TIDMPRTC
PureTech Health PLC
18 June 2020
18 June 2020
PureTech Health plc
PureTech Founded Entity Gelesis Announces Partnership for
Commercial Launch of Plenity (R) in China
Partnership includes $35 million up front licensing fees and
equity investment, with future milestone payments of up to $388
million plus royalties
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 a partnership with China Medical System
Holdings Ltd. (CMS) for the commercialisation of Plenity in China.
CMS is a well-established, innovation-driven specialty pharma
company with a focus on sales and marketing in China. According to
the Global Burden of Disease (GBD) 2015 Obesity Collaborators,
overweight and obesity accounted for 23 per cent and five per cent
of adult population in China, respectively.
Through the terms of the deal, CMS will provide $35 million
upfront in a combination of licensing fees and equity investment
with the potential for an additional $388 million in future
milestone payments as well as royalties.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"This partnership underscores the global demand for safe, effective
and clinically validated therapeutics to help individuals manage
their weight. With its non-systemic, non-stimulant method of
action, Plenity is highly attractive to both physicians and
consumers. Gelesis is committed to ensuring ease of access to
Plenity via telehealth services in the United States, and we're
delighted to see a commitment to digital access from China Medical
System Holdings. Together with the recent news that Gelesis has
received a CE mark to enable the marketing of Plenity in Europe,
this partnership marks a significant step forward in global
commercialisation of Plenity."
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces Partnership for Commercial Launch of Plenity
(R) in China
Partnership includes $35 million up front licensing fees and
equity investment, with future milestone payments of up to $388
million plus royalties
BOSTON, JUNE 18, 2020- Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat
overweight, obesity and other chronic metabolic diseases, today
announced a partnership with China Medical System Holdings Limited
(CMS) (HKG:0867) for the commercialisation of Plenity in China. CMS
is a well-established, innovation-driven specialty pharma company
with a focus on sales and marketing in China.
The partnership will build on Gelesis' commitment to providing
patient-initiated care for adults with overweight and obesity that
augments traditional healthcare provider services with digital
access to care.
Through the terms of the deal, CMS will provide $35 million
upfront in a combination of licensing fees and equity investment
with the potential for an additional $388 million in future
milestone payments as well as royalties. Plenity will complement
CMS's strong record of prescription and healthcare licensing
launches in China. Among their launches are pharmaceutical drugs in
the treatments of cardiovascular disease and depression.
"We see this as a great additional validation of the market
potential for Plenity in different geographies. We are excited to
partner with CMS and are pleased that they intend to leverage
digital technologies to expand access to care," said David Pass,
Pharm.D., Gelesis' Chief Commercial & Operating Officer. "The
patient is at the centre of everything we do, and as we continue to
expand geographically, that will be at the core of any
partnership."
Plenity, the first product based on Gelesis' proprietary
hydrogel technology platform, is an orally-administered,
non-systemic and non-stimulant aid for weight management. It is
administered in the form of capsules taken with water before lunch
and dinner. The capsules release thousands of particles that
rapidly absorb water in the stomach, creating small individual gel
pieces with the elasticity and firmness of plant-based foods (e.g.,
vegetables) without caloric value. The gel contributes to a feeling
of fullness and induces satiety. This novel treatment has been
shown in clinical studies to be effective and well-tolerated. It
was 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 company also received a CE
mark, which enables the marketing of Plenity in Europe.
According to data from the Global Burden of Disease (GBD) 2015
Obesity Collaborators, overweight and obesity accounted for 23% and
5% of adult population in China, respectively. Limited treatment
options exist there, and there is a need for more solutions with
scientific evidence.
"There is a huge need but limited options for patients seeking
treatment for overweight and obesity, so we are excited to be able
to offer Plenity to patients in China in the future. Its highly
desirable efficacy and safety profile make it an ideal choice for
many patients looking for early intervention treatment for
overweight," said Dr Huaizheng Peng, General Manager of Global
Investment and Operations of CMS.
About Plenity(R)
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. Gelesis has also received
approval to market Plenity in the European Economic Area. Plenity
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 and 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. Read
Sections 6 and 8.3 of the Instructions for Use carefully
-- Avoid use in patients with: esophageal anatomic anomalies,
including webs, diverticuli, and rings; suspected strictures (such
as patients with Crohn's disease); and complications from prior
gastrointestinal (GI) surgery that could affect GI transit and
motility
-- Use with caution in patients with active gastrointestinal
conditions such as gastro-esophageal reflux disease (GERD), ulcers,
or heartburn
-- The overall incidence of AEs in the Plenity group was no different than the placebo group
-- The most common side effects were diarrhea, distended
abdomen, infrequent bowel movements, and flatulence.
For the safe and proper use of PLENITY, refer to the U.S.
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(R), 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. It was also granted a CE mark, which allows Gelesis
to market Plenity in the European Economic Area. Plenity is
currently available in limited supply in the U.S. 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). For more information, visit
gelesis.com or connect with us on Twitter @GelesisInc.
About CMS
China Medical System Holdings Limited (CMS) is a
well-established, innovation-driven specialty pharma with a focus
on sales and marketing in China. Through global strategic
cooperation, CMS actively introduces an innovative pipeline with
relatively high innovation level, great market potential and
competitive differentiation advantages. At the same time,
capitalising on a compliant, efficient and professional promotion
system, CMS constantly builds professional brand images while
creating successful sales records for its products based on their
evidence-based medical evidence. For the year ended 2019, CMS's
promotion network had covered around 57,000 hospitals and medical
institutions in China. Over the past decade (from 2010 to 2019),
CMS has achieved rapid growth with a turnover compound annual
growth rate ("CAGR") of 25.6% and a net profit CAGR of 28.4%. By
converging the R&D forces and innovative resources around the
world, CMS will work diligently to fulfil its mission to
continually introduce more affordable innovative products with
differentiation competitive advantages to benefit more Chinese
patients and their families. CMS is listed on the Main Board of the
Stock Exchange of Hong Kong (stock code: 867.HK). For more
information, please visit: http://en.cms.net.cn/ .
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 22 product candidates and two products that have
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 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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June 18, 2020 07:01 ET (11:01 GMT)
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