FDA panel OKs a limited use of Gliadel Guilford stock falls after advisory action on brain cancer wafer

Marketing accord reached

Committee proposes drug be restricted to the most severe cases

June 15, 1996|By Mark Guidera | Mark Guidera,SUN STAFF

A Food and Drug Administration advisory panel yesterday recommended that Guilford Pharmaceutical's Gliadel wafer for treating brain cancer be approved for marketing, but that its use be restricted to patients with the most severe and aggressive form of brain cancer.

The FDA usually, but not always, follows the recommendations of its advisory panels.

The recommendation for a restricted use for Gliadel sent shares of Guilford into a tailspin yesterday. They dropped almost 20 percent from Thursday's close to finish at $27.875 in very heavy trading.

More than 2.8 million shares -- about 27 percent of the company's outstanding shares -- traded hands as jittery institutional investors dumped the Baltimore-based company's stock. For the day, Guilford was down $6.875.

In a related development yesterday, Guilford announced that it has struck a marketing agreement with Rhone-Poulenc Rorer that gives the Collegeville, Pa., drug giant the rights to sell Gliadel worldwide, except in Scandinavian countries. The deal could be worth more than $60 million to Guilford, not counting royalties, if it can get additional regulatory approvals for Gliadel in Europe, Japan and the United States.

The deal with Rhone-Poulenc was announced before the market opened, and by 9: 30 a.m. yesterday, Guilford's shares had hit a 12-month high of $37.75.

Guilford had hoped -- and investors had bet -- that the FDA's eight-member Oncologic Drugs Advisory Committee would recommend that the nickel-sized wafer, which allows a potent chemotherapy drug to be placed directly at the site of a removed tumor, be approved for much wider marketing in the United States. The company argued the wafer is an effective treatment in conjunction with surgery for different kinds of brain cancer.

Specifically, the FDA panel, in a 7-1 vote, said it thought Gliadel should be approved to treat patients who experience a recurrence of what is known medically as malignant glioblastoma multiforme, a common and fast-growing form of brain cancer.

The panel also said it thought the wafer should be used by surgeons only after they had operated to remove a tumor, and that an operation not take place only to implant the wafers. On average, about eight wafers are implanted at the time of an operation.

The advisory panel was deeply split over whether human trials of the drug in the United States and Europe showed that Gliadel provided any significant improvement in prolonging the life of patients.

Some panel members said it appeared that the wafer only lengthened a brain cancer patient's life by an average of one to two months over the one-year median survival rate.

Guilford's chance to have Gliadel approved for treating all types of malignant brain tumors was lost early in the day on a 4-4 vote.

Some panel members argued that the data presented did not clearly show a statistically significant benefit for treating all types of brain cancer, though they widely agreed the data suggested improvement in the outlook for those with the worst type of brain cancer.

However, Dr. Paul Bunn, the panel chairman and the director of the University of Colorado Cancer Center, said he was persuaded by the consistency of the trial data that Gliadel helped patients survive longer.

He argued that similar studies of survival rates done on brain cancer patients treated with chemotherapy administered intravenously showed similar survival rates.

"So if it's reasonable to offer IV treatment, it should be reasonable to offer the Gliadel treatment," he said. "We have so little to offer these patients anyway."

Dr. Richard Schilsky, a consultant to the panel and the director of the University of Chicago Cancer Research Center, said he believed Gliadel appeared to offer a safe, new treatment for brain cancer.

"I think if you were to offer a patient a choice between the IV and the wafer, most would choose the wafer," he told the panel. "It's less toxic than systemic chemotherapy, and it would save the patients trips in to see the oncologist for the IV treatments."

Despite the panel's recommendation that Gliadel be approved for limited cases, Dr. Craig Smith, Guilford chief executive officer, and officials at Rhone-Poulenc said they were pleased with the panel recommendation.

"We anticipated something like this might occur," said Smith. "Still, this is a major turning point for us. For a small biotechnology company to get its first product approval in just 2 1/2 years, I think really says something about our company and its future."

Guilford, he said, would immediately begin planning to launch a new patient study to collect more data on Gliadel with the goal of getting approval to market the wafer as a treatment for a much wider pool of brain cancer patients.

Robert Pearson, a spokesman for Rhone-Poulenc, said the company was pleased with the FDA recommendation and believes Guilford has the technology to develop new ways to deliver drugs to cancer sites.

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