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Revance recently announced enrollment in a Phase 2 study of plantar fasciitis, a common and painful musculoskeletal condition.

The company is also in a phase 2 clinical trial for cervical dystonia, a very painful and debilitating neurologic disorder.

Revance Clinical Program Update:

  • In 2016, Revance initiated a Phase 2 study for treatment of plantar fasciitis (PF). PF is a novel indication and a clinical differentiator from current neurotoxins on the market.
  • Revance initiated a Phase 2 clinical study of RT002 for treatment of cervical dystonia in September of 2015. The first two cohorts have been completely enrolled. Interim results are expected in the second half of 2016.

For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commissions, as well as the press releases we issue, or visit www.clinicaltrials.gov

Market Facts, Figures & Trends:

  • Use of botulinum toxin products for aesthetic and therapeutic indications represents an estimated $3.4 billion market globally.
  • Therapeutic indications for botulinum toxin represent more than half of the global neurotoxin market. These indications include cervical dystonia, upper and lower limb spasticity, chronic migraine, hyperhidrosis, urinary incontinence, overactive bladder and a number of neurological movement disorders.
  • There are more than 100 therapeutic uses of botulinum toxin that are currently reimbursed by healthcare providers.*

* Reimbursement market research data on file at Revance.

Cervical Dystonia

Cervical Dystonia is an extremely painful, chronic neurological movement disorder where the neck and shoulder muscles contract involuntarily and contort, causing the head to twist or turn to the left, right, upwards, and/or downwards.

Cervical dystonia (also known as Spasmodic Torticollis) affects a person’s ability to control muscle activity, and is often attributed to nervous system damage caused by a stroke, disease or trauma. A rare disorder that can occur at any age, even during infancy, cervical dystonia most often occurs in middle-aged individuals, and is more prevalent in women than men. Those with a family history of cervical dystonia or some other type of dystonia are at higher risk of developing the disorder.

Symptoms generally begin gradually and then reach a plateau where the symptoms don’t get substantially worse.

Unfortunately, there is no cure for cervical dystonia and the condition greatly impacts an individual’s quality of life. In some cases, the disorder resolves without treatment, but sustained remissions are fairly uncommon.

The most commonly prescribed treatment for cervical dystonia is the use of botulinum toxin type A, which can reduce the signs and symptoms.

Facts, Figures & Trends:

  • Muscle movement disorders, including cervical dystonia, comprise about half of the estimated $1.8 billion neurotoxin therapeutic sales, globally.*
  • Cervical dystonia is the third most common movement disorder following essential tremor and Parkinson’s disease.
  • An estimated 3 in every 10,000 people — or about 90,000 people in the US — are known to suffer from cervical dystonia. The number of cases reported in North America is approximately 300,000.
  • Treatment for cervical dystonia involves regular neurological intervention, and a durable response — as preliminarily reported with the investigational agent RT002 injectable — would be desirable.

* Global Industry Analysts, Inc. — Botulinum Toxin — A Strategic Business Report; September 2014.

For more information on cervical dystonia, visit:
https://www.dystonia-foundation.org/what-is-dystonia
http://www.mayoclinic.org/spasmodic-torticollis
https://www.dystonia-foundation.org/understanding-dystonia

Plantar Fasciitis

Plantar Fasciitis (PF) is a subacute, degenerative process that often results in debilitating pain located in the heel and bottom of the foot. The pain experienced is often most severe at the beginning of the day upon onset of physical activity.

Anatomically, the plantar fascia is a thick band of connective tissue that runs the length of the foot from the heel all the way through the arch to the base of the toes. The tissue separates into distinct segments, ultimately dividing into 5 digital bands that connect to the toe joints. In a normal, healthy state, the plantar fascia provides tension to support the foot as well as providing shock absorption during routine as well as more demanding activities like running.

Although the etiology of PF is multifactorial, it is generally believed to result from repeated pressure on the tissue that can create small tears in the fascia or overstretch the fascia. Risk factors for developing PF include foot arch problems, heel spurs, age, heel fat pad atrophy, obesity, weight gain, running activities (e.g. jogging, tennis), weight-bearing occupations, and tight Achilles tendon.

Although plantar fasciitis pain can improve over time, or even resolve itself using conservative treatment methods, progress can nonetheless be slow and frustrating. Furthermore, treatment failure is not uncommon and can lead to considering surgical intervention.

Looking to the future, the introduction of a novel treatment option like botulinum toxin may prove a welcome addition to today’s armamentarium.

