Gliadel, Guilford Pharmaceuticals Corp.'s chemotherapy-packed wafer, benefits patients who receive it during initial surgery for brain cancer, an expert panel that makes recommendations to the Food and Drug Administration found yesterday.
The $10,500 surgically implanted wafer currently is approved for use only with a certain kind of aggressive brain tumor that has recurred, requiring a second surgery. FDA approval of its use in initial surgeries would roughly triple the market for Gliadel, which generated nearly all of Guilford's $5.9 million in third-quarter revenue.
The panel, however, was divided in its finding, voting 8-5 that Gliadel helped patients.
But in a separate vote, it also decided that the company's one clinical trial, which showed patients receiving the wafer lived an additional 2.3 months, was not "adequate."
Gliadel is implanted in the cavity left after a tumor has been removed. As its outer coating slowly dissolves, it releases the anti-cancer drug carmustine.
"The strength of evidence is kind of borderline, which puts me solidly on the fence," said Stephen George, biostatistics professor at Duke University and a panel member. The FDA usually takes the advice of its expert panels.
The agency's staff will now weigh the panel members' comments and decide whether to grant expanded use, said Robert Temple, the FDA's associate director of medical policy.
Guilford Chief Executive Officer Craig Smith said he doesn't believe that the agency will ask the company to do additional clinical trials. But, he said, "they might seek additional analysis" of data Guilford already has.
"We feel very good about it," he said after yesterday's vote. But, he said, "It's not over until the agency's approval letter shows up at the office."
Shares of Guilford rose 81 cents to $12.75 yesterday on the Nasdaq stock market before trading of the stock was halted about 12:50 p.m. pending the outcome of yesterday afternoon's Oncologic Drugs Advisory Committee meeting.
Up to 12,000 patients a year have initial surgeries for glioblastoma multiforme, as the aggressive cancer is known. About 3,500 have surgeries for it when it recurs.
The vote came near the end of a year that analyst Brian Rye of Raymond James described as "tough" for the company.
Guilford learned in September that Amgen Inc. was terminating a deal under which it had paid Guilford for the rights to an entire family of nerve regeneration drugs.
The Thousand Oaks, Calif., biotechnology company made the decision after the lead drug in the family, known as NIL-A, failed to reverse motor symptoms in Parkinson's disease patients as hoped. Guilford has said it will develop the drugs itself.
The company turned its attention to getting the uses of Gliadel expanded, but it was forced to wait after the oncologic drugs committee canceled the scheduled discussion of Guilford's drug on Sept. 11, due to concern over the terrorist attacks.
Then, in late November, UBS Warburg analyst Andrew Gitkin downgraded shares of Guilford to "hold," writing that the stock - already down 62 percent from its six-month high - was trading at too high a price, given the negative developments.
He also wrote in his Nov. 28 research report that he was concerned, Gliadel aside, that the company would have few visible signs of progress in its pipeline of experimental therapies until mid-2002.
Bloomberg News contributed to this article.