Handles patients with care

y…

Delivers on efficac

s Handles Patiente With Car

e topical is indicated for th DUAC Topical Gel lgaris. ne mmator y ac vu treatment of infla

DUAC Topical Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of noninflammatory acne.

Important Safety Information DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis.

Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

Please consult accompanying full Prescribing Information.

DUAC Topical Gel for patients with inflammatory acne vulgaris ris Patient: Ryan, 17 years* P Subjective: Acne for 2 to 3 years. Has never been prescribed Rx therapy.

Tolerability is impo important to patient, as his skin is easily irritated Objective: Presents with multiple erythematous papules on forehead, cheeks, and chin. Also with large acneiform papules on forehead and chin Assessment: Moderate inflammatory in acne Plan: DUAC Topical Gel Ge once daily applied to entire face. Follow up in 4 weeks to assess tolerability tolerability. Discussed appropriate sun protection measures

Patient Patient: Jessica, 19 years* Sub Subjective: Last seen in the office 4 months ago, diagnosed with mild to moderate a acne. Now complaining that inflammatory lesions have worsened. Patient has never been prescribed a BPO-containing agent Objective: Multiple inflammatory lesions on forehead, nose, cheeks, and chin Assessment: Moderate inflammatory acne Plan: Provided samples of DUAC Topical Gel and prescription; apply to entire face once daily. Use moisturizer as needed. Discussed cleansing and proper sun care.

Follow up in 8 weeks

Patient: Brianna, 25 years* Subjective: Just completed grad school and started first full-time job.

Wants to present professional image at work and improve her acne Objective: Multiple inflammatory lesions on forehead, cheeks, and chin Assessment: Moderate inflammatory acne Assessmen Plan: Provi Provided samples of DUAC Topical Gel and prescription; apply to entire face once daily. Discussed proper sun care and cleansing regimen.

Follow up in i 8 weeks

*Hypothetical patient case study.

DUAC Topic Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris.

Important Safety Information for DUAC Topical Gel: • Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents • The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures • Avoid contact with eyes and mucous membranes • Clindamycin- and erythromycin-containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn • DUAC Topical Gel should be given to a pregnant woman only if clearly needed • Adverse reactions may include erythema, peeling, burning, and dryness Please consult accompanying full Prescribing Information.

Patient Profiles/ Actives & Vehicle

DUAC® (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel has a patented formula containing the methicone humectant glycerin and occlusive dimethicone DUAC Topical Gel contains the following active ve ingredients1,2: • Clindamycin is bacteriostatic • Benzoyl peroxide is bactericidal

The vehicle in DUAC Topical Gel contains glycerin lycerin and dimethicone to help with hydration of the skin*3,4 Glycerin—draws moisture up and promotes skin hydration 3,4 Dimethicone—helps lock moisture in 3 *The contribution to efficacy by individual components of the vehicle has not been established.

Glycerin (humectant)

Dimethicone (occlusive)

Hydrating Vehicle

3

DUAC Topical Gel demonstrated tolerability There were no reports of severe erythema, peeling, burning, or dryness.

Percent of patients experiencing moderate local reactions at baseline and during treatment with DUAC Topical Gel: combined results from 5 clinical trials Percent of particip participants experiencing local skin reaction

25 Baseline During treatment

20

(n=397)

≤2% increase in the incidence of moderate erythema, peeling, burning, or dryness

15

10

5

5% 2%

3%

0

Erythema

<1%

<1% <1%

<1% 1%

Peeling

Burning

Dryness

Percent of patients experiencing mild local reactions at baseline and during treatment treatme with DUAC Topical Gel: combined results from 5 clinical trials Percent of participants experiencing local skin reaction

50 Baseline During treatment

40

30

(n=397) 28%

26%

20

17%

10

15%

6% 3%

5%

6%

0

Erythema

Peeling

Burning

Dryness

DUAC Topical Gel demonstrated tolerability

99% of patients in clinical trials had good or excellent overall tolerance scores with DUAC Topical Gel after 11 weeks of use5

Tolerability

• Good or excellent tolerance scores were similar across all treatment arms (vehicle, 99%; clindamycin, 99%; and benzoyl peroxide, 99%)

2% of patients in clinical trials treated with DUAC Topical Gel reported a drug-related adverse a event 5 • The incidence of drug-related adverse events was similar among all treatment arms (vehicle, 2%;; clindamycin, 2%; and benzoyl peroxide, 2%)

DUAC Topical Gel is indicated for the topical treatment of inflammatory ory acne vulgaris.

