FDA Approvals & News
Biogen Releases New Safety Information for Two Drugs
Biogen Idec announced that new safety information is being added to the prescribing information for two of its medications — ibritumomab tiuxetan (Zevalin) and alefacept (Amevive). The following details the warnings:
1. In September, the Boxed Warnings, Warnings, and Adverse Reactions sections of the prescribing information was updated to note that severe cutaneous or mucocutaneous reactions, some with fatal outcome, have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Similar events have been associated with rituximab (Rituxan), a component of the Zevalin therapeutic regimen. Patients experiencing a severe cutaneous or mucocutaneous reaction should discontinue Zevalin and seek prompt medical evaluation.
2. In October, Biogen added a contraindication to its psoriasis therapy Amevive. The labeling for the drug is being revised to read as follows:
Amevive should not be administered to patients infected with HIV.
Amevive reduces CD4+ T-lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients (see Warnings, Lymphopenia and Warnings, Serious Infections).

Application for Psoriasis Drug Accepted
An application for infliximab (Remicade) for the indication of treating moderate to severe plaque psoriasis has been accepted by the FDA.
The supplemental Biologics License Application (sBLA) follows infliximab’s approval as a treatment for severe plaque psoriasis in Europe, which was approved this past September. That approval was for adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or psoralen plus ultraviolet light A.
In May of this year, infliximab was approved by the FDA for reducing the signs and symptoms of active arthritis in patients who have psoriatic arthritis.

New Food Allergy Label
Beginning Jan. 1, 2006, your patients who are allergic to some of the top food allergens will have an easier time identifying these allergens on food labels, thanks to a new food-labeling law. The law will require that manufacturers use common, easy-to-understand language to indicate whether their products contain any of the following top-eight food allergens: peanuts or tree nuts, milk, eggs, fish, wheat, soy or shellfish. These ingredients must be listed even if they are used only as ingredients in the flavorings, additives or colorings in a product.
According to the Food Allergy & Anaphylaxis Network, these eight foods are responsible for 90% of all allergic reactions to foods. The labeling comes at a time when 4% of the U.S. population, or 11 million people, have food allergies, and food allergies on the whole are on the rise in this country.

Birth Control Patch Warning
Awarning issued by the FDA indicates that women who use the Ortho Evra birth control patch, which is manufactured by Ortho McNeil, are being exposed to more hormones than previously thought.
A new warning on the product’s labeling cautions women that they will be exposed to about 60% more estrogen than women who take typical birth control pills. According to a previous report from the Associated Press, women who use the patch for birth control are three times more likely to die or suffer from blood clots than women who take oral birth control pills.

Application Accepted for Genital Wart Treatment
MediGene AG, a German-American biotech company, has had its New Drug Application (NDA) for Polyphenon E Ointment accepted by the FDA. The NDA seeks approval for the ointment to be used as a treatment for genital warts. The active substance in the ointment is a green tea extract, and the company is developing this drug for a number of skin tumors. The submission is based on data from two Phase III clinical trials that were conducted in Europe and the Americas and included more than 1,000 patients.

Squamous Cell Carcinoma Drug Granted Priority Review
The FDA has accepted a supplemental Biologics License Application (sBLA) for cetuximab (Erbitux) for the indication of treatment of squamous cell carcinoma of the head and neck. Granted priority review, this application seeks approval for the drug to treat this cancer in combination with radiation for locally or regionally advanced head and neck cancer and as monotherapy in patients with recurrent and/or metastatic disease for whom platinum-based chemotherapy has failed or was not an appropriate therapy.
Because of the priority review status granted to this IgG1 monoclonal antibody, which is offered through ImClone Systems Incorporated and Bristol-Myers Squibb, the FDA will need to take action on the sBLA filing within 6 months.

Salary Trends in Dermatology
The results of the American Medical Group Association’s (AMGA’s) 19th Annual Medical Group Compensation and Financial Survey are in, and the highlights were published in the September issue of Group Practice Journal.

For this survey, AMGA contacted 2,600 medical groups across the country and RSM McGladrey received calculable results from 197 national medical groups, representing more than 34,000 providers. This group included more than 100 specialties as well as 40 mid-level provider and administrative positions.

For the dermatology market, new dermatologists have seen a 25% increase during years 2001 to 2004. The median salary for all dermatologists was $274,000 in 2004, an increase of $53,200 from 2001. Mohs surgeons saw a more than a $30,000 increase from 2003 to 2004, bringing their median salary to $351,000.

In terms of productivity, the survey results showed productivity in general dermatology was up 35% and work RVUs were up 11%.

The Group Practice Journal article projects that dermatologists will see above-average compensation increases and continued growth in revenue.

Skincare and Women
The Society of Dermatology SkinCare Specialists (SDSS) recently released the results of its national survey of 387 women regarding their skincare knowledge. The survey results showed that more women should visit a skincare professional with cosmetic skincare concerns because they may otherwise be wasting time and money on buying the wrong products.
When asked what they would do when faced with a cosmetic skincare concern:
• 32.2% said go to a dermatologist
• 3.3% said go to an esthetician
• 22.4% said seek advice at a drug store or department store
• 18.4% said seek advice of family/friends
• 16.9% said do nothing/hope it will go away.

Some other key results included:
• 65% of respondents were not sure which ingredients would help to reduce inflammation and bruising, and almost 10% selected an ingredient for reducing inflammation that actually may cause inflammation.
• 83% were not sure which ingredient to use for anti-aging and thought they needed the advice of an expert.
• Less than half of those surveyed (46.1%) reported using some form of sun protection year-round.

In Brief...
Physician’s Choice of Arizona Celebrated… its crystal anniversary with the unveiling of a new name — PCA Advanced Skin Care Systems. The new corporate identity was selected to embody the company’s growing global presence and to unify brand recognition of the expanding family of professional treatments and products. Product lines include PCA Professional Products, PCA Skin‚ Clinical Care Products, and the company’s newest line of skin care, PCA‚ Men.
Leo Pharma A/S and Foamix Ltd., Announced…that they have signed an agreement to jointly develop two topical medicated foams for the treatment of psoriasis. The foams will be based on LEO Pharma's proprietary calcipotriene compound and its combination with specific steroids, which represent the forefront of psoriasis therapy.
MediNotes Corporation Ranked…on Inc. Magazine’s list of the top 500 fastest growing, privately held companies in the country. The list reported a 3-year growth of 364% for MediNotes, ranking the company at number 373.
Thermage Announced its Approval…from the State Food & Drug Administration of the People’s Republic of China to sell the company’s ThermaCool system in China. The company says this regulatory approval represents the opportunity to penetrate additional international markets.
Barrier Therapeutics Announced…the launch of eflornithine hydrochloride cream 13.9% (Vaniqa) in Canada. Barrier Therapeutics acquired the exclusive right to distribute Vaniqa in Canada from Shire Pharmaceutical Contracts Limited in June.