Gilead's Pill Shown Effective to Prevent, Treat Flu (Update2)
Bloomberg News September 24, 1998, 6:04 p.m. ET
Gilead's Pill Shown Effective to Prevent, Treat Flu (Update2)
(Updates closing share prices.)
San Francisco, Sept. 24 (Bloomberg) -- Gilead Sciences Inc. said company-sponsored studies showed that a flu pill it's developing with Roche Holding AG is effective in preventing and treating the disease.
Only 1.2 percent to 1.3 percent of people treated with Gilead's GS 4104 flu pill for 42 days contracted the flu, compared to 4.8 percent of those given a placebo in studies of 1,559 people. Studies of another 1,348 patients with flu symptoms found that the drug reduced the duration of the disease to 2.9 days, compared with 4.3 days in a placebo group, Gilead said.
Gilead Senior Vice President Norbert Bischofberger released the data late yesterday at a SG Cowen investor conference in San Francisco. The company, which has yet to turn a profit, will present details of those trials tomorrow at a medical conference in San Diego.
Gilead shares fell 2 7/16 today to close at 25 1/2, after rising as much as 40 percent since Sept. 1 amid hopes for the flu pill. In Zurich, Roche shares rose 125 francs to 23,950.
Some investors who expected the pill to cut short suffering during a flu bout by as much as two days may have been disappointed by the study results, which showed a one and a half day reduction in symptoms, said Rachel Leheny, a biotechnology analyst at Warburg Dillon Read in New York. However, they aren't seeing the whole picture, she said.
''You have to remember, this was a very mild season for the flu,'' Leheny said. ''If the flu had been more virulent, and lasted five or six days, they would have seen that two day reduction. It's really almost impossible to get below three days of having the flu.''
Glaxo's Flu Drug
U.K. drugmaker Glaxo Wellcome Plc, the world's No. 2 drugmaker, will also release results of trials on Relenza, a inhaled drug it's developed to prevent and treat the flu. Both will compete for a share of the estimated $10 billion spent each year in the U.S. to treat influenza.
''The question is: Will these be niche products for high- risk patients who are going to have unusually severe complications from the flu? Or is this going to be more broadly applicable to the population at large?'' said Charles Engelberg, an analyst with Americal Securities. ''I think the answer is still unknown.''
Engelberg has been advising clients to buy shares in Gilead prior to the presentation in San Diego.
New Class of Treatments
The Roche and Glaxo drugs are both part of a new class of oral flu treatments called neuraminidase inhibitors.
Currently, injected vaccines made by Medeva Plc, SmithKline Beecham Plc and other companies, are used to ward off flu. Bed rest and liquid intake are standard treatment for people who get the flu.
Relenza, developed by Melbourne, Australia-based Biota Holdings Ltd., was licensed to Glaxo in 1989 and has been filed for approval with Australian drug regulators.
Glaxo today applied for European and Canadian regulatory approval for Relenza.
Hoffmann-La Roche, the U.S. division of Roche, said GS 4104 is the first flu pill ''designed to be active against all common strains of the influenza virus.''
The most common forms are influenza A, B, and C, although there are many subtypes.
FluMist Data
At the medical conference in San Diego, Mountain View, California-based Aviron will also present data on its FluMist nasal vaccine.
The company on Aug. 3 released preliminary results of a phase 3, or final stage, clinical trial of the product, which it's dubbing as a ''painless'' vaccine since it's not given through an injection.
That analysis showed that the vaccine provided protection against the A/Sydney strain of the flu, the predominant strain circulating during last year's flu season.
A/Sydney wasn't among the three strains of the viral disease that last year's vaccine targeted.
The results being presented in San Diego will confirm that data issued in that press release, said Fred Kurland, Aviron's chief financial officer.
''The press release was very clear in a qualitative way. What you'll see (in San Diego) is quantitative data,'' Kurland said. ''The two are very consistent.''
Aviron shares plunged 42 percent on Sept. 1 after the company said the U.S. Food and Drug Administration would delay its review of what would be the company's first product. The FDA said it wants more information on how the vaccine will be produced, which the company said could hold up its review for months.
Aviron shares fell 13/16 to close at 15 1/16.
--Jim Finkle in the San Francisco newsroom (415) 912-2996 with |