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Galderma Laboratories Announces Results of Largest-Ever Rosacea Trial


11/19/2010 11:31:04 AM

FORT WORTH, TX--(Marketwire - November 19, 2010) -

Results from ORCA (Oracea® for Rosacea: A Community-Based Assessment), a community-based study of 1,421 patients with mild to severe papulopustular rosacea (PPR), found that in patients suffering from PPR, Oracea® (doxycycline 40 mg) effectively reduces rosacea pustules and papules when used as a monotherapy treatment or when added-on to other topical rosacea therapies. ORCA, sponsored by Galderma Laboratories L.P., was designed to reflect real world conditions when managing PPR in a large, diverse population of rosacea patients undergoing routine care at 271 community-based medical practices. The study was also designed to evaluate the safety and effectiveness of Oracea®, when used alone or when the physician believed that it should be added-on to existing topical therapies for rosacea. Oracea®'s unique, sub-antimicrobial, 40-mg formulation of doxycycline (30-mg immediate-release and 10-mg delayed-release beads) was developed to isolate doxycycline's anti-inflammatory properties to treat papulopustular rosacea and is the only U.S. Food and Drug Administration-approved oral medication for rosacea treatment in the disease category. Oracea® is a sub-antimicrobial dose of doxycycline, and has demonstrated no evidence of bacterial resistance. In the ORCA study, results found that the side effect profile of Oracea®, even in large populations, was consistent with that seen in controlled, clinical trials, with the most frequently reported side effects being mild to moderate nausea and diarrhea.

"These results could change the way physicians treat rosacea because the study's size and design was intended to reflect patient care in the real world, not in an optimized clinical trial environment," said study investigator Hilary E. Baldwin, M.D., State University of New York Medical Center, Brooklyn. "ORCA confirms the safety of Oracea® and its effectiveness as a papulopustular rosacea treatment, even as monotherapy, with 3 out of 4 patients showing significant improvements over 12 weeks of treatment."

Oracea® was evaluated in the ORCA trial in two arms: effectiveness of monotherapy, effectiveness of add-on therapy. Impact on the quality of life was also evaluated. Of the total intent-to-treat patient population of 1,421, efficacy was evaluated in 826 of 1,197 patients in the monotherapy arm and 140 of 224 treated with add-on therapy. Quality of life was examined in 966 patients.

Oracea® for Rosacea: A Community-Based Assessment Study Results
The primary study outcome for the monotherapy and add-on therapy arm was a change in the 5-point investigator global assessment (IGA) score from baseline to week 12, and secondary outcomes included change in the 5-point clinician erythema assessment (CEA) score from baseline to week 12, IGA success, and adverse events. In the monotherapy arm, IGA scores showed about 75% of the 826 participants were clear or near clear by week 12 while CEA scores showed about 75% had no or mild erythema after 12 weeks. In the add-on therapy arm after week 12, 75.7% of participants had IGA scores of clear or near clear and 63.6% had mild CEA scores. In the safety population of 1,196 participants in the monotherapy arm, treatment-related adverse events were reported for 6.7% and were mainly mild or moderate in severity. Adverse events that occurred in more than 1% of the safety population included diarrhea (1.2%), nausea (1.3%), and headache (1.0%). The incidence of fungal and yeast infections was 0.4%.In the add-on therapy arm, only 7% of participants (16/224) had treatment-related adverse events, and the most common treatment-related adverse events were diarrhea, nausea and rash. The treatment-related adverse events were mostly mild or moderate in severity. The most common treatment-related adverse events were diarrhea, nausea, and rash. Quality of life was assessed at baseline and week 12 with RosaQoL™, a 21-question instrument, and patient and investigator satisfaction with treatment were evaluated. In the monotherapy group and the add-on group, the mean RosaQoL score was either 3.2 or 3.3, respectively, at baseline and both arms scored 2.8 at 12 weeks. The significant decrease in scores indicates an improvement in the participants' quality of life in both treatment groups (P < .0001). Most patients expressed satisfaction with treatment and about 90% of the community-based investigators said they were likely or very likely to continue prescribing Oracea® as a papulopustular rosacea treatment.

About Rosacea
Rosacea is a chronic inflammatory disorder affecting the face. It is prevalent amongst fair-skinned individuals, especially of Celtic and northern European origin and is more common in women. The characteristic skin lesions (redness, visible blood vessels, papules and pustules) appear in the middle of the face (forehead, nose, cheeks) between the ages of 20 and 50, but typically are most common in men and women between the ages 30 to 65. Flushing due to triggers, including spicy food, alcohol, weather changes, sun, and hot showers, often have a negative impact on the patients' social life. Stinging, burning and sensitivity of the skin and an intolerance to cosmetics are also very common and in some cases the eyes can become red, dry and itchy. The pathogenesis of the disease is not yet fully known, however the inflammatory response and facial vessels may play an important role, particularly in the pustulopapular form of the disease. It is currently held that there is no bacterial pathogen directly related to the etiology of rosacea. Presently, there is no cure for rosacea, but systemic treatment and laser may suppress its signs and symptoms. Patients should avoid triggering factors, use sun protection and gentle skin-care products. Early diagnosis and management of the disease can also prevent its progression.

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 1,000 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®, Oracea®, MetroGel 1%® , Rozex®, Clobex®, Tri-Luma®, Loceryl®, Cetaphil®, Vectical®, Silkis® and Epiduo®. For more information on Galderma, visit www.galdermaUSA.com.

Important Safety Information about Oracea®
ORACEA® is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. You may experience intestinal upsets, sore throat or sinus infections/sinusitis when taking Oracea®. Do not take Oracea® if you are allergic to tetracyclines. Oracea® may cause harm to a developing fetus; so do not take Oracea® if you are pregnant or breastfeeding. As with other tetracyclines, you should stay out of direct or artificial sunlight, and make sure you tell your doctor if you have stomach or GI problems, kidney disease, have a yeast or fungal infection, take blood thinners, take oral contraceptives, or take medicine to treat acne, psoriasis or seizures.

Oracea® does not treat bacterial infections. To minimize the risk of developing bacterial resistance, Oracea® should be used only as prescribed by your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about Oracea®, see Full Prescribing Information available on www.Oracea.com.

References
1. Webster. An Open-Label, Community-Based, 12-Week Assessment of the Effectiveness and Safety of Monotherapy With Doxycycline 40 mg (30-mg Immediate-Release and 10-mg Delayed-Release Beads). Cutis. 2010;86.
2. Del Rosso. Effectiveness and Safety of Doxycycline 40 mg (30-mg Immediate-Release and 10-mg Delayed-Release Beads) Once Daily as Add-on Therapy to Existing Topical Regimens for the Treatment of Papulopustular Rosacea: Results From a Community-Based Trial. Cutis. 2010;86.
3. Baldwin. A Community-Based Study of the Effectiveness of Doxycycline 40 mg (30-mg Immediate-Release and 10-mg Delayed-Release Beads) on Quality of Life and Satisfaction With Treatment in Participants With Rosacea. Cutis. 2010;86.
4. Galderma Laboratories L.P. Why Oracea?. http://oracea.com/about-oracea/why-oracea.aspx. Accessed on October 22, 2010.
5. Galderma S.A. Rosacea. http://www.galderma.com/OurFocus/Rosacea.aspx. Accessed on October 22, 2010.
6. Webster. Topical and Systemic Treatments in the Mangement of Rosacea. April 6, 2010.


MEDIA CONTACTS:
ERIN BITTNER
WCG
212-301-7226
EBITTNER@WCGGLOBAL.COM


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