Wall Street Journal - May 2, 2001

FOSTER CITY, Calif. -- Gilead Sciences Inc. filed for regulatory approval of its AIDS drug tenofovir, a potential new weapon against drug-resistant strains of HIV that also could help the company turn a profit.

Gilead said it expects the Food and Drug Administration to review its application and render a decision within six months, an accelerated schedule common for AIDS treatments. The company also plans to submit the drug for approval in Europe in the near future.

Tenofovir is a new member of a group of drugs that attack HIV, the virus responsible for AIDS, by blocking the action of an enzyme called reverse transcriptase, which is required for the virus to replicate itself. New medicines such as tenofovir could offer hope to patients infected with strains of HIV that have grown resistant to older antiviral drugs. Gilead says it has seen no sign of resistance to tenofovir in two years of study.

The drug also could bolster the financial health of 13-year-old Gilead, which reported a net loss of $21.7 million in the first quarter. "Tenofovir is the product that can take us to profitability," said John Martin, Gilead's chief executive.

Gilead has been disappointed before. In late 1999, an FDA panel recommended against approving adefovir, an earlier reverse-transcriptase inhibitor from the company, citing concerns about kidney damage suffered by patients who had used the treatment.

The company announced the filing after the close of regular trading. In 4 p.m. in Nasdaq Stock Market trading Tuesday, Gilead was up $1.11 at $50.09. In after-hours trading, Gilead had fallen to $48.75.

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