TIDMPRTC
PureTech Health PLC
17 December 2019
17 December 2019
PureTech Health plc
PureTech Health Affiliate Gelesis Announces Partnership with Ro
to Support US Commercialisation of Plenity(TM)
In addition to collaborating with traditional healthcare
providers, Gelesis will leverage Ro's nationwide telehealth
services to make Plenity available to patients who don't have an
established healthcare provider or prefer a remote interaction
Ro provides a personalised end to end telehealth experience from
medical diagnosis to the home delivery of prescription and OTC
products
Plenity will be the only weight management treatment available
through Ro's digital clinics as Ro expands to treat new conditions
on its platform
PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical stage
biotechnology company dedicated to discovering, developing and
commercialising highly differentiated medicines for devastating
diseases, is pleased to note that its affiliate Gelesis today
announced that it is partnering with Ro, a leading US telehealth
provider, to offer high-quality remote care dedicated to weight
management and prescription fulfilment of Plenity. Through the
Gelesis-Ro partnership, Plenity will be the first FDA-cleared
weight management aid and first primary care product to launch with
both traditional healthcare provider and telehealth services,
making Plenity available to patients nationwide. Gelesis retains
worldwide sales and marketing rights for Plenity and, since FDA
clearance, has secured close to $100 million in new capital to
support the US commercial launch.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"We are pleased with the progress Gelesis has made towards the
broad commercialisation of Plenity, and this partnership with Ro
underscores the Gelesis commitment to innovation in healthcare.
Through the company's multipronged commercial strategy, Gelesis
aims to empower individuals to access care where they are most
comfortable - either through traditional providers or via a
telehealth experience."
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces Partnership with Ro on Commercial Launch of
Plenity(TM)
In addition to collaborating with traditional healthcare
providers, Gelesis will leverage Ro's nationwide telehealth
services to make Plenity available to patients who don't have an
established healthcare provider or prefer a remote interaction
Ro provides a personalised end to end telehealth experience from
medical diagnosis to the home delivery of prescription and OTC
products
Plenity will be the only weight management treatment available
through Ro's digital clinics as Ro expands to treat new conditions
on its platform
BOSTON, Dec. 17, 2019 - Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat obesity
and other chronic diseases related to the gastrointestinal (GI)
tract, and Ro, a leading US telehealth provider, announced today
they will partner to offer high-quality remote care dedicated to
weight management and prescription fulfilment of Plenity. Ro's
telehealth services will complement traditional live interactions
to ensure people seeking healthcare provider guidance for weight
loss will have easy access to multiple options. Through the
Gelesis-Ro partnership, Plenity will be the first FDA-cleared
weight management aid and first primary care product to launch with
both traditional healthcare provider and telehealth services,
making Plenity available to patients nationwide.
Plenity, an orally administered, non-systemic and non-stimulant
aid to weight management, was recently cleared for use by the FDA
in adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when used
in conjunction with diet and exercise. It is the only prescription
weight management product indicated for use by overweight adults
with a BMI as low as 25 kg/m(2) , making it available for the
largest number of adults affected by overweight and obesity of any
prescription weight-management aid.
Ro currently powers digital health clinics that provide a
personalised end to end telehealth experience from medical
diagnosis to the delivery of prescription and over-the-counter
products. Plenity will be the only weight management treatment
available through Ro's digital clinics as the company expands to
treat new conditions on its platform. Ro's portfolio currently
includes products for men's and women's sexual health, smoking
cessation and insomnia.
Obesity is a chronic progressive disease resulting from multiple
environmental and genetic factors. Because of the disease
complexity, there are numerous therapeutic and social challenges
facing individuals seeking assistance to achieve a healthier
weight. There are also limited safe and effective prescription
options to treat adults who are overweight but do not meet the
clinical threshold for obesity.
