Wichtige, eilige Frage

"We are confident in Pleconaril's ability to help these patients," said Claude Nash, the company's chief executive, in a statement. He said the company plans to maintain its schedule to file for regulatory approval to market the drug as a treatment for viral respiratory infection.

Pleconaril also did not substantially best placebos in treating children with viral meningitis, the company said. The schedule for filing for regulatory approval to treat viral meningitis may be revised, Nash said.

The drug, developed by scientists who experimented with 1,500 versions before beginning human testing, is intended to block 169 different viruses. It inhibits the function of the picornavirus capsid, a protective protein shell that surrounds viruses, enabling them to infect humans and to be transmitted between them. The drug attacks a site on the capsid common to rhinoviruses and enteroviruses.

Both are versions of a larger class, the picornavirus. The Food and Drug Administration sets strict guidelines for testing any product claiming to cure or relieve enterovirus infections, including colds, because they are known to spontaneously vanish on their own.

As ViroPharma has labored to create the drug, the company's shares have ridden a wave of stock market enthusiasm for biotechnology companies.

According to ViroPharma's most recent filings with the Securities and Exchange Commission, the company has never made any revenues, depending on cash raised in the debt and equity markets to finance its research operations.

That research, devoted primarily to developing Pleconaril, has caused a cumulative net loss of $67.1 million through Sept. 30, 1999.

Since a wave of publicity in January, when the firm Strategic Research Institute began promoting the drug as the centerpiece of a March medical conference, investors have poured money into the company's stock, buying into a business plan that depended on little other than Pleconaril.

The company's stock traded for less than $40 a share until the middle of January.

In a Jan. 25 news release, Strategic Research said the drug "excited the scientific community by demonstrating efficacy in the common cold as well as neonatal sepsis, myocardis, enterovirus infected inpatients with severe combined immunodeficiency and vaccine-acquired polio."

Doctors who have tested the drug on patients added to the excitement. "This is the cure for the common cold," Dr. Jose Romero, of Creighton University in Omaha, Neb., told the Los Angeles Times in an article published on Jan. 24.

Analysts said the results released Tuesday were not catastrophic, adding that the drug could easily be approved to treat many of the ills the company said it might.

After a conference call with company officials on Tuesday, Wall Street analysts said ViroPharma would have to rethink its plans to market the drug as a treatment for viral meningitis. Mark Augustine, an analyst for U.S. Bancorp Piper Jaffrey, said the company would have to decide "where they go from here in viral meningitis."

But experiments have shown the drug successful in treating influenza, and the drug can still be approved for a variety of uses, Augustine said. "Pleconaril has shown demonstrable biological effects and the company must now demonstrate clinical effects," he added.

"They're going to have to carefully craft the next set of clinical studies," said Augustine. The analyst lowered his rating from strong buy to buy based on the news. His firm co-managed a secondary stock offering for ViroPharma in October 1999 and co-managed a debt offering in February.

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