Arecor Therapeutics plc announced a key advancement in the development of AT307, a ready-to-use (RTU) injectable medicine, with the transfer of development activities and achievement of the next license milestone under the co-development and license agreement with Hikma. Following the agreement announced in October 2020, Arecor has successfully completed the application of its proprietary drug formulation technology platform, Arestat™, to develop a novel RTU formulation of an existing therapeutic product. Hikma has triggered the transfer of AT307 and will now take full responsibility for further development of the product and seeking approval under the U.S. Food and Drug Administration's 505(b)(2) regulatory pathway.

Hikma will generate all data required for regulatory submission and approval in its territories, including the United States. These studies will be fully funded by Hikma. Under the terms of the royalty-based agreement, a milestone payment to Arecor has also been triggered.

This follows the upfront payment to Arecor in October 2020 following signature of the co-development and license agreement between the parties. In addition, following a product portfolio review, Hikma has made the decision to deprioritise AT282, the second RTU medicine under co-development with Arecor as part of the co-development and licensing agreement. All rights to this product will be returned to Arecor and on the back of a strong data package being available for this product Arecor will assess options for seeking a new partner for this important product.