BusinessWeek just put out an interesting piece on Amgen’s (AMGN) next-up blockbuster Denosumab (Dmab).

As the world knows by now, AMGN released positive top-line results last night showing that Dmab was able to delay or reduce skeletal related events (SRE) in patients with metastases secondary to breast cancer.

BusinessWeek points out that marketing this thing is going to be an uphill climb, and AMGN agrees, kinda.

If approved for osteoporosis, Dmab will be the first nonvaccine biologic to be marketed to general practitioners.

…denosumab is not the type of product patients can inject themselves, so doctors will have to prod them to come into the office twice a year. That could be a hard sell, especially when physicians have the option of prescribing inexpensive pills. Roger Perlmutter, Amgen’s vice-president of research and development, isn’t worried. “Most elderly people are seeing a doctor every six months anyway.”

It’s anticipated that AMGN will have to go the way of direct-to-consumer (DTC) advertising to get a strong word out. A problem could arise, however, given AMGN’s past DTC problems:

In 2005, the FDA asked the company to withdraw ads for Enbrel, a rheumatoid arthritis drug that was also approved to treat psoriasis. The agency felt the psoriasis ads overstated the drug’s efficacy and understated its risks. It took eight months for the company to revamp the campaign. And last year, Congressmen John Dingell and Bart Stupak, both Michigan Democrats, looked into whether aggressive advertising of anemia drugs developed by Amgen and marketed both by it and Johnson & Johnson (JNJ) encouraged oncologists to prescribe them in excessive doses. The FDA added “black boxes” to the drugs’ labels, warning that they were associated with increased tumor growth.

Dmab has an advisory panel on August 18 for its osteoporosis indication…D-Day.

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