Auxilium Pharmaceuticals Inc announced that the UK Medicines and Healthcare products Regulatory Agency has granted approval for Testim, a patented testosterone gel, to be marketed in the United Kingdom. Testim, which was launched in the United States in February 2003, is indicated for testosterone replacement therapy to restore serum testosterone levels in men and thereby improve health problems associated with low testosterone including loss of muscle mass and a decrease in sexual desire, sexual motivation and frequency of spontaneous erections. The U.K launch of Testim is planned for later in 2003.
"We look forward to the launch of Testim in the U.K. and the opportunity to make a difference in the lives of the many men suffering from the effects of abnormally low levels of testosterone," said Gerri Henwood, president and chief executive officer of Auxilium. "We deeply appreciate the efforts of our investigators, advisors, consultants and the talented group of professionals who helped to make Auxilium's first European product approval possible."
Regulatory clearance for Testim in the U.K. was received 24 months after initiation of clinical studies in the United Kingdom and Europe. Auxilium will now work within the EU Mutual Recognition Procedure for permission to market Testim throughout the European Community.
"In the U.K. and throughout Europe, many men are recognizing the significant health problems caused by low testosterone, including decreased lean body mass, and sexual dysfunction. Clinical trials have shown Testim to be both a clinically effective and well-tolerated dosage form. Approval of this once daily, topical gel formulation therefore offers a significant advance in the treatment of hypogonadal men in the U.K.," said Thomas McNicholas, MBBS, FRCS, consultant urologist at the Department of Urology at Lister Hospital in Stevenage, United Kingdom.
The results of the largest placebo-controlled study ever conducted to measure the benefits of testosterone replacement therapy demonstrate that men treated with Testim testosterone gel have significant improvements in sexual performance, spontaneous erections and levels of sexual motivation and desire.