Important Safety Information for DUAC Topical Gel: • DUAC Topical Gel is contraindicated in patients who have shown hypersensitivity sitivity to any of its components or lincomycin • DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus • For dermatologic use only; not for ophthalmic use • Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Please consult accompanying full Prescribing Information.

5

DUAC Topical Gel demonstrated efficacy in pivotal trials DUAC Topical Gel achieved mean percent reductions in inflammatory lesions at 11 weeks across pivotal trials5 Study 1: n=120 Week 0

*P<0.05 vs benzoyl peroxide, clindamycin, and vehicle gel.

Week 2

Week 5

Week 8

Endpoint

% reduction in in inflammatory lesion count

0

–10 19%

–20 –30

34% 36%

–40

–50 –60

D DUAC Topical Gel Benzoyl Peroxide Clindamycin Vehicle Gel

* 65%

–70

Study 2 2: n=273 Week W 0

*P<0.05 vs benzoyl peroxide, clindamycin, and vehicle gel.

Week 2

Week 5

Week 8

Endpoint

% reduction in inflammatory lesion count

10 –0.4%

0 –10 –20 –30

*

30% 37%

–40 –50 –60

DUAC Topical Gel Benzoyl Peroxide Clindamycin Vehicle Gel

*

*56%

–70

Important Safety Information for DUAC Topical Gel: • Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents • The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures • Avoid contact with eyes and mucous membranes • Clindamycin- and erythromycin-containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn • DUAC Topical Gel should be given to a pregnant woman only if clearly needed • Adverse reactions may include erythema, peeling, burning, and dryness Please consult accompanying full Prescribing Information.

DUAC Topical Gel demonstrated efficacy in pivotal trials DUAC Topical Gel achieved mean percent reductions in inflammatory lesions at 11 weeks across pivotal trials5 Study 3: n=280 Week 0

P=NS vs benzoyl peroxide, clindamycin, and vehicle gel.

Week 2

Week 5

Week 8

Endpoint

% reduction in inflammatory lesion count

0 –10 –20 29% 32%

–30

38%

–40

42%

–50

DUAC Topical Gel Benzoyl Peroxide Clindamycin Vehicle Gel

–60 –70

Study 4: n=288 Week 0

P<0.05 vs clindamycin; P=NS vs benzoyl peroxide.

Week 2

Week 5

Week 8

Endpoint

–10

Efficacy

% reduction in inflammatory lesion count

0

–20 –30 –40 49%

–50

57%

DUAC Topical Gel Benzoyl Peroxide Clindamycin

–60

57%

–70

Study 5: n=358 Week 0

*P<0.05 vs benzoyl peroxide, clindamycin, and vehicle gel.

Week 2

Week 5

Week 8

Endpoint

% reduction in inflammatory lesion count

0 –10 –20 –30

29% 33%

–40

41%

–50 –60

DUAC Topical Gel Benzoyl Peroxide Clindamycin Vehicle Gel

*

* 52%

–70

DUAC Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris.

