Obesity

Arena Pharmaceuticals and Eisai : FDA Accepts Resubmission of Lorcaserin New Drug Application

2012-01-30T15:30:00.000-08:00

Jan. 10, 2012 - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.

Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, > 30) or patients who are overweight (BMI > 27) and have at least one weight-related co-morbid condition. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.

About Lorcaserin

Lorcaserin is an investigational new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain... Arena Pharmaceuticals' Press Release - [PDF] Eisai's Press Release -

Ember Therapeutics : Nature Publication of Brown Fat Biology Data

2012-01-18T09:32:00.000-08:00

January 11, 2012 - Program Exclusively Licensed from the Dana-Farber Cancer Institute -

Novel Hormone Identified that Augments Brown Fat, Increases Energy Expenditure, and Reduces Obesity and Insulin Resistance -

Ember Therapeutics, Inc., a company harnessing breakthroughs in brown fat biology and insulin sensitization to revolutionize the treatment of metabolic disease, announced the publication of key data supporting its lead brown fat biology program in the journal Nature. The paper details for the first time the discovery and identification of a new hormone, irisin, which is present and identical in mice and humans and has been shown to act on white fat cells in culture and in vivo to stimulate UCP1 expression and brown fat development. The publication outlines how even relatively short treatments of obese mice with irisin caused an increase in energy expenditure with no changes in activity levels or food intake, resulting in improved glucose homeostasis and weight loss.

This research was led by Bruce Spiegelman, Ph.D., professor of cell biology, Dana-Farber Cancer Institute, Harvard Medical School, and a co-founder of Ember, and was funded by the National Institutes of Health. Ember recently entered into an exclusive license agreement with Dana-Farber Cancer Institute for this irisin technology and is optimizing and developing a proprietary molecule designed to augment and activate the body’s brown fat... [PDF] Ember Therapeutics' Press Release -

Isis : Phase 1 Clinical Trial of ISIS-FGFR4Rx a Peripherally Acting Drug to Treat Obesity

2012-01-10T15:53:00.000-08:00

Calif., Dec. 20, 2011 - Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity. ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body's ability to store fat while simultaneously increasing fat burning and energy expenditure. Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects. Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects.

"Obesity is an epidemic in the United States and much of the rest of the industrialized world. Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers. Severely obese patients make up the most rapidly growing part of the obese population. In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients," said Richard Geary, Ph.D., Senior Vice President of Development at Isis. "Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles. Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects."... Isis Pharmaceuticals' Press Release -

Teva UK : generic anti-obesity drug Orlistat

2011-12-20T11:04:00.000-08:00

12th December 2011 - Teva UK Limited launches generic anti-obesity drug Orlistat -

We are delighted to announce the first generic launch of Orlistat, generic equivalent to Xenical® (Orlistat) from Roche...

[...]

...“As the UK’s leading supplier of generics, we’re pleased not only to have the widest portfolio of our competitors, but also to show that we’re well-placed when it comes to innovation and being the first to market.”

Indication

Orlistat is a generic version of prescription-only Xenical® from Roche and is indicated in conjunction with a mildly hypocaloric diet for the treatments of obese patients with a body mass index (BMI) greater or equal to 30kg/m2, or overweight patients (BMI ≥ 28kg/m2) with associated risk factors... Teva UK's Press Release -

Nestlé Health Science : Consensus panel calls for specialised nutritional therapy for the critically ill obese

2011-12-01T08:23:00.001-08:00

September 13, 2011 - A newly published consensus report prepared by a panel of clinical experts, with sponsorship from Nestlé Health Science, reveals that there are opportunities to do more to manage the impact of obesity on the delivery of critical care, particularly in the area of nutrition therapy. With more than 25 percent of ICU patients considered to be obese or severely obese,1 the panel of clinical experts urges hospitals and medical professionals to adapt medical care traditionally designed to meet the needs of average-weight patients to the unique needs of the obese patient population. Patients with obesity, while heterogeneous as a population, are typically predisposed to greater morbidity, higher instances of infection and organ failure, and extended length of stay, all negative clinical outcomes that affect overall recovery.

“The lack of consistent standardized nutrition interventions for the critically ill patient with obesity means that some patients may be overfed and others may be underfed or malnourished. Some may never have their nutritional needs assessed. All of these scenarios can present problems with health outcomes and recovery rates,” said Dr Stephen McClave, M.D., professor of Medicine, University of Louisville, and moderator of the consensus panel.

