San Francisco Chronicle - Wednesday, August 7, 2002
Tom Abate, Chronicle Staff Writer

The U.S. Food & Drug Administration, which generally follows the advice of these expert drug review panels, has promised to give the Foster City firm a final answer on its application to sell adefovir by Sept. 21.

Given that all 15 members of the advisory panel agreed that the new drug seemed safe and effective in treating the liver disease, Gilead Chief Financial Officer John Milligan said the company hopes to start selling adefovir within three days of getting the FDA's approval.

In October, the FDA gave Gilead the green light to sell a related antiviral drug called tenofovir, known by the brand name Viread, to treat HIV infections.

"For a small company to launch two drugs in a year is, we think, unprecedented in the annals of biotechnology," Milligan said.

Adefovir is intended for the roughly 1.25 million Americans who suffer from hepatitis B, a viral infection that attacks and can ultimately destroy the liver.

Gilead presented clinical evidence that a daily dose of adefovir lowered the concentration of hepatitis B viral particles in the bloodstream and allowed the liver to repair damage caused by the virus. "The liver is one of those rare organs that actually does heal," Milligan said.

Hepatitis B is now treated with interferon or lamivudine. Tom Dietz, an analyst with Pacific Growth Equities in San Francisco, said adefovir seems to have greater benefits with fewer side effects.

"Physicians want to get their hands on this drug," said Dietz, who owns no shares in Gilead and whose firm has done no banking business with that company in the past year.

But Dietz thinks adefovir will be a modest seller because the drug is new and the disease complex. He projects sales of $38 million in 2003 and $78 million in 2004.

The advisory panel debate, which Gilead made available via Webcast, reflected the trade-offs in approving any powerful new medicine.

For instance, panelists discussed whether adefovir, though good for the liver, could harm the kidneys in some patients, a concern given that some hepatitis B sufferers might remain on the drug for years.

Milligan said Gilead is tracking 400 patients, some of whom have been on adefovir for two years, looking for any signs of ill effects. The company will continue to study this group for a total of five years.

Winning FDA approval for adefovir would be a comeback for Gilead. In 1999, the agency rebuffed the company's bid to target adefovir -- although in a much higher dosage -- against HIV for fear that the kidney damage would be unacceptable.

Now, having greatly lowered the dose of the drug, Gilead seems poised to launch this born-again antiviral against hepatitis B. This expected approval comes on the heels of the company's first sales-driven profit in the quarter just ended.

Given its run of good news, Gilead's stock has risen while most of biotech has slumped. Its shares gained 6.8 percent or $1.95 to close at $30.86 on Monday. Trading was halted Tuesday while the advisory panel met.

E-mail Tom Abate at tabate@sfchronicle.com.

020807
SC020803

Always watch for outdated information. This article first appeared in 2002. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2002. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .