) recently gained approval for using its key drug, Botox, for
another indication. The FDA granted approval to Botox Cosmetic
for the temporary treatment of moderate to severe lateral canthal
lines, which are commonly known as "crow's feet" lines.
The FDA approval makes Botox the first and only product of its
kind to gain approval for this indication. Allergan had conducted
two randomized, multi-center, placebo-controlled studies to
establish Botox' safety and efficacy for this indication.
Botox is approved for therapeutic as well as aesthetic use.
Therapeutic indications include treatment of overactive bladder
symptoms (adults), prevention of chronic migraine headaches
(adults), treatment of increased muscle stiffness in elbow,
wrist, and fingers in adults with upper limb spasticity,
treatment of abnormal head position and neck pain related to
cervical dystonia (age ≥16), treatment of certain types of eye
muscle problems or abnormal spasm of the eyelids (age ≥12) and
treatment of the symptoms of severe underarm sweating
Cosmetic indications include the temporary improvement of
glabellar lines (frown lines between the brows) in adults below
65 years of age.
Botox is a major contributor to Allergan's top line. First
half 2013 sales came in at $970.9 million, up 12.9% from the
year-ago period. Allergan expects Botox sales of $1.94 billion -
$2.00 billion in 2013. Botox' label expansion should help
Allergan achieve the guidance. The chronic migraine, bladder and
upper limb spasticity indications represent significant
Allergan currently carries a Zacks Rank #3 (Hold). Although we
believe Allergan's presence across different segments will help
maintain growth, we remain concerned about the generic and
competitive challenges being faced by the company.
Currently, companies that look well-positioned include
). While Roche is a Zacks Rank #1 (Strong Buy) stock, Bayer and
Novo Nordisk are Zacks Rank #2 (Buy) stocks.
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