STOCKHOLM, Jan. 13, 2025 /PRNewswire/ -- Diamyd Medical has released an updated analysis of the commercial potential for its lead product candidate, the precision immunotherapy Diamyd® (rhGAD65/alum) in the U.S. market. The addressable patient population for its launch indication is estimated at over 60,000 individual patients, with annual peak sales projections well exceeding block buster potential^*. Diamyd® has Orphan Drug Designation status in the U.S. for its launch indication, and follow-on indications represent a market potential that is expected to equal or even exceed its primary indication.

*Defined as annual sales of at least $1 billion.

Addressable market at launch

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

Newly diagnosed Stage 3 Type 1 Diabetes patients
In 2024, approximately 47,000 patients in the U.S. are expected to be newly diagnosed with Stage 3 T1D. Of these, an estimated 19,000 individuals (40 %) are HLA DR3-DQ2 positive and eligible for Diamyd® treatment.
Recently diagnosed Type 1 Diabetes patients with retained beta cell function
An additional opportunity exists among recently diagnosed Type 1 Diabetes patients who retain beta cell function for up to two years following diagnosis. This population is estimated at 62,000 individuals in 2024, of whom approximately 25,000 are HLA positive. While this group is expected to shrink as Diamyd® is adopted in newly diagnosed patients, it will remain a significant contributor to the addressable market.

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

Pricing: Diamyd®'s base case gross price is projected at $157,000 per course, supported by market research with payers and providers. Limited standard Gross-to-Net discounts, which account for rebates, discounts, and other payer incentives, are expected. The final gross price will be dependent on the Phase 3 data, with potential for a gross price up to $200,000 per course. Price increases of 2% per year are expected.
Access and coverage: Diamyd® is expected to achieve over 80 % market access. This is based on broad insurance coverage of Type 1 Diabetes and expected high prior authorization approvals, reflecting its strong clinical differentiation as a disease-modifying therapy and its status having an FDA granted orphan drug designation.
Market penetration: Qualitative market research supports an estimate of at least 30 % of Type 1 Diabetes patients being a reasonable penetration assumption for base case projections.

Clear growth drivers and upsides

Latent Autoimmune Diabetes in Adults (LADA): LADA, a condition affecting approximately 7 % of the 1.2 million adults diagnosed annually with Type 2 Diabetes in the U.S., represents an addressable market that is equal or larger than the Stage 3 Type 1 Diabetes market.
Earlier Type 1 Diabetes Stages: Expanding Diamyd®'s indication to include Stage 1 and Stage 2 Type 1 Diabetes patients offers opportunities for early intervention. The size of the addressable market is heavily dependent on the availability and coverage of screening programs.
Booster courses: Booster treatments for patients previously treated with Diamyd® present an additional market segment.
Ex-U.S. market: Global opportunities could account for an additional 40 % of Diamyd®'s total sales potential, based on analogs from the Type 2 Diabetes market.

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: ulf.hannelius@diamyd.com

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