The product is being developed using Arecor’s proprietary drug formulation technology platform Arestat™, which is applied to existing therapeutic proteins and peptides to enhance their properties.  Hikma will seek approval for the product under the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway, with filing expected in 2023.

“We are pleased to expand on our partnership with Arecor and add a new ready-to-administer product to our growing pipeline of differentiated injectable medicines,” said Riad Mishlawi, President, Hikma Injectables. “Arecor’s state-of-the-art technology platform is a perfect complement to Hikma’s strong manufacturing capabilities and excellent commercial team, with its broad relationships across US hospital systems. We look forward to continuing to work together to bring an important new treatment option to patients and healthcare providers in the US.”

Sarah Howell, Chief Executive Officer of Arecor, added: “Our track record in developing ready-to-administer medicines is further strengthened by this second agreement with Hikma.  This growing partnership supports both companies’ product development strategies to bring enhanced products to market that simplify care and improve patient outcomes.  Hikma’s manufacturing expertise and strong presence in the US hospital market coupled with Arecor’s world leading formulation technology platform will enable us to jointly bring products to market that are dedicated to improving patient care and the advancement of medication delivery. We look forward to developing this relationship with Hikma further and progressing these products to market as part of this collaboration.”

Under the terms of the royalty-based agreement, Arecor will receive an upfront payment and further payments on the achievement of development, regulatory and commercial milestones.  Hikma will be responsible for the manufacture and commercialisation of the product.