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ZARS Pharma Announces Worldwide License Agreement With Galderma S.A. for Pliaglis(TM), a Topical Local Anesthetic


3/11/2008 7:09:01 AM

SALT LAKE CITY, March 10 /PRNewswire/ -- ZARS Pharma, Inc. announced today the completion of an agreement providing Galderma Pharma S.A. the exclusive promotion and distribution rights for all markets outside the United States and Canada for Pliaglis(TM) (lidocaine and tetracaine) Cream 7%/7%, a topical anesthetic that provides effective and safe local anesthesia in patients undergoing potentially painful cosmetic and other skin treatment procedures. This agreement complements the previously announced agreement between ZARS Pharma and Galderma for the promotion and distribution rights of Pliaglis in the United States and Canada and effectively grants Galderma exclusive worldwide rights for Pliaglis.

Pliaglis has been approved by the FDA for the local anesthesia of intact skin before various superficial dermatological procedures such as dermal filler procedures, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal and is anticipated to be the subject of marketing applications to be filed with additional regulatory authorities in key markets later in 2008. Other therapies for topical anesthesia are often characterized as having slow onset of action, sporadic and shallow anesthesia (especially in highly vascularized regions such as the face), short duration of effect and inadequate safety profiles. Pliaglis is indicated for use in adults and is applied for 20 to 30 minutes prior to procedures such as dermal filler injections or facial laser resurfacing, and for 60 minutes for procedures such as laser-assisted tattoo removal.

"We are delighted to announce the worldwide license agreement for Pliaglis with Galderma, a worldwide leader in the field of dermatology," said Robert Lippert, President and Chief Executive Officer of ZARS Pharma. "We believe that Pliaglis will become the topical anesthetic of choice for these procedures and will become an integral and important tool for physicians worldwide."

About Pliaglis

Pliaglis is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to painful cosmetic and other painful skin treatment procedures. Pliaglis consists of a proprietary formulation of lidocaine and tetracaine that, once applied to skin, forms a white pliable layer that releases drug into the skin. After the desired effect is achieved, Pliaglis can be easily peeled from the skin. Pliaglis can be applied over contoured parts of the body and left on for periods from 20 to 60 minutes, depending on the desired effect.

In clinical trials, the most common side effect was local skin reactions, such as erythema, edema, and blanching. Pliaglis should not be used for a longer duration than recommended, and is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine or local anesthetics of the amide or ester type. For more information on Pliaglis, visit http://www.pliaglis.com.

About ZARS Pharma

ZARS Pharma is a specialty pharmaceutical company focused on the development and commercialization of topically administered drugs using proprietary drug delivery technologies, primarily in the area of pain management and dermatology. ZARS Pharma has developed a portfolio of proprietary products and product candidates based on the CHADD® technology and on cream technologies (Peel and DuraPeel(TM)) that transform, or phase- change, from an initial liquid phase to a solid phase during application. The product portfolio for ZARS Pharma includes two products that have been approved for marketing (Pliaglis and Synera®, the latter marketed as Rapydan® in Europe). ZARS Pharma currently has one product in a late-stage clinical trial that commenced in June 2007 (ThermoProfen(TM)) and four additional products that have entered various stages of clinical development. For more information on ZARS Pharma, please visit http://www.zars.com.

About Galderma

Galderma, created in 1981 as a joint venture between Nestle and L'Oreal, is a fully integrated specialty pharmaceutical company dedicated exclusively to dermatology. The Company has a presence in 65 countries with over 1,000 sales representatives and is committed to improving the health of skin with an extensive line of products that treat a range of dermatological conditions including: acne, rosacea, fungal nail infections, psoriasis & steroid- responsive dermatoses, pigmentary disorders, medical solutions for skin senescence and skin cancer.

Galderma's new centre in Sophia Antipolis, France is the largest facility in the world dedicated to Research and Development in dermatology. Leading brands for Galderma Differin®, Rozex®/Metro®, Clobex®, Tri-Luma®, Loceryl® and Cetaphil®. Recently launched products include Epiduo®, an innovative combination product for the treatment of acne in Europe and Argentina and Dysport®, an injectable neuro-modulator for the correction of wrinkles, in Brazil and Argentina. The Company's website is http://www.galderma.com.

Source: ZARS Pharma, Inc.


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