BOTOX® Cosmetic (onabotulinumtoxinA) Celebrates 10-Year Anniversary of U.S. Food and Drug Administration Approval

IRVINE, Calif.--(BUSINESS WIRE)--

Allergan, Inc. AGN announced today that April 15, 2012 will mark the 10-year anniversary of the U.S. Food and Drug Administration's (FDA) approval of BOTOX^® Cosmetic (onabotulinumtoxinA) to improve the look of moderate to severe frown lines between the eyebrows in patients age 18-65.

“When approved by the FDA in 2002, BOTOX^® Cosmetic changed the way that physicians could treat patients who were interested in improving the appearance of their vertical frown lines between the brows,” said David E.I. Pyott, Chairman of the Board, President and CEO, Allergan, Inc. “BOTOX^® Cosmetic has become the number-one neuromodulator in the United States and the number of patients considering talking to their doctor about treatment has more than quadrupled to 5.8 million since 2002.^{1, 2”}

BOTOX^® secured its first FDA approval more than 22 years ago as a treatment for two rare eye muscle disorders, making it the first product of its kind approved in the world. In 2002, the same formulation with dosing specific to frown lines was approved under the name BOTOX^® Cosmetic.

“The FDA approval of BOTOX^® Cosmetic enhanced the practice of plastic surgery by providing plastic surgeons with a new treatment option for patients seeking to reduce the appearance of vertical frown lines between the eyebrows,” said Malcolm Z. Roth, MD, president of the American Society of Plastic Surgeons.

In the decade since BOTOX^® Cosmetic was approved, aesthetic specialty physicians – which include dermatologists, oculoplastic surgeons and facial plastic surgeons – have developed extensive experience in the art and science of administering BOTOX^® Cosmetic to yield predictable results for their patients. These physicians have performed approximately 11 million BOTOX^® Cosmetic treatment sessions since 2002 and have also contributed to the extensive clinical database demonstrating the safety and efficacy of the drug.

“The approval of BOTOX^® Cosmetic in 2002 dramatically changed our ability to treat our patients by giving them an effective option to treat the appearance of moderate to severe vertical frown lines with a minimally invasive procedure,” said Susan Weinkle, MD, president of the American Society for Dermatologic Surgery. “BOTOX^® Cosmetic has become more accepted by the public, and this treatment has brought more patients into aesthetic practices to learn about other treatments available.”

About BOTOX^® (onabotulinumtoxinA)

BOTOX^® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX^® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX^® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX^® is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient.

BOTOX^® was first approved by the FDA more than 22 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 in 1989, BOTOX^® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX^® is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

In addition to its therapeutic uses, the same formulation of BOTOX^® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX^® Cosmetic (onabotulinumtoxinA). BOTOX^® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.

In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX^® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX^® and BOTOX^® Cosmetic in Allergan's clinical trials.³ Worldwide, approximately 30 million vials of BOTOX^® and BOTOX^® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010).⁴ With approximately 2,500 articles on BOTOX^® and BOTOX^® Cosmetic in scientific and medical journals,⁵ BOTOX^® neurotoxin is one of the most widely researched medicines in the world.

BOTOX^® (onabotulinumtoxinA) & BOTOX^® Cosmetic Important Information

Indications

BOTOX^® is a prescription medicine that is injected into muscles and used:

• to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
• to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
• to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
• to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
• to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older

BOTOX^® is also injected into the skin 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 people 18 years and older.

BOTOX^® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

It is not known whether BOTOX^® and BOTOX^® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

It is not known whether BOTOX^® and BOTOX^® Cosmetic are safe or effective to treat increased stiffness in upper-limb muscles other than those in the elbow, wrist, and fingers, or to treat increased stiffness in lower-limb muscles. BOTOX^® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX^® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.

It is not known whether BOTOX^® and BOTOX^® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION

BOTOX^® and BOTOX^® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX^® or BOTOX^® Cosmetic:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX^® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, urinary incontinence in adults with overactive bladder due to neurologic disease, or when BOTOX^® Cosmetic has been used at the recommended dose to treat frown lines.

Do not take BOTOX^® or BOTOX^® Cosmetic if you: are allergic to any of the ingredients in BOTOX^® or BOTOX^® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc^® (rimabotulinumtoxinB), Dysport^® (abobotulinumtoxinA), or Xeomin^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not take BOTOX^® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.

The dose of BOTOX^® and BOTOX^® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported. These include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX^® or BOTOX^® Cosmetic should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX^® or BOTOX^® Cosmetic.

Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX^® for upper limb spasticity.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX^® for their blepharospasm, especially in people with certain nerve disorders. BOTOX^® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX^®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX^® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX^®.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX^® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.

Human albumin and spread of viral diseases. BOTOX^® and BOTOX^® Cosmetic contain albumin, a protein component of human blood. The potential risk of spreading viral diseases (eg, Creutzfeldt-Jakob disease [CJD]) via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.

Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; pain or burning with urination, frequent urination, fever, have problems emptying your bladder on your own and are being treated for urinary incontinence, are pregnant or plan to become pregnant (it is not known if BOTOX^® or BOTOX^® Cosmetic can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX^® or BOTOX^® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX^® or BOTOX^® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX^® or BOTOX^® Cosmetic in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc^®, Dysport^®, or Xeomin^® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine.

Other side effects of BOTOX^® and BOTOX^® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For BOTOX^® and BOTOX^® Cosmetic full Product Information including Boxed Warning and Medication Guide click here.

About Allergan, Inc.

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Forward-Looking Statements

This press release contains "forward-looking statements," including the statements by Mr. Pyott, Dr. Roth and Dr. Weinkle, and other statements regarding the safety, effectiveness and adverse events associated with BOTOX^® 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 and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2011 Annual Report on Form 10-K. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636.

^© 2012 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved. APC25HU12
Myobloc^® is a registered trademark of Solstice Neurosciences, Inc.
Dysport^® is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin^® is a registered trademark of Merz Pharma Gmbh & Co.

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¹ BOTOX Cosmetic Quantitative Consumer Segmentation 2002, Pg 10
² Allergan data on file; 6MM BOTOX® Cosmetic Considering, Pg 1
³ Allergan data on file; Medical Affairs
⁴ Allergan data on file; Global Regulatory Affairs
⁵ Allergan data on file; Global Literature & Information Services