leadership through innovation in facial aesthetics: botox, juvederm, latisse, vivite
DESCRIPTION
Allergan brand fillers and injectables: Botox, Juvederm, Latisse, ViviteTRANSCRIPT
Leadership Through Innovation in Facial Aesthetics
Allergan Programs Policy: Off-Label Questions
If a physician-speaker is asked an unsolicited question, he/she may briefly answer that question even if the question involves information inconsistent with Allergan’s approved product labeling
Physician-speaker must adhere to the Programs Policy when answering a question involving an off-label use of Allergan products
The physician must:– Indicate that the information under discussion is not consistent with the
FDA-approved labeling
– Note that the information being exchanged is based on his/her own professional clinical experience as a physician, and
– If the physician believes, in the exercise of his/her medical and scientific judgment, that the question should be answered, he/she may briefly answer the question, but the speaker should then immediately return the discussion to approved uses of Allergan products
The Allergan Medical Family of Products
The first and only FDA-
approved product indicated to treat hypotrichosis of the eyelashes by increasing their
growth, including length, thickness,
and darkness
The first and only FDA-
approved product indicated to treat hypotrichosis of the eyelashes by increasing their
growth, including length, thickness,
and darkness
The first treatment approved by the
FDA for moderate to severe glabellar
lines in patients 18 to 65 years of age
The first treatment approved by the
FDA for moderate to severe glabellar
lines in patients 18 to 65 years of age
The #1 selling dermal filler in the US1 with:
Smooth Flow Smooth ConsistencyProvides a smooth, natural look and feelSmooth Outcomes
The #1 selling dermal filler in the US1 with:
Smooth Flow Smooth ConsistencyProvides a smooth, natural look and feelSmooth Outcomes
Advances skin care with GLX Technology™to help daily rejuvenation
Advances skin care with GLX Technology™to help daily rejuvenation
Facial Aesthetics Portfolio
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety Information on slide 16, and LATISSE® Important Safety Information on slides 39-43.
1. Data on file, Allergan, Inc., November 2009; US Facial Injectables Market Share Report; GuidePoint Global Filler Share Tracker.
Allergan Provides a Complete Array of Products for Facial Aesthetics
Moderate to severe glabellar lines
Chin Wrinkles*
Nasolabial Folds*Perioral Lines*
Marionette Lines*
Hypotrichosis of the Eyelashes
Skin Care
*When diagnosed as a moderate to severe wrinkle or fold.
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15, JUVEDERM ® Important Safety Information on slide 16, and LATISSE® Important Safety Information on slides 39-43.
BOTOX® Cosmetic (onabotulinumtoxinA)
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Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
History of Development, FDA Approvals, andClinical Trials
FDA approval for cervical dystonia
FDA approval for moderate to
severe glabellar lines
FDA approval for hyperhidrosis
inadequately managed with topical agents
BOTOX®
(onabotulinumtoxinA)20th anniversary
Botulinum Toxin Type A first isolated
1920s 1978 1989 2000 2002 2004 20091991
FDA = US Food and Drug Administration.
First therapeutic testing in humans
with Oculinum
Dr. Allen Scott
FDA approval of Oculinum for
blepharospasm, strabismus
Allergan changes product name
to BOTOX®
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IndicationsBOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the
severity of abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information
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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
Distant Spread of Toxin EffectPostmarketing reports indicate that the effects of BOTOX® or BOTOX® Cosmetic and all
botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
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CONTRAINDICATIONSBOTOX® and BOTOX® Cosmetic are contraindicated in the presence of infection at the
proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGSThe recommended dosage and frequency of administration for BOTOX® or
BOTOX® Cosmetic should not be exceeded. Risks resulting from administrationat higher dosages are not known.
Lack of Interchangeability Between Botulinum Toxin ProductsThe potency Units of BOTOX® and BOTOX® Cosmetic are specific to the preparation and
assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® and BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
WARNINGS (continued)Spread of Toxin EffectPlease refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive, serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX®/BOTOX® Cosmetic at the labeled dose of 20 Units(for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) havebeen reported.
