Adocia strengthens its BioChaperone Combo patent portfolio

Regulatory News:

ADOCIA (Paris:ADOC)(Euronext Paris: FR0011184241 – ADOC) announced today that the two major patent families covering BioChaperone Combo were granted in two of the main potential markets for this product. BioChaperone Combo is a unique combination, enabled by proprietary BioChaperone technology, of the basal insulin glargine and the prandial insulin lispro. BioChaperone Combo has been successfully tested in 3 different clinical studies in subjects with type 1 and type 2 diabetes and is one of Adocia’s lead clinical development programs.

BioChaperone Combo is protected by two key patent families, one on BioChaperone polymers themselves, part of Adocia’s proprietary technology, and one on the formulation of the two insulins in combination with these BioChaperone polymers.

The newly-granted European patent on the BioChaperone-enabled formulation of the basal insulin glargine with a prandial insulin, such as lispro, is entitled "Injectable solution of at least one type of basal insulin” (EP2741765). This new patent, which confers protection until 2032, expands coverage already granted in the United States, France, Mexico and Singapore.

BioChaperone polymers are covered by European patents entitled "Polysaccharides containing carboxyl functional groups substituted by a hydrophobic alcohol derivative” (EP2344547). This invention is protected until 2029 by granted patents in Europe, the United States, Mexico, China, Japan, Korea, Singapore, Russia, France, Australia, and South Africa.

"We are very pleased by these positive decisions for two of our strategic patent families covering BioChaperone Combo in key markets like the US and Europe. This product has the potential to be a more efficient and safer alternative to premix for insulin intensification. In the US and Europe, insulin analog premix represents a market worth $3 billion,” said Remi Soula, Director of Business Development and Intellectual Property at Adocia. "The granting of these patents bolsters our strong patent portfolio composed of 29 families, including 11 patents already granted in the US.”

BioChaperone polymers allow insulin glargine to solubilize at physiological pH, where it is characteristically insoluble. As prandial insulins are chemically stable only at neutral pH, BioChaperone essentially permits the combination of insulin glargine with any prandial insulin. Importantly, formulation with BioChaperone does not interfere with the long action profile of glargine and the fast action of prandial insulin, as demonstrated in 3 clinical trials to date.

"These patents are a strong recognition of the originality of our BioChaperone technology. BioChaperone is an efficient and versatile platform for the development of protein solutions in physiological conditions. In this case, it enables the combination of the two gold-standard insulins, which may provide a real medical benefit to patients living with type 2 diabetes,” comments Olivier Soula, Deputy General Manager and R&D Director of ADOCIA. "We are actively pursuing the clinical development of BioChaperone Combo with two additional clinical studies planned to start in Q2 2016.”

Disclaimer

This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the ‘Risk Factors’ section of the Reference Document filed by the French Autorité des marchés financiers on April 8, 2016 (a copy of which is available on www.adocia.com) and to the development of economic conditions, financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not currently considered material by Adocia. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Adocia to be materially different from such forward-looking statements.

This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.

About ADOCIA

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. Adocia’s insulin formulation portfolio, featuring four clinical-stage programs and one preclinical program, is among the largest and most differentiated in the industry.

The proprietary BioChaperone^® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application in order to address specific patient needs.

Adocia’s clinical pipeline includes a unique formulation of PDGF-BB for the treatment of diabetic foot ulcer and four novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analogs (BioChaperone Lispro U100 and U200), a rapid-acting formulation of human insulin (HinsBet U100) and a combination of insulin glargine and a rapid-acting insulin analog (BioChaperone Combo). Adocia is also developing a concentrated, rapid-acting formulation of human insulin (HinsBet U500).

In December 2014, Adocia signed a partnership with Eli Lilly for the development and commercialization of the BioChaperone Lispro programs.

Adocia’s extended, early-stage programs include innovative monoclonal antibody formulations, featuring two ongoing collaborations programs with major pharmaceutical companies in the field, and the delivery of anticancer drugs using the proprietary DriveIn^® nanotechnology platform.

Adocia aims to deliver "Innovative medicine for everyone, everywhere.”

To learn more about Adocia, please visit us at www.adocia.com

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