Profil Institute : Expansion of Its Cardiometabolic Capabilities for Diabetes and Obesity Clinical Drug Trials

November 22, 2010 - Profil Institute Expands Its Cardiometabolic Capabilities for Diabetes and Obesity Clinical Drug Trials – Profil™ Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced the expansion of its capabilities for cardiac safety and cardiovascular efficacy studies in the company’s early phase diabetes and obesity clinical trials.
"Assessing cardiac safety is a critical early objective for the evaluation of new drugs, particularly in compounds for the treatment of diabetes," said Robert J. Schott, a cardiologist and Director of Cardiometabolic Research at the Profil Institute for Clinical Research. "At Profil Institute we are excited to be implementing new technologies and procedures which allow us to assess cardiac safety signals in Phase I drug research, specifically in our ability to detect a drug's risk for causing sudden cardiac death with prolongation of the QT interval as a marker. We understand that detection of cardiac safety signals is mission-critical in early drug development, and new technologies allow us to do this in a more cost-effective and timely manner for our customers."... [PDF] Profil™ Institute for Clinical Research's Press Release -

Cognis develops two active ingredients for weight management and cognitive performance from InterMed Discovery

July 13, 2010 - Specialty chemicals supplier Cognis and InterMed Discovery (IMD), a world class natural product lead-discovery company, are continuing their strategic cooperation: Cognis has now exclusively licensed two new active ingredients for weight management and cognitive performance from IMD, further expanding the company’s innovation pipeline. Tests on the products Cognis has already acquired from IMD are already delivering promising results.


The sales potential is increasing for active ingredients in functional foods to support weight management and benefit heart and brain health, largely because obesity is becoming a major public health problem in many parts of the world and society as a whole is getting older. During their ongoing collaboration, Cognis and IMD have utilized IMD’s database of biologically active natural substances and its unique IMD Bioprofiling® technology platform to discover innovative functional ingredients for specific food applications, and to bring suitable active substances to market-readiness... Cognis' Press Release - InterMed Discovery's Press Release -

Braasch Biotech : Novel Patent for Somatostatin Vaccines in High-Value Therapeutic Markets

29 May 2010 - Braasch Biotech LLC announces the granting of its United States patent 7,722,881, titled Chloramphenicol Acetyl Transferase (CAT)-Defective Somatostatin Fusion Protein and Uses Thereof by the United States Patent and Trademark Office (USPTO). The patent, enhances the Company’s portfolio of somatostatin vaccine intellectual property, and is directed to target the down-regulation of somatostatin, which controls circulating growth hormone and Insulin-like Growth Factor-1 (IGF-1) .The patent’s subject matter constitutes the Company’s first patent in the area of therapeutic vaccines.

“Braasch is compiling a designed portfolio of intellectual property with value tied to the unique scope of the target label claims for its somatostatin vaccines. Today’s patent issuance comes less than 2 years after its initial filing, indicative of the relevance of the technology,” stated Keith Haffer, Ph.D., president of Braasch. ”With the archetype hormone somatostatin presence in all vertebrate species, the use of our technology can be adapted for various animal models to drive our therapeutic vaccine pipeline. We view today’s milestone as more than just another patent issuance; it is a development that significantly enhances the fundamental usefulness and functionality of our growing somatostatin vaccine estate.”

Braasch Biotech is implementing a proactive strategy to continue to build and strengthen a diverse and competitive intellectual property portfolio that provides the company and its partners with a strong proprietary position in the therapeutic vaccine space. The company has filed additional patent applications in the US and Europe for its technologies for obesity, diabetes type 2, Myocardial Diseases, Rett Syndrome, as well as productivity enhancement vaccines for animal livestock... Braasch Biotech's Press Release -

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 -

Rhythm Pharmaceuticals : RM-493 Reverses Obesity and Insulin Resistance in Obese Primates

June 21, 2010— Rhythm, a biotechnology company developing peptide therapeutics for metabolic diseases, announced a study of obese primates treated with RM-493 showing a reversal of obesity and insulin resistance, and improvement in both heart rate and blood pressure. RM-493 is a novel peptide agonist targeting the melanocortin 4 receptor (MC4R) that is a clinical candidate for the treatment of obesity and diabetes. The study, “A Novel MC4R Agonist Reduces Body Weight and Improves Glucose Homeostasis in High Fat Diet-Induced Obese Rhesus Macaques,” was presented at the 92nd annual meeting of the Endocrine Society (ENDO 2010) in San Diego.

