Alza wins first approval for Concerta

Alza Corp has received its first approval, from the US Food and DrugAdministration, to market Concerta (methylphenidate extended-release) for the once-daily treatment of attention deficit hyperactivity disorder for patients over the age of six. The company, in partnership with McNeil Consumer Healthcare (a Johnson & Johnson subsidiary), is planning a launch prior to the beginning of the 2000 school year.

The approval was based on data from three clinical trials comparing one dose of Concerta with three doses of the standard methylphenidate and placebo, and involving 416 patients aged between six and 12. The firm says that in these trials, teachers and parents both reported statistically-significant improvements in attention, as well as a reduction in overactivity among children receiving once-daily Concerta versus placebo, at a more convenient dose than currently-marketed formulations.

Steven Tighe of Merrill Lynch has said that a strong launch for Concerta should provide a nice boost to gross margins for Alza by the end of the year, while SG Cowen expects annual sales of $250 million by 2004 for the drug.