Sanofi-aventis : NICE Recommends Acomplia to be included in the NHS Guidance

March 26, 2008 - Sanofi-aventis announced that the National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on Acomplia® (rimonabant) which proposes guidance recommending the use of the drug in England and Wales, within its licensed indications, as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of, or are contraindicated to other antiobesity agents that have previously been reviewed by NICE.
Sanofi-aventis is delighted that the Institute has recommended that Acomplia® should be made available for the management of obese and overweight National Health Service (NHS) patients, and believes that Acomplia® is a valuable addition to the limited treatment options currently available... [PDF] Sanofi-aventis' Press Release - [PDF] Communiqué de Presse Sanofi-aventis -

deCODE Obesity Genetics study merck

March 16, 2008 – In a paper published online today in the journal Nature, a team of deCODE scientists detail a major mechanism through which genetic factors contribute to major public health problems. In its work on the inherited components of dozens of common diseases, deCODE has discovered gene variants that significantly affect individual susceptibility or protection against disease...
...In today’s paper, the deCODE team and collaborators from Merck demonstrate one of the principal ways in which the activity of biological pathways is functionally perturbed in a quintessentially complex condition: obesity. Through analysis of adipose tissue from some 1700 Icelandic participants in obesity research cohorts, the deCODE team showed in data derived from primary human tissue that variations in gene expression – in the up-regulation or downregulation of how genes are translated into proteins – have a major impact on several parameters of clinical obesity... deCODE 's Press Release -

Arena Pharmaceuticals' Lorcaserin for Obesity

March 17, 2008 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that following a planned review by an independent Echocardiographic Data Safety Monitoring Board (EDSMB) it is continuing BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), a pivotal trial evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The EDSMB's review of unblinded echocardiographic data performed after patients completed 12 months of dosing in the trial confirmed that differences, if any, in the rates of Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet the EDSMB's predetermined stopping criteria. Based on the EDSMB's review of the rate of FDA-defined valvulopathy, Arena has been able to confirm that the statistical power calculations used in the design of the Phase 3 trial program to monitor patients for increased risk of developing valvulopathy are justified. The findings from the month-12 review build on the EDSMB's September 2007 review that evaluated echocardiograms after 6 months of dosing.

"This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin's cardiovascular safety profile. We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present. BLOOM's primary echo endpoint is based on the month-12 data," said Jack Lief, Arena's President and Chief Executive Officer. "We are committed to continued efforts to develop a robust database for submission to the FDA in our efforts to provide patients a novel, safe and effective obesity treatment."... Arena 's Press Release -

VIVUS, Enrollment in EQUATE (OB-301) Trial completed

March 4, 2008--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, announced that it has completed enrollment in the EQUATE study (OB-301). This trial, initiated in December 2007, will study the effects of Qnexa, an investigational drug, in obese patients with and without co-morbidities over 28 weeks. The EQUATE study has enrolled over 700 patients with Body Mass Index ("BMI") ranging from 30 to 45 in 35 clinical sites. The co-primary endpoints for these studies will evaluate the differences between treatments in mean percent weight loss and in the percentage of subjects achieving weight loss of 5% or more... Vivus' Press Release -

Thiakis, Novel therapy for treatment of obesity enters clinical trials

12 March 2008 – Thiakis Limited, the biopharmaceutical company focused on the development of peptide hormones for the treatment of obesity, announced that it has successfully commenced dosing in a clinical trial of TKS1225, the Company's novel oxyntomodulin analogue, for the treatment of obesity. The trial will initially focus on safety and tolerability before investigating the effects of TKS1225 on appetite and food intake.
TKS1225 is a potent, long acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. Preclinical models have demonstrated TKS1225 to be highly efficacious, ameliorating glucose intolerance as well as causing a significant reduction in body weight... [PDF] Thiakis' Press Release -