LEXINGTON, Mass., U.S. and SYDNEY, Australia – 4 January 2013 – GI Dynamics, Inc. (ASX: GID) today announced that the company has entered into separate research collaborations with GlaxoSmithKline (NYSE: GSK) and Medtronic (NYSE: MDT). The collaborations are focused on understanding how EndoBarrier® impacts continuous glucose levels (Medtronic) and evaluating hormonal changes in response to EndoBarrier Therapy (GSK) to further characterize the mechanism of action (MOA) of the EndoBarrier. Additional details of the collaborations are confidential.
“We are pleased to be collaborating with two of the world’s leading diabetes development companies – Medtronic in the device segment and GSK in the pharmaceutical sector,” stated Andy Levine, founder and chief technology officer of GI Dynamics. “We expect these collaborations will lead to a better understanding of the MOA of EndoBarrier and may lead to improvements in the device, as well as potential combinations of drug treatment and EndoBarrier Therapy to optimize patient outcomes.”
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In 13 clinical studies involving more than 500 patients, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months.
EndoBarrier is considered an investigational new device in the United States; however, it received CE Mark approval in 2010 in Europe, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months. EndoBarrier is entering a pivotal clinical trial in the United States and is currently commercially available in select countries in Europe, including Germany, Austria, the United Kingdom and the Netherlands, as well as Australia and Chile.
EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment for people with type 2 diabetes and/or obesity. Clinical studies demonstrate that EndoBarrier Therapy achieves rapid and dramatic reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months. EndoBarrier Therapy is a convenient and discreet treatment for people whose diabetes medications are no longer effective, who are at risk for serious health complications, and who want to avoid the progression to daily insulin injections. EndoBarrier Therapy does not have many of the risks associated with surgical procedures or the side effects of medications. Involving a brief endoscopic procedure, it also enables patients to avoid the lifestyle changes and frequent post-surgical interventions associated with irreversible bypass surgery and gastric banding. This first-of-its-kind therapy is helping patients around the world fight their battle against type 2 diabetes and obesity while providing a pathway to a healthier lifestyle. For more information, please visit www.EndoBarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic patients and/or obese patients during the implant period. GI Dynamics currently markets EndoBarrier in select regions in Europe, South America and Australia and is planning near-term commercial expansion into additional European countries. EndoBarrier is not approved for sale in the United States and is considered investigational. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.