The consensus report, published as a supplement to the September 2011 issue of the Journal of Parenteral and Enteral Nutrition (JPEN), explores multiple issues related to obesity in the critical care setting including the many challenges associated with applying standard nutrition therapy practice to the obese patient population. Areas of concern include assessment of nutritional status and nutrient requirements, as well as delivery of nutrients, including route of delivery, overfeeding of calories, underfeeding of protein and monitoring of feeding tolerance... Nestlé's Press Release -

Palatin : Phase 1 Trial for Obesity Compound in collaboration with AstraZeneca

2011-11-16T08:00:00.001-08:00

August 4, 2011 – Palatin Technologies, Inc. (NYSE Amex: PTN) confirmed the commencement of a Phase 1 clinical trial of AZD2820, a subcutaneously-administered peptide melanocortin receptor partial agonist, under development as a single-agent therapy for the treatment of obesity. AZD2820 is a clinical candidate selected by AstraZeneca from its collaborative research program with Palatin Technologies.

Obesity is a global problem, with the World Health Organization estimating that over 1.5 billion adults are overweight and over 500 million are obese. Worldwide obesity has more than doubled since 1980. A number of different metabolic and hormonal pathways are being evaluated by companies around the world in efforts to develop better treatments for obesity. Scientific research has established that melanocortin receptors have a role in eating behavior and energy homeostasis, and that some melanocortin receptor agonists decrease food intake and induce weight loss in animal studies.

The single center study is expected to enroll 90 subjects in a randomized, single-blind, placebo-controlled, Phase 1 trial in healthy male volunteers... Palatin Technologies' Press Release -

VIVUS : Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment

2011-11-04T09:09:00.000-07:00

Nov. 3, 2011 - Weight Loss Accompanied by Improvements in Cardio-Metabolic Risk Factors -

VIVUS, Inc. (NASDAQ: VVUS) announced that results from the 56-week EQUIP study were published in Obesity, the peer-reviewed journal of The Obesity Society. The EQUIP study evaluated the efficacy and safety of the investigational drug Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients across 91 sites in the US. In addition to average weight loss of 14.4% of initial body weight among those who completed the study at the top dose of Qnexa, severely obese patients had improvements in blood pressure, glucose, triglycerides and cholesterol. The results with Qnexa suggest the potential to effectively treat severely obese patients without surgery.

"Obesity is a serious medical condition that threatens the public health and reduces the quality and length of lives. Currently available treatments are limited and options are needed," said lead investigator Dr. David Allison, director of the Nutrition Obesity Research Center, University of Alabama at Birmingham. "In this population of severely obese patients, those taking Qnexa experienced significant weight loss and reduction in risk factors for many chronic diseases. The results refute a common notion that nonsurgical treatments are not effective for extremely obese persons. The findings are especially relevant to the 14% of the US adult population classified as extremely obese."

Patients in the study had a baseline body mass index of >/= 35 kg/m2, and an average initial weight of 256 pounds. Treatment was well tolerated, with no evidence of serious adverse events induced by treatment... VIVUS' Press Release -

Digna Biotech and Biotecnol : Cardiotrophin 1 shows promising results for treatment of obesity and metabolic syndrome

2011-09-28T15:19:00.000-07:00

14 September 2011 - Scientists from the Center for Applied Medical Research (CIMA) of the University of Navarra (Spain) have discovered that cardiotrophin 1, a protein synthesized by muscle cells and adipose tissue, has a marked effect on fat and glucose metabolism. "These new findings add to those we already know on this compound such the anti-ischemic and cytoprotective effects showed in acute liver damage and solid organ transplants gives CT-1 great possibilities to be developed in various serious conditions”, commented Pablo Ortiz, CEO of Digna Biotech.

The study was published in the August issue of Metabolism Cell, most prestigious journal in Metabolism and further details were described in the 25th August of SciBX, the Biocentury/Nature publication. The researchers found that the administration of cardiotrophin 1 accelerates the elimination of fat from the adipose tissue and increases the rate at which fat is burnt in muscles. Treatment of obese and diabetic mice with cardiotrophin 1 increases energy expenditure, reduces food intake and corrects obesity and diabetes. Investigators noticed that, in addition to its effects on fat metabolism, cardiotrophin 1 promotes the entrance of glucose into the cells and increases the sensitivity to insulin. The investigation has been leaded by M. Bustos, J. Prieto and MJ Moreno-Aliaga at CIMA.

