March 16 (Bloomberg) -- Medicis Pharmaceutical Corp.’s Reloxin, which would compete in the U.S. with Allergan Inc.’s best-selling Botox if approved by regulators, reduced the frown lines between eyebrows, a company-funded study found.

Injections with Reloxin helped improve the appearance of moderate to severe forehead furrows over 13 months, according to research published today in the March/April issue of Archives of Facial Plastic Surgery. Reloxin and Botox use a similar type of botulinum toxin to relax the muscles that make frowns.

Reloxin, which has been sold outside the U.S. for more than 15 years, awaits approval by the U.S. Food and Drug Administration. The drug is expected to win FDA clearance during the second half of this year, said Gary Nachman, an analyst for Leerink Swann & Co. in New York. The medicine may appeal to some of the millions of people who now use Botox, he said. Botox had about $1.3 billion in revenue last year, according to Allergan.

“The results of the study show that it’s as good as Botox,” Ronald Moy, the lead author of the study and a professor in the medical school at the University of California, Los Angeles, in a March 13 telephone interview. “The side effects are the same as Botox. Many of our patients liked it even better.”

Moy is a practitioner of cosmetic and skin surgery.

Kara Stancell, a spokeswoman for Scottsdale, Arizona-based Medicis, declined in an e-mail to comment on the study. Today’s findings were from the third of three phases of testing generally required for FDA approval.

Treatment Injected

Researchers injected 1,200 patients with Reloxin at five points along the frown line. Patients were required to maintain diaries to gauge the treatment’s effects. They were also called seven days after their injection to check for adverse events and then were re-examined after two weeks, 30 days and once a month until their next treatment. As many as five treatments were given during the study. The study was completed by 1,052 patients.

The researchers found that 804 of the 2,838 adverse events reported by patients were probably or possibly related to the treatment. Among the 804, 18 percent were related to pain at the site of injection, 14 percent included headaches and 9 percent were eye events such as drooping of the eyelid or brow. One patient discontinued the study because of these events.

Botox has about 83 percent of the worldwide neurotoxin market for both cosmetic and therapeutic uses, said Caroline Van Hove, a spokeswoman for Irvine, California-based Allergan. Botox sales this year are expected to be between $1.15 billion and $1.19 billion, the company said Feb. 4. Last year revenue was $1.3 billion, about half from cosmetic sales.

Distinct Products

“It’s important that people just recognize that these are different products,” said Van Hove in a March 13 telephone interview. “They can’t be used interchangeably.”

Botox costs $525 a vial, which could treat up to three to five patients, Van Hove said.

Reloxin may be priced 15 percent lower than Botox, said Nachman at Leerink Swann. Over time Reloxin may take 25 percent to 30 percent of market share from Botox, he said. U.S. sales of Reloxin may rise to about $160 million by 2012, he said.

“Ultimately this is going to come down to a marketing game. A lot of this is going to come down to pricing and how aggressive the companies are in terms of promotions and overall marketing,” said Nachman, who rates Medicis stock “market perform” and Allergan “outperform,” in a March 13 telephone interview.

Studies Urged

Moy, the researcher, said trials assessing both Botox and Reloxin are needed in order to compare the drugs’ safety and efficacy.

The study was funded by Medicis. Moy said he has no financial ties with company. Study co-author Corey Maas reported owning stock in Medicis, working as a consultant for the company and receiving research support from Medicis.

Reloxin is sold as Dysport outside the U.S. by Ipsen SA, based in Boulogne-Billancourt, France, outside Paris. In 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Reloxin as a wrinkle treatment in the U.S., Canada and Japan, according to a Medicis company filing. Ipsen is awaiting FDA approval to sell Dysport in the U.S. for muscle spasms.

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To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.

Last Updated: March 16, 2009 16:00 EDT