Adocia Announces new BioChaperone Program Combining a Basal Insulin and GLP-1s

Regulatory News:

ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on diabetes treatment with innovative formulations of approved proteins, today announced the launch of a new program employing its proprietary BioChaperone^® technology to develop combinations of insulin glargine (Lantus^®, Sanofi) and GLP-1 receptor agonists (GLP-1s).

"We are very excited about these two new combinations, the first to incorporate GLP-1 agents with our BioChaperone technology.” said Gérard Soula, Chairman and CEO. "We are committed to deliver affordable therapy options for people with diabetes, a goal which is particularly important in new classes of therapy, like the insulin and GLP-1 combinations products. This cutting-edge program is a natural complement to our BioChaperone Combo program and strengthens our position as a center of excellence in diabetes innovation.”

BioChaperone technology solubilizes and stabilizes insulin glargine in aqueous solution at physiologic pH. This change in the solubility profile of glargine enables its combination with proteins only stable at neutral pH, such as the two GLP-1s of interest to Adocia, liraglutide (Victoza^®, Novo Nordisk) and dulaglutide (Trulicity^®, Eli Lilly). This formulation strategy, built on the efficacy and safety records of already approved molecules, could shorten development time and offer lower risk compared to the development of new molecular entities.

"We are convinced that insulin glargine will remain foundational to diabetes treatment, especially with the recent emergence of glargine biosimilars. This program builds on our expertise in glargine formulation at neutral pH, which allowed us to move swiftly into preclinical development.” commented Olivier Soula, Deputy General Manager and R&D Director of Adocia. "Based on synergies with our BioChaperone Combo program, a first clinical study on a lead product could be initiated in 2017.”

Basal insulin remains an essential treatment for patients with type 2 diabetes not achieving glycemic targets on oral antidiabetic agents. Recently, GLP-1s have emerged as an alternative treatment option for these patients. The underlying mechanisms of action of these two types of molecules are complementary. In Phase 3 clinical studies, combinations of these two therapeutic agents have demonstrated an improved glycemic control while reducing the side effects compared to each agent used separately. By some estimates, 50% of people with diabetes using basal insulin as their only injectable treatment do not reach their glycemic target^*. Insulin and GLP-1 combinations could present a strong opportunity for a one product, once-daily treatment intensification option.

* Sanofi presentation Q3 2015

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 products and one preclinical product, 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 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 an aqueous formulation of human glucagon (BioChaperone Glucagon), two combinations of insulin glargine with GLP-1s (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide) and a concentrated, rapid-acting formulation of human insulin (HinsBet U500), all of which are in preclinical development.

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

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

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

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 with 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.

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