Cardiotrophin 1 is co-developed for its use in organ transplantation and tissue regeneration by Digna Biotech and Biotecnol (The Consortium). Both of the companies signed an Exclusive License and Option Agreement with Genentech, Inc (a fully owned subsidiary of the Roche group) on September 2009. Pablo Ortiz remarked: "Cardiotrophin 1 showed a very interesting effect on fat metabolism which deserves to be explored in a clinical setting. We are ready to recruit healthy volunteers in the Phase I trial before the end of the year. Phase II in liver resection is scheduled for the second quarter of 2012. We are also confident that these new applications and the progress on the clinical development will allow us to forge partnerships with other biopharmaceutical companies to reach the patients as soon as possible”... Biotecnol 's Press Release - Digna Biotech's Press Release -

Bionovo, Inc. : to Present Tissue Selective Estrogen Receptor Modulators for Obesity at the 22nd Annual Meeting of the North American Menopause Society

2011-09-20T16:46:00.000-07:00

Sept. 20, 2011 -- Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced that Dr. Mary Tagliaferri, President and Chief Medical Officer of Bionovo, will present the results of a study on the effects of two botanically-derived, tissue selective estrogen receptor modulators for the treatment of obesity at the 22nd Annual Meeting of the North American Menopause Society (NAMS) in Washington DC on Friday, September 23, 2011.

On average, women transitioning through menopause experience a 10-15 pound weight gain with a redistribution of fat to the abdomen. Menopausal changes of body weight and increased central distribution of body fat have been identified as independent predictors of cardiovascular disease and type 2 diabetes. Dr. Tagliaferri will present studies that identify a new class of botanically-derived, tissue selective estrogen receptor modulators in adipose tissue which cause weight loss in mice without the unwanted proliferative effects in breast and uterine tissue that are associated with cancer... Bionovo's Press Release -

EnteroMedics : Presentation of Maestro(R) RC System Clinical Data at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders

2011-09-05T14:27:00.000-07:00

09/02/11 -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, announced that data from the Company's VBLOC-DM2 ENABLE (DM2) trial evaluating the Company's second generation Maestro RC System in the treatment of obesity, diabetes and hypertension, was presented at the XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), held August 31 to September 3 in Hamburg, Germany. The oral presentation, titled "Treatment of Obesity-Related Co-Morbidities with VBLOC Therapy," was delivered by Miguel Herrera Hernández, M.D., Instituto Nacional de la Nutrición, Mexico, an investigator in the DM2 trial.

DM2 trial results presented at IFSO reflect statistically significant, sustained improvement in glycemic control and blood pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The 18-month data presented at IFSO included: excess weight loss (EWL) of approximately 24.6% (n=22), a mean reduction in HbA1c of 1.2 percentage points from a baseline of 8.1% (n=13), a change in fasting plasma glucose of -38.4 mg/dl from a baseline of 151.4 mg/dl (n=12) and, in hypertensive patients (n=10), a reduction in mean arterial pressure of 13.0 mmHg from a baseline of 99.5 mmHg and a reduction in diastolic blood pressure of 15.9 mmHg from a baseline of 87.2 mmHg (n=10). Through 18 months, no change in mean arterial pressure was observed in patients that did not present with hypertension (n=10)... EnteroMedics' Press Release -

BioRestorative Therapies : License Agreement with University of Utah to Obtain Adipose (fat) Tissue for its Thermostem Program to Treat Obesity and ..

2011-08-25T14:35:00.000-07:00

Aug. 25, 2011 - BioRestorative Therapies, Inc. (OTCQB: SCLZ) ("BRT") announced that it has entered into a Tangible Property License Agreement with the University of Utah. The two year license agreement enables BioRestorative Therapies to obtain adipose (fat) tissue that will be used for research purposes to develop and commercialize its ThermoStem Program, which is an adult derived stem cell-based program to treat metabolic and obesity related disorders, using the thermogenic or heat producing properties of brown fat.
The agreement marks the beginning of a strategic collaboration between BRT and the University of Utah, an institution recognized as a leader in translational stem cell-based therapies. This relationship offers BRT an opportunity to procure adipose tissues from donors (tissue and cells that are usually difficult to obtain) to be used for BRT's cellular research and characterization studies... [PDF] BioRestorative Therapies' Press Release -

