Hikma, Arecor partner on Arestat formulation technology

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Hikma taps Arestat, a formulation technology for protein- and peptide-based drugs, to develop an injectable medicine, ahead of filing for US FDA approval.

Under the exclusive agreement, Hikma, a generic drugs developer, will collaborate with Arecor for the development of an injectable medicine with an undisclosed indication by using the latter’s formulation technology platform, Arestat.

Hikma holds a portfolio of generic drugs in therapeutic areas including anti-infectives, cardiovascular, central nervous system, diabetes, oncology, pain management and respiratory.

The co-development project is expected to result in a ready-to-use, injectable medicine “designed to provide a safer, more immediate treatment option for patients,” the partners announced.

A spokesperson for Hikma could not provide us with the indication of the potential candidate, which will be announced prior to launch. Hikma plans to seek approval for the product from the US Food and Drug Administration (FDA) in 2021.

The royalty-based agreement will bring Arecor an undisclosed upfront payment, as well as further payments on the achievement of development, regulatory and commercial milestones.

Hikma will be responsible for the manufacture and commercialization of the product, with Arecor holding the right to develop and commercialize the product in certain markets outside the US.

Boosting proteins’ and peptides’ properties

According to Arecor, the Arestat technology was designed based on insights about interactions between formulation excipients and proteins, and it aims to enhance the properties of approved therapeutic proteins and peptides, in order to deliver new reformulations of existing products.

More specifically, the platform allows control of protein behavior under various stress conditions, both in vitro and in vivo, Arecor stated.

Therefore, applying Arestat to a protein or peptide has the potential to improve stability of the product in aqueous solutions, as well as to achieve low viscosity and desirable pharmacokinetic and pharmacodynamic profiles.