Patents show potential of innovative Arestat technology and the development of enhanced formulations

Arecor Therapeutics has announced that the European Patent Office has granted two patents –EP3592383B1 and EP3592385B1 – protecting the group’s novel formulations of high-concentration adalimumab until 2038.

Adalimumab, which is sold by AbbVie under the brand name Humira, has been a blockbuster monoclonal antibody product since its launch in 2003, and is indicated for a number of inflammatory diseases such as rheumatoid arthritis and Crohn’s disease.

Global sales of Humira increased by 4% in 2021 with total sales reported as $21bn. Meanwhile, several biosimilar versions of adalimumab have also entered the European market since 2018 and are due to be launched in the US in 2023.

Humira was originally approved as a adalimumab product comprising citrate as a key formulation ingredient. An improved product was subsequently launched by AbbVie with a high adalimumab concentration, in the absence of citrate, resulting in less injection site-related pain and providing greater patient convenience due to the lower injection volumes.

The market for high-concentration adalimumab has been steadily increasing both in the US and in Europe with high-concentration adalimumab now representing about 80% of the total US market. Formulating a high concentration version of adalimumab is technically challenging and further complicated by a complex patent landscape surrounding adalimumab formulations.

Using its proprietary Arestat technology, however, Arecor has developed novel formulations enabling a high-concentration adalimumab product with highly-rated stability. The two granted European patents protect the novel design space enabling these formulations.

Sarah Howell, chief executive officer of Arecor, reflected: “These European patents for high-concentration adalimumab are an important addition to Arecor’s product patent portfolio and provide further proof of the potential of our Arestat technology in the development of enhanced biologic products, including high value biosimilars.

“We have been very successful in applying the technology platform to develop enhanced versions of existing products with key enabling features, within our own In-house portfolio of proprietary products and with leading healthcare companies through our technology partnerships,” she added.