No definitive, serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm at the recommended dose (30 Units and below) or for strabismus at the labeled doses have been reported.
Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactions include
anaphylaxis, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® or BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
WARNINGS (continued)Pre-existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or
neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® or BOTOX® Cosmetic.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
PRECAUTIONSCaution should be used when BOTOX® or BOTOX® Cosmetic treatment is used in patients who have an inflammatory skin problem at the injection site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart.
Information for PatientsPatients should be counseled that if loss of strength, muscle weakness, or impairedvision occur, they should avoid driving a car or engaging in other potentially hazardous activities.
PregnancyAdministration of BOTOX® or BOTOX® Cosmetic is not recommended duringpregnancy. There are no adequate and well-controlled studies of BOTOX® orBOTOX® Cosmetic in pregnant women.
Nursing MothersIt is not known whether BOTOX® or BOTOX® Cosmetic are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® or BOTOX® Cosmetic are administered to a nursing woman.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
ADVERSE REACTIONSGeneralThe most serious adverse events reported after treatment with botulinum toxin include
spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility.
There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease.
Cervical DystoniaThe most frequently reported adverse reactions following injection of BOTOX® for cervical
dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
ADVERSE REACTIONS (continued)BlepharospasmThe most frequently reported treatment-related adverse reactions following injection of
BOTOX® for blepharospasm include ptosis (20.8%), superficial punctate keratitis (6.3%), and eye dryness (6.3%).
StrabismusThe most frequently reported adverse events following injection of BOTOX® for
strabismus include ptosis (15.7%) and vertical deviation (16.9%).
Primary Axillary HyperhidrosisThe most frequently reported adverse events (3% to 10% of patients) following injection
of BOTOX® for severe primary axillary hyperhidrosis include injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache,fever, neck or back pain, pruritus, and anxiety.
Glabellar LinesThe most frequently reported adverse events following injection of BOTOX® Cosmetic
include blepharoptosis and nausea.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
ADVERSE REACTIONS (continued)OverdosageExcessive doses of BOTOX® or BOTOX® Cosmetic may be expected to produce
neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.
In the event of suspected or actual overdosage, please contact your local or state health department to process a request for antitoxin through the Centers for Disease Control and Prevention (CDC). If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.
Note to representative: Please provide full BOTOX® and BOTOX® Cosmetic Prescribing Information, including Medication Guide, when presentingthis material.
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BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information(continued)
JUVÉDERM® Important Safety Information
JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate, lasting 7 days or less, and included temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.
BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic (onabotulinumtoxinA): Experience Worldwide
1. Data on file, Allergan, Inc.; 2. The American Society of Plastic Surgeons (ASPS). 2009 Report of the 2008 Statistics: National Clearinghouse of Plastic Surgery Statistics. The American Society of Plastic Surgeons (ASPS) Web site. http://www.plasticsurgery.org/Media/stats/2008-US-cosmetic-reconstructive-plastic-surgery-minimally-invasive-statistics.pdf. Accessed 2010.
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BOTOX® Cosmetic (onabotulinumtoxinA): Unique Molecular Structure
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Proven Treatment for Moderate to Severe Glabellar Lines
First physician-administered, nonsurgical aesthetic treatment approved by the FDA to temporarily treat moderate to severe glabellar lines in patients 18-65 years of age
High levels of patient satisfaction1,2
– Precise delivery with physician control – Predictable clinical outcomes3
Frown lines are caused by overactive facial muscles.
1. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX® Cosmetic Use Survey, April 2005.; 2. Facial Injectables Consumer User Survey; July 2009. 3. BOTOX® Cosmetic Prescribing Information, August 2009.
Precise Control for Predictable Outcomes
In clinical trials at day 7, 74% of patients demonstrated none or mild glabellar line severity at maximum frown as compared to 6% in placebo; at day 30, 80% of patients demonstrated the same as compared to 3% in placebo.1
Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising.
