Diamyd Medical updates U.S. market potential for Diamyd®

Addressable market at launch Addressable market at launch The addressable market for Diamyd® at launch consists of two distinct populations, both comprising patients aged 12 years and older. These combined populations will annually total over 60,000 patients in the U.S. the coming years when accounting for incidence and population growth. Market assumptions Clear growth drivers and upsides The market research underscores the importance of enhancing Health Care Practitioner...

Addressable market at launch

The addressable market for Diamyd® at launch consists of two distinct populations, both comprising patients aged 12 years and older.

These combined populations will annually total over 60,000 patients in the U.S. the coming years when accounting for incidence and population growth.

Market assumptions

Clear growth drivers and upsides

The market research underscores the importance of enhancing Health Care Practitioner (HCP) education and engagement, as many physicians lack familiarity with the genetic and clinical profiling necessary to identify eligible patients, such as HLA testing and C-peptide measurements. Given that Diamyd® could be the first or among the first therapies approved to preserve insulin-producing capacity in Type 1 Diabetes, measured by C-peptide, it is essential to educate HCPs, patient advocacy groups, and payers about the critical value of maintaining endogenous insulin production and its long-term benefits for patient outcomes.

The market research was conducted in collaboration with the Kondrad Consulting Group, LLC, Sarasota, FL USA, www.kondradconsulting.com.

About Diamyd Medical

Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.

Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: [email protected]

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https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-updates-u-s--market-potential-for-diamyd-,c4090306

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