TIDMPRTC
RNS Number : 6078O
PureTech Health PLC
02 June 2020
2 June 2020
PureTech Health plc
PureTech Founded Entity Gelesis Receives Approval to Market
PLENITY(TM) in Europe as a Weight Loss Treatment
CE Mark enables Gelesis to market Plenity(TM) throughout the
European Economic Area
PureTech Health plc (LSE: PRTC) ("PureTech," or the "Company"),
a clinical stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Gelesis, today announced that it has received approval to market
Plenity(TM), a novel weight loss treatment, in Europe. Gelesis
received a Conformité Européenne (CE) mark for Plenity as a class
III medical device indicated for weight loss in overweight and
obese adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when
used in conjunction with diet and exercise. Gelesis will now be
able to market Plenity throughout the European Economic Area and in
other countries that recognise the CE mark. Gelesis previously
received clearance for Plenity from the US Food and Drug
Administration and plans to bring Plenity to the US first, where it
is now available to a limited extent while the company ramps up its
commercial operations and inventory for a broad launch in 2021.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"This is an important milestone for Gelesis and for the millions of
adults across Europe who are seeking to manage their weight. We
look forward to continued progress from Gelesis' novel hydrogel
platform and to the broad launch of Plenity across of the
world."
The full text of the announcement from Gelesis is as
follows:
Gelesis Receives Approval to Market PLENITY(TM) in Europe as a
Weight Loss Treatment
CE Mark enables Gelesis to market Plenity(TM) throughout the
European Economic Area
BOSTON, June 2, 2020 - Gelesis , a biotechnology company
developing a novel hydrogel platform technology to treat obesity
and other chronic diseases related to the gastrointestinal (GI)
tract, announced today that it has received approval to market
Plenity(TM), a novel weight loss treatment, in Europe. Gelesis
received a Conformité Européenne (CE) mark for Plenity as a class
III medical device indicated for weight loss in overweight and
obese adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when
used in conjunction with diet and exercise.
"Seventy percent of the western world is affected by overweight
or obesity and there are few non-invasive, non-systemic solutions
without major risks," says John Wilding, MD, FRCP, a clinical
researcher Obesity, Diabetes and Endocrinology at the University of
Liverpool and the incoming president of the World Obesity
Federation. "Through my participation in the clinical trial, I saw
firsthand the impact Plenity can have. The CE mark will further
broaden access to a weight loss option that can impact tens of
millions of patients globally."
The CE mark indicates that Plenity has been assessed to meet
health and safety standards for products sold within the European
Economic Area (EEA), as required by the European Medical Device
Directives. Gelesis will now be able to market Plenity throughout
the EEA and in other countries that recognise the CE mark.
"Obesity is a global public health crisis, and too many
individuals have struggled to lose weight on their own, without an
effective therapeutic intervention to help them. We believe Plenity
is a highly differentiated option for this serious public health
issue," said Yishai Zohar, founder and chief executive officer of
Gelesis. "Receiving the CE mark is an important milestone for the
Gelesis team and for our hydrogel technology platform."
Gelesis plans to bring Plenity to the US first, where it is now
available by prescription to a limited extent while the company
ramps up its commercial operations and inventory for a broad launch
in 2021.
About Plenity(TM)
Plenity(TM) is an oral, non-systemic, superabsorbent hydrogel
which has received FDA clearance as an aid in weight management in
overweight and obese adults with a BMI of 25-40 kg/m(2) , when used
in conjunction with diet and exercise. It is made by cross-linking
two naturally derived building blocks, modified cellulose and
citric acid, that create a three-dimensional matrix. Plenity
particles rapidly absorb water in the stomach and homogenously mix
with ingested foods. Rather than forming one large mass, it creates
thousands of small individual gel pieces with the elasticity
(firmness) of solid plant-based foods (e.g., vegetables) without
caloric value. The Plenity hydrogel increases the volume and
elasticity of the stomach and small intestine contents and induces
a feeling of fullness and satiety. Once it arrives in the large
intestine, the hydrogel is partially broken down by enzymes and
loses its three-dimensional structure along with most of its
absorption capacity. The released water is reabsorbed in the large
intestine, and the remaining cellulosic material is eliminated
through the body's natural digestive processes. Plenity is
considered a medical device because it achieves its primary
intended purpose through mechanical modes of action consistent with
mechanobiology constructs. For more information, visit
myplenity.com .
Important Safety Information
-- PLENITY is contraindicated in patients who are pregnant or
are allergic to cellulose, citric acid, sodium stearyl fumarate,
gelatin or titanium dioxide.
-- PLENITY may alter the absorption of medications.
-- Avoid use in patients with the following conditions:
esophageal anatomic anomalies, including webs, diverticuli, and
rings; suspected strictures (such as patients with Crohn's
disease); or complications from prior gastrointestinal (GI) surgery
that could affect GI transit and motility.
-- Use with caution in patients with active GI conditions such
as gastro-esophageal reflux disease (GERD), ulcers or
heartburn.
-- Overall, the most common treatment related adverse events
(TRAEs) were GI-related with 38% of adults in the PLENITY group and
28% of adults in the placebo group.
-- The overall incidence of adverse events (AEs) in the PLENITY
group was no different than the placebo group.
For the safe and proper use of PLENITY, refer to the US
Instructions for Use or the EU Instructions for Use .
About Gelesis
Gelesis is developing a novel hydrogel platform technology to
treat overweight and obesity and chronic diseases related to the GI
pathway. Gelesis' proprietary approach is designed to act
mechanically in the GI pathway to potentially alter the course of
certain chronic diseases. In April 2019, Gelesis received FDA
clearance for its lead product candidate, Plenity(TM), as an aid
for weight management in overweight and obese adults with a Body
Mass Index (BMI) of 25-40 kg/m(2) , when used in conjunction with
diet and exercise. Plenity is currently available in limited supply
in the US. Additionally, Gelesis is developing its second
investigational candidate, Gelesis200, a hydrogel optimised for
weight loss and glycaemic control in patients with type 2 diabetes
and prediabetes. Novel hydrogel mechanotherapeutics based on the
Gelesis platform technology are also being advanced in other GI
inflammatory conditions, such as non-alcoholic steatohepatitis
(NASH) and Chronic Idiopathic Constipation (CIC). Gelesis was named
one of Fast Company's Most Innovative Companies for 2020.
The Gelesis executive and advisory team includes some of the
world's leading experts in obesity, materials science, chronic
disease research, and commercialisation. Gelesis was co-founded by
PureTech Health (LSE: PRTC). For more information, visit
gelesis.com or connect with us on Twitter @GelesisInc.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercialising highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, among others. The Company has created a broad and deep
pipeline through the expertise of its experienced research and
development team and its extensive network of scientists,
clinicians and industry leaders. This pipeline, which is being
advanced both internally and through PureTech's Founded Entities,
is comprised of 23 product candidates and one product that has been
cleared by the US Food and Drug Administration (FDA). All of the
underlying programmes and platforms that resulted in this pipeline
of product candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the interface between
those systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh
Forward Looking Statement
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments, and strategies. The
forward looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of
new information, future events or otherwise.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
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END
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