Hikma Pharmaceuticals PLC (LSE:HIK, OTC:HKMPF), the FTSE 100 drug developer, is progressing with the development of AT307, an injectable technology initially crafted by Arecor Therapeutics PLC (AIM:AREC).
In January 2023, Arecor handed over all rights and responsibilities concerning AT307 to Hikma. This transition was part of an earlier collaboration in which Arecor used its specialised drug-making platform, Arestat, to create a ready-to-use version of a pre-existing medicine.
After a constructive meeting with the US Food and Drug Administration (FDA), Hikma has confirmed its commitment to advancing AT307's development in the US.
The company will employ a specific FDA review process designed for medicines that have foundations in already established treatments. This approach aims to expedite the review, ensuring that proven and safe treatments reach patients more swiftly.
"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," said Arecor chief executive, Sarah Howell.
"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 formulations of existing therapeutic products."