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SOURCE Galderma S.A.
Expansion Completes Galderma's Global Skin Health Footprint
FORT WORTH, Texas, July 10, 2014 /PRNewswire/ -- Galderma S.A. (Galderma) announced that it has gained full rights to distribute Restylane®, Perlane®, Emervel®, Sculptra® and Dysport® from Valeant Pharmaceuticals International, Inc. The expansion into aesthetic and corrective dermatology in the U.S. and Canada completes Galderma's global skin health footprint and extends its leadership in aesthetic medicine worldwide.
"We at Galderma are delighted to bring Restylane®, Perlane®, Emervel®, and Dysport® home in the U.S. and Canada as is the case in dozens of countries around the world. Adding Sculptra® to our global portfolio allows us to bring additional indications to our broad range of medical solutions for people with skin needs," said Humberto C. Antunes, CEO and President of Galderma worldwide. "Our science-based approach to fillers and muscle relaxants takes our solutions beyond the aesthetic level to an integral part of holistic medicine, where maintaining, preserving and restoring the health of the skin is as important and as relevant as treating or correcting conditions. With Restylane, Perlane, and Dysport, as well as the innovations to come, we complement our line of prescription and self-medication products to give physicians an arsenal of effective solutions," added Antunes.
Two of Galderma's most recent innovations in the field, Emervel® Classic and Emervel® Deep, have been submitted for approval by the FDA and Health Canada and are currently under review.
"The U.S. and Canada represent more than 50 percent of the fast growing global medical aesthetics markets," said Stuart Raetzman, Vice President of Galderma for North America. "Demographics, social and cultural drivers, as well as an improving economy, make this an ideal time for Galderma to expand its geographic footprint in aesthetic and corrective medicine to the United States and Canada. At Galderma, people come first. We are thrilled to take on board the experienced teams from Valeant Aesthetics and, more than ever, our intent is to preserve the quality of the long-lasting relationships built with doctors. We look forward to partnering with healthcare providers in the growth and expansion of aesthetic and corrective medicine in North America and advancing the care and treatment of patients."
Galderma will pursue to distribute the acquired products through the existing distribution partner. Healthcare practitioners are invited to continue to order products through their current account number and phone numbers. Beginning July 28, Galderma will have a new branded distribution process. All accounts will automatically receive a new Galderma account number and information on the new ordering process.
"This agreement reinforces Galderma's long-term commitment to meet physician and patient needs worldwide. Our high level of investment in Research & Development allows us to continue to develop new products and to bring innovation with the highest standards of clinical safety and efficacy," added Antunes. "This expansion demonstrates Galderma's sole focus on dermatology and skin health and its ongoing dedication to research and innovation."
About Restylane & Perlane
The Restylane family of products includes Restylane, Restylane-L, Perlane, and Perlane-L. These products can be used to correct moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds), by adding volume and fullness to the skin. Restylane and Restylane-L may also be used for lip enhancement in patients over 21. These products have now been used in over 20 million facial aesthetic treatments in more than 65 countries worldwide, with a safety and efficacy profile supported by scientific research, clinical studies and extensive clinical experience, including over 30 scientific publications based on randomized controlled trials.
Emervel, an innovative, next generation family of hyaluronic acid soft dermal fillers, is specifically designed to enhance patient tolerability and provide long-lasting correction of facial lines, contouring and volume loss or lip enhancement. Emervel was launched in Europe in 2010. Emervel Classic and Emervel Deep have been submitted to the FDA and regulatory activities to support approval are ongoing.
Dysport (botulinum toxin A) is a prescription injection with an aesthetic indication for temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults under 65. Dysport was first approved for use outside the U.S. in 1991. It is available today for aesthetic use in 57 countries and has been approved for aesthetic use in the U.S. since 2009.
Sculptra® (Poly-L-lactic acid (PLLA)) was approved for use in Europe in 1999. In the United States, it was approved by the Food and Drug Administration in 2004 for the treatment of facial lipoatrophy associated with human immunodeficiency virus (HIV), and in 2009 for cosmetic indications in immune-competent patients. Sculptra Aesthetic is a unique treatment option in the world of Medical Aesthetic treatments that allows clinicians to work directly with the patient to help replace lost collagen, through a series of treatments. On average, three injection sessions are required over a period of a few months. The number of injection sessions and the number of injections per session vary from person to person with clinical results persisting up to 25 months.
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 5,000 employees. Galderma's extensive product portfolio is available in 80 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence. With approximately 19% of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world's leading investors in dermatology R&D. Five state-of-the-art R&D centers and five manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy. Strategic brands include Epiduo, Oracea, Clobex, Differin, Mirvaso, Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Nutraderm, Nutraplus, Metvix, Azzalure/Dysport, Restylane and Emervel.
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