COMMENTS ON BOTOX® SAFETY

ALLERGAN, INC. COMMENTS ON
BOTOX® (BOTULINUM TOXIN TYPE A) SAFETY PROFILE

WASHINGTON DC, JANUARY 31, 2008--Many of us depend on various FDA drugs prescribed for us 'Off Label' with great effect.  From anti-epileptic drugs to blood pressure medication never designed for Migraine disease, but non the less, after years of small to larger tests, these drugs have helps millions of Migraine sufferers improve their quality of life.  For some Migraineurs BOTOX® was the drug of choice used as a preventive 'Off Label' which has offered many of them a new look at life.  For those of you who use this medication, you might be interested in this resent information about it released by the maker, Allergan, Incorporated.

In Irvine, California earlier this week on January 24, Allergan, Inc. commented on a petition filed by Public Citizen yesterday with the U.S. Food and Drug Administration (FDA) suggesting additional label changes and a written communication to physicians regarding botulinum toxin products.    

The petition addresses all botulinum toxins approved in the United States and relates to labeling matters involving numerous botulinum toxins marketed globally.  Every botulinum toxin is unique and has its own safety and efficacy profile.  Allergan can only comment on its own products, BOTOX® and BOTOX® Cosmetic (botulinum toxin type A) (collectively referred to in this press release as “BOTOX®”).

There are no safety issues raised in the petition that are not already addressed in the labeling for BOTOX®.  Allergan takes its FDA-mandated labeling obligations very seriously.  The current label for BOTOX® provided to physicians in the United States provides detailed information and appropriate guidance on the proper uses of BOTOX®, including detailed directions for approved medical uses, contraindications, warnings, precautions, drug interactions, and reported adverse event information. 

Allergan is in frequent dialog with the FDA to ensure proper labeling for its products and also submits information on all adverse events that are received whether or not they are considered related to the drug.  In collaboration with the FDA and other regulatory agencies around the world, Allergan regularly reviews safety information and updates the labels for its products as appropriate.

BOTOX® has a long-established safety profile and has been approved by the FDA for more than 17 years to treat a variety of medical conditions, as well as for aesthetic use (glabellar lines) since 2002.  With more than 3,000 publications on botulinum toxin type A in scientific and medical journals, results of dozens of clinical trials involving more than 10,000 patients, and having been used in clinical practice to treat more than a million patients worldwide, BOTOX® is a widely researched medicine.  BOTOX® has been approved for 20 indications in more than 75 countries and is prescribed to patients who suffer from a range of serious or debilitating disorders, as well as to those with aesthetic needs.

For any medical inquiries related to the proper use of BOTOX®, please contact Allergan’s Medical Information Department at 1-800-433-8871.

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Important BOTOX® and BOTOX® Cosmetic (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.

BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.

Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Safety Information
BOTOX® and BOTOX® Cosmetic 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® or BOTOX® Cosmetic with caution.  Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX® or BOTOX® Cosmetic. 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.

BOTOX® Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown Lines Between the Brows in Adults 18-65: The most common side effects following injection include temporary eyelid droop and nausea.  Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection.

Forward-Looking Statements
This press release contains “forward-looking statements,” including 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, 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 2006 Form 10-K and Allergan's Form 10-Q for the quarter ended September 28, 2007.  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.
SOURCE: Allergan, Inc.
Allergan Contacts
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)
Cathy DiRamio (714) 246-5551 (media)

© 2008 Allergan, Inc. Irvine, CA 92612.  ® and ™ marks owned by Allergan, Inc.

Allergan, Inc. Annual Report Filed Filed 3/6/2006

Page 6
In many countries outside of the United States, Botox ® is also approved for treating hemifacial spasm, pediatric cerebral palsy, and poststroke focal spasticity. We are currently pursuing new indication approvals for Botox ® in the United States and Europe, including headache, post-stroke focal spasticity, overactive bladder and benign prostatic hypertrophy. In April 2005, we announced plans to move forward with a large Phase III clinical trial program to investigate the safety and efficacy of Botox ® as a prophylactic therapy in a subset of migraine patients
with chronic daily headache, and in May 2005, we reached agreement with the FDA to enter Phase III clinical trials for Botox ® to treat neurogenic overactive bladder and Phase II clinical trials for Botox ® to treat idiopathic overactive bladder. In December 2005, we initiated Phase II clinical trials for Botox ® to treat benign prostatic hypertrophy.

Page 7
In October 2005, we entered into a long-term arrangement with GlaxoSmithKline (GSK) to develop and promote Botox ® in Japan and China and to co-promote GSK’s products ImitrexSTATdose System ® (sumatriptan succinate) and Amerge ® (naratriptan hydrochloride) in the United States. Under the terms of the arrangement, we licensed to GSK all clinical development and commercial rights to Botox ® in Japan and China, markets in which GSK has extensive commercial, regulatory and research and development resources, as well as expertise in neurology.
We received an up-front payment and will receive payments for research and development and marketing support, and royalties on Japan and China Botox ® sales. We also will manufacture Botox ® for GSK as part of a long-term supply agreement and will work collaboratively to support GSK on new clinical development for Botox ® and strategic marketing in those markets. In addition, we obtained the right to copromote GSK’s products ImitrexSTATdose System ® and Amerge ® in the United States to neurologists for a 5-year period. ImitrexSTATdose
System ® is approved for the treatment of acute migraine in adults and for the acute treatment of cluster headache episodes. Amerge ® Tablets are approved for the acute treatment of migraine attacks with and without an aura in adults. We will receive both fixed and performance payments from GSK.

Page 44
Research and development spending increased in 2005 compared to 2004 primarily as a result of higher rates of investment in our eye care pharmaceuticals and Botox ® product lines and new technologies, partially offset by lower spending for our skin care product line. Spending increases in 2005 compared to 2004 were primarily driven by an increase in clinical trial costs associated with our Posurdex ® technology and certain Botox ® indications for overactive bladder and migraine headache. Also included in our spending for research and development in 2005
is $7.4 million in costs associated with two new third party technology license and development agreements associated with in-process technologies and $3.0 million related to the buy-out of a license agreement with Johns Hopkins University associated with ongoing Botox ® research activities. Research and development spending increased in 2004 compared to 2003, excluding the effect of the in-process research and development charges in 2003, primarily as a result of higher rates of investment in our eye care pharmaceuticals and Botox ® product lines
and new technologies, partially offset by a decline in spending for our skin care product line. Research and development spending in 2004 compared to 2003

Comments

[Julie Chrisler]

This makes for some fascinating facts about botulinum toxin products, some of which I was not aware of until reading this. I have found this to be very helpful. However, no mention has been made of course of the side effects of Botox. Information on the side effects of Botox may be found here: http://hubpages.com/hub/Botox-Side-Effects While the side effects are not widespread, they do exist, and should not be overlooked.