National report - The bankruptcy of Artes Medical, maker of the permanent facial filler ArteFill, will make it harder for permanent fillers to enter the U.S. market in the future, analysts say - although one such product, Contura's Aquamid, will likely seek Food and Drug Administration (FDA) approval in 2009.
EDITOR'S NOTE: Not only doctors are feeling the impact of the struggling economy on the facial aesthetics field. In this issue, Dermatology Times looks at the tightening market, including the business failure of Artes Medical, manufacturer of the permanent facial filler ArteFill. We also examine another permanent filler that, despite the downturn, is gearing up to seek U.S. approval. And check out our Web site (see our 360° Network link, To read about how derms are reacting to the failure of Artes Medical, visit http://www.dermatologytimes.com/reaction/) to read doctors' reactions to these developments.
National report - The bankruptcy of Artes Medical, maker of the permanent facial filler ArteFill, will make it harder for permanent fillers to enter the U.S. market in the future, analysts say - although one such product, Contura's Aquamid, will likely seek Food and Drug Administration (FDA) approval in 2009. (See story, "Testing the waters").
"Permanent fillers are a concept that has come and gone," says Wendy Lewis, president, Wendy Lewis & Co., Global Aesthetic Consultancy, New York.
Ms. Lewis also says the permanent filler business model never worked well for physicians, who seek return visits.
Artes officials did not return requests for comment, and the company's former public relations agency was unable to answer Dermatology Times' questions.
Not a surprise
The company's demise wasn't totally unexpected.
"Maybe the rate at which Artes went bankrupt was a surprise, but the fact that ArteFill never took off wasn't," says Peter Bye, senior analyst with New York-based Jefferies & Co.
Thanks to a particularly arduous approval process and backlash stemming from problems with ArteFill's predecessor formulation, ArteColl, Mr. Bye says, "They were in a deep hole when they started."
Still, he says, ArteFill's flameout will make it "very tough to get the next (permanent filler) approved and achieve any traction." No matter how strong future candidates are, he says, ArteFill has caused the FDA to "throw up a higher barrier" in terms of the approval process.
Other factors contributing to the ArteFill's failure include the economy and the "800-pound gorilla" created by California-based Allergan's 2005 purchase of Inamed, a maker of dermal fillers and breast implants, Mr. Bye adds.
"The economics of the dermal filler market got very crowded and deteriorated more rapidly than anyone would have imagined," he says.
For manufacturers, fillers are far less profitable than they were three years ago, he says, noting that the pricing of Restylane (hyaluronic acid, Medicis) has fallen at least 20 percent during that time.
"The only thing that's increased is marketing costs," Mr. Bye says. "That's not a great combination."