) announced that it has agreed to conduct pediatric clinical
studies following FDA's request to investigate the potential use of
Vyvanse for the treatment of Attention-Deficit/Hyperactivity
Disorder (ADHD) in children aged between 4 and 5 years.
Vyvanse is already approved in the U.S. for the treatment of
ADHD in patients aged 6 years and above.
Shire is currently developing design protocols for three
clinical trials on Vyvanse among preschool children. The three
trials include a pharmacokinetic study to help determine
appropriate dosing and evaluate safety and tolerability, an
efficacy and safety study and an open-label study to evaluate
Meanwhile, a Data Monitoring Committee will be set up to monitor
patient safety throughout the duration of the clinical program.
Shire expects to initiate the first trial in this clinical program
in the first half of 2015.
The comapny will enjoy the benefits of the Best Pharmaceuticals
for Children Act once the FDA confirms a timely submission and
review of data that fulfils the requirements of its request for the
trial. The benefits include a six-month extension for Vyvanse
patents, which expire in 2023.
We note that Shire holds a strong position in the ADHD market
driven by key drugs like Vyvanse, Intuniv and Adderall XR. The
growth engine of Shire is Vyvanse. We are also encouraged by
Shire's efforts for the label expansion of Vyvanse. Shire is
currently evaluating Vyvanse for additional indications such as the
binge eating disorder and expects to submit a Supplemental New Drug
Application (sNDA) to the FDA by the third quarter of 2014.
Shire currently carries a Zacks Rank #2 (Buy). Some other stocks
that look attractive in the healthcare sector include
While Allergan and Gilead Sciences carry a Zacks Rank #1 (Strong
Buy), Alexion Pharma is a Rank #2 (Buy) stock.
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