Calliditas Chooses PANTHERx® Rare for TARPEYO® Distribution

PANTHERx® Rare, based in Pittsburgh, announced its selection by Calliditas Therapeutics for the exclusive distribution of TARPEYO® (budesonide) delayed-release capsules. This marks a significant step in improving the treatment of primary immunoglobulin A nephropathy (IgAN), a rare autoimmune condition causing progressive kidney damage.

TARPEYO® is the first FDA-approved medication aimed at reducing kidney function loss in adults with IgAN. This disease, also known as Berger's Disease, is characterized by the immune system attacking the kidneys. The disease manifests when galactose-deficient IgA1 is recognized by autoantibodies, forming immune complexes that deposit in the kidney's glomerular mesangium. This leads to progressive damage and can result in end-stage renal disease. IgAN typically develops from the late teens to the late 30s, and a recent registry analysis indicates that most patients progress to kidney failure within 10 to 15 years of diagnosis, with a median time to failure of approximately 10 years.

TARPEYO® uses a 4mg delayed-release formulation of budesonide, designed to stay intact until it reaches the ileum. The capsules contain coated beads of budesonide targeting mucosal B-cells in the ileum, including Peyer's patches. These patches are responsible for producing galactose-deficient IgA1 antibodies that cause IgA nephropathy. By targeting these specific cells, TARPEYO® aims to reduce the harmful immune response that leads to kidney damage.

Rob Snyder, Executive Chair of PANTHERx® Rare Pharmacy, expressed enthusiasm about the partnership with Calliditas Therapeutics. He noted that patient wellbeing is central to Calliditas's mission, and their commitment to improving the lives of IgAN patients aligns with PANTHERx®'s goals. Snyder emphasized the importance of streamlining the process of delivering medicine from producers to patients, thereby enhancing health outcomes for those living with rare diseases.

PANTHERx Rare is a specialized pharmacy focused on rare and orphan diseases, distributing various orphan products and providing crucial access and support services. The pharmacy is dedicated to transforming lives by offering medical breakthroughs, clinical excellence, and access solutions to individuals with rare and severe conditions. Despite each rare disease affecting only a small number of people, collectively, rare diseases impact an estimated 25 to 30 million Americans. To date, over 7,000 rare diseases have been identified, and more than 90% remain without FDA-approved treatments. However, changes in federal policy and scientific advancements have led to a surge in FDA orphan drug approvals, providing significant hope to the rare disease community.

PANTHERx holds dual accreditation, including distinctions from the Accreditation Commission for Health Care (ACHC) in Orphan Drugs and Utilization Review Accreditation Commission (URAC) Rare Disease Center of Excellence. The pharmacy has received the prestigious MMIT Patient Choice Award six times, including the 2023 honor, underscoring its commitment to patient satisfaction. Headquartered in Pittsburgh, Pennsylvania, PANTHERx is licensed to operate in all 50 states and US territories.