- Galderma positioned to commercialize Restylane®, Perlane®, Emervel®, Sculptra®, Dysport® in the U.S. and Canada
- Galderma reinforces long-term commitment to meet physician and patient needs in aesthetic and corrective dermatology worldwide
FORT WORTH, Texas, May 28, 2014 /CNW/ - Galderma Laboratories, L.P. ("Galderma") announced today that Nestle S.A., Switzerland, one of Galderma's shareholders, has entered into an agreement with Valeant Pharmaceuticals International, Inc. and related entities ("Valeant"), through which Galderma will become the distributor of several key products in aesthetic dermatology. Galderma will gain full rights to commercialize Restylane, Perlane, Emervel, Sculptra and Dysport for use in aesthetic dermatology in the U.S. and Canada.
Humberto C. Antunes, President & CEO of Galderma worldwide, based in Lausanne, Switzerland, expressed, "We are very grateful that Nestle has continued to support Galderma through this transaction. The U.S. and Canada represent more than 50 percent of the fast growing global medical aesthetics market. This move secures Galderma's continued ability to invest in product innovation, medical education, customer service and consumer awareness. Thanks to this agreement with Valeant, Galderma will be able to provide this best-in-class portfolio of fillers and muscle relaxant for aesthetic and corrective dermatology also in the United States and Canada."
Stuart Raetzman, CEO of Galderma Laboratories, L.P. and Galderma North America, said from Fort Worth, Texas, "This further marks the commitment of Galderma employees in the United States and Canada to aesthetic and corrective dermatology. We all work together to maintain the industry's highest standards of clinical safety and efficacy, to bring a wide range of scientifically advanced and clinically proven medical solutions to physicians. Our portfolio of products, combined with exclusive services and medical training programs, positions Galderma as the preferred partner of dermatologists, plastic surgeons and aesthetic physicians."
Restylane, Perlane and Emervel are manufactured by Galderma and sold by its subsidiaries globally, except in the U.S. and Canada, where Valeant holds the distribution rights under terms of a pre-existing agreement with Medicis, which was acquired by Valeant in 2012. Through this transaction, Galderma will be able to further develop and supply these innovative and leading brands globally.
Sculptra is owned by Valeant. Through this transaction Galderma is acquiring this product and will commercialize it in the U.S. and Canada and select other markets around the world.
Dysport (branded Azzalure in Europe) is marketed by Galderma for aesthetic dermatology indications in many markets around the world. Valeant holds the distribution rights for the aesthetic dermatology indications under a similar agreement with Ipsen. Through this transaction, Galderma will gain the right to commercialize Dysport for aesthetic dermatology indications in the U.S. and Canada.
This transaction is also subject to regulatory clearance and other customary closing conditions. Credit Suisse acted as financial advisors, and Debevoise and Plimpton as legal advisors to Galderma.
In February 2014, Nestle announced that it had entered into an agreement with L'Oreal S.A. under which it will acquire the remaining 50 percent of Galderma owned by L'Oreal. The transaction between Nestle and Valeant is subject to regulatory clearance and certain other conditions, and is expected to close in July.
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. Each Restylane product is a clear gel formulation of hyaluronic acid, specifically formulated to act like the body's own naturally produced hyaluronic acid, which helps reduce moderate to severe facial wrinkles and folds or add fullness to the lips (Restylane and Restylane-L only), 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 5 hyaluronic acid soft dermal fillers, 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 for approval in the US.
Dysport (botulinum toxin A) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults under 65. It is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity.
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. Over the past 14 years, considerable experience has been gained with PLLA, and its safe and effective use has been well documented.
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.
SOURCE: Galderma Laboratories, L.P.
For further information:
Galderma Laboratories, L.P., Virginie Naigeon, Director of Public Relations and Internal Communications, U.S., Communications • Galderma North America, [email protected], office: 817 961 5014; or Margulies Communications Group, Jamie Hawkes, [email protected], office: 214-368-0909, cell: 469-867-7289