[booger]

http://abcnews.go.com/Health/wireStory?id=315281

Baxter Ends Flu Vaccine Trial; Cites Side Effects

Dec 9, 2004 — CHICAGO (Reuters) - Baxter International Inc. on Thursday said it halted a late-stage European trial of a flu vaccine because of higher-than-expected rates of fever and other symptoms.

The health-care products company said it has put further clinical studies for the vaccine, dubbed Preflucel, on hold while it analyzes data from the trial.

Deerfield, Illinois-based Baxter said preliminary data from the trial found the rate of fever and associated symptoms with its vaccine were higher when compared with other vaccines on the market.

The setback comes as U.S. officials scramble to find more flu vaccine to deal with a shortage following contamination at a Chiron Corp. plant in Britain. U.S. officials earlier this week said they would buy up to 4 million doses of a GlaxoSmithKline Plc vaccine.

Vaccine batches are made on a yearly basis and demand is unpredictable, making the business less profitable than traditional pharmaceuticals. Just a handful of drugmakers remain that make vaccines.

"Given the choppiness of the revenues related to the vaccine contracts, and the high degree of capital and clinical trial investment required, we would like to see Baxter divest this business," Glenn Reicin, a Morgan Stanley analyst, said in an investor note on Thursday.

J.P. Morgan analyst Mike Weinstein had predicted $85 million in sales for Preflucel in 2007 and $180 million in 2008. He said the trial suspension would cut the bank's 2007 and 2008 earnings forecasts for the company by 3 cents and 8 cents respectively.

But he said that could be offset by ongoing company reductions.

Shares of Baxter were down 40 cents, or 1.3 percent, to $31.72 in midday trade on the New York Stock Exchange.

Copyright 2004 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

[CanadaSue]

PrefluCel is a vax product made using cell lines rather than eggs. This one uses vero cells. Other companies are experimenting using all manner of cell cultures including... drum roll please... caterpillers.

I'd love to know what the 'other symptoms' are...

Baxter claims that;

***its proprietary vero cell technology platform, which has the potential for use with a broad range of viral vaccines. This vaccine platform has the potential to offer the advantage of a serum-free production medium, enabling high yield and purity, with no antibiotics, egg proteins, or mercury-containing preservatives.***

http://www.baxter.com/about_baxter/news_room/news_releases/2003/09-29-03-sars.html

Furthermore:

***Last year, Baxter received regulatory approval in the Netherlands for a novel influenza vaccine, PrefluCel, which also was developed using the company’s vero cell technology platform. The company is pursuing regulatory approval for PrefluCel in other European countries, and plans to initiate clinical trials in the United States in 2004.***

Back to the drawing board...

Btw, cell culture vax is no faster, just hopefully safer as this article had pointed out. I expect it depends what cell cultures are used:

***Although health experts and industry leaders caution that research going on at Protein Sciences and other biotech companies may not cut the time and price to produce usable vaccine, they support such efforts as a possible solution to the nation's flu-fighting problem.

Instead of injecting viruses in eggs, scientists infect cells - drawn from insects, African green monkeys, dogs, or human fetal retinas - with flu strains or their components. Then they grow the virus using large fermenting vats in manufacturing plants that look like breweries.

In any case, some experts and industry leaders caution that new technologies won't change the flu vaccine marketplace anytime soon, and perhaps not ever. Perfecting the technology is at least several years away. It won't make vaccine production cheaper. And it likely won't make production significantly faster.

Unlike those produced in chicken eggs, some cell culture vaccines are not processed with chemicals that can cause rare side effects, and people with egg allergies won't have dangerous reactions to them. Also, cell cultures could produce vaccines for the deadly avian flu, which might kill the chicken embryo needed to develop vaccine in an egg.

But cell cultures won't change the fundamental reason so many companies say they have left the flu vaccine business: Profits are too slim. Pharmaceutical and biotech companies would rather make drugs people take every day, not just once a year. "Cell culture is not a salvation for the flu industry," said Scott Gottlieb, a physician and former senior policy adviser to the Food and Drug Administration.***

Excerpts taken from:

http://www.bradenton.com/mld/bradenton/news/local/10286426.htm