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Ophthalmology 

By building upon almost 60 years of experience meeting the needs of eye care professionals and their patients, Allergan has become a world leader in the treatment of glaucoma, dry eye and other serious eye conditions. Now Allergan scientists are bringing this rich expertise to bear on the discovery of advanced therapies for glaucoma and devastating retinal disease such as age-related macular degeneration and macular edema (a common consequence of diabetes) - diseases that unfortunately cause sight loss in millions of patients each year and whose prevalence is increasing as the population ages.

In addition, we are investigating POSURDEX® to combat diabetic and non-diabetic macular edema as well as retinal vein occlusion. POSURDEX® involves a novel bioerodable extended-release drug delivery system that can deliver medications to the back of the eye for months following a single intraocular injection.

Product Indication Industry Partners Status
LUMIGAN® X (U.S.) Glaucoma (IOP)

Glaucoma

Glaucoma is a group of diseases affecting the optic nerve. Left untreated, glaucoma can lead to permanent damage of the optic nerve and resultant visual field loss, which can progress to blindness. There are currently no approved products available to reverse vision loss.

- Review
OZURDEX™ (U.S.) Uveitis

Uveitis

Uveitis is an inflammation inside the eye. The uvea, which provides most of the blood supply to the retina, is the area affected by uveitis. Often the cause of uveitis remains unknown, but autoimmune disorders, infection, or exposure to toxins can cause the condition.

- Review
ZYMAR® X (U.S.) Anti-Infection

Anti-Infection

Anti-infectives are a class of medications that kill or stop the spread of infectious agents on the ocular surface or elsewhere in the body.

- Review
OZURDEX™ (U.S.) Diabetic Macular Edema

Diabetic Macular Edema

Diabetic macular edema is the result of retinal microvascular changes that occur in patients with diabetes, which compromise the blood-retinal barrier. Eventually this leads to the leakage of plasma constituents in the surrounding retina and retinal edema. The World Health Organization (WHO) estimates that 15 million people have diabetes in the United States; one half of whom are undiagnosed. Untreated, there is a 25-30 percent risk of developing clinically significant macular edema (CSME) with moderate visual loss.

- Phase 3
Androgen Tear Ocular Surface Disease

Ocular Surface Disease

Dry eye syndrome is a condition caused by a change in the quality or quantity of tears. This alteration of the tear film results in irritation and changes on the eye surface that lead to the characteristic symptoms of sandy or burning sensation, discomfort, blurred vision, and redness of the eye that progress as the day goes on. About 6 million women and 3 million men in the United States have moderate or severe symptoms of the disease, and scientists estimate that an additional 20 to 30 million people in this country have mild cases of dry eye.1

1. The Schepens Eye Research Institute. Available at: www.schepens.harvard.edu. Accessed April 8, 2007

- Phase 2
Brimonidine — DDS Retinal Diseases

Retinal Diseases

Back-of-the-eye diseases, including macular edema, diabetic retinopathy and age-related macular degeneration, unfortunately cause sight loss in thousands of patients each year and are increasing in prevalence as the population ages.

- Phase 2
IOP Lowering (PG Analog) Glaucoma

Glaucoma

Glaucoma is a group of diseases affecting the optic nerve. Left untreated, glaucoma can lead to permanent damage of the optic nerve and resultant visual field loss, which can progress to blindness. There are currently no approved products available to reverse vision loss.

- Phase 2
IOP Lowering (Sustained Release) Glaucoma

Glaucoma

Glaucoma is a group of diseases affecting the optic nerve. Left untreated, glaucoma can lead to permanent damage of the optic nerve and resultant visual field loss, which can progress to blindness. There are currently no approved products available to reverse vision loss.

