Galderma Announces Interim Data Relating to Sequential Treatment Regimen of Clobex Spray Followed by Vectical Ointment in Managing Plaque Psoriasis

SAN FRANCISCO, March 06, 2009 /PRNewswire/ -- Galderma Laboratories, L.P. today announced interim findings from a study of sequential treatment of plaque psoriasis using Clobex (clobetasol propionate) Spray 0.05% followed by treatment with Vectical(TM) (calcitriol) Ointment 3mcg/g. The results of an interim analysis of the data are to be presented in a poster session at the 67th Annual Meeting of the American Academy of Dermatology on March 8th at 10:30 a.m. PT. The poster can be found under reference number 3362.

While both Clobex Spray and Vectical Ointment are indicated for the treatment of plaque psoriasis, this study was conducted to confirm the safety and efficacy of these products when used in a sequential regimen. In this study, Clobex Spray was used in the initial phase of the study to treat moderate to severe plaque psoriasis. For subjects sufficiently clear at the end of 4 weeks, Vectical Ointment was applied twice-daily for 8 weeks. Success was evaluated at week 12 based on Overall Disease Severity (ODS) scores.

The interim results indicate that sequential treatment of plaque psoriasis with Clobex Spray followed by Vectical Ointment is effective in managing plaque psoriasis over a 12-week period. Additionally, the interim results demonstrate that this sequential treatment regimen was well tolerated, with the most commonly reported side effects including mild to moderate pruritus (itching), stinging and burning and telangectasias (small dilated blood vessels near the surface of the skin).(1)

"The recent availability of Vectical Ointment fulfills an important unmet need for patients who do not have access to a steroid-free ointment that can help manage their condition both safely and effectively over the long-term," said Mark Lebwohl, M.D., Department of Dermatology, Mount Sinai School of Medicine, New York, and lead author of the study. "However, it is also exciting to have interim results that indicate the use of Clobex Spray followed by Vectical Ointment fits well within accepted and common psoriasis treatment regimens."

"These study results reinforce our commitment to bringing safe and effective therapies to the millions of patients that suffer from psoriasis," said Ron Gottschalk, M.D., Medical Director, Galderma Laboratories, L.P. "We look forward to reporting the final results of this study, which are expected to be published early next year. We believe this study will confirm that Vectical Ointment can help maintain, for at least 8 weeks, much of the gains seen when a high potency corticosteroid is used to initially treat moderate to severe plaque psoriasis."

Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, dryness, pain, hyperpigmentation around resolving plaque, irritation and atrophy. Clobex(R) (clobetasol propionate) Spray, Lotion and Shampoo, 0.05% are not recommended for use on anyone younger than 18 years of age. Treatment should be limited to four consecutive weeks for psoriasis, and to two consecutive weeks for other SRDs. The total dosage for Spray should not exceed 50 g (59 mL or 2 fl oz) per week, and for Lotion and Shampoo should not exceed 50 g (50 mL or 1.75 fl oz) per week. Patients should use Clobex(R) (clobetasol propionate) Spray, Lotion or Shampoo, 0.05%, only for the minimum period necessary to achieve desired results. It should not be used on the face, groin, or axillae.

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.

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(R), 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 Clobex Spray, visit www.clobex.com; for more information on Galderma, visit www.galdermaUSA.com.

CONTACT: Dale Weiss of Galderma, +1-817-961-5186, Dale.Weiss@galderma.com

Web site: http://www.galdermausa.com/

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Posted: March 2009

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