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Sep 3, 2009

FDA Green-Lights Shire’s Latest ADHD Therapy

  • FDA approved Shire Pharmaceuticals’ Intuniv™ Extended Release Tablets for the once-daily treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years. Shire claims that this unscheduled drug is the first selective alpha-2A adrenergic receptor agonist approved for this indication.

    The company expects to launch Intuniv in November, in four dosage strengths. It will be marketed by Shire’s existing U.S. ADHD sales team.

    The company’s marketed ADHD portfolio in the U.S. and Canada now includes four scheduled and unscheduled drugs: Adderall XR, Vyvanse, Dyatrana (a transdermal patch), and Intuniv. The company also entered the European ADHD market in February this year, with the €55 million acquisition of Equasym IR and Equasym XL from UCB. The deal covers all countries excluding the U.S., Canada, and Barbados.

    At the time, Equasym XL was approved and marketed in 10 countries (outside the U.S., Canada, and Barbados), and Equasym IR was sanctioned and marketed in four countries. In 2008 the two products generated aggregate net sales of €16.9 million in these territories.

    Shire is also continuing to develop Vyvanse for the European market, and in its 2008 annual report suggested regulatory filing could be submitted in Europe during 2010.

    Conversely, during March Shire withdrew its MAA for Daytrana, which has been available in the U.S. since 2006 as a pediatric treatment for ADHD. Shire says its decision to discontinue development of Daytrana in Europe was based on a combination of the EMEA’s request for an additional clinical study in a European patient population, and the fact that the company had now acquired Equasym IR and XL. 

    Although Adderall XR is now off-patent and facing generic competition, Shire maintains that in revenue terms, it was still its most significant product in 2008, generating 36% of the total. Sales of Adderall XR were over $1.1 billion in 2008 (up from $1.03 billion in 2007). Adderall XR’s average share of the U.S. ADHD market fell to 22.6% in 2008 from 25.5% in 2007. Shire says that in fact U.S. prescriptions for Adderall XR were down 5% in 2008 due to an 11% fall in average market share, offset by a 7% growth in the U.S. ADHD market.

    The company also expects strong growth in sales of Vyvanse to offset any loss in market share experienced by Adderall due to generic competition. Sanctioned in the U.S. for the treatment of children with ADHD in 2007, Vyvanse was cleared by FDA for use in adults in April 2008. In July 2008 Shire launched three different dosage strengths of the drug. Vyvanse achieved total sales of $318.9 million in 2008, up 317% on 2007. Sales of Daytrana were also up 23% in 2008, reaching $78.7 million.

     



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