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DewDiligence

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DewDiligence

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Wednesday, 09/21/2005 4:17:05 PM

Wednesday, September 21, 2005 4:17:05 PM

Post# of 251706
Inamed breast implants get conditional FDA OK

[In the business press, “Conditional approval” or “Conditional OK” are often misused when a company receives an Approvable Letter, as IMDC just did. It’s not surprising that IMDC has reached this stage—their main competitor, MNT, got approval for *their* silicone implants a few months ago and there is not much difference between the two products. When the same FDA advisory panel gave thumbs-up to MNT and thumbs-down to IMDC, it was a clearly preposterous outcome and an indication of just how poorly run some of these advisory panels can be.

A side point is that MRX's pending acquisition of IMDC should now go through without a hitch.]

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh64170_2005-09-21_19-40-51_n21...

>>
Wed Sep 21, 2005 03:40 PM ET

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 ) to sell its version if it meets certain requirements.

The move puts Inamed on par with rival Mentor Corp. ( MNT ) , 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.

Studies have shown the implants can cause scarring and other painful complications but have not definitively linked them to any diseases.

Women's groups and other critics have called for more data on how often silicone implants break or leak and urged the FDA to postpone any final decision.

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.

Diana Zuckerman, president of the National Research Center for Women & Families, said removing the 153 model from the data left little information to prove the devices are safe.

"It's a clear indication that FDA is making decisions that have nothing to do with science or health," she added.

National Women's Health Network Policy Director Amy Allina said Inamed's revised data should be made public.

"Given the agency's track record over the last couple of years, I have to say I don't trust them to exercise the kind of judgement [sic] that is needed to protect women's health," she said.

FDA officials said federal law prevented disclosure of its conditions for Inamed, but the company said they were similar to those discussed at FDA advisory panel meetings in 2003 and last April. At those meetings, panelists said they wanted more safety information.

"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.

Wednesday's news sent Inamed shares up $6.61, or 9.3 percent, to $77.67 in late-afternoon trade on the Nasdaq stock market. Shares of Medicis Pharmaceutical Corp. ( MRX ) , which is buying Inamed, were up $1.89, or 5.79 percent, at $34.54 on the New York Stock Exchange (NYSE).

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 approval would add $70 million next year to the overall breast implant market, which is expected to top $400 million.

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 $1.98, or 3.73 percent, to $50.60 on the NYSE.
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