Re: Use of Intergel or SprayGel with Laparoscopy
From: Dr. David Wiseman (david.wiseman@medispecialty.com)
Fri Mar 28 06:09:41 2003
The reason why in the US Intergel is not approved for laparoscopy is an
FDA one - FDA regards laparotomy and laparoscopy as two different
indications and requires clinical trials for both.
I believe that the makers of the product did consult a trial (perhaps
two) for laparoscopy, but it failed to convince the FDA.
In any event there was an announcement yesterday that Intergel had been
voluntarily withdrawn from the market. See below.
GYNECARE Voluntarily Suspends Marketing and Sales of Anti-Adhesion
Product Pending Evaluation of Postmarketing Events
Business Editors/Health/Medical Writers
CHASKA, Minn.--(BUSINESS WIRE)--March 27, 2003--LIFECORE BIOMEDICAL,
INC. (Nasdaq:LCBM) announced today that GYNECARE has voluntarily
suspended global marketing and sales of Lifecore's ferric hyaluronan
adhesion prevention product, GYNECARE INTERGEL(a) Adhesion Prevention
Solution ("INTERGEL Solution") and is voluntarily withdrawing the
product from the market in order to assess information obtained from
postmarketing experience with the device. The assessment will include a
review of technical issues, surgical techniques, and circumstances
associated with the postmarketing events, including reports from
off-label use. Since the launch of the product in August of 1998 to
February 2003, the worldwide complaint rate has been 0.29 percent of
units sold. The contribution of the device to these events is unknown.
Lifecore currently expects that such review will be conducted
expeditiously and that the product will return to the market following
completion of the review and implementation of any appropriate action.
INTERGEL Solution revenues accounted for 12 percent of Lifecore total
revenues in fiscal year 2002 and have accounted for less than 10 percent
of revenues in the current fiscal year. Terms of the Supply Agreement
require payment for outstanding firm purchase orders which is expected
to result in INTERGEL Solution revenue to Lifecore of approximately
$1,100,000 for the quarter ending June 2003. Lifecore currently expects
to reduce production levels during the quarter ending June 2003 which
will result in unused manufacturing capacity charges of approximately
$1,300,000.
Certain statements in this release are forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995.
Statements implying the successful outcome of the review of INTERGEL
Solution post-marketing experience, the accuracy of the expected
financial impact, or the likelihood of reintroduction and subsequent
marketing success are subject to change. Because of numerous risks and
uncertainties in the complex regulatory and competitive aspects of
Lifecore's business activity, actual results may differ materially from
those implied. Investors are strongly cautioned to review more detailed
discussions of those risks as presented in the Company's reports on
Forms 10-Q and 10-K.
Lifecore Biomedical develops, manufactures, and markets biomaterials and
medical devices for use in various surgical markets.
Additional general corporate information is available on the Internet at
http://www.lifecore.com.
Lifecore Biomedical's conference call will begin today at 4:00 PM,
Thursday, March 27, 2003. The replay will begin shortly after the
completion of the live call. To access the telephone replay, call (719)
457-0820.
(a) Trademark of ETHICON, INC.
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