GI Dynamics : European CE Mark Approval for 12 Months of EndoBarrier™ Treatment of Type 2 Diabetes and Obesity; Announces U.K. Launch

October 15, 2010 - Innovative Medical Device Offers Patients a Catalyst for Regaining Control of Diabetes and Weight; Targeted Rollout Begins with Centers of Excellence – GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced that it has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. This approval is specific to up to 12 months of treatment with the EndoBarrier; the product has already received CE mark approval for three and six months of treatment. Through its commercial partner, Elemental Healthcare, GI Dynamics has also announced the launch of the EndoBarrier in the United Kingdom.
Alberic Fiennes, M.D., consultant bariatric surgeon at St. Anthony's Hospital in Surrey, said: “This new procedure is pioneering in that it works as a metabolic regulator directly treating type 2 diabetes and associated weight-gain, giving patients a chance to drastically improve their condition. I was excited when I first heard about EndoBarrier and impressed at the results produced by clinical studies that showed that as early as the first week post procedure, patients can experience a significant effect on their diabetes.”
Clinical trials involving more than 300 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. In fact, the EndoBarrier has been clinically proven to lower HbA1c levels (data presented at Digestive Disease Week 2010) and achieve weight loss of more than 20.0 percent of total body weight during 12 months of treatment (data presented at the International Federation for Surgery of Obesity and Metabolic Disorders 2010 World Congress, and Obesity 2010: 28th Annual Scientific Meeting of The Obesity Society). The EndoBarrier procedure is quick, incisionless and reversible, and many patients often go home the day of the procedure. In recent clinical trials, there have been no serious adverse events and the most common potential side effects include pain, nausea and vomiting, which generally resolves in the first two weeks of treatment... GI Dynamics' Press Release -

Johnson and Johnson [JNJ] : Therapeutic Benefits of Bariatric Surgery on Diabetes Translate into Significant Economic Benefits

October 12, 2010 - Surgical Therapy Effective and Less Expensive than leaving Obese Patients with Diabetes on standard therapy – New data presented at Obesity 2010, the 28th annual scientific meeting of The Obesity Society, find that bariatric surgery is associated with reduced healthcare costs for diabetes patients who are morbidly obese. The study, conducted by Washington University School of Medicine in St. Louis, Université du Québec à Montréal (UQAM), and Analysis Group, Inc., shows that costs associated with bariatric surgery are fully recovered in two to three years post-surgery, and a significant reduction in diabetes diagnostics claims and diabetes medication claims occurs post-surgery. The study, Economic Impact of the Clinical Benefits of Bariatric Surgery in Diabetes Patients With BMI ≥35 kg/m2, also was published in last month’s online edition of Obesity (link to abstract of study in Obesity).

Diabetes mellitus is a major public health concern in the United States—and other parts of the world—because of its prevalence, considerable morbidity and mortality and economic burden. Diabetes is associated with serious complications, including coronary heart disease, kidney failure, neuropathy, blindness and amputation, and was the seventh leading cause of death in 2006, accounting for more than 72,000 deaths.

Type 2 diabetes accounts for 90 to 95 percent of all diagnosed cases.1 Obesity is a major risk factor for Type 2 diabetes, and the risk of diabetes increases directly with body mass index (BMI). Results of a 2004 meta-analysis of more than 20,000 patients who had bariatric surgery showed that diabetes was completely resolved in 76.8 percent of patients, and resolved or improved in 86 percent, following surgery.

“Weight loss is an important therapeutic goal in obese patients with type 2 diabetes, because even moderate weight loss—5 percent—improves hepatic insulin sensitivity and reduces glucose production by the liver,” says Samuel Klein, M.D., director, Center for Human Nutrition, Washington University School of Medicine, St. Louis. “Bariatric surgery is the most effective available weight-loss therapy and has considerable beneficial effects on diabetes and other obesity-related comorbidities.”... Johnson & Johnson's Press Release -

Weight Watchers and Merck Collaborate to Help Physicians Fight Obesity Through Lifestyle Management Approach

October 13, 2010 – Weight Watchers International, Inc., the world's leading provider of weight management services, and Merck, a global healthcare leader, announced an innovative collaboration focused on fighting obesity. The two companies will launch an initiative in which Merck will provide physicians and other health care providers with educational information about the Weight Watchers® program and its underlying clinical evidence to assist doctors in addressing the ongoing weight management needs of their patients.


“Recently published research at the 2010 International Congress on Obesity demonstrated that the combination of the proven Weight Watchers behavior modification approach with physician’s encouragement provides a significant increase in patient adherence to weight-loss solutions and greater weight loss success than just standard physician care alone. Weight loss is an important component of preventing and addressing many health conditions, including diabetes and cardiovascular diseases such as hypertension. Because our weight management approach helps educate people on how to live a healthy lifestyle while allowing flexibility, the Weight Watchers program delivers real weight loss results. Collaborating with Merck will enable us to arm physicians with a comprehensive, sustainable, scalable and non-pharmaceutical solution for weight loss designed to help improve the overall health of their patients... Merck's Press Release -

deCODE : Not only Size Matters: Genetic Megastudies Draw out Distinctions between Obesity and Waist-Hip Ratio

11 October 2010 – In two of the largest metastudies of their kind to date, scientists from the GIANT consortium, including deCODE as well as hundreds of academic institutions on three continents, report the discovery of eighteen new regions of the human genome contributing to obesity and thirteen new regions influencing waist-hip ratio (WHR). The studies bring together data on body mass index (BMI, a measure of obesity), WHR (a measure of body fat distribution), and detailed genotypic information, from more than a quarter of a million participants from Europe, North America and Australia. The findings demonstrate the effectiveness of collaborations such as GIANT for powering studies large enough to detect lower-impact genetic factors for common traits and diseases... deCODE's Press Release -

Bionovo : NIH Grant to Develop Drugs for the Treatment of Female-Specific Obesity and Metabolic Syndrome

Sept. 2, 2010 - Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that the U.S. National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM) Small Business Technology Transfer Program, has approved and funded a grant to be shared by Bionovo and Dr. Dale Leitman from the University of California at Berkeley (UCB). The grant will fund the first phase in a planned multi-phase study to evaluate Bionovo's plant derived tissue selective estrogen receptor modulators for preventing obesity and the metabolic syndrome.

Menopause is associated with about a 10-15 pound weight gain and a redistribution of fat to the abdomen. The increase in abdominal fat, also known as visceral fat, is known to cause inflammation which can lead to metabolic syndrome. Metabolic syndrome represents a major public health burden because it increases the risk of cardiovascular disease and Type 2 diabetes. In the US, an estimated 25% of the population (50 million people) is classified as having this condition, which has led to enormous health care expenditures... Bionovo's Press Release -