17 December 2019
PureTech Health plc
PureTech Health Affiliate Gelesis Announces Partnership with Ro to Support US Commercialisation of PlenityTM
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 PlenityTM
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/m2, 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/m2, 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™
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/m2, 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™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, 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.
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