First-time Generics
The FDA recently approved two first-time generic therapies for dermatologic conditions.
1. Ciclopirox olamine cream, an anti-fungal agent, was approved last month. Its reference listed drug is Loprox. Ciclopirox olamine is typically used to treat, for example, the following conditions: tinea corporis, tinea pedis, pityriasis
versicolor and some infections caused by Candida.
2. Clindamycin phosphate vaginal cream 2% was also recently approved as a first-time generic for the purpose of treating bacterial vaginosis. The reference listed drug is Cleocin. n

New Genetic Test Cleared
The first genetic test of its kind was recently approved by the FDA. The new test, which uses DNA microarray technology, will enable doctors to consider patients’ unique genetic information before prescribing individualized therapies for conditions such as cancer, psychiatric disease and cardiac disease.
The AmpliChip Cytochrome P450 Genotyping Test, which is manufactured by Roche Molecular Systems, Inc., employs a chip that contains millions of DNA particles to analyze cytochrome P450 genes, genes that are active in the liver and help metabolize drugs and other compounds. With this test, physicians can discover whether a patient has a variation of a specific P450 gene that will cause the patient to either metabolize certain drugs more quickly or not effectively at all. These drugs include some commonly prescribed chemotherapy drugs, antidepressants, anti-psychotics and beta-blockers.
The test is expected to be used in conjunction with a clinical evaluation and other tools to determine the best course of therapy for a patient.

Other Drug News
A new treatment for genital warts has successfully made its way through Phase III clinical trials. Approximately 500 patients participated in trials with MediGene’s Polyphenon E 15% ointment, which was tested in 50 clinical centers in North and South America and Romania.
In the trial, ointment was applied to the affected areas three times a day for up to 16 weeks. In 57% of patients treated with the ointment, complete clearance of the existing warts, and new ones that appeared during the trial, was achieved. In 78% of participants, most or all of the warts were cleared. During a 12-week follow-up, fewer than 7% of patients had recurring warts.
MediGene plans to submit a new drug application in the United States by the
middle of this year. The company also has this compound in Phase II trials for actinic
keratosis, and this trial is expected to be completed by the middle of this year as well.

Does the ABCD Criteria For Diagnosing Cutaneous Melanoma Work?
With the incidence of cutaneous melanoma increasing, its early diagnosis should become a public health priority. A recent review of the ABCD (Asymmetry, Border irregularity, Color variegation, Diameter >6 mm) criteria system for the appraisal of cutaneous pigmented lesions was examined in a recent issue of the Journal of the American Medical Association. The ABCD system was developed in 1985, but required re-examination because of data regarding the existence of small-diameter (<=6-mm) melanomas.
The authors reviewed data from the Cochrane Library and PubMed on ABCD and melanoma and small-diameter melanoma from 1980 through 2004. They found that available data do not support lowering the diameter criterion of ABCD from the current >6-mm guideline. However, the data did support expansion to ABCDE to include Evolving, so that physicians and patients are aware that they should pay attention to changes (evolving) of size, shape, symptoms (itching, tenderness), surface (especially bleeding) and shades of color.

Printing Skin and Bones
A research team at the University of Manchester has developed technology that will allow tailor-made tissues and bones to be grown simply by inputting their dimensions into a computer and printing them on an inkjet printer. This technology could produce made-to-measure skin and bones, which could be used to treat burn victims or patients with severe disfigurements.
The printers are able to create 3-dimensional structures, known as “tissue scaffolds.” These structures are created by printing very thin layers of a material repeatedly on top of each other until the structure is built. Each layer is 10 microns thick — 1,000 layers equal 1 cm in thickness.
Before being fed into the printer, the cells are suspended in a nutrient rich liquid, not dissimilar to ink, to ensure their survival. The cells are fed into the printer and seeded directly into the structure as it is built.
The Ink-Jet Printing of Human Cells Project Research Team is headed up by Professor Brian Derby, who has said that this technology could some day be used to build an organ.

In Brief...
DUSA Pharmaceuticals Announced… the hiring of Robert Doman as President/Chief Operating Officer. Mr. Doman has more than 25 years experience in the medical device industry, with domestic and international experience in general management, acquisitions/licensing, business development, sales, marketing and strategic planning. Dr. Geoffrey Shulman, the previous President and COO, has been appointed as the Chairman of the Board of Directors at DUSA. Jay Haft, the former Chairman, will now serve in the new position of Vice Chairman of the Board of Directors.

Healthpoint Dermatology... changes its name to Coria Laboratories, Ltd. The new name is reflective of the vision of the company, which is to have a “serious imprint on the treatment of diseases that affect skin, hair and nails,” said company President Stephen W. Clark in a release. The name Coria is derived from corium, the Latin word for skin.
Over the past 3 years, Healthpoint Dermatology has introduced several new products, including salicylic acid 6% (Salex Cream and Lotion), sodium sulfacetamide 10% (Ovace Wash and Foam),
clocortolone pivate cream 0.1% (Cloderm), erythromycin 2% (Akne-Mycin) and TheraSeal Hand Protectant.

The Dermatology Foundation… will honor three dermatologists whose teaching, clinical and patient-care capabilities have inspired successive generations of their colleagues. These dermatologists will be honored during the Foundation’s 40th Annual Meeting on February 19 at 5:30 p.m., in the Grand Ballroom A of the Hilton, New Orleans. Thomas George Olsen, M.D., will receive the Clark W. Finnerud Award. Gary A. Dyer, M.D., will be awarded the Foundation’s Practitioner of the Year Award. The Lifetime Career Educator Award will be given to Irwin M. Freedberg, M.D. The recipients of the Dermatology Foundation’s 2005 research awards will also be announced at the meeting.

Thermage Inc., Announced… the appointment of Stephen J. Fanning as its new President and Chief Executive Officer. Mr. Fanning has also been named to the Board of Directors of Thermage. He is replacing Robert Byrnes, who is leaving the company for personal reasons.