Hanmi : license agreement for a new anti-obesity botanical drug

16, Feb. 2012 - Hanmi pharmaceuticals announced that it has entered into a licensing agreement with AngioLab for a new anti-obesity botanical drug, ALS-L1023.

ALS-L1023 is a Melissa leaf (Lemon Balm) ethyl acetate dried extract, having excellent angiogenesis and MMP inhibitory activities. The inhibition of angiogenesis in the growing adipose tissue is a novel approach for the prevention and treatment of obesity having a high specificity to visceral fat (intra-abdominal fat).

A randomized, double-blind, placebo-controlled, phase II human trial was completed in ASAN Medical Center and Inje University Seoul Paik Hospital. The statistically significant reduction of visceral fat by 15% was observed in comparison with the baseline after 12 weeks. In safety assessment, there was no statistically significant Adverse Events. Furthermore, plasma adiponectin level has increased, while plasma free fatty acid level has decreased... Hanmi pharmaceuticals' Press Release -

Bridge Bioresearch : Completion of Preclinical Trials of 2hydroxyoleic Acid - a Novel Treatment of Obesity

LONDON, January 11, 2012 - Bridge Bioresearch PLC (BBR) announces that the company has completed the preclinical efficacy and safety trials of 2hydroxyoleic acid (2OHOA) a novel treatment of obesity and other metabolic disorders.

BBR has in- licensed 2OHOA from the University of the Balearic Islands (Spain) in 2006 and has continued research in animal models verifying the pharmacological properties as well as safety profile of the 2OHOA molecule. This is an important milestone for the further development of 2HOA and the move from pre-clinical to clinical development of the molecule as all the tests completed to-date have shown the molecule to be biologically active and safe in the standard animal models.

Søren Stenderup, CEO of BBR commented: "The successful completion of the pre-clinical programme is a significant milestone for this molecule. The fact that the product shows good biological activity and no observed toxicity gives us the confidence to commit time and resource to undertaking a full clinical development programme. The observation, in the animal models examined, that the product appears to improve other conditions associated with obesity such as hypertension and the onset of type 2 diabetes is an additional benefit that we will seek to quantify in the clinical trial programme as this will give the product benefits over other treatments for the growing problem of obesity."

About the 2hydroxyoleic acid molecule: 

2OHOA has a granted patent (PCT/ES02/00475) and the clinical development process as drug for the treatment of obesity has already been initiated following the encouraging results from the pre-clinical studies... Bridge Bioresearch's Press Release -

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

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

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

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 -