Shilpa Medicare CDMO customer reports positive results from Oxylanthanum Carbonate trial

Karnataka: Shilpa Medicare Limited's 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.

Shilpa Medicare 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 Shilpa Medicare and agreed to place a binding purchase order for supply of OLC tablets by June 30, 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026.

Apart from the supply arrangement, Shilpa Medicare 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.

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Shilpa is an integrated pharmaceutical group, headquartered at Raichur, Karnataka, India, with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.

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