Glaxo, Roche poised for battle next flu season By Ransdell Pierson
NEW YORK, July 27 (Reuters) - Glaxo Wellcome Plc (quote from Yahoo! UK & Ireland: GLXO.L) and Roche Holding AG on Tuesday girded for a likely U.S. battle during the coming influenza season with similar medicines that could revolutionize treatment of the disease.
Both drugs block an enzyme on the surface of the influenza virus, neuraminidase, thereby helping prevent the virus from replicating and spreading to other cells. In the process, they moderate flu symptoms and speed healing time by a day or two.
London-based Glaxo on Tuesday said the U.S. Food and Drug Administration had approved its new inhaled influenza treatment, Relenza (zanamivir), although an FDA advisory panel in February had recommended against approval because of questions about its efficacy in a U.S. trial.
In its announcement Tuesday, Glaxo promised to introduce Relenza in time for the coming 1999-2000 flu season, which comes in the autumn and winter.
Only hours later, Swiss rival Roche said the FDA had agreed to a six-month expedited review of its experimental anti-influenza pill, Tamiflu, formerly known as GS4104, and would hopefully approve it in time for the same season.
Charles Alfaro, a spokesman for the U.S. pharmaceuticals unit of Roche, told Reuters his company expected the FDA to decide on or before Oct. 29 whether to approve Tamiflu.
''We remain optimistic it will be on the market in time for the 1999-2000 flu season,'' Alfaro said, noting that FDA priority reviews take place over a six-month period -- half the customary review time of one year.
''The FDA is really excited about both these drugs because they are an important new class of treatment,'' said Rachel Leheny, an analyst for Warburg Dillon Read.
Leheny forecast Relenza and Tamiflu could have combined sales of up to $200 million in their first year on the market, rising by multiples of that amount in future flu seasons.
She said it was all but certain the FDA would approve Tamiflu because the Roche drug achieved statistically significant effectiveness in its major clinical trials.
''And given the fact that the Roche drug is a pill, and therefore very appealing to use,'' Leheny said Tamiflu would likely score valuable points with the FDA and an eventual possible marketing advantage over Glaxo's Relenza.
Relenza must be taken with a breath-activated device called a Diskhaler and is approved for adults and adolescents 12 years or older who have had flu symptoms for no more than two days.
Glaxo presented studies of patients in the United States, Australia and Europe, arguing that some recovered up to two and a half days quicker than the typical week it takes most flu sufferers to recover.
But FDA advisory panel members in February said the mean recovery time for patients did not seem dramatically better than the placebo group, especially in Glaxo's U.S. study.
Roche said trials of Tamiflu showed the pill significantly lessened severity of symptoms such as fever and cough -- with an overall reduction of 40 percent in a U.S. trial and 25 percent in patients studied in 11 other countries.
Roche said Tamiflu cut duration of the flu by nearly 33 percent in the U.S. trial and by 30 percent in the overseas trials when given within 36 hours of developing symptoms and 40 percent when taken within 24 hours.
Relenza was licensed to Glaxo by Biota Holdings Ltd of Australia. Tamiflu was co-developed by Roche and Foster City, Calif.-based Gilead Sciences Inc (Nasdaq:GILD - news).
Both drugs were well tolerated in clinical trials. Glaxo said Relenza had a safety profile similar to placebo, or dummy pills, while Tamiflu caused mild nausea and vomiting in some patients.
Dr. John Treanor, a University of Rochester professor who has helped test both flu drugs, said speed is of the essence in seeking treatment.
''You want to stop the virus before it has a chance to cause further damage to the respiratory tract,'' he said, predicting many doctors may diagnose patients over the telephone to allow them to have quicker treatment.
American Depositary Receipts of Glaxo rose 3 to $54.12 in New York. Gilead jumped $5.12 to $58.75 on the Nasdaq. |
