Regulatory Filings • Jun 8, 2016
Regulatory Filings
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Lyon, June 08 2016 - Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on diabetes treatment with innovative formulations of approved proteins, today announced a strategic update and the launch of a new project to develop an innovative formulation of human glucagon.
"With this fifth BioChaperone® product, we are leveraging the expertise we have established over the past 10 years, positioning Adocia as a center of excellence in protein formulation in diabetes," said Gérard Soula, President and Chief Executive Officer of Adocia. "We strongly believe in the potential of human glucagon, a key hormone in glucose control, to improve diabetes treatment. Our formulation of human glucagon could have significant advantages in terms of performance and cost-effectiveness, allowing us to open new therapeutic applications. With BioChaperone Glucagon, we are affirming our commitment to advance innovative treatments for diabetes."
One of the main challenges with many current glucose-lowering agents, especially insulin, is the risk of severe hypoglycaemia. Glucagon is a peptidic hormone that plays the opposite role of insulin, increasing blood glucose concentration by hepatic glucogenolysis. Two products based on human glucagon (GlucaGen®, Novo Nordisk and Glucagon, Eli Lilly) are approved to treat severe hypoglycaemia. However, prior to injection, these emergency kits require dissolution of freeze-dried glucagon with sterile water due to human glucagon instability in aqueous solution. One study* demonstrated that these products can be difficult to use resulting in a very low probability of injecting a proper dose.
Adocia's aqueous formulation of human glucagon could address the medical need for a ready-to-use product for severe hypoglycaemia rescue and unlock the use of glucagon as a chronic treatment for the dual hormone artificial pancreas (DHAP), congenital hyperinsulinism (CH), and bariatric surgery related hypoglycaemia, all of which represent potentially significant market opportunities. More recently, glucagon has also been envisioned as a cornerstone of innovative combinations with incretins for treating obesity.
BioChaperone technology has unique properties to solubilize and stabilize human glucagon in pure aqueous solution at physiologic pH, precluding the need for organic solvent or mutation of the native amino-acid sequence of this peptide. This formulation strategy, building on human glucagon track record in terms of safety and efficacy, could significantly shorten the clinical development plan compared to that of a new glucagon analog.
"BioChaperone Glucagon is an important addition to our portfolio, and it is a prime example of the growing relevance of our technology in treating diabetes. Based on promising preclinical results, we have established a development plan aiming to test BioChaperone Glucagon in a clinical study in the first half of 2017." said Olivier Soula, Deputy General Manager – R&D Director.
Consistent with its dedication to diabetes, Adocia has decided to strategically redeploy its resources on proprietary projects in this important therapeutic space. Consequently, its Monoclonal Antibodies and DriveIn programs will be discontinued.
* http://investor.biodel.com/releasedetail.cfm?releaseid=904936
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. http://investor.biodel.com/releasedetail.cfm?releaseid=904936
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 projects.
Adocia aims to deliver "Innovative medicine for everyone, everywhere."
To learn more about Adocia, please visit us at www.adocia.com
| Adocia | Adocia Press Relations Europe | Adocia Investor Relations USA |
|---|---|---|
| Gérard Soula | MC Services AG | The Ruth Group |
| Chairman and CEO [email protected] Tél. : +33 4 72 610 610 |
Raimund Gabriel [email protected] [email protected] Tél. : +49 89 210 228 0 |
Tram Bui [email protected] Tel.: +646.536.7035 |
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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