"Our current healthcare system is ill-equipped to assist the
millions of patients seeking to manage their weight, especially
starting at an overweight BMI of 25," said Caroline Apovian, MD,
FACP, FACN, FTOS, professor of medicine and pediatrics in the
Section of Endocrinology, Diabetes, Nutrition and Weight Management
at Boston University School of Medicine and outgoing president of
the Obesity Society. "It is important to support effective
interactions between patients and their physicians regarding weight
management while providing new modalities of access to care for
patients who do not have an established healthcare provider or for
those who prefer a different type of interaction."
Through Ro's telehealth platform, adults will have access to
physicians trained in weight management support. Those interested
in learning if Plenity is a safe and appropriate treatment for them
can seek care through an online doctor's visit dedicated to weight
management. If it is determined that an individual should be seen
in person for follow-up care or is better suited for another course
of treatment, the provider will recommend that they visit their
primary care provider or a specialist. Adults who receive a
prescription for Plenity through Ro's platform will have access to
unlimited follow up communication with their physician at no
additional cost and will be provided with educational resources and
lifestyle recommendations. Ro can also keep a patient's in-person
provider updated on their treatment plan at the patient's request
to ensure continuity of care.
"Through the millions of patient-physician interactions
facilitated on our platform, physicians have seen the dramatic and
rippling impact of weight-related health issues firsthand," said
Zachariah Reitano, co-founder and chief executive officer of Ro.
"Prior to this point, safe and effective treatment options for
weight management were limited and patients have faced significant
barriers to accessing high-quality care-whether that's due to
stigmatisation, cost or geography. Through this unique partnership,
Ro will provide high-quality, innovative treatment for weight
management, deliver Plenity straight to a patient's door, and
maintain unrivaled care on one seamless platform. Together, we can
have a profound impact on how patients and physicians tackle this
serious and pervasive health challenge."
"Our partnership with Ro reflects our shared vision of improving
access for patients in all corners of the country, including those
who may not feel comfortable talking to their primary care
physician about weight management," said David Pass, PharmD,
Gelesis head of commercial and chief operating officer. "The
objective remains simple: give people more choices, more support
and more power to manage their weight. We believe Ro is uniquely
suited to provide telehealth services that enable more individuals
to access the high-quality care they need, providing an additional
path to treatment and support for the complex, chronic health
conditions of overweight and obesity."
Gelesis retains worldwide sales and marketing rights for Plenity
and, since FDA clearance, has secured close to $100 million in new
capital to support the US commercial launch. Gelesis initiated an
early experience program as part of its targeted US launch of
Plenity earlier this year and expects that Plenity will be
available in limited supply through healthcare providers and Ro's
digital health clinics in the second half of 2020. In parallel, the
company has been expanding its commercial manufacturing
capabilities and will continue to add capacity to meet demand.
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 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 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 adverse events (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
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. Gelesis anticipates Plenity will be available by
prescription in the US in the second half of 2020. 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).
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 clinical-stage biotechnology company
dedicated to discovering, developing and commercialising highly
differentiated medicines for devastating diseases. For more
information, visit gelesis.com or connect with us on Twitter
@GelesisInc.
About Ro
Ro is a patient-driven healthcare company that puts you in
control of your health. We're patients, just like you, building
technology to make healthcare accessible, affordable, and maybe
even enjoyable. Today, we enable you to connect with a doctor and
get treatment when and where you need it. Tomorrow, we aspire to be
your first call for all your healthcare needs. Ro powers three
digital health clinics - Roman, Rory and Zero - providing a
personalised end to end telehealth experience from diagnosis to
delivery. Ro's platform has facilitated over 3 million
doctor-patient interactions through its secure healthcare portal
and is live in all 50 states.
About PureTech Health
PureTech is a clinical stage biotechnology 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 affiliates, is comprised of 24 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.
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
Ro
Meghan Pianta
+1 203 556 5970
meghan@ro.co
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contact rns@lseg.com or visit www.rns.com.
END
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