FDA OKs wider use of Guilford's Gliadel

Cancer wafer may give local firm needed boost

February 27, 2003|By Julie Bell | Julie Bell,SUN STAFF

Guilford Pharmaceuticals Inc. said yesterday that the Food and Drug Administration approved the use of its Gliadel wafer as a first-time treatment for malignant brain tumors, handing the Baltimore company a major victory after a series of hard-luck rejections that had shaken the faith of investors.

The ruling, which came 11 months after the FDA had turned down the company's initial application for expanded use, will allow Guilford to market Gliadel to newly diagnosed brain cancer patients - a population that makes up at least two-thirds of the limited market for the treatment. Gliadel previously was approved only for patients whose brain tumors had recurred.

"It's certainly long-needed good news," Chairman and Chief Executive Officer Craig R. Smith, a physician, said yesterday in an interview. "It's personally rewarding because you can't get the doctor out of me: I know what this is going to mean for brain-cancer patients."

The money-losing company also expects to be rewarded by increased revenue. Last year, Guilford sold about $14.5 million worth of Gliadel, its only product on the market. But Smith now expects the company to sell $20 million to $25 million of the treatment this year. Sales could rise to $40 million to $60 million in future years, he said.

Gliadel is a dime-size wafer containing a chemotherapy drug. Up to eight of the wafers can be implanted during surgery in the cavity left when a particularly aggressive kind of brain tumor, known as malignant glioma, is removed. As the wafers dissolve over two to three weeks, they release the drug.

About 4,000 U.S. patients have surgery each year for recurrent malignant glioma, but 8,000 to 12,000 have initial surgeries.

Though doctors can legally prescribe any drug that's on the market for whatever use they see fit, neurosurgeons shied away from using Gliadel in initial surgeries after the FDA specifically rejected it for that use last year, Smith said.

Until now, the treatment was used in only several hundred initial surgeries each year.

The approval was cause for celebration at Guilford, which has weathered far more than the FDA rejection in the past 20 months.

Its woes began in July 2001, when Guilford announced its Parkinson's disease treatment - licensed to Amgen Inc. - did not reverse motor symptoms of patients enrolled in a clinical trial. Amgen gave up, returning the rights to that drug and an entire family of similar nerve-regeneration molecules to Guilford in September 2001.

Then came the FDA's March 2002 decision to reject expanded use of Gliadel. In July, the company was forced to narrow its research focus to save money and lay off 60 employees, or about 20 percent of its work force.

And its efforts to find a buyer for some uses of its nerve-protectant drugs, known as Naaladase inhibitors, ran into roadblocks.

The company's shares went from a high of $28.21 on July 2, 2001, to a low of $2.76 this month. They gained 5 cents yesterday to close at $3.43 on the Nasdaq stock market.

Following the FDA rejection, Guilford submitted additional data showing that patients' long-term survival was improved when Gliadel was used in their initial surgeries. It was enough to change the agency's mind, and by Tuesday afternoon Guilford's elated head of regulatory affairs, Louise Peltier, was telling Smith via cell phone the good news: "We've got it," she said.

"I've always tried to maintain an even keel. At the same time, I'm a human," Smith said yesterday. "At times I felt the weight of the world on my shoulders."

But not yesterday.

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