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It's Crunch Time for Companies With Products in the Pipeline

"This one trial is very important for the future of the company," said Edward M. Rudnic, chief executive of Advancis. If the results from the amoxicillin testing are poor, he said, "I would think we would have to completely evaluate our operations. I wouldn't want to go into more detail than that."

The wild card for all drug companies this year is whether the pace of drug testing and approvals will slow because of increased pressure on the Food and Drug Administration to strengthen safety requirements after recent problems with several painkillers already on the market. An FDA spokeswoman said the agency would continue to review drug applications as it has in the past under time limits set by legislation.

MedImmune hopes to sell an improved version of its nasal-spray flu vaccine. (Jim Graham For The Washington Post)

Biotech Challenges 2005 could be a key year for a number of Washington area biotechnology companies.
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In October, a week after drug giant Merck pulled its painkiller Vioxx off the market, the agency asked GenVec Inc. of Gaithersburg to stop testing its lead product, TNFerade, a therapy for esophageal and pancreatic cancer, because a patient in the esophogeal cancer test died during the study.

An FDA official deferred comment to the company. Jeffrey Church, GenVec's chief financial officer, said company officials have been working closely with the FDA, providing extensive data from the study, and "we're hopeful that we will get the clinical hold lifted in short order."

Hittle, the analyst, said the question is how quickly the FDA will move. "Sorting things out always takes longer than expected," he said.

GenVec has several other products in early development, including treatments for coronary artery disease and for age-related macular degeneration, a disease of the eyes.

MedImmune Inc. is in a different position. The Gaithersburg firm already has several drugs on the market, including its most successful product Synagis, which treats some viral infections in babies. But it's had disappointing sales results from FluMist, its inhaled flu vaccine.

FluMist, which uses a live virus, is approved only for people ages 5 through 49. It also must be stored in a freezer, a cumbersome process for many doctors and pharmacies. MedImmune launched FluMist in 2003, producing 4 million doses. It sold fewer than 500,000.

Last year, the company cut back production, then was able to come up with only 3 million doses when the national shortage of flu shots developed.

MedImmune chief executive David M. Mott is sticking with his plan to launch an improved version of FluMist in 2007 that could be sold more broadly and handled more easily. But that timetable would require success this year in trials intended to show that the vaccine is better than a flu shot for children younger than 5 and that a refrigerated version works as well as the frozen form.

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