“The goal of this study was to determine the effects of RM-493 on food intake, weight, and cardiovascular function, as well as to evaluate safety with long-term treatment,”... Rhythm's Press Release -

Abbott : Statement on the FDA Advisory Committee Recommendation on Sibutramine

September 15, 2010 — The U.S. Food and Drug Administration (FDA) held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia® in the United States). In response to the Advisory Committee's mixed vote, Abbott issued the following statement:

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine. Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."

"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun. "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia. Abbott intends to consult with the FDA on sibutramine moving forward.

Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment. More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information... Abbott's Press Release -

Crospon : EndoFLIP® system presented at International Obesity Surgery Congress 2010

9th September 2010 - Crospon, an Irish medical device developer based in Galway, has announced results of a study presented at the 15th Annual Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO 2010), in Long Beach, CA.

The study which took place at the Speciality Surgery Center of Fort Worth, TX, a Center of the AIGB True Results clinical network, the largest gastric band placement network in the world, under the direction of Principal Investigator Dr. Robert G. Snow, demonstrated that 30% of the patients measured achieved greater than 30% excess weight loss in the 4-6 week period after surgery. Even though they had a band adjustment during surgery, no patient required their band to be loosened in the post-operative period.

Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area. Earlier this year Crospon launched its EndoFLIP® product in the U.S. market at the 12th World Congress of Endoscopic Surgery in National Harbor, Washington DC. The EndoFLIP® product which received FDA clearance in December 2009 is the first product of its kind, which allows a bariatric surgeon to measure and set a consistent gastric band stoma size during surgery... Crospon's Press Release -

Orexigen Therapeutics and Takeda Pharmaceutical : Partnership to Commercialize Contrave® in North America

September 2, 2010 – Orexigen® Therapeutics, Inc. (Nasdaq: OREX) and Takeda Pharmaceutical Company Limited (TSE: 4502), announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen’s investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.

Under the terms of the agreement, Orexigen and Takeda will work together on ongoing development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share in the costs of any future development of the product.

“Takeda is an ideal partner for Contrave given its proven track record in commercializing innovative medicines and its commitment to the treatment of obesity,” ... Takeda Pharmaceutical's Press Release - Orexigen Therapeutics' Press Release -

NeuroSearch : Interim report for H1 2010 - Tesofensine – Obesity

25 August 2010 – The Board of Directors of NeuroSearch A/S (NEUR) considered and adopted the company’s interim report for the period 1 January to 30 June 2010.

The operating result for the period was a loss of DKK 168.0 million (a loss of DKK 204.1 million in the same period of 2009). The company’s capital resources totalled DKK 808.4 million at 30 June 2010 (DKK 488.9 at 30 June 2009), consisting primarily of highly liquid short-term bonds and guaranteed future payments from partners. Financial net income for the period positively affected net results by DKK 20.5 million.

Key business events and development in the second quarter of 2010 and the subsequent period:

Huntexil® (pridopidine) – Huntington’s disease...

[...]

Tesofensine – Obesity
– A new Phase III plan is in preparation and in this relation NeuroSearch is closely following the US regulatory authorities' evaluation of other drugs to treat obesity. A revised Phase III plan is expected to be ready for discussion with the US and the European regulatory authorities in the fourth quarter of 2010.
– NeuroSearch will continue the dialogue with potential partners with the aim of signing a licensing agreement before the initiation of Phase III... NeuroSearch's Press Release -

Lannett : FDA Approval For Phentermine Hydrochloride Capsules USP 30 MG...

