Maker of Botox awaits FDA approval to market toxin for use in smoothing out wrinkles

LOS ANGELES (AP) _ Botox has erased women's wrinkles, smoothed the furrowed brows of middle-aged TV anchormen, and given poker faces to gamblers. <br><br>In the process, the muscle-paralyzing substance

Tuesday, April 2nd 2002, 12:00 am

By: News On 6

LOS ANGELES (AP) _ Botox has erased women's wrinkles, smoothed the furrowed brows of middle-aged TV anchormen, and given poker faces to gamblers.

In the process, the muscle-paralyzing substance has become one of the most profitable products for Allergan Inc., which first sold the drug more than a decade ago for treating crossed eyes.

Botox is a refined strain of botulinum toxin, the cause of botulism and one of the most poisonous substances on Earth. It is injected in extremely small doses.

Botox already is approved by regulators for treating certain spasmic disorders. But it is the drug's wrinkle-removing properties that have created all the excitement.

``It's an in-vogue product,'' said Tim Chiang, an analyst with Banc of America Securities. ``It's like having a fashion designer bag, a Louis Vuitton.''

Lisa J. Davis, a Los Angeles TV producer in her early 30s, smoothed her brow with her first treatment last month. ``I am getting to the point where the lines are a little more noticeable,'' she said. Botox ``is an easy way to soften that change.''

Botox is awaiting Food and Drug Administration approval for cosmetic use. Doctors do not need the agency's OK to use Botox to fight wrinkles _ and, in fact, injections of the drug have become the most popular cosmetic medical procedure in the nation since 2000 _ but FDA approval is likely to lead to even wider use.

Allergan submitted clinical trials of cosmetic Botox last year to the FDA, which is now in the final stages of its review process.

The Irvine, Calif., health care company cannot discuss Botox while the approval process is under way. But analysts say Allergan already has a multimillion-dollar ad campaign ready to go.

The company will pitch Botox with ads in magazines and newspapers, using the tag line ``It's not magic. It's Botox,'' according to Gregg Gilbert, an analyst with Merrill Lynch.

In a cosmetic treatment, a doctor injects Botox into the facial muscles that cause wrinkling. The drug blocks a substance called acetylcholine that transmits signals from the brain to the muscle, paralyzing the muscle. The effects last about three months, which keeps most patients returning on a regular basis for treatments that average about $400 each.

Analysts estimate Botox did $300 million in worldwide sales last year, with up to half that amount related to cosmetic use. With aging baby boomers reluctant to part with their youth and only 10 percent of the U.S. market estimated to have been tapped so far, the potential market is huge.

``Botox absolutely has potential to become a billion-dollar drug for Allergan,'' Gilbert said.

In some parts of the country, Botox is still catching on.

``Everybody knows about Botox on the two coastlines,'' said Donald Ellis, an analyst with Thomas Weisel Partners LLC. ``In between, it's not as common knowledge.''

Last year, the Midwest accounted for nearly 10 percent of procedures, the West Coast 36 percent and the upper Atlantic Coast, including New York, 32 percent, according to the American Society for Aesthetic Plastic Surgery. The 35-to-40 crowd accounted for just over half of all patients using Botox for cosmetic purposes.

Dr. Paul Nassif, a plastic surgeon in Beverly Hills, said he has already performed a few thousand Botox procedures. He recently began arranging Botox parties at the Palms Casino Resort in Las Vegas. Guests talk about what is new in plastic surgery and receive their Botox together, along with champagne, Perrier and a massage.

The treatments' side effects can include bruising, swelling, numbness and nausea. Critics also complain Botox reduces facial expression.

But Nassif insisted that is not the case if Botox is injected properly and used in modest amounts. In less than 1 percent of cases, a patient might get a droopy eyebrow or eyelid for a few weeks, he said.

Doctors are finding secondary benefits from Botox, such as relief from neck pain and certain types of headaches. The drug also prevents excessive sweating from the palms and the armpits. Botox has been used to stop sweat stains under the arms of runway models.

Allergan is also seeking FDA clearance to market the drug to treat tension headaches and migraines.