FDA Approvals & News First-of-Its-Kind Acne TreatmentThe U.S. Food and Drug Administration (FDA) has approved the first combination product of its kind for treating acne. Ziana Gel, which is a combination of clindamycin phosphate 1.2% and tretinoin 0.025%, has been approved for once-daily use for the topical treatment of acne vulgaris in patients 12 years or older. This alcohol-free gel, which is the first combination of an antibiotic and a retinoid, is available from Medicis and Dow Pharmaceutical Sciences, Inc. and is expected to be promoted and distributed to physicians by year’s end.  New Hydrogel for Atopic Dermatitis Desonide gel (Desonate 0.05%) has been approved by the FDA for the treatment of mild to moderate atopic dermatitis. This low-potency topical steroid is formulated in a proprietary water-based hydrogel vehicle, and is the first product to incorporate 0.05% desonide in a hydrogel formulation. FDA approval was based on results from Phase III clinical trials involving 582 study participants who had mild to moderate atopic dermatitis and were aged 3 months to 18 years. In these studies, Desonate was found to be statistically significantly more effective in treating atopic dermatitis than placebo. SkinMedica, Inc., and Dow Pharmaceutical Sciences, Inc., expect the drug to be available in the first quarter of 2007.  Drug for Cutaneous T-Cell Lymphoma Approved The FDA has approved Merck’s vorinostat (Zolinza) as an orphan drug for the treatment of advanced cases of cutaneous T-cell lymphoma (CTCL). Specifically, this drug, which is in a new class of anti-cancer medications known as histone deacetylase inhibitors, is approved for treating CTCL when the disease persists, worsens or returns during or after treatment with other medications. Histone deacetylase inhibitors are thought to work by “shutting off” certain genes that can cause cancer cells to proliferate.The approval of Zolinza was based on data from two clinical trials:1. Open-label, single-arm, multicenter randomized study of 74 patients with advanced CTCL (Stage IIB and higher). Patients received a daily dosage of 400 mg. Complete clearance and partial clearance (>50% decrease) response rates were measured, and patients needed to maintain response rates for at least 4 weeks. The results of this study were as follows:• Overall objective response rate was 29.7% in all patients treated with Zolinza• Median times to response were 55 and 56 days.• The median response duration was not reached because the study was still ongoing at the time of the analysis.2. Open-label, non-randomized study of 33 patients designed to test the response rate in patients with CTCL who were refractory or intolerant to at least one treatment. The results of this study were as follows:• Overall objective response rate was 24.2% in the overall study population, 25% in patients with Stage IIB or higher, and 36.4% in patients with Sezary syndrome.• The median time to response for the eight patients who responded to study treatment was 83.5 days. • The median response duration was 106 days.• The median time to progression was 211.5 days.Zolinza is the first anti-cancer drug approved for Merck in nearly 20 years, and it’s currently being studied for other cancers in 36 clinical trials.  New Surgical Solution ApprovedThe FDA recently approved 3M’s DuraPrep Surgical Solution for preoperative skin preparation. A combination of iodine povacrylex (0.7% available iodine) and isopropyl alcohol, 74% w/w, DuraPrep Surgical Solution contains a novel compound — an iodine acrylate copolymer (iodine povacrylex). The film-forming properties of this copolymer enable it to dry to a water-resistant film, thus resisting wash-off and enhancing bacterial efficacy. In addition, the copolymer enables enhanced drape adhesion.  Tissue Repair Product for Epidermolysis BullosaRecessive dystrophic epidermolysis bullosa (RDEB) patients undergoing hand reconstruction now have a tissue repair product available to them that is more likely to be readily available. Ortec International Inc. has received FDA approval for a cryopreserved version of OrCel, the company’s bilayered cellular matrix that is used for wound and burn dressings. The recent FDA approval of cryopreserved OrCel applies to hand reconstruction sites and other skin donor sites on patients with RDEB who are undergoing hand reconstruction. This will be the first time the cryopreserved version of OrCel will be approved. (Approval is conditional upon an FDA inspection of Ortec’s manufacturing facility.)  S&A News & TrendsNew Patient Assessment Tool Provides a Voice for Eczema PatientsFor the 15 million American adults and children with eczema, finding effective treatment that is long lasting can be a challenging and frustrating process. The social and emotional toll taken by having outbreaks of itchy, scaly, oozing skin affects patients’ self-image, as it’s difficult to navigate society without being stared at and avoided by those who don’t understand their disease is not contagious. Patients are notoriously shy about speaking up to their physicians about expressing the severity of the itching, burning and pain brought about by their symptoms, and a case that is perceived as mild by a health care professional may actually be taking a severe mental and emotional toll on the sufferer.