#1 Branded Topical Acne Product, Epiduo® GEL, Recieves FDA Approval For a New Convenient Pump Dispenser | Galderma US
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`> #1 Branded Topical Acne Product, Epiduo® GEL, Recieves FDA Approval For a New Convenient Pump Dispenser
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`#1 Branded Topical Acne Product, Epiduo® GEL,
`Recieves FDA Approval For a New Convenient
`Pump Dispenser
`
`S H A R E T H I S A R T I C L E
`
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`December 15, 2011
`
`Study Shows that Acne Sufferers Prefer Pump Delivery for
`Treatment Administration
`
`Fort Worth, Texas – December 15, 2011 – Galderma Laboratories, L.P. today
`received approval from the U.S. Food and Drug Administration (FDA) for a
`pump dispenser for Epiduo® (adapalene and benzoyl peroxide) Gel 0.1% /
`2.5%. This approval marks the first-ever pump dispenser for Epiduo Gel, the
`only once-daily, topical acne treatment that combines two well-established
`active ingredients adapalene, a retinoid, and benzoyl peroxide, a well-known
`antimicrobial with no evidence of promoting bacterial resistance, for patients
`12 years of age and older. Epiduo Gel is the #1 branded topical acne product
`among dermatologists and pediatricians. The Epiduo Gel pump will be
`1
`available via prescription in the first quarter of 2012 in pharmacies nationwide.
`
`“Because acne is caused by a multitude of factors, management of the
`condition has traditionally relied on combination therapy,” said Dr. Linda Stein
`Gold, Director, Dermatology Clinical Research, Henry Ford Health System,
`Detroit, and Division Head, Dermatology, Henry Ford Health System, West
`Bloomfield. “As a dermatologist I often prescribe Epiduo Gel, which combines
`two effective medications into one product to treat both inflammatory and non-
`inflammatory lesions topically. My patients have often achieved very positive
`results, and I believe that patients will be excited about the new pump delivery
`system for its convenience and administration benefits.”
`
`https://www.galderma.com/us/news/1-branded-topical-acne-product-epiduo-gel-recieves-fda-approval-new-convenient-pump-dispenser
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`Almirall EXHIBIT 2041
`
`Amneal v. Almirall
`IPR2019-00207
`
`

`

`#1 Branded Topical Acne Product, Epiduo® GEL, Recieves FDA Approval For a New Convenient Pump Dispenser | Galderma US
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`Studies indicate that Epiduo Gel is more efficacious than either of its
`components used alone, and has had no evidence of promoting antibiotic
`resistance. Epiduo Gel simplifies the management of acne and significantly
`reduces total acne lesions by approximately 18 percent as early as the first
`week of treatment. Epiduo Gel also helps to reduce the complexity of acne
`management by reducing the number of medications a patient has to
`remember to take on a daily basis, potentially increasing treatment adherence.
`
`In a recently completed preference survey, 92 percent of patients were
`satisfied or very satisfied with the new pump for Epiduo Gel. The survey,
`2a
`which ascertained patient preference for the Epiduo Gel pump vs. the tube, 2
`involved 291 physician-diagnosed acne patients, ages 12 to 35.
`The
`2b, 2c
`randomized study found that with use of the Epiduo Gel pump, patients found
`it to be more convenient, easier to use and more attractive than the tube. Of
`2d
`note, the study concluded that:
`
`• Nearly 80 percent of patients said they would request the pump over the
`tube the next time they visit their doctor.
`2e
`
`• 88 percent of patients said the Epiduo Gel pump made it easier for them to
`follow their doctor’s instructions.
`2f
`
`• More than 90 percent of patients found the Epiduo Gel pump to deliver a
`consistent amount of the gel to their face during each use, and also to save
`time during treatment administration.
`2g
`
`• 93 percent of patients said the Epiduo Gel pump was more attractive than
`the tube; in fact, 84 percent of patients said they were more likely to leave the
`Epiduo Gel pump out on the counter.
`2h
`
`About Acne
`
`Acne vulgaris is one of the most widely experienced chronic skin diseases. In
`recent years, research has lead to a greater understanding of the pathogenesis
`of the disease. The disorder begins with the onset of puberty and is thought
`3
`to result from hormonal action on the skin’s oil glands (sebaceous glands)
`leading to plugged pores and outbreaks.
`It can be challenging to manage due
`4
`to the variability in response to treatment and the need for long term therapy.
`5
`
`About Galderma
`
`Galderma, created in 1981 as a joint venture between Nestle and L'Oréal, is a
`fully-integrated specialty pharmaceutical company dedicated exclusively to the
`field of dermatology. The Company has a presence in 65 countries with over
`1,000 sales representatives and is committed to improving the health of skin
`with an extensive line of products across the world that treat a range of
`dermatological conditions including: acne, rosacea, fungal nail infections,
`psoriasis and steroid-responsive dermatoses, pigmentary disorders, medical
`solutions for skin senescence and skin cancers. With a research and
`development center in Sophia Antipolis, France, Galderma has one of the
`
`https://www.galderma.com/us/news/1-branded-topical-acne-product-epiduo-gel-recieves-fda-approval-new-convenient-pump-dispenser
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`#1 Branded Topical Acne Product, Epiduo® GEL, Recieves FDA Approval For a New Convenient Pump Dispenser | Galderma US
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`largest R&D facilities dedicated exclusively to dermatology. Leading U.S.
`brands include Epiduo® Gel, Differin® Gel, 0.3%, Differin® Lotion, 0.1%,
`MetroGel® 1%, Oracea®, Cetaphil®, Tri-Luma® Cream, and Vectical® Ointment.
`
`For more information about Galderma, please visit www.galderma.com
`(https://www.galderma.com/us/www.galderma.com).
`
`Important Safety Information
`
`Epiduo® Gel is indicated for the topical treatment of acne vulgaris in patients 12
`years and older. Apply to affected skin once per day, avoiding the eyes, lips
`and mucous membranes. The most common adverse events associated with
`use of Epiduo® Gel are redness, scaling, dryness, stinging and burning. In
`addition, you may also experience contact dermatitis and/or skin irritation.
`These side effects typically resolve during the first four weeks of treatment,
`but speak to your doctor if they persist. You should avoid excessive exposure
`to sunlight and sunlamps while using Epiduo® Gel, and using sunscreen
`products and protective clothing is recommended. Do not use irritating topical
`products that contain resorcinol, salicylic acid or sulfur when using Epiduo®
`Gel. Epiduo® Gel has not been tested in pregnant or nursing women, or with
`the elderly. Please see Full Prescribing Information.
`
`You are encouraged to report negative side effects of prescription drugs to the
`FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
`
`References: 
` Galderma Data on File.
`
`1
`
`2
`
`Galderma Laboratories, L.P. Clinical Study Report (Gli.04.Sre.Us10184).
`August 2011.
`
`3
`
` Gollnick H, Cunliffe WJ, Berson D et al. Management of Acne: A Report From
`a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003;
`49(1):S1-S37.
`
`4
`
` Nemours Foundation. Why Do I Get Acne?
`http://www.kidshealth.org/teen/your_body/skin_stuff/acne.html.
`
`5
`
`Thiboutot D, Pariser DM, Egan N et al. Adapalene gel 0.3% for the treatment
`of acne vulgaris: A multicenter, randomized, double-blind, controlled trial. J Am
`Acad Dermatol. 2006; 54:242-50.
`
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`#1 Branded Topical Acne Product, Epiduo® GEL, Recieves FDA Approval For a New Convenient Pump Dispenser | Galderma US
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