TWYNEO (tretinoin and benzoyl peroxide) Cream, 0.1%/3% unveiled at American Academy of Dermatology Annual Meeting and commercially available in spring

Fort Worth, Texas – March 25, 2022 – Galderma announced today the U.S. launch of TWYNEO (tretinoin and benzoyl peroxide) Cream, 0.1%/3% at the American Academy of Dermatology (AAD) Annual Meeting, March 25-29, 2022, in Boston, Massachusetts. TWYNEO Cream is the first and only 0.1% tretinoin and 3% benzoyl peroxide (BPO) 2-in-1 combination proven to rapidly treat moderate to severe facial acne.^1,2 Patented microencapsulation technology unites two ingredients that have not been previously combined and enables their controlled release to deliver visible results in as little as two weeks.^2-4

Acne is a widespread skin condition affecting 85% of Americans ages 12 to 24 that can trigger feelings of depression, poor body image and low self-esteem.^5,6 Despite acne being common during this age, as many as 50% of teens have reported they experience unfair treatment at school because of their acne.⁷ Teens often fail multiple over-the-counter (OTC) acne treatment options before consulting a dermatology provider, despite 70% of parents wishing they sought specialist help sooner for their teen’s acne.^4,8

“Effective prescription acne treatments currently involve multi-step regimens because there is rarely a single treatment option that addresses the multiple causes of the skin condition. These routines can often result in low adherence, especially among boys,” said Caroline Robinson, MD, FAAD, Founder of Tone Dermatology. “TWYNEO Cream may help teens with acne – especially the boys –struggling with generic tretinoin or adhering to complex treatment routines, since it's a once-daily, potent combination that can be used any time of day.”

In clinical trials,* some people saw results in as little as two weeks of using TWYNEO Cream, and their skin continued to clear over time.^3,4 These studies demonstrated a 25 percent decrease in pimples at two weeks^3,4 and a 58–66 percent decrease at 12 weeks;^3,4 with 27–41 percent of people achieving clear or almost clear skin by the end of the trial.^3,4 More than half of people who used TWYNEO Cream were satisfied at two weeks^3,4 and by 12 weeks of treatment, 8 in 10 persons were satisfied with their results^3,4 with 9 in 10 people staying on treatment until the end of the trial.^3,4 TWYNEO Cream was well tolerated and side effects were mild to moderate and decreased over time.^3,4 The most common side effects occurring in >2% of persons using TWYNEO Cream were application site pain, dryness, erythema (redness), and exfoliation.^3,4

“TWYNEO Cream is a novel and exciting medical advance because its microencapsulation technology enables the combination of BPO with the highest concentration of tretinoin available. While these two treatments can be difficult to tolerate in high concentrations, TWYNEO Cream was well tolerated,” said Hillary Baldwin, MD, Medical Director of Acne Treatment & Research Center and principal investigator for the TWYNEO Cream clinical trials. “The patented microencapsulation technology in TWYNEO Cream segregates and envelopes the active ingredients in silica core shells that keep both crystals separate and stable while gradually releasing onto the skin.”

“As a regimen in a bottle that combines two of the most trusted first-line treatments for acne, TWYNEO Cream is truly a breakthrough for teens and their parents looking for an acne treatment that fits within a simple skincare routine and provides rapid, noticeable results,” said Heather Chase, Head of Rx Marketing and Customer Experience, Galderma U.S. "TWYNEO Cream is another example of Galderma's commitment to providing cutting-edge treatments to advance dermatology for every skin story."

TWYNEO Cream will be available throughout the U.S. by prescription in Q2. A month’s supply of TWYNEO Cream costs $0 for commercially covered patients or $60 for uninsured patients with the Galderma CAREConnect savings card. TWYNEO Cream may cost less than generic tretinoin alone when using the Galderma CAREConnect savings card.

About TWYNEO^®

TWYNEO (tretinoin and benzoyl peroxide) Cream, 0.1%/3% is indicated for the topical treatment of inflammatory and noninflammatory lesions of acne vulgaris.¹ The patented microencapsulation technology in TWYNEO Cream segregates and envelopes the active ingredients in silica core shells (microcapsules) so that tretinoin is protected from the oxidizing effects of BPO, allowing the combination of both drugs into one product and gradual release onto the skin.²

Sol-Gel Technologies (Nasdaq: SLGL) received FDA approval for TWYNEO Cream on July 27, 2021, and has granted exclusive rights to Galderma to commercialize the treatment in the U.S.

For additional information, please visit www.twyneo.com/

About Galderma

Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story.

For additional information, please visit www.galderma.com/us.

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Media Relations

Shannon Iwaniuk

Director, U.S. Communications

shannon.iwaniuk@galderma.com

+1 817 961 5359

IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use TWYNEO^® Cream safely and effectively. See full prescribing information for TWYNEO Cream here.

Indication: TWYNEO (tretinoin and benzoyl peroxide) Cream, 0.1%/3% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with TWYNEO Cream were pain (stinging, burning, or pain), dryness, exfoliation, erythema (redness), dermatitis, pruritus (itching) and irritation - all at the application site. Warnings/Precautions: Patients using TWYNEO Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of TWYNEO Cream immediately and seek medical attention. Skin irritation may be experienced, including application site dryness, pain (stinging, burning or pain), exfoliation, erythema (redness), dermatitis, pruritus (itching) and irritation. Depending upon the severity, use a moisturizer, reduce the frequency of the application, or discontinue use. Avoid application to cuts, abrasions, eczematous, or sunburned skin. TWYNEO Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of TWYNEO Cream at the first evidence of sunburn.

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

1. TWYNEO (tretinoin and benzoyl peroxide) cream. Prescribing Information.
2. Sol-Gel Technologies Ltd. Sol-Gel Technologies announces FDA approval of TWYNEO. Sol-Gel Advanced Topical Therapy. https://ir.sol-gel.com/news-releases/news-release-details/sol-gel-technologies-announces-fda-approval-twyneor
3. Galderma Laboratories, L.P. Clinical Study Report SGT-65-04. 2020, May 28.
4. Galderma Laboratories LP. Clinical Study Report SGT-65-05. 2020, June 5.
5. Bhate K, Williams HC. Epidemiology of acne vulgaris. The British Journal of Dermatology 2013;168:474-85.
6. American Academy of Dermatology Association. Acne can affect more than your skin. Accessed 03/10/2022. https://www.aad.org/public/diseases/acne/acne-emotional-effects.
7. Galderma Laboratories LP. Burden Summary Report: Combined Facial & Truncal Acne. 2021, March.
8. Practical Dermatology. Survey: Parents Extremely Worried About the Physical and Emotional Toll that Severe Acne Takes on Teens. Accessed 03/10/2022. https://practicaldermatology.com/news/survey-parents-extremely-worried-about-the-physical-and-emotional-toll-that-severe-acne-takes-on-teens?c4src=news-landing:feed