Sticking its neck out to fight double chins

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The appearance-obsessed can get Botox injections to erase wrinkles, Rogaine to reseed fading hair lines and the prescription medicine Latisse to fill out flimsy eyelashes.

Soon, they may be able to get a shot to kill fat.

A Southern California company has invested millions of dollars on an injectable, fat-destroying drug that it says will do away with double chins.

Kythera Biopharmaceuticals Inc. said the drug, which for now is known by the code name ATX-101, has proved effective at diminishing double chins during trials on more than 1,000 volunteers in the United States and Canada.


The new vanity drug could generate sales of more than $500 million a year if it gets approval from the Food and Drug Administration, said Keith Leonard, the Calabasas company’s co-founder and chief executive. He wouldn’t say when Kythera would formally apply and go through the yearlong FDA process.

“We really think we’re going to be the next big thing in aesthetics,” he said.

Though the company is seeking approval to use the drug only for double chins, it might try to expand to other areas of the body.

“We’re at the very beginning of understanding the possible uses of the drug,” Leonard said.

Some physicians, such as Dr. Al Aly, a plastic surgeon and professor at UC Irvine’s medical school, are reserving judgment about the new drug.

“Anything you do that eliminates fat is not a cure-all,” he said.

Still, German pharmaceutical company Bayer was so impressed by the drug’s potential that it agreed to pay as much as $330 million for the rights to license and develop it outside the United States and Canada.

The new drug is a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. Its potential as a fat-busting drug was discovered by two doctors at Harbor-UCLA Medical Center in Torrance, who ended up signing with Kythera in 2005.


“They realized the molecule that is our active ingredient was causing fat cells to burst open and die,” Leonard said.

Kythera has paid the doctors, Michael Kolodney and Adam Rotunda, more than $5 million and has given them company stock and the promise of future royalties should the drug gain FDA approval.

Kythera expects its typical customers will be women in their 40s who are average weight to slightly overweight and who store fat near their necklines. They’re the same folks who have streamed into dermatologists’ offices for more than a decade for Botox, the $2-billion-a-year business generated by Allergan Inc. in Irvine.

It’s an industry that feeds off people’s insecurity about their appearance, said Janis Rosenberg, a Culver City psychologist who has treated scores of clients with body-image issues and eating disorders.

“I think in the short run, these little fixes can make people feel better about themselves,” Rosenberg said. “A lot of people psychologically are very addicted to image and want to feel better about their appearance.”

She said it’s unfortunate that so much time, money and energy is spent on cosmetic pharmaceuticals instead of more meaningful issues. “Wouldn’t it be better to take those tens of millions of dollars to see if they can find a better way to detect pancreatic cancer or ovarian cancer, the harder-to-find cancers?”


But the bottom line drives business, Rosenberg said.

“People love a quick fix, rather than exercising and taking care of their health with proper food and exercise,” she said. “This will definitely make money.”

Aly believes that the new drug won’t help everyone.

“If the skin quality is excellent, a product like this can be very good,” he said. “If the skin quality is very bad, meaning it’s very inelastic, simply reducing the fat is not necessarily going to solve your problem. What you’ll end up with is a lot of hanging skin.”

He figures the proposed drug could be a good option for young, healthy people who happen to store excess fat beneath the jaw. For older patients, it might not prove effective.

“One has to have some caution in saying this is the next great thing in plastic surgery,” Aly said.

Leonard co-founded Kythera in 2005 with the hope of developing several aesthetic drugs. The company is named after a Greek island that was the mythical birthplace of Aphrodite, the Greek goddess of love, beauty and pleasure.

Kythera raised $72.5 million in its 2012 initial public offering. As primarily a clinical stage, research-and-development operation, it has posted mainly quarterly losses, including $12.3 million for the second quarter.


But so far, Wall Street appears to like the company. Kythera stock has soared 47% this year, hitting a closing high of $46.29 on Oct. 14. Shares lost $1.15 on Thursday to close at $44.71.

The company bought the rights to four drugs, but ATX-101 is the only one that has survived. The drug won’t be as big as Botox -- unless it proves effective on fat elsewhere, such as love handles or flabby midsections.

“Our focus right now is on facial aesthetics,” Leonard said. “Only after we get approved by the FDA and get our feet under us will we start considering using it in other areas. We want to make sure we walk before we run.”