Shire plc (SHPGY) was boosted recently as Health Canada approved Vyvanse (lisdexamfetamine dimesylate) for treating adolescents (aged between 13 to 17 years) and adults suffering from attention deficit hyperactivity disorder (ADHD). ADHD refers to a neurobiological disorder that is often hereditary in nature. The disease gives way to lack of attention and often results in impulsiveness and hyperactivity.
The approval of Vyvanse in adolescents and adults was based on positive results of two pivotal late-stage studies. While one study evaluated the efficacy of the drug in adults the other was for adolescents. We note that Vyvanse has been available in Canada since 2009 for treating children, aged between 6 to 12 years, suffering from ADHD.
The label expansion of Vyvanse in Canada will not only boost the company’s top line but also provide much relief to ADHD patients in Canada where the disease is highly prevalent. The disease, which leaves a significant imprint on Canada’s social and economic frameworks, is estimated to cost approximately 8 million dollars annually.
We note that Vyvanse is already approved in the US for treating ADHD in children aged 6 to 12 years, adolescents aged 13 to 17 years and adults. The US approval for treating adolescents aged 13 to 17 years came in November last year.
The latest Canadian approval for Vyvanse is a shot in the arm for Shire’s ADHD portfolio. The disorder has a lucrative market and is projected to be worth approximately $4.2 billion by 2015.
The awareness regarding ADHD in the global market is quite low, where the dominant player is the US.  Apart from Shire, the market includes players such as Eli Lilly & Company (LLY), Johnson & Johnson(JNJ) and Novartis AG (NVS) with other ADHD treatments under development.
Our Take & Recommendation
We currently have a Neutral recommendation on Shire, which is supported by a Zacks #3 Rank (short-term ‘Hold’ rating). We view the Canadian approval of Vyvanse for adolescents and adults as a positive given that Shire’s ADHD franchise is shifting from Adderall XR to Vyvanse, with third quarter sales of the latter up 17%.
Longer term, we believe that Shire needs to expand its pipeline in order to maintain growth beyond 2015, as there are very few projects to be launched thereafter.


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