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Shire facing early Adderall XR competition in US

Watson subsidiary Actavis launches copy of big-selling ADHD drug

Adderall XR - Shire ADHD

Shire has been hit hard by the news that a generic competitor to its big-selling attention-deficit hyperactivity disorder (ADHD) drug Adderall XR will reach the market this week, almost a year earlier than expected.

Shares in the company fell more than 11 per cent after the US Food and Drug Administration (FDA) gave approval for Actavis to launch its generic version of Adderall XR (mixed amphetamine salts), which was Shire's second biggest-selling drug last year with sales up nearly 50 per cent to $533m.

Watson subsidiary Actavis is the first direct competitor to Adderall XR, although licensed generics from Shire's partners Teva and Impax Laboratories are already on the market.

In the first quarter of this year sales were flat at $111m, but analyst Savvas Neophytou at Panmure Gordon has said that turnover of the drug will shrink "precipitously" now that Actavis' generic is launched.

In a statement, Actavis confirmed that it had already started distributing the product in all available strengths, addressing a market for Adderall XR and its generics that was worth around $1.99bn in the 12 months ending March 31, 2012.

Shire had sought to block the approval of generics to its product via a citizen's petition that asked the FDA to insist on stringent bioequivalence data for Adderall XR generics, relying on the fact that the product is a relatively complex mixture of different salts.

The FDA agreed with its position that generics should establish bioequivalence using "partial area under the curve measurements at five hours and beyond five hours, for both d- and l- amphetamine" but concluded that Actavis had met these criteria with its product.

The company's top-selling product is another ADHD treatment - Vyvanse (lisdexamfetamine dimesylate) - which remains under patent until 2023 but has already been subject to a challenge from Novartis' subsidiary Sandoz, which filed for approval of a generic alternative last year.

In a statement, Shire said: "While recognising that there will be multiple dynamics affecting the overall market following the approval of the Actavis generic, Shire continues to believe that it will deliver good, full year 2012 earnings growth."

26th June 2012

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