July 20, 2010 – Lannett Company, Inc. (NYSE AMEX: LCI) announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.’s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg. According to Wolters Kluwer, U.S. sales of Phentermine Hydrochloride Capsules USP, 30 mg in 2009 were approximately $36.5 million at Average Wholesale Price (AWP). This does not include sales of Phentermine made directly to consumers through clinics.
Phentermine Hydrochloride is indicated as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index... [PDF] Lannett's Press Release -

TOSHIBA : MR SYSTEM ENABLES CENTRAL MISSISSIPPI MEDICAL CENTER TO SUCCESSFULLY IMAGE BARIATRIC PATIENTS

June 28, 2010 - TOSHIBA MR SYSTEM ENABLES CENTRAL MISSISSIPPI MEDICAL CENTER TO SUCCESSFULLY IMAGE BARIATRIC PATIENTS - Large Open-Bore Vantage Titan MR System Allows Facility to Image Bariatric Patients Who Were Previously Sent to Other Facilities for Imaging – Obesity is a growing trend in the United States, requiring hospitals to provide medical imaging technology designed to accommodate bariatric patients without compromising diagnostic confidence or patient comfort. To accomplish this goal, Central Mississippi Medical Center (CMMC) in Jackson, Miss., a bariatric center of excellence, recently installed Toshiba America Medical Systems, Inc.’s Vantage TitanTM MR system. The Titan’s 71 cm aperture and large open bore enables CMMC to better serve its bariatric patient population with an MR system capable of imaging obese patients with comfort and confidence.

“Before installing the Titan, we could not accommodate many of our bariatric patients using MR and had to send them elsewhere for MR imaging,”... Toshiba's Press Release -

7TM Pharma : positron emission tomography preclinical research program to successfully demonstrate peripheral restriction of its CB1 receptor...

July 12, 2010 - 7TM Pharma announced positive preclinical Positron Emission Tomography (PET) data in non human primates with their proprietary drug candidate TM38837, which was discovered at 7TM Pharma and is being developed for treatment of obesity, type 2 diabetes and related metabolic disorders. In line with a full range of other experiments, the data clearly demonstrate the principle feature of this first in class compound, namely that it is peripherally restricted. A direct comparison between TM38837 and rimonabant, a brain penetrant CB1 receptor antagonist, importantly exhibited a clear difference between their propensities to cross the blood brain barrier in favor of TM38837... 7TM Pharma's Press Release -

Eisai & Arena Pharmaceuticals : Marketing and Supply Agreement for Lorcaserin

July 1, 2010 - A Potential Treatment for Obesity and Weight Management - Companies Sign Marketing and Supply Agreement; Arena Eligible to Receive Over 30% of Eisai's Net Sales and $1.37 Billion in Other Payments - Eisai Inc., the U.S. pharmaceutical operation of Tokyo-based Eisai Co., Ltd., announced that it has entered into an agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., for exclusive U.S. rights to commercialize lorcaserin, a drug candidate for potential use in the treatment of obesity, including weight loss, for patients who are obese (Body Mass Index or BMI ≥ 30) or overweight (BMI ≥ 27) with at least one weight-related co-morbid condition. If approved by the Food and Drug Administration (FDA), Eisai will market and distribute lorcaserin in the United States. Arena will handle the manufacture and supply of the finished commercial product at its facility in Switzerland.

"Obesity is one of the most pressing public health issues of our day and one which cannot be overlooked,"... Eisai's Press Release - Arena Pharmaceuticals' Press Release -

Zafgen : Data on a New Class of Medicines to Treat Obesity at the American Diabetes Association Annual Meeting

June 26, 2010 – Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor (MetAP2), for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models. These findings are significant as they show for the first time the long-term weight- and glucose-lowering effects of MetAP2 inhibitors in rodent and non-rodent models of obesity, supporting their potential for treatment of human obesity and its related metabolic disorders. MetAP2 inhibitors work by reestablishing balance to the ways the body processes fat, leading to substantial loss of body weight and improved glucose tolerance... [PDF] Zafgen's Press Release -

Novo Nordisk : phase 3 development of liraglutide for obesity

22 June 2010 - Novo Nordisk announced the decision to re-initiate the global phase 3 development programme of liraglutide for the treatment of obesity.
Following the US approval of Victoza® for the treatment of type 2 diabetes, Novo Nordisk has been in dialogue with the FDA regarding the further progression of the development programme investigating the potential of liraglutide within obesity. Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global phase 3 programme in the first half of 2011 in clinical trials comprising approximately 5,000 patients.
The re-initiation of liraglutide obesity trials underlines Novo Nordisk's dedication to the development of the liraglutide portfolio, that is the cardiovascular outcomes trial for Victoza® (LEADER(TM)), the obesity programme, the fixed-ratio combination of insulin degludec and liraglutide, and finally a once-weekly version of liraglutide.Novo Nordisk remains committed to the development of a longer-acting GLP-1 analogue and now expects to outline the clinical development strategy for semaglutide, a once-weekly GLP-1 analogue, and the once-weekly version of liraglutide in the second half of 2011... Novo Nordisk's Press Release -