- Phase 2
RESTASIS® X (U.S.) Ocular Surface Disease

Ocular Surface Disease

Dry eye syndrome is a condition caused by a change in the quality or quantity of tears. This alteration of the tear film results in irritation and changes on the eye surface that lead to the characteristic symptoms of sandy or burning sensation, discomfort, blurred vision, and redness of the eye that progress as the day goes on. About 6 million women and 3 million men in the United States have moderate or severe symptoms of the disease, and scientists estimate that an additional 20 to 30 million people in this country have mild cases of dry eye.1

1. The Schepens Eye Research Institute. Available at: www.schepens.harvard.edu. Accessed April 8, 2007

- Phase 2
TKI Age-Related Macular Degeneration

Age-Related Macular Degeneration

Macular degeneration is a medical condition predominantly found in elderly adults in which the center of the inner lining of the eye, known as the macular area of the retina, suffers thinning, atrophy, and in some cases bleeding. According to the American Academy of Ophthalmology, it is the leading cause of central vision loss in the United States today for those over the age of 50. Age-related macular degeneration affects more than 1.75 million individuals in the United States. Owing to the rapid aging of the U.S. population, this number will increase to almost 3 million by 2020.1

1. Archives of Ophthalmology 2004; 122:564-572

- Pre-Clinical
Neurosciences 

For almost 20 years, BOTOX® (Botulinum Toxin Type A) has been the foundation for Allergan's global leadership position in neuromodulator therapy and neurosciences. During this time, Allergan has committed approximately $800 million in BOTOX® research and clinical development. Today, the development of new applications for BOTOX® is continuing in new areas where unmet medical needs are greatest.

Allergan is moving forward with Phase III studies for chronic migraine, and we are continuing to conduct Phase II studies in post-stroke spasticity in the United States. We have also initiated a clinical program for BOTOX® in the treatment of benign prostatic hypertrophy and have begun working on a next-generation BOTOX® with more selective action targeted to specific cell receptors for pain management and spasticity treatment.

Beyond BOTOX®, clinical trials are underway to investigate a unique class of alpha adrenergic agonists for neuropathic pain - an area of unmet need for non-sedating and non-addicting compounds.

Product Indication Industry Partners Status
BOTOX® (U.S.) Upper Limb Spasticity

Post-Stroke Upper Limb Spasticity

Spasticity is commonly defined as a condition marked by persistent muscle spasms and exaggerated tendon reflexes.

- Review
BOTOX® (U.S. & Europe) Chronic Migraine

Chronic Migraine

Chronic migraine is a progressive and highly disabling headache disorder characterized by headaches that occur on 15 or more days each month. It affects about 7 million Americans.1 Allergan is supporting this research because currently available preventive therapies have limitations and are widely underutilized among those who need them most. New treatment approaches are urgently needed to lessen the burden of this serious neurological condition.

1. Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache 1999. 39:190:196

- Review
Alpha Agonists (U.S.) Neuropathic Pain

Neuropathic Pain

Neuropathic pain is chronic pain usually accompanied by tissue injury. Often, the nerve fibers themselves might be damaged, dysfunctional, or injured, sending incorrect signals to other pain centers. The impact of a nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury. Some common causes of neuropathic pain include amputation, back, leg, and hip problems, cancer chemotherapy, diabetes, facial nerve problems, multiple sclerosis, and others. Symptoms include shooting pain, burning pain, tingling, and numbness. Neuropathic pain often responds poorly to standard pain treatments1, which is why Allergan is supporting research in this area.

1. The Cleveland Clinic. Available at: www.clevelandclinic.org. Accessed June 15, 2007

ACADIA Pharmaceuticals Phase 2
AGN-2XXXXX Pain

Pain

Neuropathic pain is chronic pain usually accompanied by tissue injury. Often, the nerve fibers themselves might be damaged, dysfunctional, or injured, sending incorrect signals to other pain centers. The impact of a nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury. Some common causes of neuropathic pain include amputation, back, leg, and hip problems, cancer chemotherapy, diabetes, facial nerve problems, multiple sclerosis, and others. Symptoms include shooting pain, burning pain, tingling, and numbness. Neuropathic pain often responds poorly to standard pain treatments1, which is why Allergan is supporting research in this area.

1. The Cleveland Clinic. Available at: www.clevelandclinic.org. Accessed June 15, 2007

ExonHit Therapeutics Phase 1
Targeted BOTOX® (Next Generation Neuromodulator) Pain

Pain

Neuropathic pain is chronic pain usually accompanied by tissue injury. Often, the nerve fibers themselves might be damaged, dysfunctional, or injured, sending incorrect signals to other pain centers. The impact of a nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury. Some common causes of neuropathic pain include amputation, back, leg, and hip problems, cancer chemotherapy, diabetes, facial nerve problems, multiple sclerosis, and others. Symptoms include shooting pain, burning pain, tingling, and numbness. Neuropathic pain often responds poorly to standard pain treatments1, which is why Allergan is supporting research in this area.

