ADOCIA Announces the First Patient Dosed In the BioChaperone® Lispro Phase 3 Program with Partner Tonghua Dongbao

Rhea-AI Summary

Adocia has initiated a Phase 3 clinical trial for its BioChaperone® Lispro insulin, enrolling 1,300 diabetes patients across 100 centers in China. This marks a significant milestone, triggering a $5 million payment from Tonghua Dongbao to Adocia, with potential future payments totaling $30 million linked to further developments. Additionally, the agreement includes double-digit royalties from sales in territories encompassing over 200 million diabetes patients. The Chinese insulin market is projected to grow from $3.5 billion in 2018 to $5 billion by 2025.

Positive

• Initiation of Phase 3 trial for BioChaperone® Lispro, involving 1,300 patients.
• Trigger of $5 million payment from Tonghua Dongbao, with potential additional $30 million.
• Expected double-digit royalties from sales in a market of over 200 million diabetes patients.
• Chinese insulin market projected to grow to $5 billion by 2025.

Negative

• None.

• First Patient was dosed in this large Phase 3 program enrolling 1300 people with type 1 or type 2 diabetes in 100 clinical research centers across China
• This development milestone triggers the payment of $5 million by Tonghua Dongbao to Adocia. A maximum of $30 additional million could be triggered by future development achievements until the product registration
• Future payment of double-digit yearly royalties on sales on Tonghua Dongbao territories which count 140 million people with diabetes in China and 60 million in other Asian territories such as Vietnam, Thailand, Indonesia, and the Philippines

LYON, France--(BUSINESS WIRE)-- Regulatory News:

Adocia (Paris:ADOC) (Euronext Paris: FR0011184241 – 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 dosing of the first patient with the BioChaperone^® Lispro (“BC Lispro”) Phase 3 study. BC Lispro belongs to the last generation of Ultra-Rapid Insulins together with Fiasp^® (Novo Nordisk^®) and Lyumjev^® (Eli Lilly^®).

“We are proud to be one of the very few companies bringing an innovative insulin from lab to phase 3” said Olivier Soula, Adocia's Deputy CEO & R&D Director, “Congratulations to our partner Tonghua Dongbao for achieving this important milestone. Our product BC Lispro is having a high probability to reach the largest market in the World in term of number of patients."

The Phase 3 program consists of 2 studies treating people with type 1 and type 2 diabetes in 100 clinical centers across China and will enroll a total of c. 1300 patients. The aim of this program is to demonstrate safety and efficacy in comparison to standard of care (Humalog®). Results of this program will then be submitted to the Chinese Regulatory Authorities by Tonghua Dongbao to obtain marketing authorization.

BC Lispro has been licensed-out to Tonghua Dongbao for China and major territories in Western Pacific and South-East Asia Regions that represents 200 million people suffering from diabetes¹ and an estimated 20 million are using insulin every day for their survival.

“I am delighted about this important milestone for the company: as planned Tonghua Dongbao is becoming a specialty biopharma bringing innovative products to Chinese patients.”, indicated Dr. Chunsheng Leng, Chairman and CEO of Tonghua Dongbao. “This is a crucial matter of responsibility for Tonghua Dongbao as Eli Lilly and Novo Nordisk’s Ultra-Rapid Insulins are not currently available in China where million people live with diabetes.”

In 2018, the Chinese insulin market represented more than $3.5 billion² and is forecasted to reach $5 billion² in 2025 due to increased access to medicine, diagnosis, and prevalence of diabetes.

About BioChaperone^® Lispro

BioChaperone^® (BC) Lispro is an Ultra-Rapid Insulin obtained by combining Adocia’s proprietary BioChaperone technology to the rapid-acting market leader insulin lispro (as contained in the commercial product Humalog^®).

Clinical & Quality of Life benefits

Being distributed more rapidly into the bloodstream than previous generations of insulins, BC Lispro reduces after-meal hyperglycemic excursions that are responsible for long-term comorbidities such as retinopathy, diabetic foot ulcer, kidney failure. Moreover, being eliminated faster from the body, BC Lispro may also reduce the risk of hypoglycemic events that are caused when insulin remains too long in the bloodstream after the post-meal hyperglycemia peak has declined.

On top of its direct clinical benefits, the onset of action of BC Lispro results in improved quality of life with more dose-timing flexibility at mealtime. A mealtime injection, or even right-after-mealtime, enables patients to better determine the appropriate insulin dose as the exact timing and contents of their meal is known. This avoids overdosing or delayed dosing, which can lead to hypo- or hyperglycemia respectively, and prevent their severe short and long-term consequences. It significantly reduces the stress and the mental load of those affected by insulin-dependent diabetes and their caretakers which is important in day-to-day life.

Currently, the only drugs providing similar effects in the world are Fiasp^® of Novo Nordisk Co. and Lyumjev^® of Eli Lilly and Company. Fiasp^® and Lyumjev^® are not currently available in China.

BC Lispro was licensed to Tonghua Dongbao in 2018 in exchange for a $10 million upfront fee. The agreement also includes maximum payments of $35 million subjects to the achievement of future development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao.

BC Lispro is patent protected until 2033.

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. To date, 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) AdOral^®, an oral peptide delivery technology; 3) AdoShell^®, 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 4^th and 7^th 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 Euronext^TM 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 21, 2022 (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 International Diabetes Federation, 10Atlas, 2021

² GlobalData Plc Database

View source version on businesswire.com: https://www.businesswire.com/news/home/20220509005063/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

Source: ADOCIA

FAQ

What is the purpose of the Phase 3 clinical trial for ADOCY?

The Phase 3 trial aims to demonstrate the safety and efficacy of BioChaperone® Lispro compared to standard insulin treatments.

When was the first patient dosed in the ADOCY clinical trial?

The first patient was dosed recently as part of the Phase 3 program.

What are the potential financial impacts of the agreement with Tonghua Dongbao for ADOCY?

Adocia could receive an initial $5 million payment, up to $30 million in future milestones, and double-digit royalties on sales in major Asian markets.

How many people are affected by diabetes in the territories covered by ADOCY's agreement?

The agreement covers over 200 million diabetes patients in China and other Asia-Pacific regions.

What is the significance of the Chinese insulin market for ADOCY?

The Chinese insulin market is projected to grow to $5 billion by 2025, representing a substantial opportunity for Adocia.