Sol-Gel’s IND Application for Rosacea Accepted by FDA

2009-11-11 12:14:05 -

Sol-Gel Technologies announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients.

DER45-EV Gel is an innovative topical product based on Sol-Gel’s patented drug delivery system that

is designed to enhance the efficacy, safety and stability of topical drugs. Sol-Gel’s technology does so by encapsulating the active ingredients in an inert, clear-silica microcapsule shell and by releasing the ingredients in a time-controlled manner.

Rosacea is a common and chronic skin disorder. Affecting mainly fair-skinned, middle-aged and older adults, rosacea is characterized by transient or persistent erythema, papules and pustules. The condition affects more than fourteen million Americans and can cause significant psychological, social and occupational problems if left untreated.

“As Sol-Gel’s microcapsulation forms a protective barrier between the drug and the skin, we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients,“said Dr. Stanley Shapiro, Sol-Gel’s Head of Skin Care Science & Technology.

“Comparative clinical studies performed in the treatment of acne, presented at the 10th International Congress of Dermatology in Prague, May 20-23, 2009, confirmed that the Sol-Gel drug delivery technology provides improved efficacy, when compared to a marketed topical formulation. Using our innovative core technology, we also hope to achieve a greater therapeutic window in the treatment of rosacea.” added Daniela Mavor, Senior Vice President Business Development.


Disclaimer.

The foregoing represents statements of company expectations based upon preliminary studies. Results remain to be confirmed in additional clinical trials, and further study is needed to determine directions for use. This discussion is not intended, nor should it be used, as a statement of the product indication or as a recommendation for usage in any therapeutic setting. This product is under development and its use at this time is entirely experimental. It has not been approved by the Food and Drug Administration.



About Sol-Gel Technologies

Sol-Gel Technologies is a fast-growing specialty pharmaceutical company focusing on enhancing dermatological products. Founded in 1997, the company has advanced skincare products to market and developed a pipeline of prescription and over-the-counter products, addressing dermal medical conditions affecting large patient populations.

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Sol-Gel TechnologiesDaniela Mavor, +972 8931 3430SVP
Business Development partners@sol-gel.com : mailto:partners@sol-gel.com