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The neurotoxin market is comprised of two segments, therapeutics and aesthetics. The former mainly serves physicians practicing in the fields of neurology, physical medicine & rehabilitation, pain management and urology where Botox is used to treat pain and various neuromuscular and neuroglandular disorders. The latter mainly serves specialists in the fields of dermatology and plastic surgery where Botox is used to reduce wrinkles. In 2008, sales of Botox totaled over $1.3 billion, split equally between therapeutics and aesthetics. In recent years, the botulinum toxin industry has enjoyed considerable growth in the cosmetic (15%), therapeutic (20%) and international markets (>20%).


Spasticity is a chronic neural disorder of muscle function that causes muscle tightness or spasm. The latter involves involuntary movement (jerking) of muscles, which occurs when there is damage to the central nervous system. This damage may result from a traumatic brain, injury stroke, tumor, cerebral palsy or multiple sclerosis. Spasticity may be as mild as the feeling of stiffness or tightness of muscles, or it may be so severe that it produces painful uncontrollable spasms of the extremities, usually of the legs. It may also produce feelings of pain or tightness in and around joints as well as lower back pain. In many cases, spasticity is so severe and/or frequent that patients, absent intervention, suffer significant disruption in their daily activities.

Despite the undeniable therapeutic benefits achieved by Botox, there remain several drawbacks. First, there is a small but real risk of systemic paralysis and death from botulism. For example, several children suffering from cerebral palsy recently died of botulism after receiving excessive doses of Botox. Second, some patients develop antibodies which attack the Botox molecule, thereby rendering it ineffective in future treatments. The development of immunity to their sole means of treatment would be tragic for most patients. Third, Botox's limited duration of effect causes great inconvenience to both patient and physician because of the several office treatments required annually. Clinicians and patients have expressed significant interest in a product or treatment that addresses or mitigates one or more of these shortcomings.


Botulinum toxin injections, particularly around the eye and in the forehead region, have become a hallmark of the cosmetic industry. In fact, Botox injection is the most commonly performed nonsurgical cosmetic procedure in the US, with some 4.6 million wrinkle reduction treatments in 2007 alone. That is twice as many treatments as the number two minimally invasive cosmetic product, dermal fillers, and ten times the number of breast augmentations performed annually.

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