Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q
April 18 2011 - 11:54AM
Dow Jones News
Beckman Coulter Inc. (BEC) has pushed back the timeline for two
important U.S. regulatory filings, which the company needs to clear
a test for heart problems it recalled last year, to the third
quarter.
The company had long maintained that it expected to file Food
and Drug Administration applications for the so-called troponin
test in the first half this year. But citing progress in an ongoing
clinical trial, talks with the FDA plus internal compliance and
quality efforts, the company disclosed a delay to that timeline in
a filing with the Securities and Exchange Commission Monday.
Beckman is filing two applications two cover the test's use with
different systems.
The Orange County, Calif., company recalled the test in
question, which measures a protein that signals heart problems, due
to faulty results. Beckman last year also came under fire from the
FDA, which believed the company marketed that test without the
needed agency clearance.
Danaher Corp. (DHR), which is buying Beckman for $5.87 billion,
has said that Beckman's heart-test issues were a key area of focus.
Danaher Chief Executive H. Lawrence Culp Jr. said in February that
the test could get back on the market by year-end, although he also
said Danaher has "allowed ourselves a little bit of wiggle
room."
A Danaher spokesman could not be reached for immediate comment
Monday. The company in late March said it was extending its tender
offer to acquire all outstanding Beckman shares to April 27.
Beckman shares recently traded down 18 cents to $82.97, near the
planned take-over price of $83.50 per share. Danaher shares were
recently down 2.6% to $51.35.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
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