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01/13/07 6:16 PM

#40619 RE: DewDiligence #40002

Skin Tight
Firms Face Off Over Wrinkles
By RHONDA L. RUNDLE
January 13, 2007; Page A1

[What about variations on Elixir and Fountain of youth as tradenames?]

Some five years after Botox changed the way Americans think about their foreheads, a marketing war has broken out between drug companies over a second generation of wrinkle-erasing products.

Allergan Inc., which makes Botox, an injectable neurotoxin, dominates the market for smoothing wrinkles above the nose. Medicis Pharmaceutical Corp., which sells a "dermal filler" called Restylane, is building a reputation for easing smile lines and other wrinkles on the lower half of the face.

Now each company is aiming at the other's turf, intent on gaining a bigger share of the face. This month, Allergan is rolling out nationally its own dermal filler, Juvéderm. These substances are injected under the skin to temporarily plump up folds and creases. And Medicis is hoping to have a neurotoxin on the market in 2008 to take on Botox.

Medicis set up a rewards program in 2005 for patients who use its dermal filler, modeled on programs by airlines and hotels. Allergan introduced a Botox benefit program last year. Allergan recently began advertising its filler on an electronic Jumbotron sign in Times Square. Medicis is funding a reality-television show called "Hottest Mom in America."

Atop the two companies, the rivalry is personal. On a recent afternoon, after watching a "Hot Mom" audition in Los Angeles, Medicis chief executive Jonah Shacknai pointed to his own face. "I'm sure I've had more Botox" than Allergan chief executive David E.I. Pyott, he said.

Mr. Pyott says he is unwilling to engage in a face-to-face comparison, but notes that he treats some small lines between his eyebrows with Botox "from time to time." He says he has never used a dermal filler.

His wife, he adds, tried his company's new filler for the first time just before Christmas. "I was pleased," he says, "when she came back and said Juvéderm hurt less that Restylane," Medicis's competing product.

Cosmetic medicine -- which involves the alteration of a patient's appearance -- has become big business, driven by new treatments that do not involve surgery. The market for drugs, dermal fillers and other devices used in cosmetic medicine totals about $15 billion, says Medical Insight Inc., a market-research firm in Aliso Viejo, Calif. Drugs and medical devices are streaming into the U.S. from abroad. Procedures involving surgery, such as traditional face-lifts and liposuction, fell by 5% between 2000 and 2005, but the Food and Drug Administration's recent decision to lift a 14-year ban on cosmetic use of silicone breast implants could lift those numbers.

More than 8.4 million minimally invasive cosmetic procedures were performed in the U.S. in 2005, 53% more than in 2000, according to the American Society of Plastic Surgeons. About half were on patients between 35 and 50 years old. The greatest growth occurred in the 51-to-64-year-old crowd.

Linda Wiermasz, a 59-year-old cardiopulmonary-resuscitation instructor in East Haddam, Conn., says her Restylane dermal-filler treatments, which cost about $600, removed deep facial wrinkles and bags under her eyes so she no longer looks like she's been crying. "What it did for me is it made me look like I used to look," she says.

These days, doctors involved in the booming nonsurgical-cosmetic market are getting star treatment from drug companies. Florida dermatologist Kenneth R. Beer grumbled for years that no one at Allergan returned his calls. Now, the company is wooing him and other doctors who administer Botox shots, offering some of them paid overseas trips to train other doctors in Botox use. It also is doling out free syringes of its new dermal filler, Juvéderm.

At Allergan, Mr. Pyott schmoozes with doctors, picking their brains about where the cosmetic-medicine market is heading. Says Dr. Beer: "Allergan has it scripted and timed so that the big injectors never have more than two weeks without some Allergan contact."

Medicis' Mr. Shacknai calls hundreds of physicians on their birthdays and sends cards to their wives.

The two companies' competing dermal fillers -- Juvéderm and Restylane -- are "the Pepsi and Coke in a product-driven market that is shifting away from bellwether surgical procedures like face-lifts," says Mark L. Jewell, a plastic surgeon in Eugene, Ore.

Bigger drug companies are nosing around, too. One reason they like the business is that health-insurance plans don't cover such products, leaving patients to pay cash and freeing drug companies from managed-care constraints. Last summer, Johnson & Johnson bought a small Israeli company with a wrinkle-fighting collagen product that could hit the U.S. market later this year. Recently, Pfizer Inc. held a brainstorming session with cosmetic specialists in New York.

Neurotoxins like Botox are typically injected around the eyes and forehead, temporarily paralyzing muscles and causing wrinkles to relax. (Botox has been used for years to treat eyelid spasms, among other neuromuscular problems, and only by accident was it was found to smooth wrinkles.) Allergan currently has a lock on the cosmetic neurotoxin market, but Medicis is expected to challenge it with its neurotoxin next year.

In 2003, Medicis acquired from Sweden's Q-Med AB the U.S. rights to its dermal filler, Restylane, which is commonly used on wrinkles stretching from the nose to the corners of the mouth. It introduced the filler in the U.S. in 2004, and the market for it grew rapidly. Last year, Allergan countered by acquiring Juvéderm, as part of a $3.4 billion purchase of Inamed Corp. Allergan is rolling out Juvéderm across the country this month.

