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January 13, 2011

Formulated with or without lidocaine
Offering the most comprehensive aesthetic filler solution

Paris (France) and Lausanne (Switzerland), 12 January 2011 – Galderma, a global pharmaceutical  company, today announced the launch of EMERVEL®, a complete range of nine scientifically-advanced and clinically-proven hyaluronic acid dermal fillers. Indicated for the treatment of facial lines, contouring and volume loss, the EMERVEL range of fillers carries the Medical Device CE mark 0459. It is also available with the widely-used local anaesthetic lidocaine1. Commercialisation in the UK, France, Germany, Italy, Spain, Brazil and Argentina is scheduled for 2011.

EMERVEL benefits from a manufacturing engineering innovation called Optimal Balance TechnologyTM which is responsible for the fillers’ optimal gel texture. As a result,  EMERVEL fillers integrate completely into the appropriate skin layer, giving way to good skin tolerance and long-lasting aesthetic outcomes as shown in clinical trials. EMERVEL belongs to a select group  of hyaluronic acid fillers that is based on well-designed clinical trial data.

“We constantly strive to provide a complete range of solutions that will enable doctors to best address skin senescence and to optimize patient outcomes. The launch of the EMERVEL range of fillers further marks our commitment to corrective and aesthetic dermatology. Galderma is committed to using its expertise, high standards of clinical safety and efficacy to bring best-in-class products that will add value to physicians’ daily practice and ameliorate patients’ treatment experience,” said Humberto C. Antunes, President & CEO of Galderma. “The EMERVEL filler range joins AZZALURE (botulinum toxin type A), expanding Galderma’s medical aesthetic offering in Europe and Latin America.”

EMERVEL Classic and EMERVEL Deep have been tested, prior to commercialisation, versus commonly-used hyaluronic acid fillers in the market place to ensure their high level of efficacy and safety. Both fillers were extensively evaluated in European, randomised, double-blind, active controlled, multicentre, split-face, comparative clinical trials for moderate or severe nasolabial folds.

EMERVEL Deep showed significant superiority in effectiveness at week 24 versus the comparator in the first study evaluating 68 patients with severe nasolabial folds and this superiority was sustained up to week 48. At the interim time point (week 24, 52 patients) of the second ongoing study, EMERVEL Classic and the comparator had similar efficacy in the treatment of moderate facial wrinkles.  In both studies, EMERVEL products and comparators showed a comparable safety profile. Other clinical trials are currently ongoing for the other fillers in the EMERVEL range.

“Interim data from these additional studies confirm that EMERVEL provides an excellent combination of tolerability profile and aesthetic outcomes. The results of these studies will help physicians choose the most appropriate treatment for their patients, especially in a category where there are lots of options,” said Berthold Rzany, M.D., Sc.M., Head of The Division of Evidence Based Medicine (dEBM) at the Department of Dermatology at Charité-Universitätsmedizin in Berlin, Germany and one of the study’s principal investigators. 

The EMERVEL range of fillers comes in a pre-filled, ergonomically-designed syringe. It is supplied with “ULTRA Thin Wall” needles adapted to the consistency of the fillers for a smoother injection and comfortable patient treatment experience.

1  The EMERVEL range of hyaluronic acid dermal fillers is available with or without lidocaine, except for EMERVEL Touch, only available without lidocaine.


About EMERVEL Optimal Balance Technology

EMERVEL is a complete range of nine scientifically-advanced hyaluronic acid dermal fillers which benefits from the Optimal Balance Technology. Thanks to this manufacturing engineering innovation, each of the EMERVEL fillers possesses the optimal balance between the degree of cross-linking and gel calibration, articulated around a constant hyaluronic acid concentration of 20 mg/ml.

The different variations of the gel calibration and different degrees of cross linking around this constant hyaluronic acid concentration gives way to the optimal gel texture of EMERVEL. Thicker or thinner fillers were obtained thanks to varying gel calibration, firmer or softer fillers were obtained thanks to varying cross-linking. 

This allows a suitable integration of the gel into the appropriate skin layer, thus enabling the desired lifting effect. As a result, EMERVEL fillers provide an excellent combination of tolerability profile and long-lasting aesthetic outcomes whatever the depth, area and volume correction, as shown in clinical studies.


About the EMERVEL range of fillers

The EMERVEL range of fillers is specifically designed to best match the different facial areas to provide physicians the most appropriate filler for a tailor-made correction approach.

For ultimate patient comfort, all the EMERVEL formulations, with the exception of EMERVEL Touch, are available both with and without lidocaine.

• EMERVEL Touch is designed specifically for safe and long-lasting correction of superficial wrinkles such as perioral lines and rhytides. It has the softest consistency of the EMERVEL range, according to its superficial injection site, which requires a soft gel for predictable distribution and good skin tolerance of the filler. This is the only EMERVEL filler not available with lidocaine at launch.

• EMERVEL Classic is designed specifically for safe and long-lasting correction of moderate to deep wrinkles for example moderate nasolabial folds. It has a moderately soft gel consistency and good lifting effect, compatible with its intermediate injection depth to allow predictable distribution and good skin tolerance of the filler. The favorable efficacy and safety profile of EMERVEL Classic is shown at six months of the ongoing, European, randomised, active controlled, multicentre clinical trial.

• EMERVEL Deep is designed specifically for the safe and long-lasting correction of moderate to deep wrinkles (i.e.  deep nasolabial folds). A firm gel, its consistency is in accordance with its injection into the deep dermis where support with a firm and moderately volumising gel is the most needed. The favorable efficacy and safety profile of EMERVEL Deep was proven in a one-year European, randomised, active controlled, multicentre clinical trial.
 
• EMERVEL Volume is designed specifically for the safe and long-lasting restoration of the desired facial contour for areas such as the cheeks and chin.  It has a moderately firm gel consistency and is highly volumising, in accordance with its injection into the supraperiostic zone or subcutaneous tissue for a volumising effect.

• EMERVEL Lips is designed specifically to restore and/or augment the volume of the lips.  It has a moderately firm gel consistency and a good lifting effect in accordance to the subtle firmness needed for lip enhancement.


About Galderma
Galderma’s ambition is to be recognized as the most competent and successful innovation-based company focused exclusively on meeting the needs of dermatology patients and physicians. A fully-integrated specialty pharmaceutical company, Galderma was founded in 1981 and has over 3000 employees actively collaborating with doctors, scientists, research institutes, universities, and patient advocacy groups who all share a commitment to improving the health of the skin. With approximately 20% of sales invested each year to discover and develop new products and access innovative technologies, Galderma’s R&D center in Sophia-Antipolis, France, is one of the largest R&D facilities in the world dedicated exclusively to dermatology. The company’s extensive portfolio of products is available in 70 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. Leading brands include Epiduo, Oracea, Clobex, Azzalure/Dysport*, Differin, Cetaphil, Tetralysal, Loceryl, Rozex/MetroGel, Silkis/Vectical, Metvix and Tri-Luma.

*Dysport is a brand of Ipsen Biopharm Ltd.

For more information:

Galderma  Fleishman-Hillard
Annika Öhlin       Chantal Samonte
media@galderma.com chantal.samonte@fleishman.com
+33 (0)1 58 86 46 78 / 45 73     +33 (0)1 47 42 92 84

 
 

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