Shilpa Medicare's CDMO Customer Reports Positive Clinical Trial Results, Places Binding Purchase Order

Shilpa Medicare Limited's CDMO customer, Unicycive Therapeutics, Inc., has reported positive results from a pivotal clinical trial for a new chemical entity (NCE) molecule, Oxylanthanum Carbonate (OLC). This molecule has potential treatment for hyperphosphatemia in chronic kidney disease patients. Unicycive is expected to file the New Drug Application for OLC by mid-2024 and potentially receive approval by mid-2025. Shilpa Medicare has partnered with Unicycive to provide end-to-end CDMO services for this project. Based on the outcome of the pivotal clinical studies, Unicycive has entered into a long-term manufacturing and supply agreement with Shilpa Medicare, agreeing to place a binding purchase order for supply of OLC tablets by June 30, 2025. Shilpa Medicare is expected to receive USD 10 million as milestone income, and Unicycive will fund the establishment of a new manufacturing block at Shilpa’s site in anticipation of increased product demand.