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 -

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 -

Hollis-Eden Pharmaceuticals, Positive Preliminary Data from Ongoing Phase I/II Clinical Trial with TRIOLEX in Obese Insulin Resistant Subjects

March 18, 2008--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) announced positive preliminary data from its ongoing 28-day Phase I/II clinical trial in obese insulin resistant subjects with its investigational drug candidate TRIOLEX (HE3286). TRIOLEX is a first-in-class adrenal hormone insulin sensitizer focused on the regulation of unproductive inflammation. Preliminary data to date indicate that TRIOLEX is safe and well tolerated at all doses studied. In addition, the preliminary data thus far suggest that TRIOLEX is reducing fasting blood glucose levels and improving insulin sensitivity as evaluated through euglycemic/hyperinsulinemic clamps, an industry standard measurement for assessing whole body glucose metabolism and to test compounds as potential insulin sensitizers for the treatment of type 2 diabetes. The data were presented at IBC's 6TH Annual Conference, Targeting Metabolic Disorders, being held March 17 through 19 in Chapel Hill, North Carolina, by Jaime Flores-Riveros Ph.D., Vice President of Metabolism and Endocrinology at Hollis-Eden... Hollis-Eden Pharmaceuticals' Press Release -

Bar Harbor BioTechnology : New Line of StellARrays

March 6, 2008 - Bar Harbor BioTechnology Inc. announced the launch of its new line of human StellARray™ products for gene expression research today. This initial offering of 43 different biological pathways for scientists to select from includes many major human diseases. Configured to perform gene expression or gene copy number experiments these new Real-Time PCR arrays are the first of their kind in the field of gene expression research.
"Scientists researching human diseases like obesity, osteoporosis, and Alzheimer's disease have a new method for detecting subtle changes in how a group of genes are expressed. That could lead to a breakthrough in their research," says Robert Phelps, President of Bar Harbor BioTechnology Inc... Bar Harbor BioTechnology's Press Release -

EnteroMedics, Expansion of EMPOWER Pivotal Study for Obesity to 300 Patients

Feb 26, 2008 - EnteroMedics Inc., (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that the Food and Drug Administration (FDA) has granted approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the EMPOWER Study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study.

The EMPOWER Study, which is currently enrolling patients at 10 of its projected 15 clinical sites, is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational VBLOC(TM) vagal blocking therapy using the Maestro(TM) System in obese patients. VBLOC Therapy is designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while minimizing the side effects and complications associated with existing surgical options and preserving the individual's normal anatomy... EnteroMedics' Press Release -

OREXIGEN Therapeutics, European Patent Office Allows Composition and Use Claims for its Patent on Contrave™ to Treat Obesity

Feb 28, 2008 - Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, announced that the European Patent Office has issued a Decision to Grant a Patent covering compositions and uses of bupropion and naltrexone for affecting weight loss. These two drugs are the active constituents in Contrave™, Orexigen's lead product candidate for the treatment of obesity. This development is an important milestone toward an eventual patent validation in individual European countries. This patent, once issued, would provide exclusive rights on this combination in those countries until 2024.

This is the latest in a series of decisions strengthening Orexigen's intellectual property portfolio. A notice allowing the corresponding U.S. patent was received from the United States Patent Office (USPTO) in January, and a notice of allowance from the USPTO was received earlier this month for zonisamide to treat obesity. Zonisamide is a key ingredient in Empatic™, which is in the later stages of Phase II clinical development... Orexigen's Press Release -

Athersys, Results for Phase 1 Safety Study of Its Novel Obesity Drug, ATHX-105

Feb. 27, 2008 - Athersys, Inc. (Nasdaq:ATHX) announced top-line results from its Phase 1 clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity. ATHX-105 was well-absorbed, providing good drug exposures, well-tolerated up to high doses, and had no negative effect on cardiovascular, hematology or other clinical parameters.

"We are pleased with the results of our Phase 1 study," said Gil Van Bokkelen, Ph.D., Athersys Chairman and CEO. "The data is in line with our expectations for ATHX-105, a highly selective 5HT2c agonist. As we have previously noted, we believe that high selectivity for 5HT2c relative to other receptors, such as 5HT2b and 5HT2a, is key to safety and tolerability. We believe that these results support the view that better selectivity results in superior tolerability for drugs in this class, which is an important factor for achieving effectiveness and patient compliance."... Athersys' Press Release -