LAUSANNE, SWITZERLAND--(Marketwire - October 20, 2011) - Galderma Pharma, S.A., today announced positive top-line results from a Phase 2b trial that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation for treating patients with moderate to severe facial erythema (redness) of rosacea.(1) Rosacea is a chronic dermatological condition of the face and eyes characterized by persistent redness, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans.(2)
"Currently, there are no medical therapies with FDA approval to treat the persistent facial redness of rosacea," said Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville and a principal study investigator. "The results of this study confirm CD07805/47's potential to become a viable topical treatment option that could possibly help enhance the quality of life for the millions of patients affected by the persistent facial redness of rosacea."
In the trial, CD07805/47 was shown to be rapidly effective at reducing facial redness. During the treatment and follow-up phases through the eight-week study, CD07805/47 was evaluated as safe and well-tolerated. There was no evidence of tachyphylaxis, or rebound, in the study. The results will be submitted for publication where further data and analysis will be provided. Phase 3 studies are currently ongoing.
Rosacea is a chronic inflammatory disorder affecting the face. It is prevalent amongst fair-skinned individuals, especially of Celtic and Northern or Eastern 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 after 30.
The pathophysiology of rosacea is poorly understood and may be multifactorial, involving vascular reactivity, immune system responses, and follicular microorganisms. Many of the most cited pathogenic theories on the etiology of rosacea focus on abnormalities in cutaneous vascular homeostasis. These theories are based on the prominent transient and non-transient facial erythema observed in a majority of patients with rosacea. Disease manifestations are thought to arise from cutaneous vasomotor instability, the term commonly used to refer to abnormal involuntary dilatation and reactivity of small subcutaneous resistance arteries. The etiology of vasomotor instability in patients with rosacea is unknown. Triggers for the condition may include spicy food, alcohol, weather changes, sun, and hot showers, which often have a negative impact on the patients' social life. Stinging, burning and sensitivity of the skin and intolerance to cosmetics are also very common, and in some cases, the eyes can become red, dry and itchy.(3)
Galderma's ambition is to be recognized as the most competent and successful innovation-based company focused exclusively on meeting the needs of dermatology patients and physicians. A fully-integrated specialty pharmaceutical company, Galderma was founded in 1981 and has nearly 4000 employees (of which 560 are Q-Med employees) in 31 affiliates around the world. In March 2011 Q-Med became a part of Galderma. Q-Med is a global leader in the aesthetic market and develops innovative products for aesthetic, corrective and hospital use. With approximately 20% of sales invested each year to discover and develop new products and access innovative technologies, Galderma's laboratory in Sophia-Antipolis, France, is one of the largest R&D facilities in the world dedicated exclusively to dermatology, now complemented by a state-of-the-art R&D center in Uppsala, Sweden. The company's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence. Strategic brands include Epiduo, Oracea, Clobex, Differin, Rozex/MetroGel, Silkis/Vectical, Cetaphil, Loceryl, Tri-Luma, Metvix, Azzalure, Dysport, Restylane, Macrolane and Emervel.
*Dysport is a brand of Ipsen
(1) ClinicalTrials.gov, Accessed on September 29, 2011. http://clinicaltrials.gov/ct2/show/NCT01174030?term=CD07805%2F47&rank=1
(2) The National Rosacea Society. "Managing Rosacea: Subtype 1-Facial Redness". http://www.rosacea.org/patients/materials/managing/treatment.php. Accessed on March 10, 2011.
(3) Crawford et al. (2004) "Rosacea: I. Etiology, pathogenesis, and subtype classification." Journal of the American Academy of Dermatology.