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Study Results Published in CUTIS Demonstrate Long-Term Safety and Efficacy of Vectical(TM) (calcitriol) Ointment 3 mcg/g in the Management of Mild-to-Moderate Plaque Psoriasis
Date:4/30/2009

- 52-Week Data Supports Long-term Use of Vectical(TM) Ointment, Satisfying an Unmet Need Among Psoriasis Patients -

FORT WORTH, Texas, April 30 /PRNewswire/ -- Galderma Laboratories, L.P. today announced results from a newly published clinical trial in this month's issue of CUTIS regarding the safety, tolerability and efficacy of Vectical(TM) (calcitriol) Ointment 3 mcg/g in the long-term management of mild-to-moderate chronic plaque psoriasis. Of those patients that completed the trial, nearly 50 percent (47.1 percent) reported an improvement in psoriasis symptoms over the course of the 52-week trial.

The trial established the favorable long-term safety of Vectical(TM) Ointment over a 52-week time period. Adverse events included abnormal laboratory test values, abnormal urinalysis, skin irritation and psoriasis. Additionally, Vectical(TM) Ointment demonstrated no significant clinical effect on calcium homeostasis when used continuously over one year by 116 people who were evaluated. Also during the study, patients reported a noticeable improvement in psoriasis symptoms from baseline at week 26 (52.6 percent/249 patients) for those who completed the full year, and at the completion of a year (week 52, 63.8 percent/130 patients), confirming the long-term efficacy of the therapy.

"Psoriasis takes both a physical and an emotional toll on the millions of patients who suffer from it," said Mark Lebwohl, M.D., Department of Dermatology, Mount Sinai School of Medicine, New York, and lead author of the study. "For years, patients and physicians have been waiting for a safe and effective long-term treatment. This clinical data confirms that Vectical Ointment can provide continued control in a long-term psoriasis treatment plan - satisfying an important unmet need for patients."

The study involved 324 patients with psoriasis affecting a body surface area (BSA) of up to 35 percent. During the year-long trial, BSA was maintained or improved among patients, and generally a decrease in the mean percentage of BSA from 16.1 percent at baseline to 10.7 percent at end point, was reported. Global Severity Score (GSS) with a range of 0-5 (0 signifying "clear" and 5 signifying "very severe") was used to evaluate psoriasis improvement. An overall GSS improvement was seen in patients who remained active in the trial for the full duration.

"These significant clinical trial findings demonstrate that Vectical Ointment offers long-term, continuous control of psoriasis, as indicated by improvements in both body surface area and Global Severity Score," said Ron Gottschalk, M.D., Medical Director, Galderma Laboratories, L.P. "We are pleased with these results, as they further confirm our commitment to providing innovative, well-tolerated therapies that meet the needs of psoriasis patients."

The study took place at 30 designated study centers in France, Germany, Hungary, Belgium and Poland. Of the 324 enrolled patients, 136 patients completed the entire 52-weeks of treatment and serious adverse events were reported in eight subjects using the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART), none of which researchers considered to be related to the study.

Vectical(TM) Ointment is the only topical vitamin D3 ointment of its kind now available in the United States for treating mild-to-moderate plaque psoriasis in adults. It fulfills an important unmet need for patients who do not have access to a therapy that can help manage their condition both safely and effectively over the long-term. The therapy contains calcitriol, the naturally-occurring, active form of vitamin D3, and has been shown in clinical trials to be well-tolerated, even when used on sensitive skin fold areas.

Vectical(TM) Ointment is now available by prescription in pharmacies nationwide. For more information on this new first-in-class therapy, visit http://www.vectical.com.

About Psoriasis

Psoriasis is a chronic skin disorder that affects 2 to 3 percent of the U.S. population. It is characterized by thick, red, scaly patches of skin and caused by an abnormally high growth rate of skin cells that form thick, dry scales (plaques). There is currently no cure for psoriasis, and most people with the disease require ongoing treatment and visits to the doctor. Topical treatment of the disease is typically managed by corticosteroids, which are generally not indicated for long-term use, or other vitamin D products, which have been shown to be irritating when applied to sensitive skin fold areas.

Important Safety Information About Vectical(TM) (calcitriol) Ointment 3 mcg/g

Vectical(TM) Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in patients 18 years and older. The most frequent adverse events reported in clinical trials (>3%) were lab test abnormality, urine abnormality, psoriasis, hypercalciuria and pruritus. Skin discomfort has also been reported. Vectical(TM) Ointment should be used with caution in patients with known or suspected disturbances in calcium homeostasis, who are taking calcium or Vitamin D supplements, or who are on medications known to increase serum calcium levels, such as thiazide diuretics. If aberrations in parameters of calcium metabolism occur, Vectical(TM) Ointment should be discontinued until these normalize. Patients should be cautioned to avoid excessive exposure to natural or artificial sunlight after applying the ointment. If severe irritation occurs discontinue use. Avoid contact with eyes, lips and face. Vectical(TM) Ointment has not been studied in pregnant or nursing women. Use no more than 200 grams per week.

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 the field of dermatology. The Company has a presence in 65 countries with over 1000 sales representatives and is committed to improving the health of skin with an extensive line of products across the world 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 cancers. With a research and development center in Sophia Antipolis, France, Galderma has one of the largest R&D facilities dedicated exclusively to dermatology. Leading worldwide dermatology brands include Differin(R), Epiduo(TM) Gel, Oracea(R), MetroGel(R) 1%, Rozex(R), Clobex(R), Tri-Luma(R), Loceryl(R) and Cetaphil(R).

For more information on Vectical(TM) Ointment, visit www.Vectical.com; for more information on Galderma, visit www.galdermaUSA.com.


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SOURCE Galderma Laboratories, L.P.
Copyright©2009 PR Newswire.
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