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

By Michael S. Rosenwald
Washington Post Staff Writer
Monday, January 3, 2005; Page E01

Human Genome Sciences Inc. will learn this year whether it can move any of three drugs into the final stage of human testing that is required before regulators would allow them to be sold to the public.

MedImmune Inc. is counting on positive test results on an improved version of FluMist, its inhaled flu vaccine that didn't catch on in the marketplace.

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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Supermarkets, Eager to Grow, Set Sights on Northern Virginia (The Washington Post, Jan 3, 2005)
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Metro Business: Coverage of Washington area businesses and the local economy.
_____Biotech Headlines_____
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And Digene Corp. plans to hire about 40 salespeople and launch an advertising campaign to increase use of its cervical cancer test before a drug industry giant launches a competing product.

These Washington area biotech companies and others will face pivotal moments in their development this year, finding out whether key products work before money dries up, fending off competition from bigger companies, repositioning products that stumbled and, in at least one case, perhaps filing to go public.

The confluence of events underscores that some of the area's biotech companies are moving beyond the research lab and into the business of selling products.

"To me, this year is a great indication that this community is maturing," said John Holladay, the founder of EntreMed Inc., who recently opened a bank to serve the area's biotech sector. "We've reached an age of growth."

The situation also comes with peril: Products could fail, competitors could catch up, investors could flee.

It's a lesson Human Genome Sciences Inc. already has learned.

The Rockville company, once a bellwether for Maryland biotech, has an experienced drug development chief from industry giant Genentech, a vast genomics database, and a billion bucks in the bank. But two of its drugs have failed in tests. The company's stock, which sold for $69.03 a share four years ago, closed at $12.02 on Friday.

This year, Human Genome may for the first time complete the small-scale testing on hundreds of patients that initially gauges the safety and effectiveness of new drugs. That would qualify the drugs for the final tests on thousands of people that the Food and Drug Administration requires for approval. Only 33 percent of drugs make it from small-scale testing to the final round, according to the FDA.

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