- These clinical studies conducted in Germany will contribute to the dossier for phase 3 studies in China
- BioChaperone Combo targets the premix insulin market, which accounts for 65% of insulin used in China
- The agreement for BioChaperone Combo includes future maximum payments of $50 million subject to the achievement of upcoming development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao
Regulatory News:
Adocia (Euronext Paris: FR0011184241 ADOC) (Paris:ADOC), a clinical-stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and other metabolic diseases, announced today the final approval by the German (BfArM) regulatory authorities to conduct three clinical studies on BioChaperone Combo ("BC Combo").
Tonghua Dongbao is financing the entire program which will be conducted by Adocia, with no impact on Adocia's cash in hand.
"We are pleased that this innovative drug is one step closer to the millions of Asians patients whose survival is ensured by insulin", said Dr. Chunsheng Leng, Chairman and CEO of Tonghua Dongbao. "Adocia's insulins are fully in line with national policies that encourage the development of innovative biologics, as well as with Tonghua Dongbao's business expansion strategy not only in China but also in major Asian territories covered by our agreement.
"We are delighted about the accelerated development for this innovative product, based on our proprietary BioChaperoneplatform," said Olivier Soula, Adocia's Deputy Managing Director R&D Director. "BC Combo, a combination of rapid-acting (lispro), and long-acting (glargine) modern insulins, provides better glycemic control compared to Premixes, easy-to-use insulins that are widely used throughout the world.
Adocia has demonstrated the clinical benefits of this new combination, notably the reduction of hyperglycemia and hypoglycemia compared to "premix" insulins (insulin with both a rapid-acting and long-acting profile), while maintaining the simplicity of use of a single injection1
China is the country with the largest number of people with diabetes, with more than 140 million patients, or 1 in 10 people2. China is also one of the largest users of the premix class, which accounts for 65% of the Chinese market by volume3
The program is taking place in Germany and has been validated by the Chinese authorities to ensure its admissibility in the subsequent development stages.
About BioChaperoneCombo
BioChaperone (BC) Combo is a fixed combination of two gold standard insulins: long-acting insulin glargine (as contained in the commercial product Lantus) and rapid-acting insulin lispro (as contained in the commercial product Humalog). Many patients worldwide prefer to use fixed combinations of long and rapid-acting insulins rather than two separate products (simplicity, reduced number of daily injections).
BC Combo offers a number of advantages over traditional premixes: it reduces the level of postprandial hyperglycemia and the risk of hypoglycemia, and provides better 24-hour basal control.
BC Combo was licensed to Tonghua Dongbao in 2018 in exchange for USD 40 million upfront fee. The agreement also includes future maximum payments of $50 million subject to the achievement of future development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao.
BC Combo is patent protected until 2038.
About Tonghua Dongbao
Tonghua Dongbao Pharmaceutical Co. Ltd, is a pharmaceutical company in Jilin Province, China, specializing in the R&D, manufacturing and commercialization of insulins as well as other diabetes treatment products. Founded in 1985, Tonghua Dongbao was the first Chinese company which developed and commercialized insulins. Till now it has advanced a pipeline consisting of insulins insulin analogs, GLP-1RA, novel drugs, etc., for diabetes and other metabolic diseases. Currently Tonghua Dongbao has more than 2,700 employees and a turnover of approximately US$500 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of US$3.3 billion.
About Adocia
Adocia is a biotechnology company specializing in the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity. The company has a broad portfolio of drug candidates based on three proprietary technology platforms:
1) The BioChaperone technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) An oral peptide delivery technology; 3) An immunoprotective biomaterial for cell transplantation with a first application in pancreatic cells transplantation for patients with "brittle" diabetes.
Adocia holds more than 25 patent families and was ranked 4th and 7th in the French National Institute of Industrial Property (INPI) ranking of SMEs on the number of patents filed, in 2019 and 2020 respectively.
Based in Lyon, the company has approximately 125 employees. Adocia is listed on the EuronextTM Paris market (Euronext: ADOC; ISIN: FR0011184241).
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 as being reasonable. However, there can be no guarantee that the estimates contained in such forward-looking statements will be achieved, as such estimates are subject to numerous risks including those which are set forth in the "Risk Factors" section of the universal registration document that was filed with the French Autorité des marchés financiers on April 20, 2021 (a copy of which is available at www.adocia.com), in particular uncertainties that are linked to research and development, future clinical data, analyses, and the evolution of the economic context, the 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 considered as material by Adocia as of this day. The occurrence of all or part of such risks could cause that actual results, financial conditions, performances, or achievements of Adocia be materially different from those mentioned in the 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's shares in any jurisdiction.
1 Meiffren, G, Herbrand, T, Anastassiadis, E, et al. Better glycaemic control with BioChaperone glargine lispro co-formulation than with insulin lispro Mix25 or separate glargine and lispro administrations after a test meal in people with type 2 diabetes. Diabetes Obes Metab. 2019; 21: 1570- 1575. https://doi.org/10.1111/dom.13685
2 International Diabetes Federation
3 IQVia 2020
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Contacts:
Adocia
Gérard Soula
CEO
contactinvestisseurs@adocia.com
Tel: +33 4 72 610 610
www.adocia.com
Ulysse Communication
Adocia Press and Investors Relations
Pierre-Louis Germain
plgermain@ulysse-communication.com + 33 (0)6 64 79 97 51
Margaux Puech Pays d'Alissac
mpuech@ulysse-communication.com +33 (0)7 86 16 01 09
Bruno Arabian
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