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

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

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

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

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

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 -