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Video: Allergan, Inc. Marks 20 Years Since the First Approved Indications by the U.S. Food and Drug Administration for BOTOX(R) (Botulinum Toxin Type A)

April 15, 2009

New Patient Video Vignettes and Mechanism of Action 3-D Video Illustrate the Versatility and Application of BOTOX(R) Across Several Approved Indications

IRVINE, Calif., April 15 /PRNewswire-FirstCall/ – As part of the nearly 20-year milestone since the first approved indications by the U.S. Food and Drug Administration (FDA) for BOTOX(R) (Botulinum Toxin Type A), Allergan, Inc. (NYSE: AGN), the maker of BOTOX(R) and BOTOX(R) Cosmetic, conducted a Web-based media briefing that provided an in-depth review of the evolution and science of BOTOX(R) therapy, its risk/benefit profile and how to evaluate the differences between botulinum toxin therapies. Perspectives on these topics were provided by leading researchers and Allergan scientists, and by patients who discussed their treatment with BOTOX(R) and BOTOX(R) Cosmetic.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/allergan/37769/

It has been nearly 20 years since BOTOX(R) was first approved by the FDA to treat two specific eye muscle disorders. Since 1989, the FDA has approved two additional therapeutic indications for BOTOX(R) and one aesthetic indication, using the same formulation and under the name BOTOX(R) Cosmetic (Botulinum Toxin Type A), with dosing specific to temporarily treat moderate to severe glabellar lines in people ages 18 to 65. To date, BOTOX(R) is approved for 20 different therapeutic indications in approximately 80 countries worldwide. BOTOX(R) Cosmetic is authorized for aesthetic treatment in approximately 60 countries.

The Webinar also featured a new video demonstrating in detail how BOTOX(R) therapy works by blocking overactive nerve impulses that trigger excessive muscle contractions or glandular activity.

“One of the advantages of BOTOX(R) therapy is its highly selective mechanism of action and targeted mode of administration, via injection directly into the affected muscle or gland, which in large part explains the product’s clinical performance and predictable patient outcomes,” explained Mitchell F. Brin, M.D., Allergan’s Senior Vice President of Global Development and Chief Scientific Officer for BOTOX(R).

No Two Botulinum Toxins Are Alike

With additional botulinum toxin products awaiting FDA approval, Dr. Brin reviewed the scientific differences among botulinum toxin therapies and the factors that physicians and patients should weigh when considering treatment options.

“The well-established risk/benefit profile of BOTOX(R) is unique to the product, because no two botulinum toxins are alike,” said Dr. Brin. He pointed out that botulinum toxin products are biologics – i.e., derived from living substances, in this case, from the Clostridium botulinum bacteria. This bacteria produces seven different subtypes of botulinum toxin, with type A being the most potent. Differences among subtypes may influence therapeutic effects and how long they last, or the occurrence of adverse events following treatment. Even among botulinum toxin products of the same subtype, variations in manufacturing processes can result in differences in the product’s characteristics, including formulation (e.g., molecular uniformity and weights of toxin complexes), pharmacokinetics, and clinical parameters such as efficacy, duration of effect, risk/benefit profile and immunogenicity(1).

“Because of these differences, each botulinum toxin also has distinct dosing requirements,” said Dr. Brin. “Importantly for physicians and patients, this means that BOTOX(R) is not interchangeable with other botulinum toxins and a physician cannot simply use a fixed-dose ratio and expect the same precise and predictable results.”

The Patient and Physician Experience

While practicing in the 1980s at Columbia-Presbyterian Medical Center in New York City, Dr. Brin, a neurologist, co-led one of the first clinical trials of BOTOX(R) (Botulinum Toxin Type A) as a treatment for cervical dystonia supported by the Food and Drug Administration’s Office of Orphan Product Development, when a young man named Tom Stampe was referred to him.

“I was 23 years old, and I started getting this very bad neck pain,” said Mr. Stampe. “One day the neck pain started making me go into a twitch and my head started pulling to one side to the point that it stayed stuck on my right shoulder. For three years I couldn’t move it, couldn’t turn it, couldn’t do anything. After years of misdiagnosis and disability, I was finally referred to Dr. Brin who diagnosed my condition as cervical dystonia. At that time they were trying out a new investigational drug, and he thought I’d be a very good candidate for it. It was BOTOX(R). Shortly after those first injections my head and neck began to move freely, and it’s a feeling I’ll never forget.” Today, Mr. Stampe is an advocate for cervical dystonia patients and currently serves as President of the New York chapter of the Dystonia Medical Research Foundation.

“The clinical development of BOTOX(R) (Botulinum Toxin Type A) has improved the management of a number of disabling conditions characterized by excessive muscle or glandular activity, and just as importantly for patients like Mr. Stampe, it has expanded interest in their diagnosis and treatment,” said Joseph Jankovic, M.D., Professor of Neurology, Distinguished Chair in Movement Disorders, and Director of the Parkinson’s Disease Center and Movement Disorders Clinic, Baylor College of Medicine in Houston, Texas. Dr. Jankovic, a leader in the field of neurotoxin research, led the first studies of BOTOX(R) for the treatment of cervical dystonia and blepharospasm in the 1980s.

