FDA Approves Vectical Ointment

Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis

Fort Worth, Texas – February 3, 2009 – Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Vectical (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.

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). The disease is also associated with other serious conditions such as diabetes, heart disease and obesity.

Vectical Ointment is the only vitamin D3 ointment of its kind available in the United States. Vectical Ointment contains calcitriol, the naturally-occurring, active form of vitamin D3, and is one of the only vitamin D3 products shown in clinical trials to be well-tolerated even when used on sensitive skin fold areas.

"Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," said Mark Lebwohl, M.D., Department of Dermatology, Mount Sinai School of Medicine, New York. "The FDA approval of Vectical Ointment will provide doctors and patients with a new, effective tool that has been proven safe and well-tolerated throughout 52 weeks of continuous use in treating mild-to-moderate disease. A safe, effective long-term therapy is critical to improve overall outcomes for these patients."

Approval was based on two 8-week studies of more than 800 patients that compared twice-daily doses of Vectical Ointment with a vehicle treatment. In the first study, improvements in mild-to-moderate plaque psoriasis severity began to be seen at week 2, with treatment effects sustained over the 8-week treatment period. By the end of the study, 34 percent of patients achieved treatment success (GSS clear/minimal), compared with 22 percent of those treated with vehicle. Twenty-three percent of patients demonstrated success at 8 weeks and also showed a two-grade improvement in disease severity. The second study showed similar efficacy results.

Treatment-related adverse events were similar in both the Vectical Ointment and vehicle groups, with the primary side effects being lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus and skin discomfort. In a long-term 52-week safety study, adverse events were similar to those in the two 8-week studies. In addition, while some transient increases in plasma calcium levels were reported in the studies, the drug was reported as demonstrating no significant clinical effects on calcium homeostasis when used continuously over a 52-week time period.

"Vectical Ointment was developed in response to a need for more well-tolerated, long-term treatment options for mild-to-moderate plaque psoriasis," said Albert Draaijer, President, Americas, Galderma Laboratories, L.P. "The development and launch of Vectical Ointment in the United States truly demonstrates Galderma’s continued commitment to dermatology patients."

There is currently no cure for psoriasis, and about 56 million hours of work are lost each year by people who suffer from the condition. Most people with psoriasis 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.

"The approval of Vectical Ointment is a welcome addition to the arsenal of topical treatments for mild-to-moderate plaque psoriasis that will help patients manage their condition both safely and effectively over the long-term," said Randy Beranek, president and CEO of the National Psoriasis Foundation. "Psoriasis dramatically impacts the lives of those affected – both physically and emotionally – and we thank companies like Galderma for their ongoing commitment to bringing new therapies to this important patient community."

Vectical Ointment will be available by prescription in pharmacies in the first quarter of 2009.

About Galderma

Galderma, created in 1981 as a joint venture between Nestle and L'Oréal, 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, Epiduo, Oracea, MetroGel 1%, Rozex, Clobex, Tri-Luma, Loceryl and Cetaphil.

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

Important Safety Information About Vectical Ointment

Vectical 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 puritus. Skin discomfort has also been reported. Vectical 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 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 Ointment has not been studied in pregnant or nursing women. Use no more than 200 grams per week.

Posted: February 2009

Vectical (calcitriol) FDA Approval History

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