And what do folks think of Xolair's (TNOX, DNA) chances for approval, given the safety profile and cost?
>>NEW YORK, May 14 (Reuters) - The experimental drug Xolair can prevent worsening of severe asthma but may carry an increased risk of cancer, reviewers at the U.S. Food and Drug Administration (News - Websites) said in a report.
The report was posted on Wednesday on the FDA's Web site, www.fda.gov, one day before a meeting of an advisory committee panel charged with recommending whether to approve the drug.
Xolair is being developed by Genentech Inc. (NYSE:DNA - News), Novartis AG (NOVZn.VX) and Tanox Inc. (NasdaqNM:TNOX - News). Some analysts think that if approved the drug would generate as much as $750 million by 2008. Others are less optimistic.
"The theoretical potential of the drug is very high, because there are so many patients, but the feeling among most doctors is that it's not going to improve things for patients that much," said Winton Gibbons, an analyst at William Blair & Co.
Data suggest that the risk of cancer could double in patients taking the drug, though it does not definitively establish a connection. Excluding skin cancer, that risk could increase four-fold, according to the report.
However, the authors said "the numbers of subjects with malignancy in the studies was very small, such that it is very difficult to form conclusions."
Shares of Genentech fell 8 cents to $38.15 while shares of Novartis fell 2 cents to $40.23. Tanox, a much smaller company, slumped $1.01, or 7 percent, to $13.85.
Xolair, which is given by injection once or twice a month, works by disabling a naturally-occurring antibody called IgE that triggers the release of chemicals that cause inflammation and provoke asthma and allergy attacks.
Genentech said it expects the FDA to issue its decision on Xolair in late June. If approved, the drug would be available several weeks later.
Adams, Harkness & Hill analyst Patrick Flanigan said the drug's expected high cost will be a marketing hurdle.
"In talking to pulmonologists, the cost is something that they all balk at. They are not used to prescribing drugs that cost $7,500 to $10,000 a year." (Additional reporting by Jed Seltzer, Ransdell Pierson, Deena Beasley; editing by Toni Reinhold; Reuters Messaging: jed.seltzer.reuters.com@reuters.net; 646-223-6035)) <<
Got to check out BSTE, that's gotten rich looking, but I know nada. Ditto GPRO.
TIA & Cheers, Tuck |
