Gelesis Announces Partnership for Commercial Launch of Plenity® 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–(BUSINESS WIRE)–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 commercialization 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 center 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/m², 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^®

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. 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®, 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. 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 optimized 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 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, capitalizing 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 fulfill 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/.

Contacts

Katie Sullivan

+1 857 201 5309

[email protected]