1. BOTOX® Cosmetic Prescribing Information, August 2009.
Unretouched photos taken at maximum frown before treatment with BOTOX® Cosmetic and taken at maximum frown after treatment with BOTOX® Cosmetic at days 2 and 14. The photos featured here are of actual BOTOX® Cosmetic patients. Individual results may vary.
Before Day 14Day 2
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Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX® Cosmetic (onabotulinumtoxinA)Begins Working Within 24 to 48 Hours1
1. BOTOX® Cosmetic Prescribing Information, August 2009.
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7480
70
48
25
8289
82
63
39
6 3 2 2 29 7 4 3 1
7 30a 60 90 120 7 30a 60 90 120
BOTOX Cosmetic (onabotulinumtoxinA) (N = 405) Placebo (N = 132)
BOTOX® Cosmetic (onabotulinumtoxinA): 74% “Full Response” by Day 71
aDay 30: Co-primary efficacy time point, P < .001.
1. BOTOX® Cosmetic Prescribing Information, August 2009.
Day of Investigator’s Assessment Day of Subject’s Assessment
®
Res
po
nd
ers
(%)
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Patient Satisfaction Is Paramount in Aesthetic Practices
1. Fagien S, et al. Plast Reconstr Surg. 2008.
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX® Cosmetic (onabotulinumtoxinA):97% Patient Satisfaction in Surveyed Patients1,2
1. Facial Injectables Consumer User Survey; July 2009; 2. Aesthetic Surgery Education and Research Foundation (ASERF), BOTOX® Cosmetic Use Survey, April 2005.
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Very Satisfied
69.2%
Somewhat Satisfied27.4%Not Satisfied
3.4%
Self-reported responsesN = 117
Why High Satisfaction With BOTOX® Cosmetic (onabotulinumtoxinA)
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. BOTOX® Cosmetic Prescribing Information, 2009.
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
BOTOX® Cosmetic (onabotulinumtoxinA): A Specific Formulation Not Shared by Any Other Product
≈ 5 nanograms of onabotulinumtoxinA, ≈ 900-kDa neurotoxin complex
0.9 mg sodium chloride0.5 mg serum albumin
BOTOX® Cosmetic (onabotulinumtoxinA): A Legacy of Experience
1. The American Society of Plastic Surgeons (ASPS) Web site. Accessed 2010; 2. Aesthetic Surgery Education and Research Foundation (ASERF),BOTOX® Cosmetic Use Survey, April 2005; 3. Facial Injectables Consumer User Survey; July 2009; 4. BOTOX® Cosmetic Prescribing Information, 2009.
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Summary of FDA Labeling Changes to BOTOX® Cosmetic (onabotulinumtoxinA)
Unique nonproprietary name Addition of Boxed Warning regarding distant spread of toxin effect
– No definitive reports of distant spread of toxin effect with BOTOX® Cosmetic at the labeled dose of 20 U
Revised lack of interchangeability Statement of nondetectability of BOTOX® Cosmetic in peripheral blood Revised content regarding:
– Pre-existing neuromuscular disorders– Dysphagia and breathing difficulties in the treatment of cervical dystonia– Information for patients/provision of approved patient Medication Guide
by physician– Adverse reactions regarding local weakness of muscles adjacent to injection– Overdosage including the addition of new text and instructions
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Summary of BOTOX® Cosmetic (onabotulinumtoxinA) Risk Evaluation and Mitigation Strategies (REMS)
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• Medication Guide– Included in each carton– Notice to distribute Medication Guide to patient– Additional copies of Medication Guide available from Allergan
• Communication Plan– Support healthcare providers in the implementation of REMS– “Dear Healthcare Provider” Letter (DHPL)– DHPL, updated prescribing information, and Medication Guide provided to all
BOTOX®/BOTOX® Cosmetic (onabotulinumtoxinA) purchasers
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Allergan’s Proactive Steps to Protect Patient Safety
Importation of pharmaceuticals
and biologic products into the United States has
drawn media attention
Direct-to-physician sales help ensure product integrity
Exacta® vial to ensure product authenticity• Flip-top cap and purple-
colored crimp• ALLERGAN appears on
the holographic label
Importation of Foreign Pharmaceuticals or Biologics Into the United States Without FDA Approval Remains Illegal
Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Botulinum Toxin Units Are Not Interchangeable According to the Label
1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009.
