Celltech wins US approval for once-daily methylphenidate for ADHD

4 April 2001

Celltech has been granted approval by the US Food and DrugAdministration for Metadate CD, its once-daily 20mg formulation of the attention-deficit hyperactivity disorder drug methylphenidate. The product is indicated for the treatment of ADHD in patients six years of age and over, and is expected to be launched by the third quarter of this year.

The approval of Metadate CD sets up a battle in the highly-competitive US market for methylphenidate, which has seen companies in a race to develop value-added formulations to lend an edge to marketing. Most of the current formulations of the drug require dosing three times daily. The benefits of a once-daily formulation are clear, in that a single dose before school controls inattentiveness, disruptive behavior and other symptoms of ADHD while eliminating the inconvenience and embarrassment of having to deliver doses during school time.

Celltech's leading competitor in the value-added end of the market is Alza, which recently launched its own once-daily methylphenidate product, Concerta, in the USA. This product achieved sales of $68 million in its first five months on the market (Marketletter April 2), at a time when immediate-release, generic versions of the drug have seen their sales slide. Celltech's own generic form of methylphenidate saw turnover down 37% in 2000 to L24.9 million ($35.3 million).

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