7

DUAC Topical Gel improved overall inflammatory lesion reduction The difference between DUAC Topical Gel and its active ingredients and vehicle was significant in 3 of 5 clinical trials at week 11 DUAC Topical Gel achieved inflammatory lesion reductions of up to 65% at week 115

% reduction in inflammatory lesion count

Inflammatory lesion reductions at week 11 were -0.4% to 29% for vehicle gel,l, 30% to 49% for clindamycin gel, and 32% to 57% for benzoyl peroxide gel

Week 0

Week 2

Week 5

Week 8

E Endpoint d i t

0 –10 –20 –30 –40 –50 –60

Study 1 (n=120)* Study 2 (n=273)* Study 3 (n=280) Study 4 (n=288) Study 5 (n=358)*

42% 52% 56% 57% 65%

–70 *P<0.05 DUAC Topical Gel vs individual components at 11 weeks. *P

DUAC Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris.

DUAC Topical Gel demonstrated efficacy in pivotal trials The majority of patients (57% weighted average) ge) using DUAC A Topical T Ge Gel reported good to excellent global improvement across all clinical trials5 • Weighted averages were 22% for vehicle gel, 42% for clindamycin, and 44% for benzoyl peroxide

Percent of patients with good to excellent global improvement (week 11)5 Study 1† (n=120)

Study 2† (n=273)

Study 3‡ (n=280)

Study 4§ (n=288)

Study 5|| (n=358)

DUAC Topical Gel

75%

63%

32%

68%

58%

Benzoyl Peroxide

42%

41%

33%

55%

44%

Clindamycin

38%

35%

44%

54%

30%

Vehicle Gel

15%

7%

35%

—

26%

DUAC Topical Gel delivered good to excellent global improvement (good=51% to 75% improvement; excellent=76% to 100% improvement) at week 11 in significantly more patients vs benzoyl peroxide, clindamycin, and vehicle gel in studies 1 and 2. Results from study 5 were significant against clindamycin and vehicle gel. Study 4 did not assess performance against vehicle gel.

Studies 1 and 2: P≤0.05 vs benzoyl peroxide, clindamycin, and vehicle gel.

Study 3: P=NS vs benzoyl peroxide, clindamycin, and vehicle gel. § Study 4: P≤0.05 vs clindamycin; P=NS vs benzoyl peroxide; vehicle gel not evaluated. || Study 5: P≤0.05 vs clindamycin and vehicle gel; P=NS vs benzoyl peroxide. † ‡

Efficacy

Important Safety Information for DUAC Topical Gel: • DUAC Topical Gel is contraindicated in patients who have shown hypersensitivity to any of its components or lincomycin • DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus • For dermatologic use only; not for ophthalmic use • Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Please consult accompanying full Prescribing Information.

9

DUAC Topical Gel has a breadth of clinical experience

D DUAC Topical Gel demonstrated efficacy in pivotal trials • 1319 total patients enrolled (5 pivotal studies, all arms) • 397 completed treatment with DUAC Topical Gel

DUAC Topical Gel has years of treatment experience • First pivotal trial completed in 1994 4 • FDA approved for use in 2002

More than 6 million total prescriptions of DUAC Topical Gel and DUAC CS have been dispensed since launch6

DUAC Topical Gel is brought to you by a leader in dermatology, Stiefel, a GSK company

DUAC Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris.

References: 1. Tan H. Topical antibacterial treatments for acne vulgaris: comparative review and guide to selection. Am J Clin Dermatol. 2004;5(2):79-84. 2. Anderson DM. Dorland’s Illustrated Medical Dictionary. 30th ed. Philadelphia, PA: Elsevier; 2003:191,192. 3. Draelos Z. Therapeutic moisturizers. Derm Clin. 2000;18:597-607. 4. Eichenfeld L. Fixed combination monotherapy with clindamycin 1%--benzoyl peroxide 5% gel: focus on acne patient benefits and clinical use. Cutis. 2009;84(5S):2-4. 5. Data on file. Stiefel, a GSK Company. 6. SDI. VectorOne: National (VONA). October 2009. 7. Electronic Orange Book. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm.

Accessed April 1, 2010. 8. BenzaClin Topical Gel [package insert]. Bridgewater, NJ: sanofiaventis US LLC; 2009. 9. Epiduo Gel [package insert]. Fort Worth, TX; Galderma Laboratories, LP; 2008. 10. Aczone Gel [package insert]. Irvine, CA: Allergan, Inc; 2009. 11. Acanya Gel [package insert]. Aliso Viejo, CA; Coria Laboratories; 2008.

