Recently, Shire Plc. (SHPGY) presented data from a late stage trial of Vyvanse, which was conducted to study the safety and efficacy of the product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. The drug, with first quarter 2010 sales of $154 million, is currently approved for the treatment of ADHD in children of 6-12 years of age and adults. 

Recently, Shire submitted a supplemental New Drug Application (sNDA) for the approval of Vyvanse to treat adolescents with ADHD in the age group of 13 to 17 years. The four-week phase III trial was conducted with 309 adolescents. They were randomized to receive either Vyvanse in three dosages (30, 50 and 70 mg/day) or a placebo. It was observed that Vyvanse significantly improved ADHD symptoms compared to placebo. 

ADHD is one of the most common psychiatric disorders in children and adolescents. In the US, estimates from a survey indicate that approximately 9.7% of adolescents aged 13 to 17 years are diagnosed with ADHD. 

Shire is primarily focused on central nervous system and gastro intestinal disorders. During the first quarter of 2010, these two areas generated sales of $301.5 million and $121.8 million, respectively. Vyvanse, with first quarter sales of $154.4 million, is the flagship ADHD product at Shire. 

Another significant drug in Shire’s portfolio, Adderall XR, lost patent exclusivity in the first quarter of 2009. As a result, a generic version of the product was launched in April 2009 by Teva Pharmaceuticals (TEVA) and Impax Laboratories in October 2009. With generics entering the markets, sales of Adderall plunged and recorded a 69% drop during the first quarter to $92 million. 

Shire continues to promote Vyvanse as a superior alternative to Adderall XR. Management stresses that Vyvanse is not a substitute for Adderall XR but is instead an advanced product expected to gain additional market share despite the presence of generic XR. 

Vyvanse received approval in Canada earlier this year marking the first launch of the drug outside the US. We believe expansion of the label into the 13-17 years age group will increase the patient base substantially, thus boosting the top line.
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