04.03.2008 02:45:00
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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
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®
(botulinum toxin type A) for therapeutic indications.
The subpoena broadly requests documents regarding promotional,
educational and other activities relating to BOTOX®.
Allergan’s current understanding is that the
inquiry involves questions regarding alleged off label promotion
relating to the use of BOTOX®
for the treatment of headache. While Allergan is currently in phase III
clinical studies investigating the use of BOTOX®
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®
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®
(Botulinum Toxin Type A) Information
BOTOX® 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® 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®
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®
is ineffective in chronic paralytic strabismus except when used in
conjunction with surgical repair to reduce antagonist contracture.
And BOTOX® is
indicated for the treatment of severe primary axillary hyperhidrosis
that is inadequately managed with topical agents.
Important BOTOX®
(Botulinum Toxin Type A) Safety Information
BOTOX® 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® with
caution. Patients with neuromuscular disorders may be at increased risk
of clinically significant systemic side effects with BOTOX®.
For full prescribing information, please visit www.botox.com
and www.botoxcosmetic.com.
BOTOX® for
Blepharospasm in Patients = 12 Years of Age:
Reduced blinking from BOTOX® 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® for
Strabismus in Patients = 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® 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® 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®.
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.
© 2008 Allergan,
Inc. Irvine, CA 92612. ®
and ™ marks owned by Allergan, Inc.
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