Allergan celebrates 20th anniversary of BOTOX in Canada

BOTOX(R): A Canadian Highlight in the Treatment of a Broad Range of Medical Conditions

Twenty years ago, the first approved use of BOTOX(R) (botulinum toxin type A), a neurotoxin widely used to treat several life altering medical conditions, was granted in Canada. As part of the 20th anniversary celebrations, healthcare professionals from coast to coast reflect upon the discovery, science and evolution of a therapy that has impacted the lives of millions of patients worldwide.

BOTOX(R), a purified protein derived from the naturally-occurring bacterium Clostridium botulinum, was first approved by Health Canada on March 14th,1990 for the treatment of strabismus (crossed eyes), blepharospasm (uncontrollable blinking), and VII nerve disorder. Other approvals for the medical uses of BOTOX(R) soon followed and included:

- To reduce the subjective symptoms and objective signs of cervical dystonia (muscle contractions in the neck) on March 29th, 1995; - For the treatment of dynamic equinus foot deformity due to spasticity in pediatric cerebral palsy in patients two years of age or older on July 7th, 1999; - For the treatment of hyperhidrosis of the axilla (excessive underarm sweating) on August 31st, 2001; and - In the management of focal spasticity (muscle tightness that can affect multiple areas of the body) on October 24th, 2001.

The same product, marketed under the name BOTOX Cosmetic(R), is also approved for the treatment of:

- Glabellar lines (vertical "frown lines" between the eyebrows), approved on April 4th, 2001; - Upper facial rhytides (forehead wrinkles), approved on November 4th, 2005; and - Lateral canthus (crow's feet), approved on November 4th, 2005.

"Not only is this an important milestone for Allergan, but it is a significant moment in history for Canadian patients and physicians who have relied on BOTOX(R) as a therapeutic and aesthetic option for the last 20 years," says Kevin Skule, President and General Manager, Allergan Canada. "Healthcare professionals ranging from ophthalmologists and neurologists to physiatrists to dermatologists to plastic surgeons have used BOTOX(R) with great success to treat patients suffering from a variety of conditions. One of the key advantages of BOTOX(R) is the fact that it has a very selective mechanism of action and mode of administration that provides precise and predictable benefits to patients."

BOTOX(R) is a simple, minimally invasive treatment that can deliver effective results to a wide range of patients. Today, the product benefits 21 different patient populations across approximately 80 countries, ranging from very compromised patients to healthy individuals who want to look and feel their best.

The safety and efficacy of BOTOX(R) has been well-established in more than 50 randomized, placebo-controlled clinical trials and in more than 11,000 patients treated with BOTOX(R) and BOTOX Cosmetic(R). Since its first approval in Canada in 1990, serious adverse events, whether or not considered to be related to BOTOX(R) and BOTOX Cosmetic(R), have been reported rarely and vary by treatment indication.

The Patient and Physician Perspective

"It's tremendously exciting for me to think about the evolution of BOTOX(R) and BOTOX Cosmetic(R) and how far we've come in the last 20 years," says Dr. Jean Carruthers, Clinical Professor, Department of Ophthalmology & Visual Sciences, University of British Columbia, and pioneer for the aesthetic use of BOTOX(R). "BOTOX Cosmetic(R) has truly set the aesthetic bar to new heights and has become widely accepted by women and men, both for its predictable effectiveness and its remarkable safety."

Dr. Earl Consky, neurologist in Toronto specializing in movement disorders has been treating patients with botulinum toxin therapy for 21 years.

"Botulinum toxin has revolutionized the treatment of a vast array of neurologic disorders previously unresponsive to traditional medical and surgical therapy," says Dr. Consky. "It has had a dramatic impact on the quality of life for many patients, particularly those with focal dystonia, and is now accepted as the standard of care for these conditions."

Now 34, Joelle Cooper was just 15 years old when a stroke left her left side completely paralyzed. The stroke led to dystonia, a movement disorder, which led to life altering muscle stiffness in her leg, which she and her physiatrist have since been successfully treating with BOTOX(R), as well as other therapeutic modalities including a strict physiotherapy regiment.

"I've been brace-free now for over a year and a half and that change happened because of BOTOX(R) treatments," said Joelle of her experience with the therapy. "I'm now back to having a lot more energy and engaging in the activities that I enjoy."

BOTOX(R) Research and Development

Over the course of 20 years, Allergan, a world leader in neurotoxin science and botulinum toxin product development, has worked with some of the world's pre-eminent scientists and physicians to conduct the pivotal clinical trials that have demonstrated efficacy and safety of BOTOX(R) in the treatment of serious or life altering medical conditions and of BOTOX Cosmetic(R) for aesthetic use. Today, Allergan continues to collaborate with leading academic institutions, researchers, scientists and physicians to explore the full therapeutic potential of BOTOX(R) with a focus on areas where there is a need for safe and effective new treatment options that make a meaningful difference to large numbers of patients, many of whom have no other treatment options. Specifically, Allergan has participated in clinical trials to explore the use of BOTOX(R) for the prevention treatment of headache in adults suffering from chronic migraine. The company is also studying the use of BOTOX(R) as a potential treatment in disorders that affect smooth muscles in the area of urology, such as overactive bladder and benign prostate hyperplasia (also referred to as BPH).

Botulinum Toxins are Unique

Each botulinum toxin has its own specific safety and efficacy profile, requiring its own dosing regimen for each indication that should always be discussed by the physician with his or her patient prior to treatment. Misconceptions about product interchangeability could present significant patient risks, which is why the BOTOX(R) and BOTOX Cosmetic(R) product monographs specifically caution that the "Allergan units" used to describe BOTOX(R) activity is different from those used to describe that of other botulinum toxin preparations and as such are not interchangeable with other products.

20th Anniversary: Helping Patients' Lives

Healthcare professionals and patients from across the country are available for comment in the following cities:

- British Columbia - Vancouver and Victoria - Alberta - Edmonton and Calgary - Saskatchewan - Saskatoon - Manitoba - Winnipeg - Ontario - Toronto, Ottawa, London, Hamilton, Windsor - Quebec - Montreal - New Brunswick - Fredericton, Sackville - Nova Scotia - Halifax