GMAB - AbbVie-partnered blood cancer candidate granted FDA's orphan drug status

Danish biotech, Genmab (NASDAQ:GMAB) announced on Tuesday that the U.S. Food and Drug Administration (FDA) granted the orphan-drug designation to Epcoritamab for the treatment of follicular lymphoma (FL). An IgG1-bispecific antibody, Epcoritamab, is being co-developed by Genmab (GMAB) with U.S. pharma giant, AbbVie (NYSE:ABBV) across several clinical trials as a treatment for FL patients. With its orphan drug designation, the FDA aims to offer financial incentives to drug developers targeting rare diseases and conditions. In addition to tax credits for clinical trial costs and waiver of the user fee for marketing applications, the developers of orphan drugs can claim seven years of marketing exclusivity upon regulatory approval for the treatment. In June 2020, Genmab (GMAB) partnered with AbbVie (ABBV) to jointly develop and commercialize three of its bispecific antibodies, including epcoritamab (DuoBody-CD3xCD20). Per the terms, the company can receive up to ~$3.2B in milestone payments in addition to $750M of upfront payments.

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AbbVie-partnered blood cancer candidate granted FDA’s orphan drug status