Shire plc (SHPG) recently received some encouraging news from Europe regarding its attention deficit/hyperactivity disorder (:ADHD) drug, Vyvanse (proposed trade name in Europe: Elvanse). The Ireland based company announced a favorable outcome from the European Decentralised Procedure (:DCP) regarding its ADHD drug, which will be marketed as Tyvense in Ireland.
We note that the drug is marketed in the US and Canada under the trade name Vyvanse, for treating ADHD in children, adolescents and adults. Moreover, the drug is marketed in Brazil under the trade name Venvanse for treating children in the age-group of 6-12 years suffering from ADHD.
Elvanse will be marketed in Europe (on approval) for treating children aged 6 years and above following inadequate response to methylphenidate therapy. We note that the UK Medicines and Healthcare products Regulatory Agency (:MHRA) was the reference member state on behalf of seven other European nations (Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden), which participated in the process. The countries have agreed regarding labeling of the drug. The approval to market the drug in the individual European countries will be issued by the respective regulatory authorities. The process is expected to consume one to three months more. The MHRA accepted the ADHD drug for review in January 2012.
We note that Vyvanse is one of the most widely prescribed ADHD therapies in the US. Approval in additional markets would further boost the sales potential of the drug. The ADHD market offers significant commercial potential. Apart from Shire, the ADHD market boasts of players, such as Johnson & Johnson (JNJ) and Novartis (NVS).
We currently have a Neutral recommendation on Shire. It carries a Zacks #3 Rank (Hold rating) in the short run.
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