Formulations of a drug that can help a number of inflammatory diseases including rheumatoid arthritis and Crohn’s disease have been issued patents by the European Patent Office (EPO).
The EPO issued two patents that will protect Arecor Therapeutics’ formulations of high-concentration adalimumab until 2038. The company made the announcement today (August 9).
Adalimumab, sold by AbbVie under the brand name Humira, has been a blockbuster monoclonal antibody product since its launch in 2003.
Global sales of Humira increased by 4% in 2021 with total sales reported as $21 billion. Several biosimilar versions of adalimumab have also entered the European market since 2018 and are due to be launched in the U.S. in 2023.
Originally Humira was approved as a 50mg/mL adalimumab product using citrate as a key formulation ingredient. This was subsequently improved by using a higher concentration of adalimumab (100mg/mL) without the citrate which had been causing injection site-related pain. It is now more comfortable for patients because of the lower injection volumes.
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 U.S. 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, Arecor has developed novel formulations enabling a high-concentration adalimumab product (100 mg/mL or higher) with excellent stability. Corresponding patents in the US are expected to be granted later in 2022.
Sarah Howell, CEO of Arecor, said: “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.
“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.
Last week Arecor bought all of Tetris Pharma Ltd shares adding a key commercial diabetes product to its portfolio.
And last month, AbbVie submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn’s disease.