Arecor Therapeutics PLC (AIM:AREC) said it will transfer the development of AT307, a ready-to-use (RTU) injectable medicine, to Hikma Pharmaceuticals PLC (LSE:HIK, OTC:HKMPF) as part of a co-development deal inked in 2020.
Arecor said it has now successfully completed the application of its proprietary drug formulation technology platform, Arestat, to develop the new RTU formulation of an existing but unnamed therapeutic product.
As a result, the FTSE 250 drugs group has triggered the transfer of AT307 and will now take full responsibility for the further development of the product.
In doing so, it will seek regulatory approval for it under the US 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 US.
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, investors were told.
Arecor chief executive Sarah Howell described the transfer as a “significant milestone” for the company.
She added: “The transfer of this differentiated RTU product to Hikma demonstrates their commitment to its further development and future commercialisation to bring this important medicine to patients. It also meets a financial licence milestone under our royalty-bearing agreement.”
Following a product portfolio review, Hikma has made the decision to “deprioritise” AT282, the second RTU medicine under co-development.