is to produce enough GAD65 to meet the market demand for retogatein as well as to be a key player in the production of biological substances for other drug projects.
EU Legislative Interests
We are primarily interested in discussing with individuals from HERA on how we can assist in preparedness efforts related to the manufacturing of biologics, such as vaccines. Our biologics manufacturing facility is currently under construction, and our main focus is the manufacturing of our own active substance. However, we will have some excess capacity and are therefore open to acting as a contingency unit for the production of biologics. In the Legislative Observatory "2022/2076 (INI) COVID-19 pandemic: lessons learned & recommendations for the future" the need for a global supply chain for vaccines is mentioned. We are interested in discussing with HERA on how Diamyd Medicals manufacturing facility for biologics could aid in such a supply chain. We believe that the possibility to offer a contingency unit for production of biologics, such as vaccines, in the North of Sweden would be of most importance for Europe, specifically the Northern parts of Europe, if a great need for certain vaccines occur and there is a problem with logistics due to war etc.
Communication Activities
We are in contact with a representative at HERA and our aim is to discuss this matter with the representative during a meeting.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
INNODIA: https://www.innodia.eu/ Critical Path Institute: https://c-path.org/
Organisation Members
Breakthrough T1D, https://www.breakthrought1d.org/clinical-trials/
Additional Information
The work done so far regarding our efforts to aid in the possibility for a global supply chain for biologics, such as vaccines, has just begun and hence the low cost.
Connected Legislation
Commissioner Meetings
No recorded meetings with EU commissioners.