Pharmacyclics drug questioned
By Debra McGarry, CBS Marketwatch
Last Update: 10:34 PM ET Jul 22, 2000
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SUNNYVALE, Calif. (CBS.MW) -- Pharmacyclics plans to ask for regulatory approval from the Food and Drug Administration of its cancer drug Xcytrin by late next year.
While there is huge potential for the drug, some researchers are questioning its effectiveness, according to a report in Barron's.
Xcytrin was developed to improve radiation therapy's effects and is now being studied for how the substance works in brain-cancer patients. The drug is in its final phase of human trials.
Critics contend that Pharmacyclics (PCYC: news, msgs) hasn't fully substantiated its scientific findings.
An article describing how Xcytrin works was just rejected for publication by a prestigious academic journal, according to the Barron's report.
The company is racking up losses, which have widened amid rising costs. The company, however, is expected to be profitable by 2002, according to Morgan Stanley's health care analyst Douglas Lind.
Lind estimates that Xcytrin might sell for $3,000 per patient per year. If the drug were approved for brain-cancer treatment, the company could immediately capture 4 percent
of the radiation-therapy market, giving it sales of $84 million, the article said.
But academic researchers are questioning the drug's effectiveness, Barron's said. Four academic cancer research institutions tried to duplicate the company's promising results. But each concluded independently that the drug didn't work, according to the article.
"We didn't see anything," said the University of Pennsylvania's Dr. Eric Bernhard. "It didn't work. I don't know how the company got their results."
"Under no circumstances was there any evidence that this showed any sensitization to radiation," said Dr. Martin Brown, chief of the Department of Radiological Oncology at
Stanford. "It was inactive."
The company said the outside researchers didn't know how to use the drug.
Shares of Pharmacyclics closed down 3 3/4 Friday at 68 7/8.
Debra McGarry is a reporter for CBS.MarketWatch.com. |
