A Drug to Cure Double Chins?


From Daily News (Los Angeles, CA) (June 27, 2012)


June 26--Could embarrassing and unsightly double chins become a thing of the past for image-conscious aging baby boomers?

They could if a drug invented at little-known nonprofit Los Angeles Biomedical Research Institute, based on the County Harbor-UCLA Medical Center campus near Torrance, is as effective as it appears in clinical trials.

There is no drug that has yet proven an effective treatment for treating so-called submental -- below the chin -- fat.

Dubbed ATX-101, the injectable drug could win regulatory approval in Europe in 2013 and in the U.S. sometime after that, said Keith Leonard, president and chief executive officer of Calabasas-based Kythera Biopharmaceuticals.

Kythera -- named after a Mediterranean island that was the center of worship for Aphrodite, the Greek goddess of beauty -- is a biotechnology startup spun off in 2005 from LA BioMed , as the South Bay research institute is known.

Leonard and several other members of Kythera's senior management team were formerly with Thousand Oaks-based biotech pioneer Amgen.

Kythera, which employs 40 people, expects big things from its sole product so far. In mid-May, it filed for an initial public offering that could raise up to $86 million.

The drug is somewhat of a departure for LA BioMed.

Founded in 1952, the low-profile nonprofit is perhaps best known for occupying a ramshackle collection of World War II-era buildings it shares with a large colony of feral cats. State-of-the-art labs in modern buildings are gradually replacing the deteriorating former barracks.

Despite the substandard conditions, researchers at LA BioMed have developed such medical innovations as paramedics and the blood test routinely used to detect cholesterol levels.

The elimination of fatty double chins could be next.

"There's a huge market for people who are paranoid about their appearance," said David Meyer, president and CEO of LA BioMed, which has 100 researchers. "This is not the usual LA BioMed kind of area. It wasn't our original intent to treat submental fat; it just turned out to be very effective at doing that."

Indeed, Kythera's IPO filing notes that last year about $2.1 billion was spent worldwide on injectable cosmetic facial procedures such as Botox. That figure is expected to grow 12 percent a year through 2018.

Kythera, which will be listed on the Nasdaq stock exchange, expects ATX-101 to generate annual sales of $500 million in the United States alone.

However, because there are no drugs yet available to treat the fatty deposit that causes some double chins, liposuction is currently the only option.

But for obvious reasons, the growth of nonsurgical cosmetic procedures is far outpacing liposuction.

"It's a lot less invasive than liposuction," said Dr. Michael Kolodney, co-inventor of ATX-101 and a professor of dermatology at UCLA.

"You don't have to break the skin," he added. "There's less chance of bleeding."

Patients also need a couple of weeks of sometimes painful recovery, Kythera stated in its IPO filing.

Presumably, a simple injection will also be cheaper than liposuction.

Torrance plastic surgeon Dr. James Black said liposuction can take up to two hours and cost as much as $5,000 for a surgical fee alone.

But only about 25 percent of people with double chins suffer solely from excessive fat and are eligible for liposuction, he said.

More common is an expensive neck-lift, which also treats loose skin or muscle that can contribute to double chins, Black said. ATX-101, which is made from compound found in human bile, only targets below-the-chin fat.

Still, the magnitude of the market worldwide convinced German drug giant Bayer in 2010 to purchase the rights to ATX-101 outside the U.S. and Canada.

The company will pay Kythera up to $330 million as part of the licensing and development agreement as well as double-digit royalties on net sales; Kythera has already received more than $70 million from Bayer including $33.3 million earlier this month.

LA BioMed owns a "tiny portion" of Kythera stock, and could receive payments of up to $5 million from the company and low single-digit royalties, Meyer said.

"Our partnership is an example of how companies and research institutions can work together very effectively," Leonard said via email. "As we strive to build Kythera into a leading aesthetics company, collaborations, like that with LA BioMed, will be instrumental to achieving success."

Despite the market potential, Kythera has an accumulated deficit of more than $90 million, according to its IPO filing.

Bayer completed European phase-3 clinical trials in April; Kythera began that stage of clinical trials in the U.S. in March and expects to report results in 2013, Leonard said.

The company currently is in the U.S. Securities & Exchange Commission-mandated "quiet period" before the IPO. As a result, Leonard and other company officials declined further comment.

In Europe, patients received up to four injections of ATX-101 at 28-day intervals.

The result was a "well-tolerated and statistically significant reduction of unwanted submental fat," Bayer reported in a press release. The worst side effect was "moderate and transient" pain, swelling, numbness and bruising.

"A small reduction in fat in that region produces a very obvious cosmetic improvement," Kolodney said.

nick.green@dailybreeze.com

Twitter.com/nickgreen007

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(c)2012 the Daily News (Los Angeles)

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Posted: June 2012


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