For supply of Oxylanthanum Carbonate Tablets post NDA approval in mid-2025
Shilpa Medicare's (SML) CDMO customer, Unicycive Therapeutics, Inc. has reported positive results from pivotal clinical trial of Oxylanthanum Carbonate (OLC), a NCE molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients which has several benefits for various patients in this chronic disease. Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025.
SML has partnered with Unicycive to provide end-to-end CDMO services right from development & supply of APIs to finished dosage form. Based on the outcome of the pivotal clinical studies, Unicycive has entered into long term manufacturing and supply agreement with SML and agreed to place a binding purchase order for supply of OLC tablets by 30 June 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between 31 December 2025, and 30 June 2026.
Apart from the supply arrangement, SML is expected to receive US$ 10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpa's site.
For SML, this is a significant milestone which establishes the credentials of the Shilpa group as a one-stop reliable partner for all the CDMO requirements of global pharma companies providing development, manufacturing, supply, and other chemistry, and controls (CMC)-related services.
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