EnteroMedics : Data From VBLOC-DM2 ENABLE Study to Be Presented at American Society for Metabolic and Bariatric Surgery Meeting

Jun 22, 2010 -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that updated clinical results from the Company's VBLOC-DM2 ENABLE (DM2) study will be presented on June 26, 2010 at 11:30 AM PT at the 27th Annual Meeting of the American Society of Metabolic and Bariatric Surgeons (ASMBS), being held June 21-26 in Las Vegas, NV. The Company also announced updated data from its EMPOWER(TM) study in obesity.

"The Maestro System has been studied in over 400 people to date, with some patients into their fifth year of follow-up," said President and CEO Mark B. Knudson, Ph.D. "Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community."... EnteroMedics' Press Release -

TransEnterix SPIDER Surgical System : In Use at Hospitals Across the U.S.

4/1/10 - Officials at TransEnterix announce that surgeons at hospitals across the United States now are treating patients with the company’s proprietary SPIDER® Surgical System.

Starting last week, surgeons used the platform to perform a wide variety of multi specialty procedures ranging from gallbladder removal to weight-loss gastric banding to colon resections. Participating surgeons and medical centers included:

Dr. John Bagnato at Palmyra Medical Center in Albany, Ga., Dr. Tiffany Jessee at Palms of Pasadena Hospital in St. Petersburg, Fla., Dr. Wade Naziri at Pitt County Memorial Hospital in Greenville, N.C., and Dr. William Kelley at Henrico Doctors’ Hospital in Richmond, Va. “In the past 20 years, we have seen the evolution of abdominal surgery go from large, 6- to 8-inch incisions to multiple small, less-than 1-inch keyhole incisions, which greatly improves patient recovery,” Bagnato said. “With the SPIDER Surgical System, the technology now exists to attain a standard in patient care where a safe single keyhole incision is a reality.”

With the successful deployment of the SPIDER Surgical System, TransEnterix is doing more than introducing a new medical device, said Todd M. Pope, president and CEO. The company is creating an entirely new category of surgery, Flexible Laparoscopy, which Pope described as combining the capabilities of small, catheter-based instruments with the proven techniques of traditional laparoscopic surgery... TransEnterix's Press Release -

INTERLEUKIN GENETICS AND STANFORD UNIVERSITY : GENETIC TEST IMPROVES WEIGHT LOSS SUCCESS

March 3, 2010 – Interleukin Genetics, Inc. (NYSE Amex: ILI) announced presentation of findings from a retrospective clinical study on weight management conducted in collaboration with Stanford University. The study results and conclusions were presented by investigators from Stanford Prevention Research Center at Stanford University School of Medicine during an oral presentation titled “Genotype Patterns Predict Weight Loss Success: The Right Diet Does Matter,” at the American Heart Association’s Joint 50th Cardiovascular Disease Epidemiology and Prevention – and – Nutrition, Physical Activity and Metabolism conference, being held March 2-5 in San Francisco, CA.

In 2008, Interleukin Genetics and Stanford University began a research collaboration to determine whether individuals who were assigned diets that were appropriate for their genotype could lose more weight than those who followed a diet inappropriate for their genotype, as determined by the Interleukin Genetics proprietary Weight Management Genetic Test. The findings showed statistically significant greater weight loss, metabolic benefit and other improvements when compared to individuals on diets not matched to their genotype... Interleukin Genetics' Press Release -

Allergan : Campaign to Urge Greater Attention to Critical Need for Both Prevention and Treatment to Effectively Address Adult Obesity

