Shire Receives FDA Approval

We are pleased to hear that yesterday, the US Food and Drug Administration (FDA) has approved Shire Plc’s (SHPGY - Snapshot Report) Intuniv (guanfacine) extended release tablets. The drug is for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years. The drug, in four dosage strengths (1 mg, 2 mg, 3 mg and 4 mg) is expected to be available in the US from November.

Although the Prescription Drug User Fee Act (PDUFA) date for Intuniv was July 27, 2009, the approval was delayed as Shire and the FDA were unable to reach an agreement on final product labeling. With the introduction of Intuniv, Shire is intending to expand and diversify its ADHD portfolio. Apart from Intuniv, Shire now has Daytrana, Equasym, Vyvanse, Adderall XR as ADHD treatment options.

ADHD is one of the most common psychiatric disorders in children and adolescents. According to the Centers for Disease Control and Prevention (CDC), in the US, about 7.8% of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives. Not only children -- adults are also affected by the disease.

Per a patent litigation settlement agreement with Barr Pharmaceuticals -- now a part of Teva (TEVA - Analyst Report) -- Shire authorized the sale of generic Adderall XR. Shire will receive royalties on sales of Barr’s generic product throughout their 180 day exclusivity period. Adderall XR, with $1.1 billion of sales in 2008, was the leading brand in the US ADHD market with a 22.6% average share. But with the introduction of generics from Teva, sales declined 77% to $67 million in the second quarter of 2009.

Shire had anticipated this beforehand and had been promoting Vyvanse as a superior alternative to Adderrall XR users. Sales of Vyvanse during the second quarter were $114.2 million, an increase of 75% from the year-ago period.

The other two drugs of this segment, Daytrana and Equasym, recorded sales of $14.9 million and $4.9 million, respectively, during the second quarter of 2009. With Adderall XR going generic, Shire’s share of the total US ADHD market during the quarter declined to 24.5% from 32.3% in 2008.

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