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Friday, March 21, 2008

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 -

Alizyme's cetilistat,Phase III development programme, for type 2 diabetes as well as for obesity

6 March 2008 - Alizyme plc (“Alizyme”) (LSE: AZM) announces that FDA has agreed
the remaining two protocols for its Phase III development programme for cetilistat under the Special Protocol Assessment (“SPA”) procedure and recommended that Alizyme open a separate diabetes IND.
Cetilistat is Alizyme's metabolic product under development for the treatment of obesity and associated comorbidities, including type 2 diabetes. It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme’s outline plan for the Phase III clinical development programme of cetilistat... [PDF] Alizyme's Press Release -

Merck, Innovative Research Method to Identify Changes in Gene Networks Linked to Obesity

March 17, 2008 - Merck & Co., Inc. announced the publication of two studies providing evidence that genetic susceptibility to obesity involves changes in entire networks of genes and is not limited to mutations in several specific genes. The work also showcases how genomic techniques may be used to understand the complex changes at the root of common diseases where multiple complex genetic changes are thought to be involved. The studies were published online in the peer-reviewed journal Nature.
Scientists at Merck Research Laboratories (MRL) and their collaborators performed genetic and gene expression analysis of tissues from a model of metabolic syndrome (a group of conditions that increases the risk of cardiovascular disease and diabetes) and a human population known to be susceptible to obesity. The resulting data were analyzed using powerful computational methods that integrate data from several sources to identify networks of gene interactions altered in individuals susceptible to obesity... Merck's Press Release -

Marcadia Biotech and Merck, strategic collaboration

March 6, 2008 – Marcadia Biotech, Inc., a privately held drug development company, announced a strategic collaboration with Merck & Co., Inc. to jointly discover, develop and commercialize novel biopharmaceutical therapies targeting the glucagon and related receptors for the treatment of diabetes and obesity.

“Merck is a world leader in the discovery of breakthrough medicines and has proven expertise in the development and commercialization of drugs that treat metabolic diseases,” said Fritz French, CEO of Marcadia. “We are excited about the opportunity to significantly leverage the research we have accomplished to date through this collaboration with Merck.”... [PDF] Marcadia Biotech's Press Release -