May 13, 2010 - Campaign Highlights Importance of Prevention Programs While Calling for Urgent Recognition of Necessity of Treatment to Help the 70 Million Americans Currently Struggling with Obesity - Allergan, Inc., (NYSE: AGN) makers of the LAP-BAND(R) Adjustable Gastric Banding System, announced the launch of a new national public awareness and advocacy campaign called C.H.O.I.C.E. Choosing Health over Obesity Inspiring Change through Empowerment which advocates for consumers, healthcare professionals and Congress to work together to successfully address the obesity epidemic through a dual focus on prevention and treatment. The campaign calls for greater understanding and recognition that obesity is NOT a choice self-selected by those struggling with excess weight, but rather a serious disease that remains the second leading cause of preventable death in the United States, second only to smoking,(2) and as such requires the same national attention and urgent treatment as other serious diseases, such as cancer and heart disease. Through a range of initiatives starting in May 2010, the C.H.O.I.C.E. Campaign will drive and encourage dialogue and action among communities, members of the media and Congress to change how America views obesity and raise awareness of the critical need for greater access to and acceptance of all effective treatments to fight obesity, including weight-loss surgery for those individuals who are severely obese (defined as approximately 100 pounds or more overweight)... Allergan's Press Release -

SPO Medical : Innovative Wellness Bracelet

May 25 2010 - SPO Medical Inc. (SPOM), a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices, announced that it has designed a unique bracelet to measure the overall daily activity level of an individual and specifically for use by those who are deemed to be overweight or obese. The bracelet, designed both for children and adults, has innovative features including display functionality and a time-piece which continuously measures number of daily movements against preset recommended goals. Furthermore, the attractive wrist design is designed to encourage these individuals to wear the bracelet with pride.
According to independent reports, approximately 100 million adults and children today in the US are considered to be obese; a condition defined as having a Body Mass Index (BMI) in excess of 30. In addition, obesity is known to be a major factor for cardiovascular disease, diabetes and certain types of cancer... [PDF] SPO Medical's Press Release -

Aegis Therapeutics and Albany Medical : Collaboration for Novel Oral Anti-Obesity Drug

August 26, 2009 – Aegis Therapeutics and Albany Medical College announced that they have expanded their existing research relationship, entering into a joint commercialization agreement to promote the clinical development of Albany Medical College’s patented anti-obesity peptide drug. Under this agreement, Aegis will be responsible for developing an appropriate partnership with a pharmaceutical company interested in commercializing this exciting new drug in the obesity and diabetes fields... [PDF]Aegis Therapeutics' Press Release -

Spatz FGIA : First Implants of Spatz (TM) Adjustable Intragastric Balloon System

October 19, 2009 - Spatz FGIA, Inc., a privately held medical device company, announced the first implants of its Spatz (TM) Adjustable Balloon System. The Spatz (TM) Adjustable Balloon System is a non-surgical weight loss therapy for the overweight and obese. The system’s innovative features offer greater weight-loss success, increased patient safety, and ease of use for the physician... Spatz FGIA's Press Release -

PROLOR Biotech : LICENSE OPTION FROM YEDA FOR DEVELOPMENT OF LONG-ACTING ANTI-OBESITY DRUG

July 27, 2009 -- PROLOR Biotech, Inc. (OTCBB: PBTH) formerly Modigene Inc., announced that it has entered into an evaluation and option agreement with Yeda Research and Development Company Ltd., the technology transfer arm of the Weizmann Institute of Science. Under the terms of the evaluation and option agreement, PROLOR may obtain from Yeda a license to develop a number of peptide drug candidates, including an anti obesity peptide, utilizing a delivery technology developed at the Weizmann Institute. The Weizmann Institute of Science is a world-renowned center of natural and exact sciences research and higher learning based in Rehovot, Israel... [PDF] PROLOR Biotech's Press Release -

Mylan Pharmaceuticals : Marketing First Generic Version of Desoxyn(R)

April 26, 2010 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market Methamphetamine Hydrochloride Tablets USP, 5 mg, based on an agreement with licensing partner Coastal Pharmaceuticals. This product, used for the treatment of attention deficit hyperactivity disorder or obesity, is the first generic version of Lundbeck's Desoxyn(R) to be approved by the U.S. Food and Drug Administration (FDA)... Mylan' Press Release -

Gelesis : novel non-invasive capsulated device for obesity and presents clinical data

4/22/10 -Boston-based medical technology firm Gelesis, Inc. unveiled its capsulated device Attiva™, and presented data showing that Attiva™ significantly increased the post-meal feeling of satiety and reduced hunger between meals in obese patients. This data was presented at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting & Clinical Congress.

