) announced positive top-line results from two phase III studies
on attention deficit and hyperactivity disorder (ADHD) drug
Vyvanse for additional indications.
We note that Shire is developing Vyvanse for additional
indications such as the treatment of negative symptoms of
schizophrenia and binge eating disorder (BED).
The two randomized phase III studies were conducted to
evaluate the safety and efficacy of Vyvanse compared to placebo
in adults suffering from BED. The results from the study showed
that Vyvanse was statistically superior to placebo on the primary
efficacy analysis while maintaining a safety profile.
Consequently, Shire plans to submit a Supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration for
the treatment of BED in adults (ages 18 to 55) by the third
quarter of 2014.
We are also encouraged by Shire's efforts for the label
expansion of Vyvanse. We remind investors that Shire holds a
strong position in the ADHD market driven by key drugs like
Vyvanse, Intuniv and Adderall XR.
Shire's growth engine is Vyvanse, which accounted for
approximately 24.4% of total revenues in the first nine months of
2013. Shire is now focused on exploring Vyvanse outside the U.S.
Vyvanse (under trade name Elvanse) was approved in the EU in Dec
2012. Shire plans to capture 75% of the total EU market by
Shire currently carries a Zacks Rank #1 (Strong Buy). Other
stocks that currently look attractive include
NPS Pharmaceuticals, Inc
). All three carry a Zacks Rank #2 (Buy).
FOREST LABS A (FRX): Free Stock Analysis
NPS PHARMA INC (NPSP): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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