“Physicians often don’t have a clue about the impact of this disease,” says Susan Tofte, F.N.P., an Assistant Professor of Dermatology at the Oregon Health and Science University in Portland. “We have to improve awareness about eczema, and the burden and impact it has on the people who have it.”The Eczema Assessment Tool, a new worksheet designed to more accurately measure the quality-of-life impact of eczema and improve communication between physicians and their eczema patients, was unveiled at the July 2006 American Academy of Dermatology meeting in San Diego. The tool was developed by the Life Improvement for Eczema (LIFE) Committee, a distinguished panel of health professionals and patient advocates, and is supported by the National Eczema Association (NEA).The tool, which consists of six straightforward questions with a simple rating scale and two images that patients shade to indicate recent outbreaks, is aimed at simplifying reporting of symptoms. The Life Committee and the NEA hope the brief yet targeted structure of the tool will make it easier for patients to provide an accurate assessment of their symptoms and quality of life to their physicians.“We originally had a longer form,” Ms. Tofte (who helped in the development of the tool) says, “but then realized it needed to be more succinct so that it could be used and would be helpful at even the busiest practice.”The form, which can easily be administered at either each office visit or at periodic examinations, takes only minutes to complete, is designed to provide insight to the physician and as a springboard for dialogue for the patient.For more information and to download the Eczema Assessment Tool free of charge for your patients, go to: http://www.nationaleczema.org/Life.html.  Practice ProfileThe American Academy of Dermatology recently conducted the 2005 Dermatology Practice Profile Survey to gather information on the field of dermatology and practice characteristics of dermatologists. The survey, completed by 1,619 dermatologists, asked participants about practice location, practice type, hours worked, use of physician extenders, and more. According to the AAD, the survey results showed that 44% of dermatologists work in solo practice and 32% of the dermatology workforce is female. More results are summarized in the chart below. Dermatology Practices in BriefAverage new patient appointment time: 34 daysAverage number of patients seen per day: 34Average number of patients seen per week: 142Practices employing non-physician practitioners (PA or NP): 29%Practices employing an aesthetician: 19%Average number of patients seen per week by a PA or NP: 85  In Brief…3M Announced that it has reached…an agreement to sell its pharmaceuticals business for approximately $2.1 billion. Graceway Pharmaceuticals Inc., has agreed to acquire 3M’s pharmaceutical operations in the United States, Canada and Latin America for $875 million. Meda AB has agreed to acquire th business in Europe for $857 million. Ironbridge Capital and Archer Capital have agreed to acquire the operations in the Asia Pacific region, including Australia and South Africa for $349 million.Connetics Corporation announced…that it has signed a definitive merger agreement with Stiefel Laboratories, Inc. Upon the closing of the transaction, holders of Connetics’ common stock will receive $17.50 per share in cash, representing a 62% premium to Connetics’ average closing price for the 4 weeks prior to the agreement. The aggregate value to be received by Connetics’ stockholders is about $640 million. After the combination, Stiefel Laboratories, Inc. will have more than 3,500 employees worldwide, with more than 30 subsidiaries and sales in more than 100 countries.Stiefel Laboratories Has Announced…that Jeffrey S. Thompson has been named to the newly created position of Chief Operating Officer. He is responsible for operations on a global level. He also oversees the operations of Glades Pharmaceuticals and StoneBridge Pharma, two wholly-owned subsidiaries. Dr. William H. Eaglstein has been appointed Vice President, R&D Pipeline Development & Scientific Affairs. He will provide scientific and medical assessment of new product technologies and new business opportunities.The Sturge-Weber Foundation…will pay tribute and honor Jeffrey S. Dover, M.D., F.R.C.P.C., at a gala event on Feb. 2, 2007, 6 to 11:30 p.m. in Washington, D.C., at the Ritz Carlton Hotel. For more information, contact (973) 895-4445 ext. 3.The Murdough Foundation Has Awarded…University Hospitals Health System’s Department of Dermatology a $5 million gift to advance the research and treatment of psoriasis. The Murdough Family Center for Psoriasis will support and stimulate clinical research and treatment for, and education about, psoriasis. Syneron Introduced…a new Contour Applicator for its VelaSmooth cellulite reduction system line. This smaller applicator is currently under study to evaluate the use of the device to reduce thigh circumference. Clinical trials, to date, have revealed the Contour Applicator has increased benefits from the original VelaSmooth treatment in contouring and shaping the body, specifically in smaller areas.The Women’s Dermatologic Society Announced…California volunteer dermatologists identified a significant number of potential skin cancers, referring 26% of people screened for further diagnosis at the recent Long's Drugs LPGA Challenge at the Blackhawk Country Club in Danville, CA. Of the 208 people screened, 55 were referred for further diagnosis/biopsy, including two possible melanomas.Charles W. Stiefel Has Been…nominated for the national Ernst & Young Entrepreneur Of The Year 2006 Award. The Chief Executive Officer and Chairman of the Board at Stiefel Laboratories has also endowed a chair in the Department of Dermatology and Cutaneous Surgery at the University of Miami Leonard M. Miller School of Medicine. The Stiefel Laboratories, Inc. Chair in Medical Dermatology will help advance the school’s dermatology department.Foamix Ltd. Announced…that it has licensed a novel topical foam product, PerFoam 1% for the contemporary treatment of head lice to Taro Pharmaceutical Industries Ltd. Under the terms of the agreement, Foamix will transfer technology to Taro and Taro will upscale, manufacture, register and commercialize PerFoam1% for distribution in Israel and the Palestinian Territories.