ADDING MULTIMEDIA Newly Approved Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Prescription Treatment Now Available for Acne Patients Nationwide

– Patients who struggle with hard-to-treat inflammatory acne now have
a new, antibiotic-free option –

FT. WORTH, Texas–(BUSINESS WIRE)–Galderma Laboratories, L.P. announced that Epiduo^® Forte
(adapalene and benzoyl peroxide) Gel, 0.3%/2.5%, is now available in
retail pharmacies nationwide and in Puerto Rico. It was recently
approved by the U.S. Food and Drug Administration (FDA) for the
once-daily, topical treatment of acne vulgaris.

Epiduo Forte Gel offers patients and physicians a unique treatment that
combines two antibiotic-free medicines in one gel and is proven to
control moderate to severe inflammatory acne. Left untreated,
inflammatory acne may lead to long-term, skin-health issues including
scarring. With the highest-available concentration of the retinoid
adapalene combined with benzoyl peroxide, Epiduo Forte Gel helps treat
moderate to severe inflammatory acne, by reducing the inflammation and
redness associated with acne, and by unclogging pores and killing
bacteria under the skin. Epiduo Forte Gel can help to simplify the
management of hard-to-treat acne, being a 2-in-1 combination product
that comes in an easy to use pump for the treatment of acne on the face,
chest, back or shoulders.

“Acne, the most common skin condition in the United States, can have a
wide-ranging negative impact on those with moderate to severe disease.
Patients with significant acne suffer both emotionally, as it
contributes to low self-esteem and depression, and physically, due to
permanent physical scarring,” said Jonathan S. Weiss, MD, a board
certified dermatologist at Gwinnett Dermatology, P.C., Galderma
consultant and leading clinical investigator for the phase 3 trials of
Epiduo Forte Gel. “I am confident that the availability of Epiduo Forte
Gel will provide relief for patients, as it is the first combination of
these strengths of adapalene and benzoyl peroxide developed to treat
moderate to severe inflammatory acne.”

The approval of Epiduo Forte Gel was based on a pivotal phase 3,
multicenter, randomized, double-blind, 12-week, placebo-controlled study
in which it met each of its primary efficacy endpoints when compared to
placebo gel in 217 acne subjects. The study demonstrated superiority of
Epiduo Forte Gel over placebo gel (33.7% vs 11.0%) in the overall study
population (moderate to severe) at week 12 for the Investigator’s Global
Assessment Success Rate and for changes in inflammatory (-68.7% vs
-39.2%) and non-inflammatory lesion count (-68.3% vs -37.3%,
respectively) (all P < .001). Additionally, subjects who were “severe”
at baseline (50%) were required to go from “severe” to “clear” or
“almost clear” within the 12-week trial to be considered a treatment
success. More than half of study subjects treated with Epiduo Forte Gel
reported a marked improvement in their severe acne (50.5%).

In the pivotal study of subjects with moderate to severe acne, Epiduo
Forte Gel results were seen as early as one week, and more than 90
percent of subjects reported complete, significant or moderate
improvement in their acne by week 12. Epiduo Forte Gel was shown to be
safe, well tolerated, and can be considered for long-term use. Some
study subjects (≥1%) experienced skin irritation, eczema, atopic
dermatitis and skin burning sensation while using Epiduo Forte Gel.

“At Galderma, we recognize the impact that acne has on various aspects
of patients’ lives and we are committed to ensure all acne sufferers
have suitable treatment options available by expanding our robust acne
franchise,” said Todd Zavodnick, President and General Manager of
Galderma Laboratories, L.P. “The availability of Epiduo Forte Gel
provides moderate to severe acne patients with a safe, effective and
antibiotic-free treatment option and also underscores Galderma’s
commitment to combat antibiotic resistance and acne simultaneously.”

Additional information on Epiduo Forte Gel can be found in the full
prescribing information and important safety information at www.epiduoforte.com.

About Acne

Acne is the most common skin condition in the United States, affecting
more than 40 to 50 million people. Acne appears when pores
clog with dead skin cells, and can have a wide-ranging negative impact
on sufferers that includes both emotional and physical scars. Studies
show that many people who have acne suffer from low self-esteem and
depression, and that teens who believe they have “bad” acne
were more likely to think about hurting themselves. Acne not only
affects teenagers but also can be seen in men and women of all ages with
research showing that the onset of acne is frequently seen in
prepubescent patients.

When it comes to acne treatment, long-term use of antibiotics may be a
contributing factor to the overall global antibiotic resistance issue.
Propionibacterium acnes (P. acnes), a bacteria linked to acne, is
increasingly becoming resistant to topical and oral antibiotics, which
may potentially cause a decrease in treatment efficacy against acne.

About Galderma

Dating back to 1961, Galderma is now present in 80 countries with an
extensive product portfolio to treat a range of dermatological
conditions. The company partners with health care professionals around
the world to meet the skin health needs of people throughout their
lifetime. Galderma is a leader in research and development of
scientifically-defined and medically-proven solutions for the skin, hair
and nails.

Strategic brands in the U.S. include Epiduo^® Gel, Oracea^®
Capsules, Clobex^® Spray, Differin^® Gel, Mirvaso^®
Gel, MetroGel^® Gel, Soolantra^® Cream, Vectical^®
Cream, Tri-Luma^® Cream, Cetaphil^®, Benzac^®
Acne Solutions, Restylane^®, Restylane^® Silk,
Restylane^® Lyft, Dysport^® and Sculptra^®
Aesthetic.

For more information, please visit www.galderma.com
and www.galdermausa.com.

All trademarks are the property of their respective owners.

Important Safety Information

Indication: Epiduo^® Forte (adapalene and benzoyl
peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne
vulgaris. Adverse Events: In the pivotal study, the most commonly
reported adverse reactions (≥1%) in patients treated with Epiduo Forte
Gel were skin irritation, eczema, atopic dermatitis and skin burning
sensation. Warnings/Precautions: Patients using Epiduo Forte Gel
should avoid exposure to sunlight and sunlamps and wear sunscreen when
sun exposure cannot be avoided. Erythema, scaling, dryness,
stinging/burning, irritant and allergic contact dermatitis may occur
with use of Epiduo Forte Gel and may necessitate discontinuation. When
applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips
and mucous membranes.

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.

Contacts

Galderma
Virginie Naigeon
Director of Communications, U.S.
Virginie.naigeon@galderma.com
or
Twist
Mktg
Brooke Shenkin, 212-301-7202
bshenkin@w2ogroup.com