Schering AG announced that the European mutual recognition procedure for the approval of Nebido, a new preparation for the treatment of testosterone deficiency (hypogonadism) in men, has successfully been completed. After conversion into national approvals this clears the way for marketing the product in the big pharmaceutical European markets like Germany, France and United Kingdom, a company release said.
The initial phase of the product launch will occur in Finland in October, and in Germany in November 2004. Other European countries will follow in 2005, and after receipt of approval, it will be introduced in the first Latin American and Asian countries.
"Nebido offers patients a double advantage: improved tolerability because it maintains a steady testosterone level in the blood and a significant reduction in the number of injections required," said Philip Smits, head of Gynecology& Andrology at Schering AG. "Following up on our European leadership, our goal is to also become the market leader for testosterone therapy in Latin America and Asia," he added further.
Nebido is a testosterone depot preparation, which is administered by injection. The innovative formula guarantees that the blood testosterone level remains steady and normal for a period of about twelve weeks. Until now, patients received up to twenty-two injections annually. This can be reduced to only four per year using Nebido.
Hypogonadism is an indication of reduced testosterone formation because of underactive testes, which lowers the concentration of this most important male sexual hormone in the blood. Testosterone deficiency can lead to severe health problems and considerably impair quality of life. Various symptoms can be observed, depending on the man's age and how long the hormone deficiency has persisted. These include for example: fatigue, loss of energy, impotence and loss of libido, anaemia and osteoporosis.