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Arecor: positive Hikma FDA pre-IND meeting
Arecor: positive Hikma FDA pre-IND meeting.
About this update from Arecor Therapeutics Plc
[{"type":"text","content":"\n\nArecor Therapeutics plc\n(\"Arecor\" or the \"Group\")\n \nARECOR ANNOUNCES POSITIVE PRE-IND MEETING WITH FDA FOR NOVEL READY-TO-USE MEDICINE AT307 LICENSED TO HIKMA\n \n- Positive feedback from pre-IND meeting with FDA confirms Hikma's continued development of AT307 under the 505(b)(2) regulatory pathway \n- Abbreviated 505(b)(2) submission offers an efficient and streamlined development pathway with reduced risk\n \nCambridge, UK, 7th September 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today's therapies to enable healthier lives, is pleased to announce further progress from Hikma in the development of ready-to-use (\"RTU\") injectable medicine AT307, following a recent positive pre-investigational new drug application (pre-IND) meeting between Hikma and the US Food and Drug Administration (FDA).\n \nIn January 2023, Arecor transferred all rights and responsibility for future development and commercialisation of AT307 to Hikma as part of an earlier co-development and license agreement in which Arecor used its proprietary drug formulation technology platform, Arestat™, to develop a novel RTU formulation of an existing therapeutic product.\n \nBased on positive feedback from a pre-IND meeting held with the FDA, Hikma has communicated to Arecor its intention to continue development of AT307 in the US using the FDA's 505(b)(2) regulatory pathway. This pathway provides companies with an abbreviated regulatory review process when evidence of safety and clinical efficacy generated for an originator product is deemed suitable to be relied upon in new marketing applications. \n \nSarah Howell, Chief Executive Officer at Arecor, said: \"We are very pleased with this confirmatory news that Hikma is able to pursue an abbreviated 505(b)(2) approval pathway for AT307, providing an opportunity to progress the development and regulatory review process and bring this medicine to patients more rapidly than through a traditional new drug approval route. This also further validates a fundamental assumption within our business that the abbreviated 505(b)(2) pathway can be utilised across our specialty hospital portfolio where we are developing enhanced, ready-to-use and ready-to-administer formulation...