) 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
We currently have a Neutral recommendation on Shire. It carries a
Zacks #3 Rank (Hold rating) in the short run.
JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
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