7TM Pharma Announces Selection of a New Pre-clinical Development Candidate

Published: Feb 06, 2008

Denmark – February 6, 2008: 7TM Pharma has selected a new pre-clinical development candidate, TM38837, for the treatment of obesity and related metabolic diseases. TM38837 is derived from 7TM Pharma’s discovery program targeting the development of Cannabinoid type 1 receptor antagonists (CB1 antagonists) acting specifically in the periphery of the body.

TM38837 has shown a substantial and robust weight reduction effect in various chronic animal models for obesity. Importantly, it has further been shown to have a very favorable side effect profile in various animal models compared to other known CB1 antagonists.

CB1 antagonists have been demonstrated in a number of clinical trials to reduce body weight and improve obesity associated risk factors, for example Type 2 diabetes. Compounds currently in clinical development and on the market exert their effects via CB1 receptors both in the periphery and in the brain. However, the presence of these compounds in the brain is believed to lead to undesired side effects such as depression and anxiety reported for these compounds. TM38837 has been designed to exclusively exert its therapeutic effect through CB1 receptors located in the peripheral tissue, thereby avoiding these undesired side effects.

“We are very excited about our peripherally acting CB1 program and the selection of our first pre-clinical candidate from this program.” says Mette Kirstine Agger, CEO of 7TM Pharma. “Previous CB1 antagonists have shown clear effects in terms of weight reduction and improvement of associated risk factors. Maintaining this effect with TM38837, while simultaneously improving the safety profile is an important step forwards towards safe and effective medicines in this field and significantly strengthens our pipeline focusing on metabolic disorders.” 7TM Pharma expects to initiate Phase I clinical trials end 2008.

About CB1 antagonists The CB1 receptor antagonist Acomplia® (rimonabant) was the first CB1 receptor antagonist to reach the market in the European Union in June 2006. However, the European Medicines Agency (EMEA) in July 2007, after review by the Committee for Medicinal Products for Human Use (CHMP), recommended not using the product for weight loss in patients suffering from depression or being treated with antidepressants. This was based on the risk of adverse reactions in the form of depression and suicidal thoughts or the worsening of such conditions. In June 2007, the sponsor Sanofi-Aventis withdrew their New Drug Application to have the product marketed in the US after an unfavorable recommendation by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee under the Center for Drug Evaluation and Research (CDER). Unfavorable psychiatric side effects by CB1 antagonists may be mediated by the actions of the drug in the brain.

About obesity Obesity and related metabolic diseases are considered a serious health problem and a challenge to the industrialized world. Obesity substantially increases the risk of developing cardiovascular diseases and Type 2 diabetes and contributes to significant costs in healthcare budgets. According to the WHO, there are more than 400 million clinically obese people worldwide – i.e. people with a BMI of more than 30 – and the number is increasing rapidly. In spite of this, there is only a handful of therapeutics available. These drugs have a limited efficacy with significant side effects, thus there is a large, unmet need for new and safer therapies.

About Type 2 diabetes Type 2 diabetes is the most common form of diabetes and is very closely associated with obesity. Type 2 diabetes accounts for around 90% of all diabetes worldwide. There is an emerging global epidemic of diabetes that can be traced back to rapid increases in overweight, obesity and physical inactivity. WHO estimates that more than 180 million people worldwide have diabetes. This number is likely to more than double by 2030.

About 7TM Pharma 7TM Pharma is a biotech company focusing on discovery and development of new drugs targeting 7TM receptors. 7TM Pharma’s primary therapeutic area is metabolic diseases, including obesity, diabetes and cardiovascular diseases. The basis for 7TM Pharma’s drug discovery is thorough and comprehensive knowledge about 7TM receptors and their structures, which the company uses in the design of new potential drugs. In recent years, the company has established a broad pipeline of research and development programs based on in-house drug discovery and development, and entered into several research partnerships, including with Ortho-McNeil Inc. (a subsidiary of Johnson & Johnson). Since its inception in 2000, 7TM Pharma has raised DKK 610 million (EUR 82 million). Investors include Index Ventures, Novo A/S, Alta Partners, LD Pensions, Johnson & Johnson Development Corporation, Dansk Innovationsinvestering, Sofinnova Capital, Healthcare Private Equity Limited Partnership, Lombard Odier Darier Hentsch & Cie, SR One, Global Life Science Ventures, Baker/Tisch Investments, Credit Agricole Private Equity, GIMV and BioMedinvest AG. For more information on 7TM Pharma, please visit www.7tm.com.

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