1. The Cleveland Clinic. Available at: www.clevelandclinic.org. Accessed June 15, 2007

- Phase 1
Medical Aesthetics 

Allergan is deeply committed to the Science of Rejuvenation™ - that is, to delivering innovative and high-quality, science-based medical solutions in the areas of breast and facial aesthetics. Allergan's R&D efforts are focused on the development of next-generation dermal fillers for facial aesthetic use, and on innovations in breast aesthetics including new materials, enhanced manufacturing processes and product design.

Product Indication Industry Partners Status
Natrelle® Style 410 (U.S.) Breast Reconstruction & Augmentation

Breast Reconstruction & Augmentation

A diverse group of women chose breast aesthetic surgery each year using saline-filled or silicone-gel filled breast implants. Many of whom desire a more proportionate figure, which can be achieved by restoring or reshaping the natural look of their breasts. Whether after breast feeding, the birth of a child, after significant weight loss or surviving breast cancer, women often choose breast surgery to match their outer appearance with the positive way they feel on the inside. This individuality demands a broad range of breast implant options of varying shapes, fillers, projections and textures.

- Review
JUVÉDERM® Ultra and Ultra Plus with lidocaine (U.S.) Facial Aesthetics

Facial Aesthetics

There are two particularly important substances - collagen and hyaluronic acid - that play important roles in keeping facial skin looking smooth and supple. As the skin ages and is exposed to environmental pollutants and ultraviolet rays, collagen and hyaluronic acid in the skin diminish, the skin loses structure and volume, and unwelcome lines and wrinkles appear. As a world leader in medical aesthetics, Allergan is deeply committed to the Science of Rejuvenation™ - that is, to developing and delivering high quality, science-based aesthetic solutions and experiences.

- Review
VOLUMA™ (U.S.) Facial Aesthetics

Facial Aesthetics

There are two particularly important substances - collagen and hyaluronic acid - that play important roles in keeping facial skin looking smooth and supple. As the skin ages and is exposed to environmental pollutants and ultraviolet rays, collagen and hyaluronic acid in the skin diminish, the skin loses structure and volume, and unwelcome lines and wrinkles appear. As a world leader in medical aesthetics, Allergan is deeply committed to the Science of Rejuvenation™ - that is, to developing and delivering high quality, science-based aesthetic solutions and experiences.

- Clinical
Gastroenterology/Obesity Intervention 

Recognizing the serious consequences of the obesity epidemic, Allergan is pursuing the development and commercialization of next-generation products capable of providing healthier and less traumatic long-term weight-loss solutions.

Product Indication Industry Partners Status
LAP-BAND® System (U.S.) Adolescent Indication

Adolescent Indication

Obesity is a global epidemic that crosses the boundaries of age, gender and race. The World Health Organization estimates that there are 400 million people considered clinically obese worldwide. This chronic disease is caused by any one or a combination of environmental (social and cultural), genetic, physiologic, metabolic, behavioral and psychological factors.1,2

1. American Obesity Association. Obesity Surgery. Available at: www.obesity.org/treatment/obesity.shtml. Accessed January 18, 2007

2. CDC. Diseases and Conditions. Available at: www.cdc.gov/node.do/id/0900f3ec8000e035. Accessed March 9, 2007

- Review
LAP-BAND® System (U.S.) Lower Body Mass Index (BMI)

Lower Body Mass Index (BMI)

The most common measurement for obesity is Body Mass Index (BMI). BMI is calculated by dividing body weight (lb.) by height in inches squared (in2) and multiplying that amount by 704.5. The metric calculation for BMI is kg/m2.

