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Subject: Nursing Home & Elder Business Alert

NEWSRX                                               March 22, 2010

NEWSRX NURSING HOME & ELDER BUSINESS ALERT
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BOTOX(R) OnabotulinumtoxinA Receives FDA Approval for Treatment of Upper
Limb Spasticity in Adults

Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug
Administration (FDA) has approved BOTOX(R) (onabotulinumtoxinA) for the
treatment of increased muscle stiffness in the elbow, wrist and fingers in
adults with upper limb spasticity.


Spasticity is a debilitating condition impacting approximately 1 million
Americans1, many of whom suffer from spasticity in the upper limbs following
a stroke. Upper limb spasticity may also occur following a spinal cord or
traumatic brain injury or in patients affected by multiple sclerosis or
adults with a history of cerebral palsy.

Although not a life-threatening condition, upper limb spasticity can be
severely debilitating and painful, producing disfiguring muscle contractions
that can result in stiff, tight muscles in the elbow, wrist and fingers, or
a clenched fist. This stiffness hinders a patient's ability to perform
simple tasks, such as dressing or washing the hand, and often leaves the
patient dependent on a caregiver to help with simple activities.

"Upper limb spasticity can manifest weeks, months or even years after the
original injury, possibly after a patient has stopped seeing a neurologist,
physiatrist or their rehabilitation specialist, which is why it is severely
undertreated and there's a low awareness of the condition," said Mitchell F.
Brin, MD, Allergan's Senior Vice President Global Development, Chief
Scientific Officer, BOTOX(R). "The approval of BOTOX(R) marks another
important evolution in medical care, as we look to raise greater recognition
and understanding of upper limb spasticity among patients affected by the
condition, and refer them to a neurologist or physiatrist to explore their
various treatment options."

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In patients diagnosed with upper limb spasticity, BOTOX(R) is injected by a
trained specialist directly into the affected muscles, blocking overactive
nerve impulses that trigger these disabling contractions to reduce the
severity of increased muscle tone in the elbow, wrist and fingers. In
clinical studies, the efficacy of BOTOX(R) persisted up to three months on
average. BOTOX(R) is the first and only neurotoxin approved by the FDA for
the treatment of upper limb spasticity. Clinical Studies Evaluating BOTOX(R)
For the Treatment of Upper Limb Spasticity Allergan has conducted multiple
studies evaluating the use of BOTOX(R) to treat upper limb spasticity,
including three double-blind, placebo-controlled studies, two of which were
published in The New England Journal of Medicine,2 and Archives of Physical
and Medical Rehabilitation3. The first double-blind, placebo-controlled
trial compared the safety and efficacy of BOTOX(R) treatment (200-240 units
(U)) with placebo over a!
  12-week period in 126 patients who had suffered a stroke at least 6 months
prior and experienced increased wrist and finger flexor tone (scores of at
least 3 for wrist flexor tone and at least 2 for finger flexor tone based on
the Ashworth Scale). The Ashworth Scale is a globally accepted measure of
muscle tone4, which rates passive movement from 1 (normal muscle tone) to 4
(extreme increase in muscle tone).

The study found that BOTOX(R) neurotoxin produced a statistically
significant reduction in both wrist flexor and finger flexor muscle tone
seen at the week six primary endpoint (P < .05 versus placebo).5,6 Further,
evaluation by the Physician's Global Assessment score, an investigator's
measure of a patient's response to treatment, correlated with the Ashworth
scores, showing a statistically significant difference favoring BOTOX(R)
versus placebo at the primary endpoint (week 4).7,8 The second study
compared three doses of BOTOX(R) (360 U, 180 U, 90 U) with placebo over 24
weeks in 91 patients at least 6 weeks post-stroke with increased elbow
flexor and wrist flexor tone (a score of at least 2 for elbow flexor tone
and at least 3 for wrist flexor tone based on an expanded Ashworth Scale).
9,10 In this study, the 360 U group achieved statistically significant
reduction versus placebo in wrist flexor tone at the week 6 primary
endpoint.

Similar results were observed in a clinical study that compared the same
dosing regimens of BOTOX(R) (360 U, 180 U, 90 U) with placebo over 12 weeks
in 88 patients at least 6 weeks post-stroke with increased elbow tone and
wrist and/or finger tone (scores of at least 2 for elbow flexor tone and at
least 3 for wrist and/or finger flexor tone based on the Ashworth Scale)11.
This study showed BOTOX(R) decreased muscle tone and achieved statistically
significant decreases in wrist flexor tone, finger flexor tone and elbow
flexor tone in the 360 U group at week 412.

"For patients who suffer from upper limb spasticity, simple activities can
be so challenging they must rely on a caregiver to pry open their hand and
stretch back their fingers so they can wash their hands or get dressed,"
said Allison Brashear, M.D., Professor and Chair, Department of Neurology at
Wake Forest University Baptist Medical Center in Winston-Salem, NC. "In the
clinical studies, we saw improvement in muscle tone in patients injected
with BOTOX(R), which was maintained for up to three months with no further
injection."

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In the double-blind, placebo-controlled studies of BOTOX(R) for the
treatment of upper limb spasticity, the most common adverse events occurred
in less than 7 percent of patients and included pain in extremity, fatigue,
muscle weakness, nausea and bronchitis .13 About BOTOX(R) BOTOX(R) is a
prescription-only medical product that contains tiny amounts of highly
purified botulinum toxin protein refined from the bacterium, Clostridium
botulinum. BOTOX(R) has a unique, protected molecular structure that
stabilizes the core toxin in BOTOX(R) from degradation. When injected at
approved and labeled doses into a specific muscle or gland, BOTOX(R)
neurotoxin is expected to diffuse locally and expected to produce a safe and
effective result by producing a localized and temporary reduction in the
overacting muscle or gland, usually lasting up to approximately 3 to 6.7
months depending on the individual patient and indication. Specifically, the
incidence of immunogenicity in patients tr!
 eated with BOTOX(R) for upper limb spasticity is 0.53%.

BOTOX(R) was first approved by the FDA 20 years ago for the treatment of
strabismus and blepharospasm, two eye muscle disorders, making it the first
botulinum toxin type A product approved in the world. Since its first
approval, BOTOX(R) has been recognized by regulatory authorities worldwide
as an effective treatment for 21 different indications in approximately 80
countries, benefiting patients worldwide. In the United States, BOTOX(R) is
also approved to treat the abnormal head position and neck pain that happens
with cervical dystonia (CD) in adults, and to treat the symptoms of severe
underarm sweating (severe primary axillary hyperhidrosis) when medicines
used on the skin (topical) do not work well enough.

In addition to its therapeutic uses, the same formulation of BOTOX(R) with
dosing specific to glabellar lines was approved by the FDA in 2002 under the
trade name BOTOX(R) Cosmetic (onabotulinumtoxinA). The FDA approval of
BOTOX(R) for the treatment of upper limb spasticity in adult patients marks
the fifth therapeutic indication for the product in the United States since
1989.

Keywords: Biotechnology, Brain Injuries, Central Nervous System Disease,
Cerebral Palsy, Clinical Trial Research, FDA, Food, General Health, Health,
Neurology, Neurotoxins, Pharmaceutical, Regulatory Actions, Sclerosis,
Spasticity, Stroke, Therapy, Treatment, U.S. Food and Drug Administration,
Allergan Inc.

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