Pharmacology
A Trial to control an epidemic called Obesity
By Akanksha,Pharmacology Correspondent
Jan 21, 2005, 10:32

If there is a metabolic disorder which is most common,is a costly affair to manage and is prevalent worldwide,it is obesity.The World Bank estimates that obesity alone accounts for more than 12% of the U.S. national health care budget.Nearly 61% of all Americans are considered to be overweight, and 26% percent are considered to be obese.The National Institutes of Health estimated that direct costs for the treatment of obesity in 1988 were in excess of $45 billion and accounted for nearly 8% of the total national cost of health care; a decade later, annual direct costs for the treatment of obesity had risen to $102.2 billion dollars.These statistics clearly illustrate that obesity is a rapidly growing, is a costly disease, for which there is currently no effective treatment.

The United States Food and Drug Administration (FDA) has accepted an Investigational New Drug Application (IND) from Manhattan Pharmaceuticals, Inc., for the human clinical testing of its orally administered obesity therapeutic, Oleoyl estrone (OE).

This allows Manhattan to move forward into the next stage of OE's development and was granted on the preclinical chemistry, manufacturing, and safety data submitted to the FDA by the Company.

Oleoyl-estrone (OE), is an orally administered small molecule that has been shown to cause significant weight loss in extensive preclinical animal studies, without the need for dietary modifications. In such studies, OE appears to be safe and effective with no evidence of rebound weight gain after treatment has been discontinued.

Developed by researchers at the University of Barcelona, OE has been tested in both obese and lean rats; treatment with OE resulted in significant weight loss even in the presence of abundant food and water. It is believed that OE will prove to be a safe and effective treatment of obesity, representing a significant advantage over currently available anti-obesity medications.

Diet and physical exercise regimens are difficult to maintain. As a result, most overweight patients can lose only moderate amounts of weight, and usually only for a short period of time.

The current medications for the treatment of obesity have significant side effects that limit their use. In this situation,a safe & effective, orally administered compound that not only produces, but also sustains weight loss, would be a breakthrough in the treatment of obesity, and represent a significant advantage over currently available treatments. The future market opportunity is estimated in the multi-billions of dollars range, given that 2001 sales of the currently approved therapeutics amounted to more than $800 million.

Manhattan expects to commence a Phase I clinical trial in Switzerland in the first quarter of 2005. The Company previously announced approval by the Swiss governmental medical regulatory authority, SwissMedic, to initiate human trials. This double-blinded, placebo controlled trial is designed to evaluate the safety and tolerability of defined doses of orally administered Oleoyl estrone in obese adults.

In November 2003, Manhattan announced the first peer reviewed publication reporting human physiologic responses to OE, including marked weight loss, during 27 months of oral administration. More recently, Company scientists reported favorable preclinical toxicology data for OE at the 13th Annual Meeting of the European Congress on Obesity in May 2004 and additional pharmacology data at the North American Association for the Study of Obesity Annual Meeting in November of 2004.

Patent protection is in place for OE through issued U.S. patents, and foreign patent applications; several additional patent applications have been filed, and others are under development related to formulations. Manhattan Pharmaceuticals, Inc., is the exclusive, worldwide licensee of OE, including derivatives that are currently in development.

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Manhattan Pharmaceuticals, Inc., a development stage pharmaceutical company, acquires and develops proprietary prescription drugs for large, underserved patient populations. In view of the worldwide obesity epidemic, the Company is developing Oleoyl estrone, an orally administered novel therapeutic for weight loss.

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