- 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 BioChaperone®
platform," 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 BioChaperone® Combo
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220411005370/en/
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 barabian@ulysse-communication.com / +33 (0)6 87 88 47
26
Adocia (EU:ADOC)
過去 株価チャート
から 10 2024 まで 11 2024
Adocia (EU:ADOC)
過去 株価チャート
から 11 2023 まで 11 2024
