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Obagi Medical Products Reveals Results of a Meta-Analysis Comparing the Company’s Novel 5 Percent Solubilized BPO to Other Prescription 5 Percent BPO and Combination BPO/Clindamycin Topical Products
Thursday, July 30, 2009 7:09 AM


Meta-Analysis of Randomized Controlled Trials Shows Faster Improvement in Non-Inflammatory Lesions in Weeks 2 – 4 with 5 Percent Solubilized BPO vs. Benzoyl Peroxide and Clindamycin Topical Treatments

Today Obagi Medical Products, Inc. (Nasdaq:OMPI), the leader in topical aesthetic and therapeutic skin health systems, announced the results of a meta-analysis of 23 randomized controlled clinical trials (RCTs) that compared the company’s patented solubilized 5 percent BPO (sBPO) against existing 5 percent BPO, 1-1.2 percent clindamycin (CL) and combination BPO/CL products in reducing acne lesions. The announcement was made at the American Academy of Dermatology’s (AAD) Summer Academy Meeting in Boston, Mass. The data from the meta-analysis, using data adjusted for each study’s size, shows that this new 5 percent sBPO has an equal to superior lesion reduction profile when compared to the leading prescription BPO, combination BPO/CL and topical CL products.

“Our findings indicate that the use of this BPO regimen is as effective as similar acne treatments on the market today and appears to work faster in reducing non-inflammatory lesions,” says Alexa Kimball, MD, MPH, board-certified dermatologist and director of the Clinical Unit for Research Trials in Skin, Massachusetts General Hospital, and Associate Professor, Harvard Medical School in Boston, Mass. “These results may be due to the solubilized BPO formulation’s improved ability to penetrate the hair follicle.”

NON-INFLAMMATORY LESION REDUCTION

TREATMENT           WEEK 2 -4           WEEK 10-12
5% sBPO           42.7%           47.7%
5% BPO           19.1%           30.9%
1-1.2% CL           10.0%           32.6%
BPO/clindamycin           26.2%           40.3%
                   

INFLAMMATORY LESION REDUCTION

TREATMENT           WEEK 2 -4           WEEK 10-12
5% sBPO           55.2%           51.8%
5% BPO           33.4%           43.7%
1-1.2% CL           21.5%           45.9%
BPO/clindamycin           40.7%           55.6%

“For years, physicians have struggled with providing their acne patients with a treatment that provides fast results with minimal side effects,” said Jim Hartman, Vice President of Marketing at Obagi Medical Products. “Considering the desire to minimize exposure to topical and systemic antibiotics, we are pleased to see the results of this meta-analysis that indicate a topical antibiotic may not be needed in the treatment of acne.”

Study Methodology

A meta-analysis following the Cochrane collaboration guidelines in accordance with the PRISMA statement was conducted. Data sources included the PubMed database from 1987 to the present, FDA summaries for the basis of drug approval, and posters and unpublished statistical analyses of studies where available. This analysis included randomized controlled trials (RCTs) that treated subjects with either 5% BPO, 1-1.2% CL or combination BPO/CL. Studies included endpoints of actual lesion reduction and/or percent lesion reduction of inflammatory and/or non-inflammatory lesions at 2-4 weeks and/or 10-12 weeks. Search criteria included 124 potential RCTs. After review, 23 RCTs met all inclusion and exclusion criteria and were deemed valid to include in the meta-analysis. Data was grouped by type of topical treatment and endpoint (at 2-4 weeks, 5% sBPO: n=4 studies, s=210 subjects, 5% BPO: n=10, s=824, 1-1.2% CL: n=14, s=3143, combination BPO/CL: n=15, s=1923, placebo: n=9, s=1308). The overall mean percent reduction and actual reduction in inflammatory and non-inflammatory lesion counts were calculated at 2-4 and 10-12 weeks.

About Solubilized Benzoyl Peroxide

Obagi Medical’s proprietary, solubilized BPO, known as SoluZyl Technology, is 1/10,000 the size of any other benzoyl peroxide molecule available, so it can penetrate deep into the root of the follicle and treat acne where it starts. Obagi Medical’s solubilized 5% BPO is clinically proven to kill more P. acnes bacteria faster than the leading gel BPO/antibiotic combination product.

The solubilized BPO is available in both gel and lotion forms and can be purchased individually or as part of a CLENZIderm M.D. Acne Therapeutic System. The Systems come in two formulations, one for normal to oily skin patients (Gel) and one for normal to dry skin patients (Lotion).

The CLENZIderm M.D. Systems are not available over the counter and can only be obtained through physician offices.

About Obagi Medical Products, Inc.

Obagi Medical Products develops and commercializes skin health products for the dermatology, plastic surgery, and related aesthetic markets. Using its Penetrating Therapeutics™ technologies, Obagi Medical's products are designed to improve penetration of agents across the skin barrier for common and visible skin conditions in adult skin including chloasma, melasma, senile lentigines, acne vulgaris and sun damage. The history of Obagi's skin care product introductions is as follows: Obagi Nu-Derm®, 1988; Obagi-C® Rx (the first and only prescription-strength vitamin C and hydroquinone system), 2004; Obagi® Professional-C (a line of highly stable vitamin C serums), 2005; Obagi® Condition and Enhance for use with cosmetic procedures to enhance patient outcomes and satisfaction, 2006; Obagi ELASTIderm™ eye treatment and Obagi CLENZIderm® M.D. acne therapeutic systems, 2007; a formulation of Obagi CLENZIderm® M.D. Systems for normal to dry skin, June 2007; and Obagi ELASTIderm™ Décolletage System, January 2008, and Obagi Rosaclear™ System in January 2009. Visit www.obagi.com for information.

Forward Looking Statements

There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should," "potential," "anticipates," "plans," or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to the intense competition our products face and will face in the future, the level of market acceptance of our products, the possibility that our products could be rendered obsolete by technological or medical advances, the possibility that we may become involved in intellectual property claims and litigation that could adversely affect the profitability of or our ability to sell our products, the possibility that our products may cause undesirable side effects and the fact that our ability to commercially distribute our products may be significantly harmed if the regulatory environment governing our products changes. A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2008. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Obagi Medical Products does not intend to update this information.

Press Contact:
Creative Media Marketing
Lori Tomonari, 212-979-8884
LoriT@cmmpr.com
or
Investor Contact:
OMP, Inc.
Preston Romm, Chief Financial Officer, 562-256-1007

(Source: Business Wire )


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