Arecor successfully defends a key European Patent in opposition proceedings on the subject of mitigation of aggregation of therapeutic proteins during storage.

Arecor Ltd, the UK-based leading formulation technology company, focused on developing superior biopharmaceuticals via the innovative reformulation of proteins and peptides, continues to build a strong patent portfolio protecting the Company’s proprietary technology and product assets.

Arecor is pleased to announce the successful outcome of the opposition proceedings at the European Patent Office in relation to a key patent of the Company’s broad portfolio that leads to the prevention of aggregation of therapeutic proteins during storage.

Arecor’s proprietary formulation technology, Arestat™, enables unparalleled biopharmaceutical product profiles across a broad range of therapies, including products that can be used outside the cold chain or highly concentrated compositions allowing convenient delivery to the patient. Arecor partners with leading pharmaceutical and biotech companies to deliver differentiated reformulations of their proprietary products, which would otherwise not be possible using conventional formulation science. In addition, Arecor is leveraging its technology to develop a portfolio of proprietary products that will enable improved treatments for diabetes via the innovative reformulation of approved proteins and peptides.

The Company has invested considerably into building a strong patent portfolio to protect the technology as well as the product assets that the technology enables. Arecor’s intellectual property portfolio currently comprises 28 patent families within which 26 individual patents have been granted in key territories. European patents can be opposed by other companies within a certain period of time following their formal grant. The ensuing opposition process follows strictly defined rules and can result in the patent being revoked, amended or upheld in the original form. The Company’s technology patent on the mitigation of aggregation of therapeutic proteins during storage has recently been opposed and the 2 years of opposition process culminated in oral proceedings at the Opposition Division of the European Patent Office. The decision of the Opposition Division was favourable to Arecor and the patent was upheld.

The successfully defended patent protects novel compositions that are highly effective in preventing the process of aggregation of therapeutic proteins. Aggregation is one of the main problems affecting the stability of high-value therapeutic protein products, such as those used in oncology, autoimmune diseases or metabolic disorders, because aggregated proteins may trigger an immune response that can negatively impact the therapeutic efficacy, as well as in some cases, the safety of administering the product. For that reason, the levels of aggregated protein must be maintained to a minimum. The novel compositions protected by this patent can achieve exactly that and thus allow development of safe dosage forms. In addition, application of the patented technology enables the development of improved products that can be used more conveniently by the patient or the healthcare professional, either through better and easier storage or via enabling products that do not require refrigerated storage.

Dr Jan Jezek, Chief Scientific Officer at Arecor, commented: “We are delighted about the successful outcome of the opposition proceedings. Having developed a highly innovative formulation technology, Arecor has established itself firmly as a world leader in the formulation of superior biopharmaceuticals. However, the value of our technology would be significantly diminished without strong patent protection, which is why we have been systematically building a complex patent portfolio around our technology and product assets. Our success in the opposition proceedings is great news, as it demonstrates the value and the strength of our innovative formulation science and the associated intellectual property. The upheld patent protects a highly effective method of preventing aggregation in the compositions of therapeutic proteins, with aggregation being one of the key challenges in developing safe and convenient biopharmaceutical products.”

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