Galderma Announces Positive Outcome of European Decentralised Procedure for Approval of SOOLANTRA® (ivermectin) Cream 10mg/g for Rosacea Patients

Galderma, a global specialty pharmaceutical company focused on dermatology, announced today a positive outcome of the European Decentralised Procedure (DCP) for SOOLANTRA^® (ivermectin) Cream 10mg/g for the once-daily topical treatment of inflammatory lesions of papulopustular rosacea in adult patients. The Medical Products Agency (MPA) in Sweden acted as Reference Member State (RMS) on behalf of 28 EU Member States, which all agreed that SOOLANTRA Cream can be approved.

“As a world leader in skin health, Galderma is committed to providing innovative treatment options for clinicians and patients, and the approval of SOOLANTRA Cream highlights our continuous efforts,” said Stuart Raetzman, CEO of Galderma Pharma SA. “A clear focus on skin health has helped us expand our rosacea franchise to deliver more medicines that offer a novel approach, addressing important patient needs.”

The Marketing Authorisation application of SOOLANTRA Cream was based on three Phase III studies, which involved over 2,300 subjects. Two 12-week treatment vehicle-controlled studies demonstrated superiority of SOOLANTRA Cream efficacy over vehicle cream within 4 weeks. In a 16-week treatment active-controlled study, SOOLANTRA Cream was shown to be superior to Metronidazole 7.5 mg/g cream twice-daily in reducing Inflammatory Lesion Counts (ILC) as of Week 3 and until Week 16. After 16 weeks of treatment with SOOLANTRA, the reduction in ILC reached 83.0% from baseline. This is reflected in the European prescribing information.

While the SOOLANTRA Cream mechanism of action is not completely understood, ivermectin – its active ingredient – has been reported to have both anti-inflammatory and anti-parasitic properties.

“There are currently few effective treatments that reduce the papules and pustules of rosacea, and these may take in excess of four weeks to show results,” commented Jürgen Schauber, MD, Ludwig-Maximilian University, Munich, Germany. “SOOLANTRA Cream has demonstrated a quick onset and improved efficacy over an existing reference treatment in clinical studies, making it a new therapeutic option that meets the needs of rosacea patients.”

About Rosacea

Rosacea is a common inflammatory skin disease that presents variable clinical characteristics, of which the most common are flushing, permanent erythema, papules and pustules. It mainly affects the central areas of the face, such as the cheeks and nose. The disease affects both adult men and women, usually after the age of 30. Additionally, symptoms such as stinging, burning and increased sensitivity of the skin are common, and in some cases the eyes can become red, dry and itchy.

Although the cause of the disease is still under debate, various trigger factors are known, including spicy foods, alcohol, emotional stress, sun/UV-exposure, hot baths and beverages. Demodex, generally harmless mites, can also be found in the skin in an elevated quantity in people with rosacea.

Rosacea may worsen over time if left untreated. People that suspect they suffer from rosacea should visit their dermatologist or healthcare provider for diagnosis, and discuss what treatment is right for them. Because rosacea is a highly visible disease, it is known to cause embarrassment and anxiety in some patients, which in turn may cause frustration and have a negative impact on their social life.

About Galderma

Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime, while serving healthcare professionals around the world. The company has 34 wholly-owned affiliates with a worldwide network of distributors and more than 5,500 employees. Galderma’s extensive product portfolio is available in 80 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis and steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.

Galderma is the operating company of Nestlé Skin Health, a global leader focused on enhancing the quality of life by delivering science-based solutions for the health of skin, hair and nails. Five state-of-the-art R&D centers and six manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy.

Strategic Galderma brands include Epiduo^®, Oracea^®, Differin^®, Mirvaso^®, Soolantra^®, Tri-Luma^®, Loceryl^®, Cetaphil^®, Metvix^®, Azzalure^®/ Dysport^®, Restylane^® and Emervel^®.

For more information, please visit Galderma’s website: www.galderma.com

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Contact information

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Galderma
Sébastien Cros, +33 1 58 86 45 92
media@galderma.com