Shire files ADHD drug application

Shire has announced, with New River Pharmaceuticals, it has filed a new drug application with the US Food and Drug Administration (FDA).

The compounded NRP104 is aimed at helping in the treatment of children between six and 12 with attention deficit hyperactivity disorder (ADHD).

Shire chief executive officer Matthew Emmens said: “The filing of NRP104 is excellent news for both Shire and New River.

“We are pleased that this application has been submitted on schedule and we look forward to working with New River toward an approval and subsequent launch in 2006.”

Shire and New River have signed a collaborative agreement to develop and commercialise NRP104 and under the terms of the agreement, the parties will work together on NRP104 development, manufacturing, marketing and sales in the US.

Upon FDA approval, the two companies will divide profits giving Shire a 75 per cent share for the first two years following launch and after they will share profits equally.

Outside the US, Shire has a license to develop and commercialise NRP104 and New River will receive a low double-digit royalty on net sales.

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