04.06.2014 18:30:00

Adocia to Present Successful Clinical Results for BioChaperone® Lispro and BioChaperone Combo at the American Diabetes Association 74th Scientific Sessions on June 15th 2014

Regulatory News:

ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 - ADOC) announced today that two posters on the company’s research in diabetes have been accepted for presentation at the 74th Scientific Sessions of the American Diabetes Association (ADA) which will take place in San Francisco, CA from June 13 – 17.

The annual meeting of the ADA is the largest worldwide scientific meetings for clinicians and researchers involved in diabetes. During this meeting, Dr. Tim Heise, MD (Profil Neuss), medical advisor to Adocia for insulins, will present two posters on final phase 2 clinical results of Adocia’s two lead insulin products, BioChaperone® Ultra-Fast-Lispro and BioChaperone Combo.

"We are very pleased to share the complete clinical data for BioChaperone Lispro and BioChaperone Combo. It is clear from these results that our products are competitive with both the ultra-fast insulin and the insulins combo from Novo Nordisk,” said Olivier Soula, R&D Director and Deputy General Manager of Adocia. "We are convinced that insulin treatments will undergo significant evolution in the coming years, ultra-fast insulins should replace fast-acting insulin analogs and insulins combos should supplant insulin analogs premixes.”

BioChaperone Lispro is an ultra-fast formulation of insulin lispro (Eli Lilly’s Humalog®), which aims to improve prandial glycemic control for patients under insulin therapy. BioChaperone Lispro presents an action profile closer to the physiological prandial insulin response compared to insulin analogs. Adocia will present detailed Pharmacokinetic (PK) and Pharmacodynamic (PD) profiles for this product, obtained in a phase IIa clinical trial conducted on 36 type 1 diabetics versus Humalog.

Presentation of the poster 78-LB "The Ultra-Rapid BioChaperone Insulin Lispro shows a Faster Onset of Action and Stronger Early Metabolic Effect than Native Insulin Lispro” in category 01-B Clinical Therapeutics/New Technology–Insulins

Sunday Jun 15, 2014 12:00 PM - 2:00 PM Pacific Time

BioChaperone Combo is a unique combination of two insulin analogs, glargine, the gold standard of basal insulins (Sanofi’s Lantus®) and lispro, one of the best-selling prandial insulins (Eli Lilly’s Humalog®). BioChaperone Combo allows patients to limit the number of daily injections to two or even one meanwhile improving glycemic control compared to a Premix. BioChaperone Combo is the only glargine-based combination tested in clinics. Adocia will present detailed PK and PD profiles for this product obtained in a phase I/II clinical trial conducted on 20 type 1 diabetics versus HumalogMix 25.

Presentation of the poster 83-LB "Pharmacokinetic (PK) and Pharmacodynamic (PD) Characteristics of BioChaperone Combo (BC Combo), the First Fixed Combination of Glargine and Lispro, in Type 1 Diabetes” in category 01-B Clinical Therapeutics/New Technology–Insulins

Sunday Jun 15, 2014 12:00 PM - 2:00 PM Pacific Time

About the ADA Scientific Sessions
The annual meeting of the ADA is the largest diabetes meeting in the world, bringing together nearly 18,000 participants — including more than 14,000 clinicians and researchers from the U.S. and 117 countries. The 5-day annual meeting features timely and significant advances in basic science and the prevention, diagnosis, and treatment of diabetes. There are over 3,000 original presentations which include symposia, oral abstract sessions, meet the expert sessions, interest group discussions, guided audio poster tours, and poster presentations. It also includes approximately 175 exhibitors showcasing the latest in diabetes-related products, services, and technology available to health care professionals. For more information, go to http://www.diabetes.org.

