US FDA dispute panel backs LifeCore surgical gel
By Lisa Richwine
GAITHERSBURG, Md., Sept. 6 (Reuters) - A dispute resolution panel on Thursday ruled in favor of LifeCore Biomedical Inc.<LCBM.O> surgical gel for women, unanimously urging regulators to approve a product they rejected last year.
The vote, the panel's first ever, was a victory for the small medical device maker, which was dealt a setback in November 2000 when the Food and Drug Administration turned down the surgical solution called Gynecare Intergel.
The agency said it was not convinced the product reduced potentially troublesome adhesions after gynecological surgery and expressed concerns about infection risks.
Now, the panel recommendation will go to Dr. David Feigal, head of the FDA's center that reviews devices. Feigal is expected to decide within about six weeks whether to approve Intergel for sale in the United States.
At the panel meeting, the company and the FDA clashed over what was the proper statistical analysis of a study conducted in the United States and Europe. LifeCore presented a series of experts it hired who said the company's conclusions were statistically sound, and panel members said all their concerns were addressed.
"It was clear the LifeCore presentation was compelling to the panel, both in the way they presented evidence and the strength of the evidence," said Scott Ramsey, the panel's acting chairman and an internist at the University of Washington in Seattle.
The meeting was the first test of the dispute resolution panel, which was set up under a 1997 FDA reform law to give medical device makers a way to challenge product rejections.
Jim Bracke, LifeCore's chief executive and president, said the panel was the last resort for getting the product into the large U.S. market. "I think the process worked ... We had been a victim of the system, but we are not a victim anymore," Bracke told reporters.
Bracke said Intergel, already sold in about two dozen countries, could have U.S. sales of hundreds of millions of dollars if approved. LifeCore has a co-marketing agreement with Johnson & Johnson <JNJ.N>.
Lee Schafer, an analyst with Bluefire Research, said he expected Feigal to follow the panel recommendation and estimated U.S. sales of about $18 million by mid-2003, making it the Chaska, Minnesota-based company's top-selling product.
"It's vindication for them. They took an enormous amount of criticism" from investors after an FDA advisory panel urged against approval in January 2000, said Schafer, who has an "outperform" rating on LifeCore stock.
About 3 million women annually have open gynecological surgeries, and between 60 and 90 percent develop post-surgical adhesions, LifeCore said. The adhesions, scar tissue that binds normally separate body parts, can be painful and can cause infertility or bowel obstructions.
Surgeons use the gel, which has a consistency similar to motor oil, by squirting it into the body as they finish surgery. Several physicians said it is much easier to use than other products now on the market.
Richard Kotz, an FDA statistician, said patients in Europe and the United States started with different levels of adhesions and other disparities, which meant their results should not be combined for analysis.
When looking only at U.S. patients, "it is clear there is very little difference between Intergel and control" in reducing adhesions, Kotz told the panel. Another FDA reviewer said rates of infections appeared higher in patients treated with Intergel.
Trading of LifeCore shares was halted during the panel meeting.
18:52 09-06-01 |
