Arecor granted European patents protecting proprietary formulations of high concentration Humira® biosimilar

• Patents demonstrate strength of innovative ArestatTM technology and its potential in development of enhanced formulations of high value biologics
• Further strengthens Group’s extensive patent portfolio protecting its proprietary Arestat™ technology and proprietary products

Cambridge, UK, 9 August 2022: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, is pleased to announce 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, sold by AbbVie under the brand name Humira®, has been a blockbuster monoclonal antibody product since its launch in 2003, 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 $21bn1. 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 50 mg/mL adalimumab product comprising citrate as a key formulation ingredient. An improved product was subsequently launched by AbbVie with a high adalimumab concentration (100 mg/mL) 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 market2.

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, Arecor has developed novel formulations enabling a high-concentration adalimumab product (100 mg/mL or higher) with excellent stability. The two granted European patents protect the novel design space enabling these formulations. Corresponding patents in the US are expected to be granted later in 2022.

Sarah Howell, CEO of Arecor, commented: “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 ArestatTM 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. The biologics field is one in which we have considerable experience, as demonstrated by the novel and differentiated formulation of AT220, a separate biosimilar product in our current partnered programmes, formulated by Arecor and licensed to one of our global pharmaceutical partners, which is now in late-stage development.”

Arecor has invested in building a strong patent portfolio to protect the Arestat™ technology platform and its proprietary pipeline products. The Group’s intellectual property (IP) portfolio currently comprises 36 patent families, including >50 granted patents in Europe, the US and in other key territories. As part of this strategy, Arecor has been developing robust IP directed to the novel compositions of differentiated therapeutic products that offer greater convenience of use for patients or healthcare professionals. EP3592383B1 and EP3592385B1 represent a growing number of the Group’s patents in this area.

1. AbbVie Form 10-K 2021 p41
2. https://www.centerforbiosimilars.com/view/samsung-bioepis-and-organiz-seek-to-enter-the-market-for-high-concentration-adalimumab