Will Enable Access to Insulia®, an FDA-cleared and CE marked Digital Therapeutic, for Insulin-dependent Type 2 Diabetes Patients

BENGALURU, India & PARIS & LONDON--(BUSINESS WIRE)--Regulatory News:

Biocon Biologics India Limited, a fully integrated ‘pure play’ biosimilars company, a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), and Voluntis (Paris:VTX) (Euronext Paris, Ticker: VTX - ISIN: FR0004183960), a leader in digital therapeutics, today announced a global collaboration agreement between Biocon Biologics’ subsidiary Biocon Sdn. Bhd., Malaysia and Voluntis to develop and distribute innovative digital therapeutics supporting people with diabetes on biologics therapy.

The licensing agreement will make Biocon Biologics one of the first insulins companies to offer a U.S. Food and Drug Administration-cleared and CE-marked, highly validated digital therapeutic product, Insulia®, to Type 2 diabetes patients, across several markets in the world. Insulia® provides automated insulin dose recommendations enabling people with diabetes to self-manage their condition and healthcare teams to remotely monitor progress.

Insulia® is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulins. The demand for at-home treatment and telemedicine solutions is dramatically increasing around the world, with select healthcare systems offering reimbursement for patients eligible for digital therapeutic solutions.

Biocon Biologics aspires to reimagine the patient ecosystem by developing a technology dependent operating model that enables personalization of care, thus going beyond the product to reduce both the cost of the drug as well as the cost of administering the drug. This is aligned with the organization’s philosophy of keeping patients at the core of the business. It seeks to gather insights from patients through digitally enabled platforms and then leverage data science to integrate these insights into its development programs enabling it to design a service or solution around the patient. By leveraging best-in-class digital therapeutic solutions, Biocon Biologics wants to focus on enhancing the patient experience.

Christiane Hamacher, CEO and Managing Director, Biocon Biologics, said: “We are delighted to collaborate with Voluntis for this unique digital therapeutic solution that has U.S. FDA clearance and CE marked to help manage the treatment of Type 2 diabetes. Biocon Biologics will be one of the first insulin companies globally to offer this innovation for the benefit of people with diabetes. We believe pairing our products with a digital therapeutic solution will help improve patient outcomes and reduce costs to healthcare systems in the long term. We remain committed to impact patients’ lives through innovative solutions.”

Pierre Leurent, CEO of Voluntis: “We are excited to partner with Biocon Biologics who is a leading global player committed to expanding patients’ access to premier biologics while caring about treatment affordability. By combining best-in-class digital and therapeutic solutions, we aim to transform treatment experiences and advance new business models. This collaboration will help patients around the globe achieve optimal outcomes on their insulin journey, and illustrates digital therapeutics’ growing importance as part of the new standards of care.”

Once developed, the Insulia® digital companion will be offered to people with Type 2 diabetes using Biocon Biologics’ insulins, in key global markets. Going forward, by extending the Insulia® platform to its complete range of insulin products, including Recombinant Human Insulin, Insulin Glargine and Insulin Aspart, Biocon Biologics will create a comprehensive digital therapeutics portfolio for patients.

Notes - CE Mark: The Conformité Européenne (CE) Mark is defined as the European Union's (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer's declaration that products comply with the EU's New Approach Directives.

About Insulia®

Insulia^® provides automated insulin dose recommendations and coaching messages for people with diabetes while enabling the healthcare team to remotely monitor progress. A healthcare practitioner prescribes Insulia® using their dedicated web portal and sets up the treatment plan rules that will adjust basal insulin dosing based on the person’s specific needs. The user then receives an activation code to get started with their personalized app. Once downloaded, the app uses blood glucose readings and any hypo symptoms to recommend doses in real-time. These are constantly updated using clinical algorithms built into the application. Data is automatically shared with the healthcare team, who can remotely monitor the patient’s progress towards their goal thanks to tailored notifications. This enables providers to deliver tailored telemedicine services, a practice increasingly supported by payers worldwide. For further information: http://www.insulia.com

About Biocon Biologics India Ltd.

Biocon Limited’s subsidiary Biocon Biologics India Limited is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world. Building on the four pillars of Patients, People, Partners and Business, Biocon Biologics is committed to transforming healthcare and transforming lives. Biocon Biologics is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a platform of 28 biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Five molecules from Biocon Biologics’ portfolio have been taken from lab to market, of which three have been commercialized in developed markets like EU, Australia, United States, Canada and Japan. It aspires to benefit 5 million patient lives with its biosimilars and attain a revenue milestone of USD 1 billion in FY22. Follow-us on Twitter: @BioconBiologics

About Biocon Limited

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe. It also has a pipeline of promising novel assets in immunotherapy under development. www.biocon.com Follow-us on Twitter: @bioconlimited

About Voluntis

Voluntis creates digital therapeutics that empower people suffering from chronic conditions to self- manage their treatment every day, thus improving real-world outcomes. Combining mobile and web apps, Voluntis’ solutions deliver personalized recommendations to the patient and the care team so that they can, for example, adjust treatment dosage, manage side effects or monitor symptoms. These real-time recommendations are based on digitized clinical algorithms. Leveraging its Theraxium technology platform, Voluntis has designed and operates multiple digital therapeutics, especially in diabetes and oncology. Voluntis has long-standing partnerships with leading life science companies. Based out of Boston and Paris, France, Voluntis is a founding member of the Digital Therapeutics Alliance. For more information, please visit: www.voluntis.com

Contacts

Biocon Biologics Contacts

Media
Seema Ahuja
Global Head of Communications

& Corporate Brand

[email protected]
+91 997231779

Investors
Saurabh Paliwal
Head, Investor Relations

[email protected]
+91 80 6775 2040

Voluntis Contacts

Voluntis
Matthieu Plessis
Chief Financial Officer
[email protected]
+33 (0)1 41 38 39 20

NewCap
Investor Relations
Louis-Victor Delouvrier
[email protected]
+33 (0)1 44 71 94 94

NewCap
Media relations
Nicolas Merigeau
[email protected]
+33 (0)1 44 71 94 98