“Now it is decades later, and we have a wealth of clinical data on BOTOX(R), as well as expertise in its administration and a thorough scientific understanding of the product, and we know that optimal results with BOTOX(R) depend on several critical factors,” explained Dr. Jankovic. “Unlike oral drugs, there are many technical aspects involved in administering BOTOX(R), including dosing, dilution and injection placement and technique. Therefore, the injecting physician should have extensive knowledge of these treatment factors, along with a thorough understanding of the disease and its symptoms to ensure the product can deliver a targeted and precise effect.” Dr. Jankovic emphasized the importance to patients, whether they are considering medical treatment with BOTOX(R) or aesthetic treatment with BOTOX(R) Cosmetic (Botulinum Toxin Type A), of seeking a well-trained physician with the qualifications necessary to evaluate and determine the best injection plan for each patient.

BOTOX(R) Research and Development

In concluding the Webinar, Scott Whitcup, M.D., Allergan’s Executive Vice President for Research and Development, noted that Allergan is building upon its two decades of research and clinical experience with BOTOX(R) to investigate new medical uses for the product, with research focused on areas where safe and effective new treatment options will make a meaningful difference to large numbers of patients. Allergan also is exploring novel next generation neurotoxins with the potential for even more specific modes of action.

About BOTOX(R)

BOTOX(R) was first approved by the FDA in 1989 for the blepharospasm (excessive eye blinking) and strabismus (misalignment of the eye). Since then BOTOX(R) also has been approved by the FDA for the treatment of cervical dystonia (a painful twisting of the neck) and severe primary axillary hyperhidrosis (excessive underarm sweating that is inadequately managed by topical agents). The same product, with dosing specific to treat glabellar lines (vertical frown lines between the brows), received FDA approval in 2002 under the name BOTOX(R) Cosmetic (to differentiate between its therapeutic and aesthetic applications). With that approval, BOTOX(R) Cosmetic has been the most popular physician-administered, aesthetic injectable treatment for the past seven years(2).

Nearly 17 million treatment sessions with BOTOX(R) and BOTOX(R) Cosmetic have been recorded in the United States alone over the past 14 years(3), with approximately 22 million vials of BOTOX(R) and BOTOX(R) Cosmetic distributed worldwide to date(4). In addition to this extensive clinical experience with the product, the safety and efficacy of BOTOX(R) has been studied in approximately 50 randomized, placebo-controlled clinical trials(5). Additionally, approximately 11,000 patients have been treated with BOTOX(R) and BOTOX(R) Cosmetic in Allergan-sponsored trials(6). With approximately 2,000 articles on BOTOX(R) and BOTOX(R) Cosmetic in peer-reviewed publications, BOTOX(R) is the most widely researched neurotoxin, and one of the most widely researched medicines in the world.

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

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

BOTOX(R) Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 – 65.

Important Safety Information

Who should not be treated with BOTOX(R)

BOTOX(R) injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX(R) product.

Warnings

Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other reactions, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.

Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX(R).

Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.

Precautions

Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.

Side Effects

Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.

In cervical dystonia, the most common side effects following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

In blepharospasm, the most common side effects following injection include ptosis (20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).

In strabismus, the most common side effects following injection include ptosis (15.7%) and vertical deviation (16.9%).

In severe primary axillary hyperhidrosis, the most common side effects (3-10% of patients) following injection include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.

The most common side effects following BOTOX(R) Cosmetic injections include temporary eyelid droop and nausea.

Please see accompanying full product information for BOTOX(R) and BOTOX(R) Cosmetic, also available at www.botox.com and www.botoxcosmetic.com.

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 approximately 8,500 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.

Forward-Looking Statements

This press release contains “forward-looking statements”, including the statements by Drs. Brin, Jankovic and Whitcup and Mr. Stampe and statements regarding the safety, effectiveness, market potential and adverse events associated with BOTOX(R) and BOTOX(R) Cosmetic.

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 market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing new products; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.

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 2008 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 (714) 246-4636.

(C) 2009 Allergan, Inc. Irvine, CA 92612. (R) and (TM)marks owned by Allergan, Inc.

APC99IJ09

(1)Sampaio C, Costa J, Ferreira JJ. Clinical comparability of marketed formulations of botulinum toxin. Mov Disord. 2004;19(suppl 8):S129-136

(2)American Society of Plastic Surgeons; “Top Five Minimally-Invasive Cosmetic Procedures” 2002, 2003, 2004, 2005, 2006, 2007, 2008

(3)Allergan data on file; Global Regulatory Affairs

(4)Allergan data on file; Global Regulatory Affairs

(5)Allergan data on file; Medical Affairs

(6)Allergan data on file; Medical Affairs

SOURCE Allergan, Inc.


Source: newswire



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