Biopharmaceutical developer Arecor Therapeutics has been granted two European patents protecting its novel formulations of high-concentration ‘adalimumab’ until 2038, it announced on Tuesday.
The AIM-traded firm described adalimumab, sold by AbbVie under the brand name ‘Humira’, as 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 4% in 2021, with total sales reported as $21bn.
Several biosimilar versions of adalimumab had also entered the European market in 2018, and were due to be launched in the US in 2023.
Humira was originally approved as a 50 mg adalimumab product comprising citrate as a key formulation ingredient.
An improved product was subsequently launched by AbbVie with a high adalimumab concentration of 100 mg in the absence of citrate, resulting in less injection site-related pain and providing greater patient convenience due to the lower injection volumes.
The company said the market for high-concentration adalimumab had 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 was “technically challenging”, Arecor said, further complicated by a complex patent landscape surrounding adalimumab formulations.
Using its proprietary ‘Arestat’ technology, Arecor developed novel formulations enabling a high-concentration adalimumab product of 100 mg or higher, with “excellent stability”.
The two granted European patents protected the novel design space enabling the formulations, with corresponding patents in the US expected to be granted later in the year.
“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,” said chief executive officer Sarah Howell.
“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.”
At 1121 BST, shares in Arecor Therapeutics were down 2.26% at 303p.
Reporting by Josh White at Sharecast.com.
