UPDATE 3-Inamed breast implants get conditional FDA OK
Wed Sep 21, 2005 11:51 AM ET
(Adds FDA, analyst comments, byline; updates share prices)
By Susan Heavey
WASHINGTON, Sept 21 (Reuters) - U.S. regulators granted conditional approval to a second maker of silicone gel-filled breast implants on Wednesday, allowing Inamed Corp. (IMDC.O: Quote, Profile, Research) to sell its version if it meets certain requirements.
The move puts Inamed on par with rival Mentor Corp. (MNT.N: Quote, Profile, Research) , which received similar approval in July, and signals the impending return of the controversial implants to the U.S. market after a 13-year restriction.
In 1992, the Food and Drug Administration limited sales to breast cancer survivors and others needing reconstruction or implant replacements amid concerns that leaking implants could cause long-term, disabling diseases such as lupus or rheumatoid arthritis.
Analysts said final FDA approval could come by the end of 2005 or the first quarter of 2006.
Jayson Bedford of Adams Harkness Inc. said final approval would add $70 million next year to the overall breast implant market, which is expected to top $400 million.
Wednesday's news sent Inamed shares up $5.95, or 8.4 percent, to $77.01 in late-morning trade on the Nasdaq stock market.
Shares of Medicis Pharmaceutical Corp. (MRX.N: Quote, Profile, Research) , which is buying Inamed, were up $1.40, or 4.3 percent, at $34.05 on the New York Stock Exchange.
CIBC World Markets analyst John Calcagnini said Inamed's approval would boost its profits, but the pending merger could disrupt sales staff. "Mentor continues to gain market share," he added.
Mentor shares fell $2.33, or 4.4 percent, $50.23 on the New York Stock Exchange.
In April, an FDA advisory panel narrowly voted against recommending the lifting of sales restrictions on Inamed's implants but urged approval for similar implants from Mentor.
"Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel. Inamed has also said that it will no longer make available Style 153, which raised particular safety issues for the panel," the FDA said in a statement.
Women's groups and other critics have called for more data on how often silicone implants break or leak.
The FDA said federal law prevented it from disclosing the requirements imposed on Inamed as a condition of approval, but the company said they were in line with its expectations and discussions at FDA advisory panel meetings in 2003 and last April. It said it would work with the FDA to address them.
"We respect the thoroughness of the FDA review process and are pleased with this decision," said a statement by Nick Teti, Inamed chairman, president and chief executive.