Press Releases

Allergan awaits FDA approval to market Botox for cosmetic use

By Simon Avery, The Associated Press
Saturday March 30, 2002

LOS ANGELES — Not since the early days of Viagra has a lifestyle drug garnered so much attention as Botox. 

Botox has erased early wrinkles on young women, flattened the furrowed brows of middle-aged TV anchormen, removed sweat stains under the arms of runway models, and even erased gamblers’ unwanted facial expressions. 

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

Botox is a laboratory refined strain of botulinum toxin — one of the most poisonous substances on earth — that’s given in extremely small therapeutic doses. Botulinum toxin causes botulism and is a favored tool of bioterrorists. The cult Aum Shinrikyo dispersed a strain of it in aerosol form in several failed attacks in Japan in the early 1990s. 

Botox already has regulatory approval to treat certain spasmic disorders. But it’s the drug’s wrinkle-busting properties that have created a national buzz. 

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

Men and women of all ages have made Botox injections the most popular cosmetic medical procedure in the nation since 2000, even though the procedure falls in a gray area and may produce side effects such as swelling or numbness. 

The Food and Drug Administration has yet to approve the drug for cosmetic use, but the agency doesn’t prevent doctors from using it in this way. 

This kind of “off-label” use could change soon. 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 firm is restricted from discussing Botox or its plans for the drug while the regulatory process continues. But analysts say Allergan already has a multimillion-dollar ad campaign ready to launch soon after winning approval. 

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 normally last about three months, which keeps most patients returning on a regular basis for treatments that average about $400. 

The recurring costs are just one reason analysts say Botox will boost Allergan’s profits. They estimate it costs the company $40 to produce a vial of Botox. The firm sells it to doctors for $400. 

With aging baby boomers reluctant to part with their youth, no serious competition on the market, and only 10 percent of the U.S. market estimated to have been tapped so far, Wall Street sees plenty of upside. 

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

Botox did about $300 million in worldwide sales last year, of which as much as half related to cosmetic use, according to analysts’ estimates. 

In cities such as New York and Los Angeles, Botox is already the talk of beauty parlors and cocktail parties. 

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

But in other parts of the country, Botox is still catching on. 

“Everybody knows about Botox on the two coast lines,” 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 north Atlantic coast, including New York, 32 percent, according to the American Society for Aesthetic Plastic Surgery. 

The procedure was most popular among the 35-40 crowd, which accounted for just over half of all patients using Botox for cosmetic purposes in 2001. 

Paul Nassif, a facial plastic and reconstructive surgeon in Beverly Hills, expects a slight increase in business if the FDA approves the process. He said he has already performed a few thousand Botox procedures and interest has been growing in the past few months. 

He recently began arranging bimonthly Botox parties at the Palms Casino Resort in Las Vegas. Guests talk about what’s new in plastic surgery and receive their Botox together, along with champagne, Perrier and a light massage. The sessions also give prospective patients a chance to see how the treatment is done. 

Bachelorette parties are a big market to tap in Las Vegas, Nassif said. 

The treatments do not come without side effects, which can include bruising or nausea. Critics complain Botox also erases facial expression. 

But Nassif insists that’s not the case if Botox is injected properly and used in modest amounts to remove frown lines or eye wrinkles. In less than one percent of cases though, a patient may get a droopy eyebrow or eye lid for a few weeks, he said. 

Nassif and other doctors are finding secondary benefits from Botox, such as relief from neck pain and certain types of headaches. The drug also prevents excessive sweating on palms or under armpits. 

“Botox is still in its infancy,” said Chiang. “It can help anything muscle-related, and your whole body is covered in muscles.” 

Allergan wants to expand Botox sales in other markets, too. The firm is spending $50 million a year on research and development of Botox, Gilbert said. 

The company is also currently seeking FDA clearance to market the drug to treat tension headaches and migraines.