- The patent extends Larimar’s intellectual property protection for CTI-1601 until at least July 2040
BALA CYNWYD, Pa., Oct. 20, 2022 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) LMR, a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, announced today that it has been granted U.S. Patent No. 11,459,363. The patent, entitled “Materials and Methods for Treating Friedreich’s Ataxia,” provides material protection for CTI-1601 through at least July 2040. Larimar has an exclusive license to the patent under a prior agreement with Indiana University.
“This new patent represents a fundamental part of our intellectual property portfolio as it extends our patent protection for CTI-1601 by more than fourteen years,” said Carole Ben-Maimon, MD, Larimar’s President and Chief Executive Officer. “It also highlights the novelty of CTI-1601, which was elegantly engineered to address the root cause of Friedreich’s ataxia by delivering mature frataxin to the mitochondria. We look forward to further development of CTI-1601 and remain on track to commence a Phase 2 trial later this year.”
In addition to and independent of patent protection, CTI-1601 should be eligible for seven years of orphan drug exclusivity and 12 years of reference product data exclusivity in the United States upon US Food and Drug Administration (FDA) approval and 10 years of orphan drug and drug status Market exclusivity in the European Union after marketing approval by the European Medicines Agency.
About CTI-1601
CTI-1601 is a recombinant fusion protein designed to deliver human frataxin into the mitochondria of patients with Friedreich’s ataxia who are unable to produce enough of this essential protein. CTI-1601 has been approved by the United States Food and Drug Administration (FDA) as a Rare Pediatric Disease, Fast Track and Orphan Drug, by the European Commission as an Orphan Drug, and by the European Medicines…
Read full story here https://www.benzinga.com/pressreleases/22/10/g29339264/larimar-therapeutics-announces-issuance-of-u-s-patent-providing-composition-of-matter-protection-f