About diabetes
Diabetes is a chronic condition in which the person has high blood glucose (hyperglycemia), either because insulin production is inadequate, or because the body's cells do not respond properly to insulin, or both. Over time, chronic hyperglycemia contributes to disease progression and results in macrovascular and microvascular complications. Worldwide, more than 382 million individuals are currently suffering from diabetes, with a forecast of 592 million individuals by 2035, i.e. an average increase of 55%, and an increase of as much as 70% in emerging countries. (Source: International Diabetes Federation, 2013). All type 1 diabetic patients require insulin to manage their disease. In the case of type 2 diabetes, disease intensification also leads most patients to use insulin.

About BioChaperone Lispro
BioChaperone Lispro is an ultra-fast formulation of insulin analog Lispro (Eli Lilly’s Humalog®). Available prandial insulin treatments act with a delay of 15 to 30 min after injection, which fails to replicate the immediate secretion of insulin observed in healthy individuals during a meal. This delay results in an unsatisfactory glycemic control (hyper and hypoglycemias), itself responsible for long-term complications and weight gain. Ultra-fast BioChaperone Lispro aims to accelerate the action of insulin lispro, thus improving prandial glycemic control for insulin-dependent diabetics. In a Phase IIa clinical trial, BioChaperone Lispro showed significant acceleration of its onset of action compared to insulin lispro.

About BioChaperone Combo
BioChaperone Combo is a combination, in one product of two insulin analogs, glargine, the gold standard of basal insulins (Sanofi’s Lantus) and lispro, one of the best sellers in prandial insulins (Eli Lilly’s Humalog®). Combining basal and prandial insulins in one injection is crucial to improve both compliance and treatment comfort for diabetic patients. To date, combining glargine to a prandial insulin was considered impossible, due to physical chemical incompatibilities between both types of products. While premix products are available, they do not match the efficacy profile of a double injection. BioChaperone Combo allows to combine both products in one single injection, while preserving their respective efficacy profiles. BioChaperone Combo showed superiority to HumalogMix (Eli Lilly’s lispro-based premix product) both in terms of onset of action and duration of action. In particular, the duration of action of BioChaperone Combo suggests that it could be used once-a-day, while available Premix products require two injections daily.

About Adocia
To be a global leader in the delivery of insulins and therapeutic proteins
Adocia is clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. It has a particularly strong expertise in the field of insulins. Adocia’s proprietary BioChaperone® technological platform is designed to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients.
Adocia has successfully completed two Phase I and II studies of a fast-acting human insulin formulation, two Phase I and II studies of an ultra-fast-acting insulin lispro and a Phase I/II of a unique combination of insulin glargine, the gold-standard of basal insulin and insulin lispro, a fast-acting insulin analog. Dose-escalation Phase IIa studies of all three products are scheduled for 2014.
The company has also obtained positive results in a Phase I/II study of a diabetic-foot-ulcer-healing product based on PDGF-BB (Platelet-Derived Growth-Factor BB). A phase III clinical trial dossier has been filed with Indian regulatory authorities, and the trial is expected to start in 2014.
Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold-standard biologics for the treatment of various chronic pathologies (cancer, inflammation, etc.). Adocia is engaged in collaborative programs with two major pharmaceutical companies in this field.

Fighting cancer with targeted treatments
DriveIn® is a nanotechnology which is remarkably efficient in delivering active compounds into cancer cells. This new platform constitutes an exceptional opportunity to enter the oncology market by improving the efficacy of both already approved treatments and novel proprietary molecules.

"Innovative medicine for everyone, everywhere”
Adocia’s therapeutic innovations aim at providing solutions in a profoundly changing global pharmaceutical and economic context, characterized by (i) an increased prevalence and impact of the targeted pathologies, (ii) a growing and ageing population, (iii) a need to control public health expenditures and (iv) an increasing demand from emerging countries.

Adocia is listed on the regulated market of Euronext Paris (ISIN: FR0011184241; Reuters/Bloomberg ticker: ADOC, ADOC.PA, ADOC.FP) and its share price is included in the Next Biotech index.
American Depositary Receipts representing Adocia common stock are traded on the US OTC market under the ticker symbol ADOCY.
For more information, visit 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 registered by the Autorite des marches financiers on April 24, 2014 under number R.14-020 (a copy of which is available on hhtp://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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