GI Dynamics : Australian TGA Approval For the EndoBarrier® Gastrointestinal Liner for the Treatment of Type 2 Diabetes and Obesity

2011-08-04T14:07:00.000-07:00

July 25, 2011 – GI Dynamics, Inc. (GI Dynamics), a company focused on the development and commercialization of effective, non-surgical approaches for the treatment of type 2 diabetes and obesity, announced that the Australian Therapeutic Goods Administration (TGA) has approved the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) for inclusion on the Australian Register of Therapeutic Goods (ARTG). The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.
“Gaining approval to commercialize the EndoBarrier in Australia is another important milestone for our company,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We look forward to working with Australian diabetes experts and leading centers to bring the EndoBarrier to market in this country.”... GI Dynamics' Press Release -

Unigene : Positive Advanced Preclinical Data for UGP281 a Potent, Orally Delivered Anorexigenic Peptide

2011-07-19T14:23:00.000-07:00

Jun 27, 2011 - UGP281 demonstrated significant and sustained weight reduction over several weeks using oral formulation - Unigene expects to file IND and commence Phase 1 studies in 1H 2012 - Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced that the Company presented positive preclinical data for UGP281, its potent, orally-delivered anorexigenic peptide as a late-breaking poster presentation at the American Diabetes Association (ADA) 71st Scientific Sessions being held June 24-28 in San Diego, California.

Poster Presentation

Titled: "Preclinical Studies with UGP281, a Potent, Orally Delivered, Anorexigenic Peptide", and authored by N. Mehta, W. Stern, A. Sturner, S. Carl, V. Ray, A. Conslavo, C. Sisk, F. Ritacco, N. Souders, S. Pennington, J. Jiacchi, K. Veintimilla, C. Meenan, A. Vryhoff and A. Bolat.

Summary

UGP281 is a peptide hormone analog that shows an acute dramatic reduction in food intake in a rat model at low doses. The peptide has been produced by recombinant expression in E. coli and has also been formulated in enteric-coated capsules for oral delivery. The effect of UGP281 on food intake and body mass has been investigated in several preclinical studies. In a 20 day chronic dosing study, young rats injected daily with UGP281 at doses of 5 ug/kg and 20 ug/kg exhibited an immediate acute dose dependent reduction in food intake of 55% and 84%, respectively and a sustained weight loss relative to placebo of 5.7% and 8.8%, respectively. A placebo-controlled study in Beagle dogs with enteric-coated capsules containing UGP281 demonstrated a sustained weight reduction of >8% compared to placebo for a period of 5 weeks. In comparative studies at comparable concentrations, UGP281 demonstrates greater reductions in body weight than other peptide drugs currently in development. Based on the results to date, UGP281 was well tolerated and offers the potential of a patient friendly orally dosed peptide therapy for the management of obesity... Unigene Laboratories' Press Release -

AMRI : Successful Completion of Phase I Clinical Study of Obesity Compound

2011-07-06T14:56:00.000-07:00

May 31, 2011 - Phase 1 data support the continued development of ALB-127158(a) as a potential treatment for obesity — AMRI (NASDAQ: AMRI) announced the results from its Phase I clinical study on its novel MCH1 receptor antagonist, ALB-127158(a). The results indicate that ALB-127158(a) is well tolerated at the doses tested and shows preliminary evidence of efficacy.

The results were presented at the 18th European Congress on Obesity by Dr. Nicholas Moore, director of development and pharmacology at AMRI. The placebo-controlled study evaluated the safety, tolerability and efficacy of ALB-127158(a) in male volunteers. The study consisted of three components: a single ascending dose arm (SAD) in lean subjects (BMI ≤ 25), a fed/fasted crossover in overweight subjects (BMI ≥ 27) and a 14-day ascending dose arm (MAD) in overweight subjects. Standard safety assessments, ECG monitoring and PK measurements were conducted.