Attiva™, the first and only superabsorbent hydrogel composed entirely from food components, is administered in the form of small particles that are designed to swell after ingestion with water and occupy the gastric and intestinal cavities, inducing a feeling of satiety that lasts beyond its transit time in the stomach. Afterwards, it safely degrades in the colon and releases absorbed liquids. When fully swollen, the product creates very small and individual gel beads that are mixed homogenously with the food in the stomach and also have the same elasticity and viscosity as foods.

"For the first time a group was able to overcome the enormous technical hurdles in creating a super-absorbent polymer made entirely out of food,"... Gelesis' Press Release -

ZenBio Licenses an Important Cell Line from Harvard to Drive Metabolic Disease Research RESEARCH

December 1, 2009 - ZenBio announce that they will be a commercial source for the popular murine 3T3-L1 cell line, which has been fundamental in metabolic disease research for 30 years. Originally derived from Swiss mouse embryo tissue by Dr. Howard Green of the Department of Cell Biology at Harvard Medical School, the 3T3-L1 system has been pivotal in advancing the understanding of basic cellular mechanisms associated with diabetes, obesity and other related disorders.
3T3-L1 is a cell line derived from 3T3 cells that is used extensively in research on adipose tissue, making the line popular for metabolic disease research studies. 3T3-L1 cells have a morphology that resembles fibroblasts, but under the right conditions the cells will differentiate into a phenotype that mimics the behavior of adipocytes. The 3T3-L1 in vitro system has proven a highly useful complement to primary human adipocyte cultures, and has been used extensively by scientists to unlock many of the mysteries of metabolic diseases. The 3T3-L1 cell line is recognized as a very well-characterized, consistent in vitro system, and has served as the basis for a wide range of published studies... [PDF] ZenBio's Press Release -

MDRNA : Patent Allowance Covering Intranasal Formulations for Y2-Receptor Agonists

Apr 12, 2010 - Allowance Broadens Portfolio for the Treatment of Obesity and Related Diseases - MDRNA, Inc. (NASDAQ: MRNA), a leading RNA interference (RNAi)-based drug discovery and development company, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application U.S. 12/234,547 covering formulations for the intranasal delivery of Y2 receptor selective agonists.

Y2-receptor agonists are a family of peptides (pancreatic polypeptide, peptide YY, and neuropeptide Y) that play a central role in caloric intake. The natural release of these peptides in association with meals directly influences how efficient and effective the body utilizes sugars, carbohydrates and other nutrients. Y2-receptor agonists can regulate food intake at the level of the brain, pancreas, and intestinal tract, and may provide treatment to prevent overeating and excessive weight gain, and the numerous adverse health effects associated with obesity.

"MDRNA's focus remains the development of therapeutic products based on RNAi, however we believe that our legacy nasal assets have significant value,"... MDRNA's Press Release -

Orexigen Therapeutics and Patheon : Exclusive Manufacturing Agreement for Contrave(R)

March 12, 2010 - Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc. (TSX: PTI), a global provider of drug development and manufacturing services, announced a long-term agreement for commercial manufacturing of Contrave(R) (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products. The financial terms of the deal were not disclosed.


"Patheon's manufacturing capabilities provide us a proven platform to help ensure successful market entry and stable commercial supply of Contrave in the event it is approved,"... [PDF] Patheon's Press Release - Orexigen's Press Release -

Amylin and Takeda : Decision to Advance Development of Pramlintide/Metreleptin Combination Treatment for Obesity

February 22, 2010 – Phase 2 Extension Study Demonstrated Sustained Weight Loss - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.


