The Wall Street Journal - October 15, 1999
Ron Winslow, Staff Reporter of the Wall Street Journal

The drug, one of a class of compounds called nucleoside reverse transcriptase inhibitors, was being tested in a so-called phase II study at three different doses and in combination with two other AIDS medications that are already on the market.

The biotechnology company, based in West Conshohocken, Pa., had hoped to demonstrate, among other things, that lodenosine would prove effective in delaying or preventing the ability of HIV, the virus that causes AIDS, to develop resistance to various medications used to combat the disease.

The decision to suspend the trial follows by three weeks the announcement that MedImmune Inc., Gaithersburg, Md., agreed to acquire U.S. Bioscience in a stock swap valued at $40 million. Representatives for both companies said the developments in the lodenosine trial wouldn't affect the transaction.

Nevertheless, MedImmune stock fell by $6.0625, or 5.2%, to $110.5625 in Nasdaq Stock Market trading. U.S. Bioscience fell 75 cents, or 4.7%, to $15.125 in American Stock Exchange composite trading.

The company said 209 patients were enrolled in the randomized trial, including 176 who had been given lodenosine. Other drugs involved in the trial included Merck & Co.'s Crixivan, a protease inhibitor, and Bristol-Myers Squibb Corp.'s Zerit, which is in the same class as lodenosine. Lodenosine treatment has been discontinued for all patients, the company said.

Ellen Evans, senior director, business development and new-product planning at U.S. Bioscience, said the company would review a variety of data on the study before deciding in conjunction with the Food and Drug Administration whether to resume or permanently halt the trial. She said the company had reported favorable preliminary results from the trial based on 66 patients at a scientific meeting last month in San Francisco. The apparent problems with the medicine arose after the presentation of those data, she said.

The company said the patient who died was getting lodenosine and not a placebo. He died Monday afternoon of liver failure. Though it isn't certain the drug was implicated, the death, and evidence of liver and kidney damage in a few other patients, led to the decision on Wednesday to suspend the study, after consultation with the FDA, the company added.

Lori A. Weiman, a spokeswoman for MedImmune, said lodenosine wasn't a significant factor in her company's interest in acquiring U.S. Bioscience. MedImmune is primarily attracted to U.S. Bioscience's cancer-product pipeline, including a drug recently approved by the FDA for treatment of dry mouth in head-cancer and neck-cancer patients who undergo radiation treatment. "We currently plan on moving forward [with the transaction] as previously announced," Ms. Weiman said.

A U.S. Bioscience spokesman said both companies hope to close the deal by the end of the year.
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