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Promius Pharma Llc Presents Ongoing Data

Results Across Subgroups by Distribution of Dermatitis

Bridgewater, NJ - March 2011– In its research into the effects of EpiCeram® Skin Barrier Emulsion on atopic dermatitis (AD), Promius Pharma launched the “EPIC” study in over 50 sites in 2009 to gather data from clinical practices on over 200 patients. A poster presented at the Annual Winter meeting of the American Academy of Dermatology in New Orleans in February 2011 looked at results across subgroups by distribution of dermatitis.

In this sub-group analysis investigators Leon H. Kircik, MD, FAAD and James Q. Del Rosso DO looked at the outcome of using EpiCeram Emulsion on various areas of the body. This clinical study was designed to help understand and optimize the role of EpiCeram Emulsion in therapeutic strategies for atopic patients in the community dermatology office setting. In this poster, subjects were grouped by location of AD lesion – either head or trunk only, extremities only, or having lesions in both areas. EpiCeram Emulsion demonstrated clinical efficacy for subjects as a mono or combination therapy regardless of location of lesion.

Subjects who used EpiCeram Emulsion for their mild to moderate atopic dermatitis, either as monotherapy or in combination with a topical steroid or topical calcineurin inhibitor, reported high levels of satisfaction (either somewhat satisfied, satisfied or very satisfied) regardless of location of lesion. Statistically significant improvement in IGA score and pruritus compared to baseline was seen after 21 days of treatment for all lesion location groups. Many subjects in the study (71% of total subjects) did not require the addition of a topical steroid or topical calcineurin inhibitor during their treatment with EpiCeram Emulsion. Limitations of the study include the open-label design and lack of control group.

Overall, 71 percent of subjects chose to use only EpiCeram Emulsion during the 3-week treatment period, and 54% of all subjects had success (defined as clear or almost clear) with IGA at week 3. Subgroups were subjects with head/trunk only disease (n=28), extremity only disease (n=69) and both locations (n=106) with 61%, 51%, and 53% of subjects having success with IGA, respectively. There was no statistical difference across groups. The study’s investigators concluded that EpiCeram Emulsion appears to be equally effective across all disease site body locations with an average success rate of 54%. These results confirm the efficacy that was seen in the pivotal comparative trial in pediatric patients where 61% of subjects achieved success.

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About Atopic Dermatitis
Atopic dermatitis (AD) is an inflammatory skin disease that usually starts in early infancy and is characterized by pruritus, eczematous lesions, dry skin, and lichenification. In the United States, the prevalence rate of AD is 10-12% in children and ~1% in adults. A number of studies have reported that the financial burden to families and government is similar to that of asthma, arthritis, and diabetes mellitus. In children, the disease causes significant psychological burden to families and loss of school days. Although the pathophysiology of AD is not fully understood, it is known to be characterized by a complex interaction of immunology, genetics, and skin barrier dysfunction. While earlier treatment approaches emphasized the suppression of Th2-mediated inflammation and pruritus, the current treatment models emphasize skin barrier repair and maintenance as an essential step in the management of AD.

About EpiCeram® Skin Barrier Emulsion
EpiCeram® Skin Barrier Emulsion (Promius Pharma, LLC) is an FDA-cleared, prescription, steroid-free, fragrance-free, ceramide-dominant skin barrier repair emulsion. EpiCeram Emulsion is indicated for the treatment of dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatologic conditions including AD, irritant contact dermatitis and radiation dermatitis. EpiCeram Emulsion has a 3:1:1 molar ratio of ceramide, cholesterol and free fatty acids, which has been determined to be an optimal ratio to help skin barrier repair. EpiCeram Emulsion has an excellent safety profile with no known risks, aside from occasional transient tingling upon application, and can be used for all age groups, without restriction on face or intertriginous area application.

About Promius Pharma, LLC
Promius Pharma is a wholly owned, branded specialty company, of Dr. Reddy’s Laboratories, Inc. It is located in Bridgewater, NJ. Promius Pharma is a focused, leading-edge company that develops and markets innovative solutions for challenging dermatological conditions with an eye to the future to redefine therapeutic options for physicians and patients.

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CONTACT: Suzanne Lane . Lane Communications Group . 212.757.6880

EpiCeram is a registered trademark of Ceragenix Pharmaceuticals, Inc.


Posted: March 2011