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“…Units of biological activity of
BOTOX® Cosmetic cannot be compared to or
converted into Units of any other botulinum toxin…”1
“…Units of biological activity of
BOTOX® Cosmetic cannot be compared to or
converted into Units of any other botulinum toxin…”1
“The potency Units of Dysport™ are specific to
the preparation and assay method utilized. They are not interchangeable with
other preparations of botulinum
toxin products…”2
“The potency Units of Dysport™ are specific to
the preparation and assay method utilized. They are not interchangeable with
other preparations of botulinum
toxin products…”2
Evaluating Botulinum Toxin Properties
1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Dysport™ Prescribing Information, 2009; 3. Lietzow et al. Protein J. 2008; 4. Hambleton. J Neurol. 1992.; 5. Wenzel et al. J Clin Pharm Ther. 2007; 6. Panjwani et al. Botulinum J. 2008.
BOTOX® Cosmetic(onabotulinumtoxinA)
(2002)
Dysport™
(abobotulinumtoxinA)(1991)
BoNT A SNAP-251
BoNT ASNAP-252
≈ 9003 ≥ 3004
Vacuum-driedNaCl
Albumin1
Freeze-dried2
Lactose2
Albumin2
Neutral5 Neutral5
100 U1 300 U/500 U2
≈ 5 ng5 4.35 ng per 500 LD50 U6
2.5 mL per 100 U1
1.5 mL per 300 Uor
2.5 mL per 300 U2
20 U4 U per .01 mL x 51
50 U2
10 U per .05 mL x 52 or 10 U per .08 mL x 52
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Serotype/SubstrateSerotype/Substrate
Complex weight (kDa)Complex weight (kDa)
FormulationFormulation
pHpH
Units/VialUnits/Vial
Total Protein Total Protein (ng/vial)(ng/vial)
ReconstitutionReconstitution
Approved doseApproved dose
Botulinum Toxin Injection Patterns Vary
1. BOTOX® Cosmetic Prescribing Information, 2009; 2. Moy et al. Arch Facial Plastic Surg. 2009.
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Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
Botulinum Toxins Perform Differently: Results From a Double-Blind, Randomized, Parallel-Group Study1
1. Lowe et al. J Am Acad Dermatol. 2006.
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Glabellar Line Severity Improved With BOTOX® Cosmetic (onabotulinumtoxinA)1
Duration from a double-blind, randomized, parallel-group study.Incidence of at least a 1-grade improvement from baseline in
glabellar line severity at maximum contraction.
1. Lowe et al. J Am Acad Dermatol. 2006.
94%(29/31)
77%(24/31)
53%(16/30)
97%(29/30)
59%(17/29)
28%(8/29)
0
20
40
60
80
100
8 12 16
P = .04
Pat
ien
ts (
%)
Weeks
BOTOX® Cosmetic (onabotulinumtoxinA) (20 U)
Dysport™ (abobotulinumtoxinA) (50 U)
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Considerations in Switching to Another Botulinum Toxin
Physicians considering switching to another botulinum toxin need to evaluate: Differences in the approved dose, dilution, volume, and
injection sites Potential side effects
Patients considering treatment with another botulinum toxin need to evaluate: Experience of injector with specific toxin Side effects with specific toxin Effectiveness of specific toxin
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Please see BOTOX® Cosmetic Important Safety Information including Boxed Warning on slides 7-15.
The Science of LATISSE®
(bimatoprost ophthalmic solution) 0.03%
©2010 Allergan, Inc., Irvine, CA 92612® and ™ marks owned by Allergan, Inc.JUVÉDERM® mark owned by Allergan Industrie, SAS. Dysport is a trademark of Ipsen Biopharm Limited.Perlane and Restylane are registered trademarks of HA North American Sales AB.PowerPoint is a registered trademark of Microsoft Corporation in the United States and/or other countries. www.botoxcosmetic.com 1-800-BOTOXMD www.juvederm.com/professional Re-order: APC58HR10
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