TIDMPRTC
PureTech Health PLC
25 April 2019
25 April 2019
PureTech Health plc
PureTech Health Affiliate Gelesis Announces $10.6 (EUR9.4)
Million Grant to Support Commercial Manufacturing of
PLENITY(TM)
Non-dilutive grant awarded by regional body in Italy, location
of Gelesis manufacturing operations
Targeted US launch of PLENITY expected in 2H 2019, with broader
US availability by prescription in 2020
PureTech Health plc (LSE:PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to
announce that its affiliate Gelesis today announced the receipt of
a $10.6 (EUR9.4) million grant to support the commercial
manufacturing of PLENITY(TM), the company's first product. PLENITY
has been cleared by the FDA as an aid for weight management in
adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when used in
conjunction with diet and exercise. The grant was provided by the
Puglia (Apulia) Region as part of a European regional development
programme.
The full text announcement from Gelesis is as follows:
Gelesis Awarded $10.6 (EUR9.4) Million Grant to Support
Commercial Manufacturing of PLENITY(TM)
PLENITY manufacturing facility will be the first factory to
commercially produce medical super-absorbent hydrogels synthesised
from naturally derived building blocks
Targeted US launch of PLENITY expected in 2H 2019, with broader
US availability by prescription in 2020
BOSTON, April 25, 2019 - Gelesis, a biotechnology company at the
forefront of developing mechanobiology-based therapies to treat
chronic diseases related to the gastrointestinal (GI) system, today
announced it has received a non-dilutive $10.6 (EUR9.4) million
grant to support the commercial manufacturing facility of
PLENITY(TM), the company's first commercial product, which was
recently cleared by the FDA as an aid for weight management in
adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when used in
conjunction with diet and exercise.
"Gelesis is moving rapidly to build out its supporting
infrastructure for the launch of PLENITY as a prescription therapy,
and this support from the Puglia Region and the European Community
is a welcome non-dilutive addition to our preparations," said David
Pass, chief operating officer and head of commercial of Gelesis.
"We are excited to build the first commercial manufacturing
facility in the world capable of producing super absorbent
hydrogels synthesised from naturally derived building blocks, based
on the Gelesis core proprietary technology. This achievement is the
result of many years of dedicated effort by our multi-disciplinary
engineering teams. We will continue to invest in our manufacturing
processes and capacity to meet demand for both commercial and
clinical supply across our portfolio of hydrogel therapies in
development for chronic disease."
Gelesis' proprietary hydrogels are orally administered and
synthesised from two naturally derived building blocks - modified
cellulose cross-linked with citric acid - that create a
three-dimensional matrix to achieve specific mechanical properties
through the GI system.
The grant was provided by the Puglia Region, where Gelesis'
current material science research & development and clinical
supply manufacturing is located. The grant is intended to support
the development of a new commercial-scale manufacturing facility in
the region. The grant uses funds provided by the European Community
via the Operative Program of the European Fund for Regional
Development (FESR), which supports small enterprises with research
and industrialisation-integrated activity. This award marks the
second grant awarded from the Puglia region of Italy. In 2011,
Gelesis was awarded a $1 million grant to scale up its laboratory
and manufacturing facility near the town of Lecce in Italy. Gelesis
expects significant growth of its headcount as it continues its
preparations for a targeted US launch in the second half of 2019,
before broader US availability by prescription in 2020.
About PLENITY(TM)
PLENITY 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 mass 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 expelled in the
feces. 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 oxide
-- PLENITY may alter the absorption of medications. Read
Sections 6 and 8.3 of the Instructions for Use carefully
-- 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 AEs in the PLENITY group was no different than the placebo group
Rx Only. For the safe and proper use of PLENITY, refer to the
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
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. Gelesis is preparing to initiate a targeted US launch of
PLENITY in the second half of 2019 and anticipates PLENITY will be
broadly available by prescription in the US in 2020. Additionally,
Gelesis is developing its second investigational candidate,
Gelesis200, a hydrogel optimised for weight loss and glycemic
control in patients with type 2 diabetes and prediabetes. Novel
hydrogel mechanotherapeutics based on the Gelesis platform
technology are also being advanced through a pipeline in other GI
inflammatory conditions where gut barrier and gut permeability
potentially play a role, such as non-alcoholic steatohepatitis
(NASH) and inflammatory bowel disease (IBD).
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), a biopharmaceutical company focused on
the Brain-Immune-Gut (BIG) axis. For more information, visit
gelesis.com or connect with us on Twitter @GelesisInc.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing BIG medicines for dysfunctions of the
Brain-Immune-Gut axis. The Company has gained deep insights into
the connection between these systems and the resulting role in
diseases that have proven resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech Health is developing new categories of medicines with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies with an unbiased, non-binary, and capital efficient
R&D model across its affiliates and its internal labs.
PureTech's affiliates include seven clinical-stage platforms,
including one product that has been cleared by the US Food and Drug
Administration (FDA) and a second product candidate that has been
filed with the FDA for review, and several other novel preclinical
programmes. The PureTech Health pipeline includes ground-breaking
platforms and therapeutic candidates that were developed in
collaboration with some of the world's leading experts.
PureTech's internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
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.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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