ALB-127158(a) was well tolerated in both the SAD and the MAD; reported events were mild and showed little dose relationship. One of the most common events reported in both the SAD and the MAD was loss of appetite. No drug-related changes in cardiovascular parameters or sleep were observed during any phase of the study. Reductions in “hunger,” “desire to eat,” and test meal consumption were observed. The study met both its primary and secondary objectives, demonstrating safety and tolerability. The data support the continued development of ALB-127158(a) as a potential treatment for obesity... AMRI's Press Release -

VIVUS : Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity

2011-06-30T15:06:00.000-07:00

May 31, 2011 - Presentations to European Medical Community Highlight the Benefits of QNEXA Treatment Including:
- Prevention of Progression to Diabetes
- Sustained Weight Loss over Two Years, and
- Reduction in Cardiometabolic Risk

- VIVUS, Inc. (NASDAQ: VVUS) announced that multiple abstracts were presented over the weekend at the European Congress on Obesity (ECO) in Istanbul, Turkey. ECO is the official obesity congress of The European Association for the Study of Obesity (EASO). ECO is regularly attended by more than 2500 participants from over 75 countries and is considered to be the most important annual scientific event on obesity in Europe.

Highlights from the ECO presentations were as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline. Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes. In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo). In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).

"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight. The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes. This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.

The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks. Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994). All patients received lifestyle modification instruction. QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001). Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.

Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo). The differences between both treatment groups and placebo were significant starting at week 8. Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072). Specifically categorical weight loss over two years was as follows...VIVUS' Press Release -

EndoSphere : Patent for Obesity Treatment

2011-06-24T14:20:00.000-07:00

June 15, 2011 - Patent covers endoscopically implantable devices representing significant innovation in the treatment of metabolic diseases, including obesity and type 2 diabetes - EndoSphere Inc., a medical technology company that holds 23 U.S. and international issued and pending patents, announced that the U.S. Patent and Trademark Office has issued the company a patent covering the use of its endoscopically implantable devices for the treatment of metabolic diseases, including obesity and type 2 diabetes.
U.S. Patent number 7,931,693 titled "Method and Apparatus for Reducing Obesity" describes a noninvasive device that uses the body's natural physiology to regulate appetite and satiety among other potential uses.
"This strong initial patent position, in combination with significant clinical interest, makes EndoSphere an attractive partner in the rapidly growing fields of interventional gastroenterology and obesity treatments... EndoSphere's Press Release -

Boehringer Ingelheim and Zealand Pharma : licence and collaboration agreement to advance novel compounds to treat Type-2 diabetes and obesity

2011-06-21T14:43:00.000-07:00

16 June 2011 - Boehringer Ingelheim obtains global rights to glucagon/GLP-1 dual agonists, including ZP2929, Zealand Pharma’s lead drug candidate in this class - Zealand Pharma is eligible to receive total projected milestone payments of up to €376 million for ZP2929 – ...Zealand Pharma (NASDAQ OMX: ZEAL), a Copenhagen based biopharmaceutical company, and Boehringer Ingelheim, one of the world’s leading pharmaceutical companies, jointly announced an exclusive global licence and collaboration agreement for dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with Type-2 diabetes and patients with obesity.

As part of the agreement, Boehringer Ingelheim obtains global development and commercialisation rights to ZP2929, Zealand Pharma’s lead glucagon/GLP-1 dual agonist drug candidate. Zealand Pharma will be responsible for conducting the first Phase I study with ZP2929 and Boehringer Ingelheim will fund the research, development and commercialisation of products under the agreement.

Depending on the achievement of pre-defined development, regulatory and commercial milestones, Zealand Pharma is eligible to receive payments for ZP2929 and may also receive additional milestone payments if other products covered by the collaboration are advanced through development. Further, Zealand Pharma is entitled to tiered royalties that range from high single to low double digits on global sales of products under the agreement. Zealand Pharma retains co-promotion rights in Scandinavia... Zealand Pharma's Press Release - Boehringer Ingelheim's Press Release -

Regulus Therapeutics and Alnylam Pharmaceuticals : Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes

2011-06-15T13:46:00.000-07:00

June 8, 2011 – Work of scientists with Regulus, Alnylam and ETH Zurich shows microRNAs103/107 are upregulated in mouse models of obesity; targeting with anti-miRs improves glucose homeostasis and insulin sensitivity – Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced the publication in Nature of new pre-clinical data in mice about the antagonism of microRNA-103 and microRNA-107 (miR-103/107). Data from a collaborative study performed by Regulus, Alnylam and ETH Zurich demonstrated that antagonism of miR-103/107 with proprietary chemically modified anti-miR oligonucleotides could promote insulin signaling in both liver and adipose tissue. Silencing miR-103/107 in animal models of obesity improved glucose homeostasis, suggesting that these microRNAs are potential targets for the treatment of diabetes.

