Will Enable Access to Insulia®, an
FDA-cleared and CE marked Digital Therapeutic, for
Insulin-dependent Type 2 Diabetes Patients
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
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Biocon Biologics Contacts
Media Seema Ahuja Global Head of Communications
& Corporate Brand seema.ahuja@biocon.com +91 997231779
Investors Saurabh Paliwal Head, Investor Relations
investor.relations@biocon.com +91 80 6775 2040
Voluntis Contacts
Voluntis Matthieu Plessis Chief Financial Officer
investors@voluntis.com +33 (0)1 41 38 39 20
NewCap Investor Relations Louis-Victor Delouvrier
voluntis@newcap.eu +33 (0)1 44 71 94 94
NewCap Media relations Nicolas Merigeau
voluntis@newcap.eu +33 (0)1 44 71 94 98