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Human Genome Sciences suffers setback

Maryland-based Human Genome Sciences said yesterday it did not expect its hepatitis C drug Zalbin to be approved by the FDA.

Feedback from the Food and Drug Administration on its current Biologics License Application for the treatment “expressed concerns regarding the risk benefit” of the proposed dose regime, said the company. Novartis, the partner of Human Genome Science on this drug, withdrew a European licensing application in April.

The staff at Human Genome Sciences might be hoping for a period of quiet following this latest news. The company filed an application for a lupus drug it is developing with GSK last week, prompting positive coverage. But before that it announced that a cancer drug it is working on appeared to have failed in phase two trials. As you might expect a graph of its recent share price has a slightly sawtoothed profile.

If those staff need cheering up after this latest set back, yesterday the NY Times ran a nice piece on the company saying:

For the pharmaceutical industry, the genomics gold rush did not begin with the White House ceremony in June 2000. It started seven years earlier, in May 1993.

That was when the drug giant SmithKline Beecham agreed to pay an eye-opening $125 million for access to a database of genes compiled by Human Genome Sciences, an aptly named upstart company that has come to epitomize the riches to rags — and possibly riches again — story of the genomics business.

The FDA is still considering the US application for Zalbin, which is called Joulferon in Europe.

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