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Sunday, February 03, 2013

A New Unmet Medical Need: Excess Adipose Tissue Syndrome

As reported by FierceBiotech (here), "Bayer Healthcare touted upbeat data from a pair of late-stage studies of an investigational drug [ATX-101, a synthetic version of a human bile component] targeting chin fat, setting the stage for the giant to step into growing aesthetic treatment market. And the results provide a victory from Kythera, which licensed the injected drug to Bayer for markets outside the U.S. and Canada".

“An injectable solution for reduction of submental fat is an unmet need in aesthetic medicine," said Patricia S. Walker, M.D., Ph.D., KYTHERA’s Chief Medical Officer.

"Based on evidence-based experience, ATX-101 represents a promising candidate for the reduction of submental fat," said Dr. Kemal Malik, Bayer's head of global development.

The "evidence" includes Patient-Reported Outcomes (PRO) that were evaluated on the basis of a 7-point "Subject Satisfaction Rating Scale (SSRS), a validated 5-point Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and a Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Calipers, an objective measure of submental fat thickness, also were used to assess the reduction of submental fat."

If this drug is approved in the U.S. I envision Bayer launching an innovative, "in your face," direct-to-consumer (DTC) advertising campaign. The first stage of the campaign will be focused on disease awareness.

First, you have to invent some new medical terminology. "Chin Fat" doesn't sound serious. Plus, you just don't say the "Fat" word in public. "Double Chin" is a common name given to this condition, but it also doesn't sound serious. Doctors need serious medical terms to use if they are going to prescribe drugs to treat what some people might not see as serious conditions.

More importantly, these names cannot be trademarked for marketing purposes. And marketers love medical conditions with memorable acronyms.

Therefore, let me suggest "Excess Adipose Tissue Syndrome" or EATS for the new medical condition/syndrome that Bayer can use in its disease awareness advertising campaign. Note that this terminology will also help foster "off-label" use of ATX-101 to treat other fatty areas of the body. While Bayer may eventually seek additional approved indications beyond chin fat, off-label use may be so popular that FDA approval for such uses will not be necessary.

The ads probably won't use images of EATS sufferers like the guy depicted above. First of all, Bayer is likely to begin by focusing on women. And not just older women, who don't have as much disposal income (I don't imagine that ATX-101 will be covered by Medicare).

A hint of the image that Bayer might opt for is shown in the screen shot below, which was taken from a site that is recruiting subjects for "The Double Chin Research Study" clinical trial in the U.S.

(click on the image for a larger view)

Here you have a "typical" EATS sufferer: a young, affluent, woman who probably also uses BOTOX to smooth her frown lines. She can go to her cosmetic physician and get TWO shots: one for Botox and one for ATX-101, which is delivered via injection.

When it comes time to do branded DTC advertising, Bayer might opt to follow Allergan's BOTOX DTC strategy: i.e., stick to "reminder ads" -- A reminder ad mentions the pharmaceutical brand name but not the indication or medical condition it treats. Such ads do not need to mention any side effects, not even the dangerous side effects, if any.

But wait! Bayer HealthCare is a signatory to PhRMA's Guiding Principles for Direct-to-Consumer (DTC) advertising, which prohibits reminder ads. PhRMA's principles, however, apply only to TV and magazine (print) ads. So Bayer can use the technique on the Internet, YouTube, via social media, or in outdoor ads such as this Levita (marketed by Bayer) Reminder Ad Sighting.

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