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Sparks commentary - OSE Immunotherapeutics

Healthcare

Sparks - OSE Immunotherapeutics

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OSE-Immunotherapeutics_resized
OSE Immunotherapeutics (PAR: OSE): ODD announced for pegrizeprument (VEL-101)
Published by Arron Aatkar, PhD

OSE Immunotherapeutics’ partner, Veloxis Pharmaceuticals, has announced that the US FDA has granted Orphan Drug designation (ODD) for pegrizeprument (VEL-101), for the prophylaxis of heart allograft rejection in patients receiving a heart transplant. Benefits of ODD include: potential seven years of market exclusivity; tax credits of up to 25% for clinical testing costs; waiver of Prescription Drug User Fee Act application fees. This regulatory designation is incremental to ODD granted in January 2026 for the asset for the prevention of organ rejection in patients receiving a liver transplant.

Pegrizeprument (also referred to as VEL-101) was licensed from OSE to Veloxis in 2021 for all transplant-related indications. Veloxis is responsible for all development, manufacturing and commercial rights. Under the terms of the partnership, OSE received an upfront payment of €7m, and is eligible for up to €308m in milestone payments, alongside tiered royalties on any future sales.

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