CHASKA, MN. January 12, 2000 -- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced that earlier today the Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee had voted not to approve Lifecore’s pre-market application (PMA) for its ferric hyaluronate product, INTERGEL® Adhesion Prevention Solution. The product is designed to reduce post-surgical adhesion formation after gynecological laparotomy procedures (traditional open surgery). In voting the product non-approvable, the Panel indicated that it did not accept the Company’s premise that the clinical trial data successfully demonstrated INTERGEL® Solution to be a safe and effective surgical adjuvant for reducing the incidence, extent, and severity of post-surgical adhesions. While disappointed with the Advisory panel vote, Lifecore President and CEO, Jim Bracke stated “we are actively discussing follow-up options with the FDA”. He indicated that the Company continues to believe in the potential opportunity for INTERGEL® Solution as an effective surgical adjuvant for the prevention of post-surgical adhesions. Lifecore will continue its ongoing process of expanding the number of new country registrations for the international distribution of the product. Lifecore’s marketing partner, Gynecare, a division of ETHICON, INC., has indicated that they will continue to work closely with Lifecore to help ensure that necessary data and other relevant information are submitted to satisfy FDA requirements. INTERGEL® Solution has been under evaluation in pivotal human clinical trials since March 1996. The current premarket approval application was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. A second clinical trial using laparoscopy (a less invasive, closed surgical procedure) is ongoing. Gynecare, a division of ETHICON, INC., currently markets Lifecore’s ferric hyaluronate outside the US in selected countries under the trademark, INTERGEL® Adhesion Prevention Solution. -----Original Message----- From: Sue Ann Murray <murraysa@penn.com> To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net> Date: Wednesday, January 26, 2000 12:00 AM Subject: Re: Warning on Propulsid
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>>Now can people understand just why it may have been in our best interest
>NOT
>>to have had the Intergel appproved by the FDA?? Better to be safe then
>sorry
>>and I sure don't want to have to know the first fatality in the event
>>something isn't ready to be be approved...let the experiments stay in the
>>research labs and not get out until things are ready to be used safely on
>>those who need them!
>>
>>If any of you still harbored any feelings against the FDA for not
approving
>>the Intergel...may those feelings be laid to rest with this announcement!
>>
>
> I understand what you're saying, but hasn't propulsid already been
>approved by the FDA? If not, how would it already be on the market?
> And while I'm not saying that intergel should be approved or not,
>specifically for the use of adhesion prevention, I can only speak from my
>experience and it did help me. And the non-approval of the intergel had
>nothing to do with its safety or anything like that, from what I've been
>told. "Sodium hyaluronate ("hyaluronate"), the chemical which is the base
>for intergel, is already approved for other medical uses. The approval
>lifecore was seeking this time was specifically for its use in pelvic
>surgery to prevent adhesions. If it doesn't get approved, it would simply
>mean that they can't sell it/advertise it for adhesion prevention (in this
>country), but could still market it for its other uses. The panel
>recommended against it (as I understand) because Lifecore hadn't done it's
>statistics correctly, according to FDA standards, so there wasn't
>statistical proof that it made any significant difference for the
prevention
>of adhesions. According to Dr. Wiseman, it was lifecore's problem, not the
>FDA'S. But intergel is way beyond the research lab stage. It has already
>been approved for use in Europe a couple of years ago so has passed
clinical
>trials there. It has already been through a laparotomy trial here in the
>US, (which are the results the FDA panel was looking at) and I don't know
if
>the laproscopic trial is done yet or not. I haven't gotten my copy of the
>results yet, in any case. I do believe the FDA has our best interests at
>heart. But even they aren't infallible. Keep in mind that once a drug
>(and I'm not sure if this works the same with a "device" like intergel) is
>approved, the FDA has no control over how doctors prescribe it. And even
>though they are not supposed to make any claims that haven't been tested,
it
>happens. Fenphen is a good example. The two individual drugs that made up
>fen -phen were both tested and approved separately. It was doctors who
>started putting them together, and that's when problems developed.
>