said Monday its first-quarter loss widened and expenses grew, as the company continues efforts to get its flu vaccine approved in the U.S. for the 2006-2007 season.
ID Biomedical, based in Vancouver, B.C., hopes to submit an application to the Food and Drug Administration later this year for its Fluviral injectable vaccine. Dr. Anthony Holler, the company's chief executive, said getting a vaccine into the U.S. for the 2006-2007 flu season is his top priority, adding that he is optimistic that goal can be achieved.
In March, the company said its vaccine was declared eligible for an accelerated review by the FDA. Also in March, the company completed enrollment in a late-stage clinical trial involving 1,000 people to support its Fluviral application. The trial covers people in the 18-to-64 age bracket.
Holler told analysts and investors during a telephone conference Monday that he expects the results to be available in September and that his company would file its flu shot application with the FDA during the fourth quarter.
ID Biomedical, which provides 75% of the flu vaccine purchased by the Canadian government, also is conducting clinical tests in Canada for people 50 to 64 and for those over 64. These results will be used in its U.S. application.
ID Biomedical predicts it could produce 20 million to 25 million doses for the U.S. market for the 2006-2007 season, assuming the FDA grants approval by May 2006. ID Biomedical won't provide any flu vaccine to the U.S. for the upcoming flu season.
The U.S. flu vaccine supply is always subject to variations. During the 2003-2004 season, for example, there were 83 million doses available. In the 2004-2005 season, the federal government had predicted there would be about 100 million doses, but only 61 million doses were available because one supplier,
, could not sell its vaccine.
The upcoming season is still filled with uncertainty.
The major supplier is
, which is expected to provide about 60 million units.
, maker of the nasal spray vaccine FluMist, is expected to provide about 3 million doses.
The two question marks are Chiron and
. In early October, just as the flu season was starting, manufacturing problems at a plant in England forced Chiron to scrap its entire U.S. flu vaccine effort. Chiron had been expected to produce 50 million doses, or about half the anticipated U.S. supply.
In March, Chiron was told by British health regulators that it could resume production. The company says it could make 25 million to 30 million doses for the 2005-2006 season, assuming the FDA rules that its plant meets U.S. standards. The FDA is expected to review the plant's operations between mid-June and mid-July.
GlaxoSmithKline, which provided 1.2 million doses on an emergency basis last year, is seeking formal FDA approval to enter the U.S. market. A recent research note from Standard & Poor's says GlaxoSmithKline could make as much as 10 million doses for the upcoming flu season.
As for ID Biomedical, it lost $27.6 million (in Canadian dollars), or 64 cents, on revenue of $12.8 million for the three months ended March 31. For the same period last year, the company lost $10.9 million, or 28 cents a share, on revenue of $1.5 million. The loss was in line with ID Biomedical's expectations, said Todd Patrick, the company's president.
ID Biomedical released its financial information after markets had closed. In regular U.S trading, the stock closed at $17.49, gaining 49 cents, or 2.9%. In after-hours trading, the stock lost a penny.