Defects in insulin signaling are among the most common and earliest defects that predispose an individual to the development of type 2 diabetes. The new findings demonstrated that miR-103/107 are upregulated in obese mice, and silencing with anti-miRs could improve glucose homeostasis and insulin sensitivity, while gain of function in liver or fat caused impaired glucose homeostasis. Direct targets of miR-103/107 identified include caveolin-1, a critical regulator of the insulin receptor. Upon miR-103/107 inactivation, caveolin-1 is upregulated, resulting in stabilization of the insulin receptor, enhanced insulin signaling, decreased adipocyte size and enhanced insulin-stimulated glucose uptake... Regulus Therapeutics' Press Release - Alnylam Pharmaceuticals' Press Release -

New GE Technology Targets Obesity-related Disease

2011-06-06T14:10:00.000-07:00

25 May 2011 - Visceral “Belly” Fat Application on GE Body Composition Systems Aids in Obesity Assessment and Monitoring - GE Healthcare announced 510k clearance of CoreScan – a widely-accessible application dedicated to quickly and accurately quantifying visceral adipose tissue (VAT), or visceral “belly” fat, during body composition analysis. Hosted on GE Lunar’s iDXA body composition system, CoreScan provides patients and physicians an advanced tool to quantify VAT in order to help assess, manage, and treat obesity-related disease.

“CoreScan offers instant, precise and reproducible fat-quantifying results that go beyond the bathroom scale,” said Laura Stoltenberg, general manager of GE Healthcare’s Lunar business. “As part of an iDXA body composition exam, CoreScan can help patients and physicians tailor individualized health and wellness plans while addressing the growing global danger of obesity-related disease.”... GE Healthcare's Press Release -

Archimedes, Inc. and FDA : Collaboration to Evaluate the Clinical Risks and Benefits of Weight Loss Medications

2011-05-24T21:53:00.000-07:00

January 20, 2011 - Clinical Trial Simulation Will Model Obesity Interventions — Archimedes Inc., a healthcare modeling company, announced that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

The computer model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16 percent more likely to suffer serious cardiac events than those who received a placebo. The model is expected to provide insight into the relationship between patient outcomes and cardiovascular risk factors such as blood pressure, heart rate and cholesterol. The model will then be used to explore outcomes over a 10-year simulated extension of the SCOUT trial.

"We are excited about the collaborative work we are conducting with the FDA to further understand the effects of weight loss medications in a population of 'virtual' patients... Archimedes' Press Release -

GlaxoSmithKline : non-core OTC products to be divested

2011-05-10T13:49:00.000-07:00

Thursday 14 April 2011 - GSK identified the non-core OTC brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. GSK’s intention to divest its non-core Consumer assets was announced at the company’s fourth quarter 2010 results on 3rd February 2011.
The products to be divested, which are primarily sold in Europe and the United States, had sales in 2010 of approximately £500 million, 10% of GSK’s total Consumer Healthcare turnover. They include analgesics: Solpadeine, BC and Goody’s; vitamin and supplement product Abtei; feminine hygiene treatment Lactacyd; and alli for weight management.
Individually, the brands to be divested have strong heritage and good prospects, but GSK has lacked sufficient critical mass in some product categories and certain brands have lacked focus due to other global priorities. GSK therefore believes that other companies are better placed to maximise the potential they offer... GSK 's Press Release -

SATIETY’S TOGA SYSTEM : TOP MEDICAL INNOVATION

2011-04-20T13:15:00.000-07:00

November 10, 2010 - Satiety, Inc. announced that its TOGA® System which enables an incision-free weight loss procedure was named one of the Top 10 Medical Innovations for 2011 by a group of 60 experts from the Cleveland Clinic. The TOGA System was the only therapeutic medical device named to the list among a field of innovative drugs, diagnostics, vaccines and monitoring equipment. One of the selection criteria was that “the innovation had to have significant clinical impact and offer significant patient benefit in comparison to current practices.” The TOGA System was noted as potentially making a weight loss procedure more accessible “for patients who want to lose weight and improve their health but without undergoing major surgery.” In the U.S., there are approximately 22 million surgical candidates by BMI, but only about 1% of these patients undergo surgery each year. According to Company market research, one of the primary reasons many of these patients do not choose surgery is because of their concerns about surgical complications. The TOGA Procedure may be an attractive option for some of these patients who are currently not opting for surgery... Satiety's Press Release -