- Clinical
ORBERA™ Intragastric Balloon System (U.S.) Obesity

Obesity

Obesity is now recognized by leading government health authorities, such as the Centers for Disease Control (CDC) and National Institutes of Health (NIH), as a disease. The World Health Organization (WHO) estimates that there are 400 million people considered clinically obese worldwide. In the United States, obesity is considered the second leading cause of preventable death.3 This chronic disease is caused by any one or a combination of environmental (social and cultural), genetic, physiologic, metabolic, behavioral and psychological factors.1,2

1. American Obesity Association. Obesity Surgery. Available: at www.obesity.org/treatment/obesity.shtml. Accessed January 18, 2007

2. CDC. Diseases and Conditions. Available at: www.cdc.gov/node.do/id/0900f3ec8000e035. Accessed March 9, 2007

3. American Obesity Association. AOA Fact Sheets. Available at: www.obesity.org. Accessed January 18, 2007

- Clinical
EASYBAND™ (U.S.) Obesity

Obesity

Obesity is now recognized by leading government health authorities, such as the Centers for Disease Control (CDC) and National Institutes of Health (NIH), as a disease. The World Health Organization (WHO) estimates that there are 400 million people considered clinically obese worldwide. In the United States, obesity is considered the second leading cause of preventable death.3 This chronic disease is caused by any one or a combination of environmental (social and cultural), genetic, physiologic, metabolic, behavioral and psychological factors.1,2

1. American Obesity Association. Obesity Surgery. Available: at www.obesity.org/treatment/obesity.shtml. Accessed January 18, 2007

2. CDC. Diseases and Conditions. Available at: www.cdc.gov/node.do/id/0900f3ec8000e035. Accessed March 9, 2007

3. American Obesity Association. AOA Fact Sheets. Available at: www.obesity.org. Accessed January 18, 2007

- Feasibility
Urology 

Pursuing the potential of BOTOX® (Botulinum Toxin Type A) to address new areas of unmet medical need, Allergan is conducting Phase III clinical trials to study BOTOX® as a treatment for neurogenic overactive bladder (OAB) associated with spinal cord and nervous system disorders, and is investigating the use of BOTOX® to treat idiopathic OAB (due to unknown cause) in Phase II clinical trials. Non-neurogenic OAB is estimated to affect between 13-33 million people in the United States alone. We also are investigating BOTOX® for the treatment of benign prostatic hyperplasia (BPH), a non-cancerous growth of the prostate that can interfere with urination and is one of the most common diseases affecting men.

Product Indication Industry Partners Status
BOTOX® (U.S.) Overactive Bladder - Neurogenic

Overactive Bladder - Neurogenic

Overactive bladder (OAB) is a condition that results from an involuntary contraction of the muscle in the wall of the urinary bladder, causing a sudden and unstoppable need to urinate. OAB affects approximately 33 million Americans.1 Symptoms include frequent and urgent need to urinate, possibly followed by leaking or involuntary and complete voiding.2 OAB can be caused by nerve damage or neurological disease; however, other identifiable, underlying causes include bladder stones and drug side effects.

1. Wein AJ, Rovner, ES. Definition and Epidemiology of Overactive Bladder. Urology 2002; 60(suppl 5A): 7-12

2. Urology Channel. Available at: www.urologychannel.com. Accessed June 15, 2007

- Phase 3
BOTOX® (U.S.) Overactive Bladder - Idiopathic

Overactive Bladder - Idiopathic Overactive Bladder - Neurogenic

Overactive bladder (OAB) is a condition that results from an involuntary contraction of the muscle in the wall of the urinary bladder, causing a sudden and unstoppable need to urinate. OAB affects approximately 33 million Americans.1 Symptoms include frequent and urgent need to urinate, possibly followed by leaking or involuntary and complete voiding.2 OAB can be caused by nerve damage or neurological disease; however, other identifiable, underlying causes include bladder stones and drug side effects.

1. Wein AJ, Rovner, ES. Definition and Epidemiology of Overactive Bladder. Urology 2002; 60(suppl 5A): 7-12

2. Urology Channel. Available at: www.urologychannel.com. Accessed June 15, 2007

- Phase 3
BOTOX® (U.S.) Benign Prostate Hyperplasia

Benign Prostate Hyperplasia

A common condition in which the prostate gland becomes enlarged as a man ages. Many symptoms of BPH stem from obstruction of the urethra and gradual loss of bladder function, which results in incomplete emptying of the bladder. Symptoms of BPH vary, but most commonly involve changes or problems with urination, such as weak or hesitant urine flow, urgent urination, leaking or dribbling, and more frequent urination, especially at night. More than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH.1

1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Available at: www.niddk.nih.gov. Accessed June 15, 2007

- Phase 2