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Shire withdraws ADHD patch filing

Published on 19/03/09 at 12:29pm

Shire has withdrawn the European marketing application for its Attention Deficit Hyperactivity Disorder (ADHD) patch product Daytrana.

The product's active ingredient is methylphenidate, the standard treatment for ADHD, but is the first time the drug has been formulated into a patch.

Part of the reason for the decision to withdraw the application was that European regulators wanted additional clinical studies on Daytrana (Methylphenidate Transdermal System) in European patients.

But the pull-out of the approval process also comes after Shire bought the global rights (outside the US, Canada and Barbados) for two established ADHD treatments, Equasym XL and Equasym IR, from UCB last month. Sales of the products hit 16.9 million euros in 2008.

The 55m euros acquisition will give Shire an immediate European presence in this common psychiatric disorder.

The market is competitive, with rival anti-ADHD products including Novartis' Ritalin. NICE estimates that 500,000 children suffer from ADHD in the UK.

ADHD tends to affect children and adolescents, with 7.8% of all US school-aged children diagnosed at some point in their lives. It is also estimated to affect 4.4% of US adults aged 18-44.

Equasym XL is approved and marketed for children over six years of age with ADHD. In Europe it is in seven countries outside the UK: Denmark, Finland, Germany, Ireland, Netherlands, Norway and Sweden.

Shire will be working to push forward a number of additional planned launches for the brand in Europe and further afield, the company said. The product is already also available in Mexico and South Korea.

In a statement the company added: "Equasym will allow Shire to build on its status as the leader in the United States ADHD market with patients and customers in Europe."

The US patent on Adderall XR, Shire's established ADHD drug - which has more than 20% of the market there - is close to expiry. Shire never pursued a European marketing licence for it.

But the company will also use Equasym as a bridge for Shire's other ADHD treatments, including its flagship Vyvanse, in territories outside the US. The company is currently recruiting patients to phase III trials of Vyvanse in Europe.

The brand was launched in the US nearly two years ago and Daytrana has been available there since 2006.

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