Facts, Figures & Trends:

  • An estimated 1 in 10 adults in the U.S. will suffer from plantar fasciitis at some point in their lifetime, with approximately 1 million patient visits per year attributed to PF. 1
  • Plantar fasciitis is the most common cause of heel pain and is responsible for 80% of the cases. 1
  • The incidence and prevalence of PF in women is twice that of men, although the condition is seen in adults of all ages. 2
  • The annual cost of evaluation and treatment for PF is estimated to be more than $250 million dollars. 2

1. Rosenbaum AJ, DiPreta JA, Misener D. Plantar Heel Pain. Med Clin N Am 98. 2014: 339–352 http://dx.doi.org/10.1016/j.mcna.2013.10.009 2. Medscape http://emedicine.medscape.com/article/86143-overview

Chronic Migraine

Migraine is a neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms.

Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families. The exact mechanisms of migraine are not known. It is, however, believed to be a neurovascular disorder.

Typically, migraine headache affects one half of the head, is pulsating in nature, and lasts from two to 72 hours. Associated symptoms may include nausea, vomiting, visual aura, and increased sensitivity to light, sound, and/or smell. Migraine pain can be debilitating and is generally made worse by physical activity.

Botulinum toxin type A has been found to be useful in treating those with chronic migraines.

Facts, Figures & Trends:

  • It’s estimated that approximately 15% of the world’s population is affected by migraines at some point in life.
  • Chronic migraine occurs when individuals meet criteria for migraine and average 15 or more headache days/month for at least 3 months 1,2
  • 1.3% of women and 0.5% of men in the US meet criteria for chronic migraine 3
  • Both migraine and chronic migraine are 2-3 times more common in women than men 3,4

1. Headache Classification Subcommittee of the IHS. ICHD-III (beta). Cephalalgia. 2013;33:629-808. 2. Silberstein SD, Lipton RB, Dodick DW. Operational diagnostic criteria for chronic migraine: expert opinion. Headache. 2014;54:1258-1266. 3. Buse DC, Manack AN, Fanning KM et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012;52:1456-1470. 4. Buse DC, Loder EW, Gorman JA et al. Sex differences in prevalence, symptoms, and other features of migraine, probable migraine and other severe headache: results of the American Migraine Prevalence and Prevention Study. Headache.2013;53:1278-1299.

For more information on chronic migraine, visit:
http://www.americanmigrainefoundation.org

Overactive Bladder

Overactive Bladder (or OAB) is a condition where a person experiences the abnormally increased need or a frequent feeling of needing to urinate to a degree that it negatively affects that person’s life.

Urgency is considered the hallmark symptom of OAB. The frequent need to urinate may occur during the day, at night, or both.

The cause of overactive bladder is unknown. Risk factors include obesity, caffeine, and constipation. People often have the symptoms for a long time before seeking treatment and the condition is sometimes identified by caregivers.

If there is loss of bladder control, then it is known as urge incontinence. It is not life-threatening, yet most individuals with OAB experience problems for years.

Botulinum toxin injections appear to be an effective therapy for refractory OAB symptoms.

Facts, Figures & Trends:

  • Overactive bladder (OAB) is estimated to occur in 7-27% of men and 9-43% of women. It becomes more common with age. Some studies suggest that the condition is more common in women, especially when associated with loss of bladder control.
  • More than 40% of people with overactive bladder have incontinence, while about 40% to 70% of urinary incontinence is due to overactive bladder.
  • OAB symptom prevalence and severity tend to increase with age.
  • A proportion of OAB cases (37-39%) decline during a given year, but the majority of patients have symptoms for years.

For more information on overactive bladder, visit:
https://www.auanet.org/Overactive-Bladder.pdf
http://www.urologyhealth.org/overactive-bladder

Hyperhidrosis

Hyperhidrosis is a skin disorder characterized by abnormally increased sweating in excess of that required for thermoregulation (regulation of body temperature).

It can be associated with a significant quality of life burden from a psychological, emotional, occupational, and social perspective. A large number of individuals who suffer from hyperhidrosis consider their condition intolerable. Hyperhidrosis is sometimes referred to as 'the silent handicap'. The number of cases of hyperhidrosis are underreported by patients and underdiagnosed by physicians.

Hyperhidrosis can either be generalized, or localized to specific parts of the body. Hands, feet, armpits, and the groin area are among the most active regions of perspiration due to the high number of sweat glands in these areas.

Use of botulinum toxin type A has been used to block neural control of sweat glands.

Facts, Figures & Trends:

  • An estimated 9 million individuals in the U.S. (approximately 2.8% of the total population) suffer from hyperhidrosis, and more than 50% of those people are not diagnosed or receiving treatment.
  • Currently, axillary hyperhidrosis can be treated with a series of 15 injections of botulinum toxin for each underarm. This painful procedure prohibits the vast majority from seeking treatment.
  • Revance’s RT001 topical has been explored as a potential treatment for axillary hyperhidrosis (severe underarm sweating) — a condition well-suited to topical application.

For more information on hyperhidrosis, visit:
International Hyperhidrosis Society: http://www.sweathelp.org/

 

RT002 injectable and RT001 topical are investigational product candidates. RT002 is currently undergoing clinical studies for both therapeutic and aesthetic indications. RT001 is in preclinical development.