Key Lifecore product wins FDA nod on second try
Terry Fiedler
Star Tribune
Published Sep 7 2001
More than a year and a half after a devastating setback,
Lifecore Biomedical Inc. got redemption from a Food and
Drug Administration panel Thursday, which recommended
approval of Lifecore's most promising product, a gynecological
surgical gel meant to forestall the development of painful
internal scarring.
The unanimous decision was the first ever by the Medical
Devices Dispute Resolution Panel, created in 1997 to allow
companies to challenge FDA product rejections.
The next step before final approval for the product to be sold
domestically will be an FDA review. The FDA normally
follows the recommendations of its panels of experts.
The panel decision is 'vindication for Lifecore, good for
patients and it's good for medical device companies, which
have another pathway to get approved,' said U.S. Bancorp
Piper Jaffray analyst Thomas Gunderson.
Gunderson estimated that Lifecore's product, Intergel, can
become the dominant product in the $500 million U.S. market
for products that address adhesions resulting from
gynecological surgery. He expected FDA approval for the
product within 30 to 60 days and a U.S. product launch by the
start of next year.
'We are very pleased with the outcome of the dispute resolution
process,' said CEO Jim Bracke. 'Our belief that the underlying
issues in this dispute were the result of a misunderstanding of
the complex clinical dataset proved correct.'
The stock market didn't have a chance to respond to the news
because trading in Lifecore shares was halted during the day
because of the pending decision. The stock began Thursday at
$5.90 a share.
On Jan. 13, 2000, the Chaska-based company endured a nearly
60 percent drop in its stock, from $22.25 to $9.50, after an
FDA panel rejected the company's plans to sell Intergel
domestically. The panel said evidence of the product's
effectiveness was unconvincing.
At the time, Bracke called the decision a 'tremendous travesty
of the process.' The FDA echoed the panel by rejecting plans to
market Intergel in the United States.
Intergel has been in development since 1989 and is meant to
promote the healing of wounds created in abdominal surgeries,
such as those on ovaries and fallopian tubes. Left to themselves,
the wounds can heal improperly, causing internal scars called
adhesions that can be painful and lead to infertility or bowel
obstructions.
The company's data suggested that the use of Intergel resulted
in a significant decrease in the number of surgery patients who
developed adhesions compared with those given a placebo.
Lifecore makes other biomaterial and surgical products,
recording revenue of $34.1 million and a loss of $3.7 million for
the 12 months ended March 31. Intergel has been the focus of
most investor interest in the company because of its growth
potential.
Johnson & Johnson distributes Intergel in Europe and plans to
handle domestic distribution as well.
-- Terry Fiedler is at tfiedler@startribune.com .
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