Recent recalls push early tox market

In August, Australia’s Therapeutic Goods Administration asked Novartis AG to pull the pain reliever Prexige from store shelves because of a handful of reports about severe liver reactions in patients taking the drug, including two deaths.

Randall C Willis
STORY UPDATE
OTTAWA—October 4, 2007—Following the lead of Australia and New Zealand, Health Canada announced it has stopped the sale of Prexige, Novartis's COX-2 NSAID, in Canada, canceling the drug's market authorization on the basis of recent deaths and adverse events related to liver toxicity.
 
 
ROCKVILLE, Md.—In August, Australia's Therapeutic Goods Administration asked Novartis AG to pull the pain reliever Prexige from store shelves because of a handful of reports about severe liver reactions in patients taking the drug, including two deaths. At the time of the withdrawal, the company was said to be re-examining its dosing strategy for the drug, which is sold in 50 countries, but not the United States.

The ripple effect then took hold, as shortly thereafter, Canadian health officials decided to re-examine its position on the safety of Prexige, even though the drug was only available in doses of 100 mg, lower than the 200-mg dose associated with the problems in Australia. New Zealand has since added its concerns and like Australia, has pulled the drug from its shelves.

This is just the latest in a series of events that have led the pharmaceutical and biotechnology industry to re-evaluate its efforts to identify drug-induced toxicity issues, following on the heels of similar—and very public—post-market issues with drugs like Vioxx, Baycol, and FenPhen.

"The lawsuits, expense, and negative publicity have been costly to their suppliers," says Jack Gardner, a pharmaceutical market analyst with Kalorama Information. "The toxicity problems with these drugs should have been caught before they reached clinical trials, but they weren't. This was not because of ineptitude of the companies involved, it was because better tools for determining toxicity were not available."

In his June 2007 report Early Toxicology: Markets and Approaches, Gardner suggests the market for early toxicology, which currently sits around $947 million, can expect significant growth in the next couple of years and will likely surpass $1.5 billion by 2010. These numbers include in vitro, in vivo, and in silico platforms, as well as services.

"Ten years ago, nobody would have considered outsourcing early tox services," Gardner says. "Now many pharmas and biotechs are doing it routinely. The change started with the mega-mergers of the late '90s. Newly formed, merged pharmas didn't have enough resources to do all their optimization work in-house."

In particular, he sees pharma looking increasingly to toxicology outsourcing to solve their problems. Outsourcing, he says, allows companies to explore new technologies without making significant capital investments and truly focus their efforts on drug candidates without having to alter their R&D processes.

Using small and mid-sized CROs as a barometer of future growth in the early toxicology service sector markets, he adds, "Many of these companies are innovative, dynamic, and growing rapidly. This indicates a healthy marketplace, where one can expect annual growth rates in the 15 percent range over the next five years."
 

Randall C Willis

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