It’s no cure for cancer, but the researchers at at Kythera Biopharmaceuticals say they are getting closer to solving a problem that plenty of people would be happy to get rid of: The double chin.
You can deal with with that extra chin via liposuction or a nip and tuck, but both of these are a little too invasive for many patients. Kythera’s product, currently named ATX-101, can be injected, making it comparable to a shot of botox.
The company’s stock is up almost 25% today after it released some new results from clinical trials it expects will form the basis of its application for FDA approval. The results impressed analysts following the company: “We see a very high probability of a 2015 approval for ATX-101 in the US and Europe,” wrote J.P. Morgan, calling the new data “better than expected.”
Dealing with double chins — which the people in white coats refer to as submental fat — could be big business. Here’s how Kythera’s CEO, Keith Leonard, explained the opportunity in an earnings call back in August:
The submental region is visually important and impacts overall facial harmony and balance. Research indicates a suboptimal chin profile resulting from excess submental fat is a hallmark of aging of the lower face and neck and can lead to negative self image. Further, an excess of submental fat may be coincident with other aging processes such as sagging and lipoatrophy of the lower face, and can also have dietary causes, or result from a genetic predisposition. Regardless of the cause, excessive submental fat and the resulting unsatisfactory submental profile can result in low self-esteem and dissatisfaction.
Despite being visually and psychologically important, the submental region is often overlooked and undertreated. In fact, there are no current FDA-approved injectable drugs for the reduction of submental fat. While liposuction or lower face and neck lift can be effective for removing excess submental fat, we know that not everyone wants or is a candidate for surgery.
If approved, ATX-101 will be the only nonsurgical, submental contouring drug to improve the appearance of the face and neck. Moreover, in our studies to date, we observed that the reduction in submental fat leads to significant positive changes in patient self-perception. We believe that if approved, ATX-101 will compete largely on the basis of the following competitive factors: Consistent, meaningful and durable results, a favorable safety profile, and a low barrier to physician adoption. We plan to target ATX-101 to a ready group of patients who are already receiving facial injectables, as well as facilitate physician practice expansion into patients who are naive to facial injectable.
What exactly is ATX-101? Kythera describes it as a “a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat.” Treatment with the drug involves injections spaced out over a number of months; the drug dissolves fat cells but leaves other tissue alone. Kythera calls it “targeted destruction.”
J.P. Morgan is also excited about the opportunity:
ATX-101 could address a significant unmet need and large market opportunity. There are currently no approved non-surgical options for the reduction of submental (under-chin) fat and Kythera will target this market with a non-invasive injectable therapy. We see meaningful opportunity for ATX-101 in toxin and filler experienced patients as well as aesthetic naïve patients and over time, see a potentially meaningful off-label market for the product. We estimate annual sales for this product could be $500 million+.