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Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metabolic Syndrome
Date:6/17/2008

New Data Highlights the Need for Testosterone Screening in At-Risk

Hypogonadal Men

BEDMINSTER, N.J., June 17 /PRNewswire/ -- New data from a 12-month, international, multi-center study showed that treatment for low testosterone with Tostran(R), a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity and sexual function among hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome. These data were presented today at the Endocrine Society's 90th Annual Meeting in San Francisco. Tostran, also marketed as Fortigel, Tostrex and Itnogen, is available in 13 countries across Europe, and ProStrakan (LSE: PSK), an international specialty pharmaceutical company, plans to file Tostran with U.S. regulatory authorities later this year.

The Testosterone replacement In hypogonadal men with either MEtabolic Syndrome or type 2 diabetes (TIMES 2) study looked at the effects of Tostran on insulin resistance, diabetic control, lipids, quality of life and symptoms of hypogonadism. The placebo-controlled study of 220 hypogonadal men met its primary endpoint by showing a statistically significant improvement in insulin sensitivity in testosterone treated patients at six and 12 months (p=0.05 and p=0.01, respectively), as measured by homeostasis model assessment as an index of insulin resistance (HOMA-IR). Further, measured by the Index of Erectile Function (IIEF), patients using the testosterone gel saw significant improvement in sexual function at six and 12 months (p <0.05).

"These data tell us that replacement therapy for low testosterone in hypogonadal males not only improves sexual function but, more importantly, can also have impact on insulin sensitivity," said lead investigator T. Hugh Jones BSc, MD, FRCP, Consultant Physician & Endocrinologist and Hon. Professor of Andrology, Barnsley Hospital and University of Sheffield, UK. "The TIMES 2 study indicates for the first time the role that testosterone may play over the long-term in hypogonadal men with Type 2 diabetes."

In U.S. men aged 40-69 years, it is estimated that there are about 481,000 new cases of hypogonadism per year. Overall, approximately 2.4 million U.S. men suffer from the condition.(1) Hypogonadism results from a deficiency in testosterone secretion that may occur naturally with increasing age, or as a result of disorders of the hypothalamus, pituitary glands or testes. Men with the condition can experience reduced libido and sexual function, reductions in energy and body strength, changed physique, alterations in well-being, and reduced quality of life.(2)

"Awareness of the problems caused by low testosterone is becoming more widespread and its connection to health issues like diabetes continues to become increasingly apparent," said Professor Jones. "As the incidence of hypogonadism continues to grow along with the aging population, we need to be acutely aware and implement a more rigorous screening program, particularly in men with Type 2 diabetes."

About TIMES 2

The TIMES 2 study was a randomized, double-blind, placebo-controlled, multi-center, international study to assess the effect of daily transdermal testosterone replacement therapy in hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome.

The primary endpoint of the study was to determine the effect of 2% testosterone gel (Tostran) on insulin resistance in all patients. This was measured by sampling the patients' blood and measuring insulin and glucose levels to calculate HOMA-IR, an index of insulin resistance. Insulin resistance is a major biochemical defect in Type 2 diabetes and Metabolic Syndrome. It is associated not only with the development of high blood sugars but also with abnormalities in the lipid profile and other biochemical changes which increase the risk of cardiovascular disease.

Secondary endpoints included: change in lipid profile and abdominal obesity; glycemic control as measured by HbA1c; sexual satisfaction and other quality of life scores.

The study, which was conducted in Belgium, France, Germany, Italy, Netherlands, Spain, Sweden and the UK, recruited 220 patients who were randomized to 2% testosterone gel treatment, or placebo gel, applied once a day to the thigh or abdomen. The study followed patients on treatment for one year.

About TOSTRAN

Tostran is the first metered dose 2% testosterone gel for use as replacement therapy in male hypogonadism, a condition with serious consequences and associations. Following its launch in Sweden in 2005, where it has over 30 percent of the testosterone gel market, Tostran is now available in all main European countries. ProStrakan plans to file Tostran with the U.S. Food and Drug Administration.

About ProStrakan

Scottish-based ProStrakan is one of Europe's fastest growing pharmaceutical companies, with new U.S. headquarters in Bedminster, New Jersey. Listed on the main London Stock Exchange, ProStrakan is committed to developing innovative therapies to improve the lives of patients. Our current products range from cancer, women's health, men's health, anesthesiology, and cardiovascular disease. For more information on ProStrakan, please visit http://www.ProStrakan-USA.com.

(1) Araujo AB et al. J Clin Endocrinol Metab, December 2004, 89 (12):

5920-5926

(2) Bhasin S et al. J Clin Endocrinol Metab, June 2006, 91 (6): 1995-2010


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