) recently presented positive results on Venvanse (lisdexamfetamine
dimesylate) from a phase III study at the EUNETHYDIS 2nd
International Attention-Deficit/Hyperactivity Disorder (ADHD)
In this phase III double-blind, placebo-controlled, randomized
study, long-term maintenance of efficacy and safety of Venvanse in
children and adolescents aged 6 to 17 years with moderately
symptomatic ADHD was evaluated. Significantly less treatment
failures were observed in the Venvanse arm (13.5%) as compared to
placebo arm (65.8%).
In December 2011, Shire had submitted a marketing application
seeking European approval of Venvanse for the treatment of children
and adolescents aged between 6 and 17 years who are diagnosed with
ADHD. Results from this phase III study are an important part of
the European submission package and will augment the chances of the
drug getting approved.
Venvanse is currently marketed for ADHD in children, adolescents
and adults in the U.S. and Canada under the trade name Vyvanse. The
product is also marketed in Brazil for the treatment of ADHD in
Shire is also evaluating the product for major depressive
disorder (phase III), excessive daytime sleepiness (phase II),
negative symptoms of schizophrenia (phase II) and other non-ADHD
indications in adults (phase II).
Vyvanse, with $260 million revenues in the first quarter of
2012, is the top revenue grosser at Shire. As per data provided by
IMS Health National Prescription Audit, Vyvanse enjoys a 17% share
of the U.S. ADHD market. In the first quarter of 2012, Vyvanse's
growth of 29% was significantly higher than the U.S. ADHD market's
growth of 10%.
However, we note that competition in the U.S. market increased
significantly in 2011 with the launch of generic versions of
Johnson & Johnson's
) Concerta and
) Ritalin. Moreover, a new drug, Kapvay, was launched by Japanese
pharmaceutical company, Shionogi & Co., Ltd, in 2011.
Meanwhile, Shire is facing patent challenges for Vyvanse. Six
companies, including Sandoz, Inc., Amneal Pharmaceuticals LLC,
), Roxane Laboratories, Inc.,
Mylan Pharmaceuticals, Inc.
) and Actavis have filed abbreviated new drug applications (ANDAs)
for their generic versions of Vyvanse. Shire has filed patent
infringement lawsuits against all these companies.
We currently have a Neutral recommendation on Shire. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
JOHNSON & JOHNS (JNJ): Free Stock Analysis
MYLAN INC (MYL): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SHIRE PLC-ADR (SHPGY): Free Stock Analysis
WATSON PHARMA (WPI): Free Stock Analysis Report
To read this article on Zacks.com click here.