Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
San Francisco Chronicle - Thursday, November 22, 2001
Tom Abate, Chronicle Staff Writer
Before yesterday's announcement, Chiron had spent nearly two years testing the experimental compound on 2,000 patients afflicted with sepsis, a condition in which the immune system overreacts to an infection, causing blood clots that can lead to death in 30 to 50 percent of cases.
Yesterday morning, Chiron reported that its clinical study, ironically code- named Optimist, failed to show that patients who took the experimental medicine had a better survival rate after 28 days than those patients who took a placebo.
Chiron shares fell $4.50 on the news to end the day at $45.56.
"It didn't work," Chiron Chief Financial Officer Jim Sulat said. "It's always discouraging when you come to a Phase III trial and a drug fails, but sepsis is a tough condition to beat."
Indeed, sepsis has turned out to be such a complex condition that many companies over the years have failed to develop successful treatments. In a happy coincidence for patients, however, one of Chiron's rivals finally succeeded yesterday.
The U.S. Food and Drug Administration gave final approval yesterday to a competing sepsis treatment called Xigris, developed by the Indianapolis drugmaker Eli Lily. The FDA said Xigris reduced death rates 13 percent for the most severly ill sepsis patients.
A Chiron spokesman said the company would study the data from its failed clinical trial before deciding whether to craft a new experiment or scrub the project. Financial analysts, however, seemed to have already written off the project.
Merrill Lynch analyst Eric Hecht issued a statement saying that he hadn't had "high expectations" that the drug would work, and had not factored it into earnings models that postulate a 17 percent growth rate for Chiron earnings.
Instead, analysts expect that Chiron earnings will be driven by a new blood screening test. Chiron's nucleic acid test (NAT) is designed to detect particles of HIV and hepatitis C in donated blood earlier and with greater sensitivity than current tests. FDA approval is expected soon.
Anticipation of the FDA's approval of the NAT test, along with some successes in Chiron's European vaccine business, have made Chiron one of the stars in a year that has been tough on biotech stocks.
Year to date, Chiron stock is up 1 percent, compared with a decline of nearly 50 percent in the American Stock Exchange biotech index, a basket of 17 leading biotech companies. Shares of Genentech, the Bay Area's other biotech giant, have slid 16 percent so far this year.
In other biotech news, Dublin's SuperGen Inc. won FDA approval yesterday to sell daunorubicin, a generic chemotherapy treatment for leukemia.
SuperGen already sells two other generic chemotherapy agents, Nipent and mitomycin. Robert Cohen, SuperGen's vice president for investor relations, said the company has Phase III clinical trials under way on two novel anti- cancer treatments, Rubitecan and Decitabine, but final results from those experiments are not due for many months.
SuperGen shares, which had been climbing in recent weeks, slid yesterday 41 cents to $12.61.
E-mail Tom Abate at tabate@sfchronicle.com.
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