A new joint agreement between Hikma Pharmaceuticals and Arecor is set to co-develop new, ready-to-use injectable medicine in the US through Hikma’s affiliate, Hikma Pharmaceuticals USA.
The companies have revealed that the product, which will be announced prior to launch, is being developed using Arecor’s proprietary drug formulation technology platform Arestat; currenty used to enhance the properties of approved therapeutic proteins and peptides to deliver new reformulations of existing, complex products.
Hikma has said that it will seek approval for the product under the US Food and Drug Administration’s 505(b)(2) regulatory pathway, with filing expected in 2021.
Arecor says that under the terms of the royalty-based agreement, it will receive an upfront payment and further payments on the achievement of development, regulatory and commercial milestones. Hikma will then be responsible for the manufacture and commercialisation of the product.
The partnership is “another important step forward for Hikma in developing and commercialising complex medicines and delivery systems that benefit patients and position our business for continued long-term growth,” said Riad Mishlawi, president, Hikma Injectables.
He continued to say that the company is “confident that Arecor’s state-of-the-art development platform, combined with Hikma’s strong manufacturing capabilities and excellent commercial team, with its broad relationships across US hospital systems, will bring an important new treatment option to patients and healthcare providers.”