Microsoft word - 131106 pr adocia combo en vf vda.docx
Adocia announces the initiation of a clinical trial on its
combination of the long-acting insulin Glargine and a fast-
acting insulin analog
This phase I/II clinical trial on Type 1 Diabetics seeks to compare the
performance of this Combo based on insulin Glargine with
Lyon, November 13, 2013 -
Adocia (NYSE Euronext Paris: FR0011184241 - ADOC), a
biotechnology company specializing in the development of ‘best-in-class’ medicines from
already approved therapeutic proteins, announces today that it has launched the first clinical
trial of its innovative formulation combining insulin Glargine (Lantus®, Sanofi), the gold-
standard of long acting insulin, to a fast-acting insulin analog, insulin Lispro (Humalog®, Eli
Lilly). This unique combination is made possible thanks to the BioChaperone® technology
developed by Adocia, which makes insulin Glargine compatible with fast-acting insulin
This clinical trial aims to demonstrate that the combination could offer diabetic patients improved glycemic control compared to a Premix of insulin analog such as HumalogMix, based on insulin Lispro (Eli Lilly), or NovoMix®, based on insulin Aspart (Novo Nordisk). Hence, pharmacodynamic and pharmacokinetic profiles of the combination BioChaperone Glargine/Lispro will be compared to the pharmacodynamic and pharmacokinetic profiles of HumalogMix in a cross-over design on 20 Type 1 diabetic patients under euglycemic clamp. The first patients of this double-blind study conducted in Germany have already been dosed Today, Type 1 and Type 2 diabetic patients requiring intensive insulin therapy have two treatment options: either a Premix, which is a formulation of a single insulin with both fast and long actions, or an association of two products, a long-acting insulin and a fast-acting insulin. The current gold-standard of long-acting insulin is Lantus, which generated $6.5 billion in 2012. Premix products, NovoMix (Novo Nordisk) and HumalogMix (Eli Lilly), ease everyday life for diabetics, who can manage their glycaemia using only one product injected twice daily. These Premix have been commercialized for more than ten years and generate annual revenues of more than $2.3 billion, with significant growth in emerging markets. However,
these products put patients at higher risk of hypoglycemia compared to separate injections
of Lantus and a fast-acting analog insulin.
“There is a real need to provide patients using Lantus and a fast-acting insulin with the
simplicity afforded by Premix products, as well as to offer Premix-using patients the greater
medical efficacy obtained with Lantus, real gold-standard,”
said Gérard Soula, Adocia’s CEO.
This combination could therefore extend Glargine’s market potential towards the Premix
market. This Combo based on insulin Glargine, insulin off-patent in 2015, has been
internationally patented in 2012.
“Adocia’s BioChaperone proprietary technology allows for a clear and stable solution of
insulin Glargine and a fast-acting analog insulin, two products that are not compatible under
” explains Olivier Soula, Deputy General Director and R&D Director at
Adocia. “In this clinical trial, we are testing one of the potential combinations but alternative
combinations, namely with insulin Glulisine (Apidra®, Sanofi) and insulin Aspart (NovoLog®,
Novo Nordisk) have also been validated in preclinics.”
Results from this study are expected during the first quarter of 2014. Next event
Adocia will attend ODDO Midcap Forum
, Lyon, France – January 9th and 10th, 2014.
“Innovative medicine for everyone, everywhere”
Adocia is a biotech company specialized in the development of best-in-class drugs from the innovative
formulation of certain already-approved therapeutic proteins.
Adocia is specialized in insulin therapy and the treatment of the diabetic foot, one of the main
complications of diabetes. Worldwide, more than 366 million individuals are currently suffering from
diabetes (with a forecast of 552 million individuals by 2030, i.e. a 51% increase, reaching 70% in
emerging countries). 15% of these patients will develop a foot ulcer during their lifetime. The markets
targeted by Adocia represent more than USD20 billion (USD17 billion for insulin therapy and USD3
billion for diabetic foot ulcer healing).
Through its BioChaperone® state-of-the-art technological platform, Adocia intends to enhance the
effectiveness and safety of therapeutic proteins and their ease of use for patients, with the aim of
making these medicines accessible to the broadest public.
Adocia successfully completed two phases I and II studies on the formulation of a fast-acting human
insulin and obtained promising phase I/II results on a diabetic foot ulcer-healing product. Furthermore,
Adocia is developing a unique combination of fast-acting insulin and slow-acting insulin, for an optimal
insulin therapy with one single product. To be a global leader for the formulation of therapeutic proteins
Based on its experience and recognized know-how, Adocia has extended its activities to the
formulation of monoclonal antibodies, which are gold standard molecules for the treatment of
numerous chronic pathologies (oncology, inflammation, etc.). In this field, Adocia is engaged in
collaborative programs with two major pharmaceutical companies.
Adocia’s therapeutic innovations aim at bringing solutions to a profoundly changing global
pharmaceutical and economic context, characterized in particular by the increased prevalence and
impact of the targeted pathologies, population growth and ageing, the need to control public health
expenditures and increasing demand from emerging countries.
Adocia is listed on the regulated market of NYSE Euronext in Paris (ISIN: FR0011184241, mnemo /
Reuters / Bloomberg: ADOC, ADOC.PA, ADOC.FP) and its share included in the Next Biotech index.
For more information: www.adocia.com Contact
Gérard Soula - firstname.lastname@example.org
Chairman and CEO of Adocia
Tel. : +33 4 72 610 610 Press Relations
Financial communication & Investor Relations
Andrew Lloyd & Associates
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 Autorité des marchés financiers on April 25, 2013 under number R13-
017 (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.
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