ARROWHEAD RESEARCH INCREASES OWNERSHIP IN ABLARIS TO 64%

2011-04-13T09:36:00.000-07:00

April 6, 2011 - Ablaris Secures $2.9 Million to Enter Phase I Trial in Second Half 2011 — Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in oncology, obesity and regenerative medicine, announced that majority-owned subsidiary Ablaris Therapeutics, Inc. has completed a second closing of its Series A financing round for gross proceeds of $1.2 million, with aggregate gross proceeds of $2.9 million to date. Arrowhead invested $1.3 million in the offering and holds a 64% stake in the obesity company post closing. Use of proceeds includes upfront licensing payments and expenses associated with preparation for a Phase I clinical trial, expected in the second half of 2011.
"The offering achieved our goal of securing outside capital for Ablaris' license and operations, and provides for incidental costs as we make our way to the clinic," said Arrowhead President and CEO Dr. Chris Anzalone. Direct costs for a Phase 1 clinical trial of Ablaris' first compound are expected to be borne by licensor MD Anderson Cancer Center.

"Preclinical studies of Ablaris' technology have demonstrated considerable promise as a novel way to treat the growing problem of obesity," continued Dr. Anzalone. "While much attention has been given to various anti-obesity therapeutic candidates, the FDA has not approved a new anti-obesity drug in over a decade, leaving a large underserved market in search of a safe and effective treatment. We believe Ablaris’ unique technology that directly targets blood vessels feeding white fat tissue presents a significant advantage as we look to enter the clinic with Ablaris' first drug candidate later this year."
Arrowhead launched Ablaris in December 2010 to commercialize the innovative technology platform developed by Drs. Wadih Arap and Renata Pasqualini at MD Anderson Cancer Center for use in weight loss and obesity-related metabolic conditions... Arrowhead Research's Press Release -

UK Surgeons Perform Europe's First Incisionless POSE Procedures Using USGI Medical's Incisionless Operating Platform™ (IOP)

2011-04-06T13:51:00.000-07:00

September 15, 2010 - SCAR-FREE PROCEDURE DESIGNED TO REDUCE STOMACH SIZE IN OVERWEIGHT AND OBESE PATIENTS - USGI Medical, Inc. the Incisionless Surgery Company, announced that surgeons in the UK are the first in Europe to offer POSE (Primary Obesity Surgery, Endolumenal) to patients for weight loss. The surgeons used USGI's Incisionless Operating Platform™ (IOP), to perform the scar-free procedure designed to reduce the size of the stomach helping patients feel full after consuming less food.

Surgeons Mr. James Byrne and Mr. Jamie Kelly performed Europe's first POSE procedures on six patients at a private hospital in Southampton on August 26. The patients who underwent the procedure returned to work or normal activities within 2-3 days.

"Given the lack of long-term success patients experience with diets and weight loss drugs, we're very proud to be the first in Europe to offer this incisionless procedure to help overweight and obese patients feel full and eat less," Mr. Jamie Kelly said. "This discreet outpatient procedure should result in less pain, shorter hospitalisation, less risk of infection and no visible scars compared to traditional surgeries performed through the abdomen. Our first patients were back at their jobs without any bandages or signs of surgery within two to three days."... USGI Medical's Press Release -

Verva Pharmaceuticals: Isis Pharmaceuticals, Inc. Adds FGFR Drug to Development Pipeline

2011-03-31T14:00:00.000-07:00

31 January, 2011 - Verva Pharmaceuticals Ltd. is pleased to report that Isis Pharmaceuticals Inc. (Nasdaq: ISIS) has formally added ISIS-FGFR4Rx (fibroblast growth factor receptor 4 antisense oligonucleotide) to its development pipeline. In August 2009, Verva announced an agreement providing Isis an exclusive license to Verva’s intellectual property targeting FGFRs with antisense technology for the treatment of metabolic disorders, including obesity. ISIS-FGFR4Rx is the first drug in Isis’ metabolic franchise to treat obesity.

Further details on the ISIS-FGF4Rx program can be found in the recent Isis press release at www.isispharm.com.

Verva CEO Vince Wacher commented: “Isis has been an excellent partner and we are very pleased with the results from our collaborative work on this important target. Isis has advanced its FGFR anti-obesity drug into development... Verva Pharmaceuticals' Press Release -