The cost of getting facial injections varies widely, by doctor and by face. They are available from plastic surgeons and dermatologists, and increasingly, from nurses working for spas. A single dermal-filler treatment, which lasts at least six months, can cost $600 or more. Botox shots, which last for about four months, can cost $500 or more. Some patients get both kinds of injectables -- neurotoxins for the top of the face and fillers for the bottom. None of the products have faced any significant safety issues; some patients experience temporary redness or bruising at the injection site.

Ileene Fisher, a lawyer from West Palm Beach, Fla., who retired to raise her kids, says she was getting "Botoxed" a couple years ago when she asked Dr. Beer if there was anything he could do about the lines running from her nose to her mouth. It was just before her older daughter's Bat Mitzvah, she explains, and "I was feeling like my face was showing the stress."

Ms. Fisher, who declines to reveal her age, says she's "nowhere near ready yet for a face-lift and the idea terrifies me." Her first Restylane treatment, she says, lasted for over a year. The full Botox and Restylane regimen, she says, cost roughly $2,000.

Allergan has promised to unleash a big consumer advertising campaign for its competing filler product. "Our people see big numbers on the table," says Mr. Pyott, Allergan's chief executive.

Medicis's chief, Mr. Shacknai, vows he won't cede "a single account" to Allergan. In an effort to keep its own filler in the spotlight, Medicis is making "Hottest Mom in America," a reality television show it hopes will air later this year. The show, inspired by "American Idol," features auditions in half a dozen cities to pick a Restylane spokeswoman. Medicis is shopping it to TV networks.

Mr. Shacknai says he founded Scottsdale, Ariz.-based Medicis in 1988 with "under a few million dollars." A one-time Congressional staffer and lawyer, he says he saw dermatology as a promising business opportunity because big pharmaceutical companies were abandoning it at that time. Medicis reported 2005 revenue of $360 million.

To his salespeople, Mr. Shacknai preached customer service. Dr. Beers recalls that a Medicis representative visiting his Florida office in 2004 pitched in to help his staff secure the workplace for an impending hurricane. New York plastic surgeon Michael Kane, a paid consultant to both Allergan and Medicis, recalls needing Allergan's Botox in a hurry to demonstrate injections to other doctors gathered in Chicago, but being unable to get an Allergan representative on the phone. A Medicis representative was at the meeting and "actually made a million phone calls and ran out and got me Botox," he recalls.

Allergan, based in Irvine, Calif., has been around for more than 50 years. It made its name in eye-care medicines. In 2005 it reported sales of $2.32 billion.

Medicis's Mr. Shacknai argues that Allergan's corporate culture is too staid for the business of prettifying faces and enlarging busts, and that his rival chief executive, Mr. Pyott, isn't comfortable with it. Allergan disagrees, noting that it pioneered the aesthetic-medicine marketplace with Botox. Allergan acquired a breast-implant line as part of the Inamed acquisition.

To promote its new dermal filler, Allergan is marketing so aggressively that, in one instance, Medicis has complained of unfair play. In November and December, Allergan offered physicians who use lots of Botox -- its "platinum" users -- 24 free syringes of Juvéderm Ultra and 16 of Juvéderm Ultra Plus, a thicker version for deeper folds. To qualify for the freebies, physicians had to use it in a so-called experience trial on patients who had used Medicis's competing product during the prior 12 months.

Medicis saw it as a ploy to steal customers. It dashed off a letter to thousands of physicians, lambasting the trial as a marketing gimmick "under the guise of science."

Allergan has defended the trial as a way to obtain more information about Juvéderm and patients' reactions to it.

Doctors who use Botox say they want Medicis to break Allergan's near-monopoly on the cosmetic-neurotoxin market. Many of them are irate about Botox price increases. The drug now costs $505 per vial, about 50% more than it cost nine years ago. "It's upsetting," says Joel Schlessinger, a dermatologist in Omaha, Neb. Doctors say it's difficult to pass on Botox price increases because of mounting competition among doctors and medical spas.

Allergan says the price increases have been modest, given its investments in research and its increasing manufacturing costs. Mr. Pyott says Allergan won't give Botox discounts even to doctors who use lots of it because it worries that those doctors could resell it to doctors who use Botox to correct medical problems such as eyelid-muscle spasms, which are covered by insurance. Last year's nearly $1 billion of Botox sales was roughly evenly split between cosmetic and therapeutic uses.

The rivalry between Allergan and Medicis has been colored by a clash over an acquisition. In 2004, the two companies discussed a marketing joint venture that would have paired Allergan's Botox and Medicis's Restylane. Then a third drug maker, Inamed, which held licensing rights for Juvéderm, approached Medicis about a merger. Medicis abruptly ended the joint-venture talks with Allergan without revealing why, and in early 2005, unveiled a plan to merge with Inamed.

By then, however, Allergan also had its eye on Juvéderm. As Allergan's Mr. Pyott analyzed Inamed, he concluded that its other products, including an obesity-intervention device that is implanted surgically, were also attractive. Allergan made a competing bid for all of Inamed, which was eventually accepted. The deal closed in March 2006.

Allergan now had a dermal filler to compete with Medicis's. To gain regulatory approval for the acquisition, Allergen had to give up Inamed's rights to Reloxin, a neurotoxin similar to Botox. Medicis scooped up the U.S. rights, and began laying plans to mount a challenge to Botox. The competing product is now in human trials in the U.S., with a commercial launch at least a year away.

Write to Rhonda L. Rundle at rhonda.rundle@wsj.com
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