There is no therapeutically equivalent generic substitute approved by the FDA for DUAC Topical Gel*7 • Patented formula containing the humectant glycerin and the occlusive dimethicone • FDA approved for once-a-day use • Premixed prior to dispensing –Other clindamycin/benzoyl peroxide combination products are individually mixed at the pharmacy

√

Vehicle gel contains both dimethicone and glycerin

6

Once-daily dosing

6

Dispensed in tube that has a flip-top cap

6

Premixed prior to dispensing

6

Acanya™11 (clindamycin phosphate, 1.2%/ benzoyl peroxide, 2.5%) Gel

6

Aczone®10 (dapsone) Gel, 5%

BenzaClin®8 (clindamycin, 1%/ benzoyl peroxide, 5%) Gel

Contains bactericidal benzoyl peroxide and bacteriostatic clindamycin†

Epiduo™9 (adapalene and benzoyl peroxide) Gel 0.1%/2.5%

DUAC Topical Gel

*According to the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).

√

√

√ √

√

√

†

There is insufficient evidence from adequate well-controlled clinical trials to support efficacy and/or safety comparisons among these products.

The brands listed are trademarks of their respective owners and are not trademarks of Stiefel Laboratories, Inc. The makers of these brands are not affiliated with and do not endorse Stiefel or their respective products.

Important Safety Information for DUAC Topical Gel:

Please consult accompanying full Prescribing Information.

Experience & Benefits

• DUAC Topical Gel is contraindicated in patients who have shown hypersensitivity to any of its components or lincomycin • DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus • For dermatologic use only; not for ophthalmic use • Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure 11

DUAC Topical Gel—delivers on efficacy… … handles patients with care DUAC Topical Gel is indicated for the topical treatment of inflammatory acne vulgaris Tolerability profile • 99% of patients in clinical trials had good or excellent overall tolerance scores with DUAC Topical Gel after 11 weeks of use5 – Good or excellent tolerance scores were similar across all treatment arms (vehicle, 99%; clindamycin, 99%; and benzoyl peroxide, 99%)

Efficacy in pivotal trials • DUAC Topical Gel demonstrated greater reductions in inflammatory lesion counts and improvements in investigator global assessment scores than the benzoyl peroxide, clindamycin, and vehicle groups in 3 of 5 clinical studies5

Breadth of experience • Years of treatment experience – FDA approved for use in 20025 – Dispensed over 6 million times since launch6

No therapeutically equivalent generic substitute7 • Patented formula with the humectant glycerin and the occlusive dimethicone • FDA approved for once-a-day use • Premixed prior to dispensing

The STIEFELCARE® Program is a comprehensive insurance and support program for patients who are prescribed any Stiefel product The STIEFELCARE Program provides insurance verification assistance, prior authorization assistance, and other helpful information.

For insurance coverage assistance and information, please call 1.800.572.3225, Monday through Friday,, 8:00 AM – 8:00 PM ET.

Impor Important Safety Information for DUAC Topical Gel: • DUAC Topical T Gel is contraindicated in patients who have shown hypersensitivity to any of its components or lincomycin omycin • DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, colitis or antibiotic-associated colitis • Diarrhea, Diarr bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus Fo dermatologic use only; not for ophthalmic use • For A • Adverse reactions may include erythema, peeling, burning, and dryness • Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure • Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents • The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs, discontinue use of this medication and take appropriate measures • Clindamycin- and erythromycin-containing products should not be used in combination. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn • DUAC Topical Gel should be given to a pregnant woman only if clearly needed Please consult accompanying full Prescribing Information.

DUAC is a registered trademark of Stiefel Laboratories, Inc. ©2010 Stiefel Laboratories, Inc. All rights reserved.

Printed in USA. DUA029R0 April 2010