Allergan Comments on the United States Department of Justice Subpoena for the Production...

Mon Mar 3, 2008 9:45pm EST

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Allergan Comments on the United States Department of Justice Subpoena for the Production of Documents Relating to Promotional Practices of BOTOX(R) for Therapeutic Uses

IRVINE, Calif.--(Business Wire)--
Allergan, Inc. (NYSE: AGN) today announced that it received a
subpoena from the United States Department of Justice, United States
Attorney's Office for the Northern District of Georgia requesting the
production of documents regarding promotional practices involving
BOTOX(R) (botulinum toxin type A) for therapeutic indications.

The subpoena broadly requests documents regarding promotional,
educational and other activities relating to BOTOX(R). Allergan's
current understanding is that the inquiry involves questions regarding
alleged off label promotion relating to the use of BOTOX(R) for the
treatment of headache. While Allergan is currently in phase III
clinical studies investigating the use of BOTOX(R) for the treatment
of headache, this is not an FDA-approved use.

Although healthcare professionals, exercising their medical
judgment, may generally prescribe or dispense a drug for indications
not approved by the FDA (i.e., off label), it is Allergan's policy to
promote its products only in a manner consistent with the FDA-approved
product labeling.

In all circumstances, it is Allergan's policy to fully comply with
all applicable laws, rules and regulations. Allergan's Healthcare Law
Compliance Program is intended to ensure continued compliance with all
applicable laws, regulations and industry guidance governing the sale
and marketing of pharmaceutical and medical device products, as well
as laws and regulations governing the reporting of prices for
Government-reimbursed products.

Since its first approval in 1989, BOTOX(R) is indicated and used
in the United States to treat a variety of often serious medical
conditions, including cervical dystonia, blepharospasm, strabismus and
hyperhidrosis, and is approved for 20 different indications by
regulatory authorities across 70 countries worldwide.

Allergan will provide updates as it responds to the subpoena, and
will fully cooperate with the U.S. Department of Justice to
satisfactorily address any and all of their questions regarding this
matter.

Important BOTOX(R) (Botulinum Toxin Type A) Information

BOTOX(R) is indicated for the treatment of cervical dystonia in
adults to decrease the severity of abnormal head position and neck
pain associated with cervical dystonia.

BOTOX(R) is also indicated for the treatment of strabismus and
blepharospasm associated with dystonia, including benign essential
blepharospasm or VII nerve disorders in patients 12 years of age and
above.

The efficacy of BOTOX(R) treatment in deviations over 50 prism
diopters, in restrictive strabismus, in Duane's syndrome with lateral
rectus weakness, and in secondary strabismus caused by prior surgical
over-recession of the antagonist has not been established. BOTOX(R) is
ineffective in chronic paralytic strabismus except when used in
conjunction with surgical repair to reduce antagonist contracture.

And BOTOX(R) is indicated for the treatment of severe primary
axillary hyperhidrosis that is inadequately managed with topical
agents.

Important BOTOX(R) (Botulinum Toxin Type A) Safety Information

BOTOX(R) treatment should not be injected in the presence of
infection at the proposed injection site(s) and in individuals with
known hypersensitivity to any ingredient in the formulation.

Serious heart problems and serious allergic reactions have been
reported rarely. If you think you're having an allergic reaction or
other unusual symptoms, such as difficulty swallowing, speaking or
breathing, call your doctor immediately. Individuals with peripheral
motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or
motor neuropathy) or neuromuscular junctional disorders (e.g.,
myasthenia gravis or Lambert-Eaton syndrome) should only receive
BOTOX(R) with caution. Patients with neuromuscular disorders may be at
increased risk of clinically significant systemic side effects with
BOTOX(R). For full prescribing information, please visit www.botox.com
and www.botoxcosmetic.com.

BOTOX(R) for Blepharospasm in Patients greater than or equal to 12
Years of Age: Reduced blinking from BOTOX(R) injection of the
orbicularis muscle can lead to corneal exposure, persistent epithelial
defect and corneal perforation. The most frequently reported
treatment-related adverse reactions in these patients are ptosis
(20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).

BOTOX(R) for Strabismus in Patients greater than or equal to 12
Years of Age: Inducing paralysis in one or more extraocular muscles
may produce spatial disorientation, double vision or past pointing.
The most commonly reported adverse effects are ptosis (16%) and
vertical deviation (17%).

BOTOX(R) for Cervical Dystonia in Adults: There have been rare
cases of dysphagia severe enough to warrant the insertion of a gastric
feeding tube. The most frequently reported adverse reactions in
patients with cervical dystonia are dysphagia (19%), upper respiratory
infection (12%), neck pain (11%), and headache (11%).

BOTOX(R) for Severe Primary Axillary Hyperhidrosis Inadequately
Managed with Topical Agents: The most frequently reported adverse
events (3 - 10%) are injection site pain and hemorrhage, non-axillary
sweating, infection, pharyngitis, flu syndrome, headache, fever, neck
or back pain, pruritus, and anxiety.

Forward-Looking Statements

This press release contains "forward-looking statements,"
including statements regarding a federal subpoena and statements
regarding the safety, effectiveness and adverse events associated with
BOTOX(R).

These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
Allergan's expectations and projections. Risks and uncertainties
include, among other things, general industry, economic, biologic and
pharmaceutical market conditions; technological advances and patents
attained by competitors; challenges inherent in the research and
development and regulatory processes; inconsistency of treatment
results among patients; potential difficulties in manufacturing; and
governmental laws and regulations affecting domestic and foreign
operations. Additional information concerning these and other risk
factors can be found in press releases issued by Allergan, as well as
Allergan's public periodic filings with the Securities and Exchange
Commission, including the discussion under the heading "Risk Factors"
in Allergan's 2007 Form 10-K. Copies of Allergan's press releases and
additional information about Allergan is available on the World Wide
Web at www.allergan.com or you can contact the Allergan Investor
Relations Department by calling 1-714-246-4636.

About Allergan, Inc.

Founded in 1950, Allergan, Inc., with headquarters in Irvine,
California, is a multi-specialty health care company that discovers,
develops and commercializes innovative pharmaceuticals, biologics and
medical devices that enable people to live life to its greatest
potential - to see more clearly, move more freely, express themselves
more fully. The Company employs more than 7,500 people worldwide and
operates state-of-the-art R&D facilities and world-class manufacturing
plants. In addition to its discovery-to-development research
organization, Allergan has global marketing and sales capabilities
with a presence in more than 100 countries.

Allergan
Jim Hindman, 714-246-4636 (investors)
Joann Bradley, 714-246-4766 (investors)
Emil Schultz, 714-246-4474 (investors)
Caroline Van Hove, 714-246-5134 (media)