Shire pharma faces early challenge.

Investors Chronicle, August, 2004

Shire Pharmaceuticals' attention-deficit drug Adderall XR could face generic competition as early as 2006, despite its approval this week by the US Food and Drug Administration (FDA) for adult use.

The drug, which accounts for 46 per cent of revenues, remains subject to a patent challenge from Barr Laboratories. The court case is scheduled for 2006.

To secure three years' marketing exclusivity, Shire needed to win approval for higher doses. Unfortunately, the FDA has withheld approval pending further clinical data.

Analysts at Cannacord are also concerned that Shire's HIV royalty stream from GlaxoSmithKline, which accounts for 37 per cent of profits, is under serious threat from the launch this month of US company Gilead's once-a-day drug,...

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