“There is an enormous unmet need to help reduce the individual and economic burden of obesity,”... Takeda's Press Release - Amylin's Press Release -

Ipsen Grants Rhythm Exclusive Worldwide License for Two Programs in the Field of Metabolic Disorders

March 12, 2010— Ipsen (Euronext: FR0010259150; IPN), a global biotechnology specialty care group, and Rhythm Pharmaceuticals (Rhythm), a biotechnology company developing peptide therapeutics for metabolic diseases, announced that they have concluded a license agreement for Ipsen’s proprietary peptide therapeutics targeting obesity, metabolic diseases, and gastrointestinal disorders. Under the terms of the agreement, Ipsen has granted Rhythm an exclusive worldwide license for research, development, and commercialization of its melanocortin and ghrelin programs originating from Ipsen research.


“The agreement with Rhythm is a clear catalyst for the development of proprietary molecules from Ipsen in promising indications within the area of metabolic diseases, which are outside of our core strategic focus... Rhythm Pharmaceuticals' Press Release - [PDF] Ipsen's Press Release -

Envoy Therapeutics : Diabetes and Obesity Collaboration with Merck & Co., Inc.

January 26, 2010 - Envoy Therapeutics, Inc. announced that it has entered into a multi-year research collaboration agreement with an affiliate of Merck & Co., Inc. to discover novel diabetes and obesity drug targets.

Under the agreement, Envoy will use its proprietary bacTRAP® technology to identify proteins expressed specifically in certain cell types. Merck will then work to identify and develop compounds that modulate protein targets with therapeutic potential for the treatment of metabolic disorders. Merck will pay Envoy an upfront fee and research funding. In addition, Envoy is eligible to receive payments upon achievement of certain milestones associated with development of drug candidates and royalties on any products derived from the collaboration... [PDF] Envoy Therapeutics' Press Release - Merck's Press Release -

Madeira Therapeutics : Overweight kids are coronary time bombs

11.13.09 - Studies suggest overweight kids are coronary time bombs - CNN recently reported that, with childhood obesity on a disturbing rise, children are becoming coronary time bombs. The evidence is mounting that children are trading playing outside for television and video games. At Madeira Therapeutics, we understand that there is a combination of circumstances contributing to the childhood obesity rate, which has tripled since 1970. We have found heterozygous familial hypercholesterolemia (HeFH) preconditions some children to develop cardiovascular complications, while a less active, more fast food-minded culture has worsened the issue.

While education regarding the urgency of this situation is intensifying, medical professionals are currently burdened with the lack of appropriate treatment options for its complications. Physicians are often compelled to resort to off-label prescriptions of adult formulations, a practice that lacks suitable dose titrations and standardized regulations... Madeira Therapeutics' Press Releases -

BiolActis : filing of a new patent protecting a major discovery with respect to the modulation of the obesity related metabolic pathway

December 11, 2009 - Technologie Biolactis Inc. announces the filing of a new patent protecting a major discovery with respect to the modulation of the obesity related metabolic pathway: Method of regulating PPAR, obesity related pathway and their associated metabolic impact - Technologie Biolactis Inc., a Canadian biotechnology company specializing in the development of lactoceuticals focused on cardiovascular, metabolic and obesity-associated disorders, is pleased to announce the filing of a new patent application protecting the recent discovery of an obesity related metabolic pathway modulation.

Obesity is a chronic disorder of energy imbalance characterized by an excess of energy intake in the long term compared with limited energy expenditure, leading to storage of the excess energy in the form of adipose tissue. Obesity contributes directly to numerous dangerous co-morbidities, including type 2 diabetes, cardio-metabolic diseases, hepatic disorders, cardiovascular disease, inflammatory diseases, premature aging, and some forms of cancer. Obesity has reached epidemic proportions globally with more than 1 billion adults overweight, at least 300 million of them clinical obese.

Following the genomic analysis of the mechanism of action, the bioactive ingredients of BiolActis, called MPM (Malleable Protein Matrix), demonstrated the capacity to modulate specific nuclear receptor, the peroxisome proliferator activated receptors (PPARs), and some biological pathway associated to obesity.

It has been well established that PPARs agonists are key players in establishing strategy to fight obesity. The PPARs are important regulators of carbohydrate and lipid metabolism, cell growth and differentiation, immune-regulation and the inflammatory response. Biological processes modulated by PPARs include, for example, plasma lipid transport and fatty acid catabolism, regulation of insulin sensitivity and blood glucose levels, inflammatory response, weight control and body composition... Technologie BiolActis' Press Release -