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 -