Shire under pressure as U.S. approves new generic ADHD drug

Hannah Blake

pharmaphorum

Shire’s shares have suffered a near-12pc slide in price after U.S. regulators ruled against the biopharmaceutical company in a battle over generic versions of its ADHD drug, Adderall XR.

Shire, a FTSE 100 pharma company, announced that a rival firm has been given the all-clear from the FDA to produce a cut-price version of its own hyperactivity drug, Adderall XR. Despite an appeal against the move from Shire, U.S. regulators unexpectedly approved a generic version of the hyperactivity drug to be manufactured by Swiss company, Actavis, which is currently being acquired by Watson Pharmaceuticals.

Adderall XR is a once-a-day, amphetamine-based treatment for Attention Deficit Hyperactivity Disorder (ADHD). Until now, Shire has supplied the only two authorised generic forms of Adderall XR.

“Shire believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR, and through its two authorized generic partners, Teva and Impax.”

Shire Pharmaceuticals’ press release, June 23rd 2012

Shire’s successful marketing of drugs for ADHD, which includes Adderall XR as well as Vyvanse and Intuniv, has seen the company expand rapidly over the past few years. Adderall XR was approved by the FDA for treatment of children with ADHD in 2001, and then for adults in 2004.

Shire are adamant they will continue to deliver “good, full year 2012 earnings growth”, despite the setbacks.

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Related news:

Shire Announces that the US Food and Drug Administration has Responded to Its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR (Shire)

Shire hit as U.S. approves new generic ADHD drug (Reuters UK)

Shire shares slide on hyperactivity drug decision (Telegraph)

Shire faces pressure from Watson generic ADHD drug (Guardian)

Reference links:

Shire

Shire Canada

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