Austin's Introgen gets cancer drug on FDA's fast track

Austin company could be first to sell gene-based drug

By Robert Elder Jr.
Thursday, September 18, 2003

Federal regulators put the leading cancer drug from Introgen Therapeutics Inc. on the fast track for approval Wednesday, bringing the Austin company closer to tapping into an estimated $1 billion market for its gene-based drugs.

The U.S. Food and Drug Administration granted fast-track status for Advexin, an Introgen drug used to treat head and neck cancer.

Most importantly, the news offers hope for people with cancer. It also brightens the prospects and public profile of Introgen, perhaps the most prominent of Austin's handful of biotechnology concerns. Until a recent sale of additional stock to investors, Introgen was running low on cash while working feverishly on advanced trials of Advexin. The FDA news sent Introgen's stock surging 23 percent to close at $10.66 per share, a 52-week high.

The FDA's decision doesn't necessarily mean it's more likely to approve Advexin, but fast-track status shortens the approval process by letting a company file its application piecemeal. Typically, fast-track drugs come up for approval within six months, compared with about 10 months for the normal process.

Introgen could be selling Advexin for head and neck cancer by early 2005. If that happens, Introgen is likely to be the first company in the world to sell a gene-based drug.

The FDA grants fast-track status for drugs that show they have the potential to address life-threatening diseases for which no treatments are available. There is no approved drug treatment for head and neck cancer, which affects about 40,000 Americans per year.

With other uses for Advexin being tested -- including promising results for lung and ovarian cancers -- the overall market for Introgen's line of gene-based drugs could hit $1 billion, said Navdeep Jaikaria, senior biotechnology analyst with Rodman & Renshaw in New York.

David Nance, Introgen's chief executive and president, wouldn't comment on that figure, but he said Advexin "should experience significant growth" once approved because it can be used in conjunction with surgery and other methods of treating cancers.

"It has a bright future," he said.

If Advexin meets those lofty sales projections, it would give Austin a big-name public biotechnology company and boost the region's negligible profile as a biosciences center, although Introgen has just a handful of its 50 employees in Austin, mostly corporate executives.

Its research facilities are in Houston, and the company's roots date to research done at the University of Texas M.D. Anderson Cancer Center.

Nance, who was a founding investor in the company, said Advexin's potential success in the market at large will "validate the idea that a company headquartered in Austin can develop drugs in the absence of a large university hospital" and other major health-care research facilities.

Jaikaria estimated Advexin drug sales would reach $215 million by 2007. He said fast-track status essentially "lowers the bar for regulatory approval."

"Biotech investors understand that," he said, referring to the spike in Introgen's share price Wednesday.

Advexin is the most advanced experimental drug from Introgen, a 10-year-old company that went public in October 2000.

Advexin delivers a gene into the body that halts the growth of cancer cells while sparing healthy ones. The drug delivers a protein called p53, which is thought to kill cells containing DNA damage -- a symptom of cancer.

Although the FDA decision concerns the use of Advexin for head and neck cancers, oncologists often use newly approved cancer drugs to treat other forms of the disease. That means sales of new drugs can explode once they hit the market.

One recent example is Idec Pharmaceutical Corp.'s best-selling drug Rituxan, which was approved to treat a relapse of a specific type of non-Hodgkin's lymphoma. It rocketed to more than $1 billion in sales a few years after its 1997 introduction because of other uses.; 445-3671