Swish, Spit, Survive
By Bill Mann
December 8, 2003
Denis Leary may turn out to be disappointed. His 1992 comedy album, "No Cure for Cancer," may be proven to be wrong by modern science. There are dozens of pharmaceutical and biotechnology companies that are actively seeking cures for cancer -- each has its own specialty. One of the coolest treatments that I have come across is entering Phase II trials. It's called Advexin, and the company that is developing it is Introgen Therapeutics (Nasdaq: INGN).
Advexin's already gone into Phase II trials (during which the therapy is tested on patients with the disease) for breast, esophagus, and lung cancers, and Phase III for head and neck cancers. Each of these has a relatively high rate of mortality. The latest Advexin trial is for mouth and throat cancers, and it delivers the drug using, of all things, a mouthwash.
One of the problems with many cancer therapies is that the treatment is sometimes nearly as bad as the disease. Had you suggested to me years ago that cancer treatments would be well advanced by this time, I would have readily believed you. But the thought that some deadly forms of cancer might be treated topically, and not invasively, is mind-blowing.
Every cell in the human body has a protein called p53, also known as the "cellular policeman," which detects whether something is amiss in a cell. If so, p53 causes the cell to destroy itself. With many forms of cancer, this process is suppressed, so cells that ought to kill themselves fail to do so. Tumors form when these mutated cells multiply instead. Medicine has long understood the role of rapid reproduction of cells in cancer, but the role of the failure of cells to police themselves has only recently become more understood.
Finding a way to reintroduce p53 to mutated cells would allow them to do what nature intended them to do in the first place -- put themselves to sleep. This could be substantially less toxic than existing therapies that destroy both cancerous and healthy cells indiscriminately.
Introgen's rights include an adenoviral delivery system for p53. Just in the way that viruses introduce influenza, malaria, or other diseases to a system, some can also be altered to introduce p53.
Introgen's financial statements are awful. Like most biotechnology companies, it has minimal revenues prior to approval of its drugs, though it does have plenty of cash and minimal debt. But the delivery system is so ingenious that I was intrigued enough to ask a Georgetown University oncologist, Dr. Jimmy Hwang, what he knew about p53, Advexin, and Introgen.
Dr. Hwang explained that he found it interesting that there is substantially more information about this therapy in business publications than in medical journals, and noted that a drug's passing to Phase II only means "that the drug is safe." Still, he called the reintroduction of p53 to be a sort of Holy Grail for cancer treatment. From an investment standpoint, Introgen most likely falls under the low confidence/high potential return category.
Still, the thought of a swish that can kill cancer cells is something I find completely fascinating.
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Introgen prepares for boom
Biotech company moving toward full production of its cancer drug
By Colin Pope
Austin Business Journal
Dec. 8 — After laying relatively dormant for a decade, Introgen Therapeutics Inc. is gearing up for a growth spurt as its novel cancer-fighting treatment is on the verge of being approved by federal regulators.
At Introgen's manufacturing plant in Houston, workers already are stockpiling the promising Advexin drug for commercial sale -- possibly as early as late 2004.
At the corporate headquarters in Austin, dealmakers are reaching out to pharmaceutical giants and other companies that could market Advexin worldwide. They're also considering ways to establish an internal sales force. The company's regulatory experts are preparing to ask the U.S. Food and Drug Administration for permission to sell Advexin, and Introgen's financial team has strengthened the company's balance sheet by offering $20 million more of common stock.
"There's no question," founder and CEO David Nance says, "we're getting ready for a very important year for Introgen."
Introgen [Nasdaq: INGN] has waited a decade for something many Austin startups demand within a matter of months -- a product launch.
After 10 years, $500 million and a plethora of promising results from FDA studies, Introgen's flagship product -- a drug called Advexin -- appears to be on the brink of distribution.
Advexin's primary target now, head and neck cancer, has a peak sales opportunity as high as $500 million, according to the New York-based investment bank Rodman & Renshaw Inc. But Navdeep Jaikaria, the Rodman & Renshaw analyst who follows Introgen, says the overall market for Introgen's gene-based drug easily could top $1 billion.
That's because oncologists have a tendency to use newly approved cancer drugs to treat other forms of the disease. So although Advexin might have the FDA's approval only for head and neck cancer next year, the drug could be used to treat other types of cancer.
The medical community already is keeping close tabs on Introgen because of Advexin's potential effect on a variety of cancers such as lung, breast, prostate, ovarian, bladder and brain cancers, says Phil Nadeau, an analyst at SG Cowen Securities Corp. in New York.
Unlike chemotherapy, radiation and surgery, Introgen's cancer combatant involves the p53 gene, which humans naturally produce. The p53 gene recognizes that cells aren't normal and either fixes the damage or kills the cell when it is injected into a tumor. It leaves the healthy cells alone.
Introgen has just a few more steps to get Advexin on the market. The most signific ant move is expected sometime next year, Nance says, when Introgen submits to the FDA a biologics license application.
After the application is turned in, federal regulators have about six months to tell Introgen it can or can't market Advexin. Once Introgen gets the OK, Nance says, the stockpile of Advexin in Houston will be shipped out almost immediately.
"We'll begin the distribution right away," Nance says. "Every day it's not on the market, we're missing an opportunity -- not just for sales, but to save patients."
Introgen already is talking to potential marketing partners that could sell Advexin in Europe and Asia, Nance says. Potential partners include nearly all the major pharmaceutical firms and a handful of large biotech companies that have marketing arms, such as Genentech Inc. or Amgen Inc., both of which are based in California but have worldwide operations.
Although a partner will sell Advexin abroad, Introgen is looking at creating an internal sales team to market Advexin to cancer centers and oncologists in the United States and Canada, Nance says. Those jobs might be spread between Austin and Houston, he says.
Introgen now has about 80 employees -- only the executive team works in Austin -- but Nance expects to add to the workforce here and in Houston next year.
After selling $20 million worth of shares late last month, Nance says Introgen has about $40 million of cash on hand, which is enough to cover operating costs until about mid-2004. Introgen already has regulators' permission to offer $80 million more of stock when the need arises.
So far, as much as $500 million has been invested to bring Advexin to the market, which begs the question: How could Introgen afford to spend half a billion dollars over a 10-year period?
It couldn't. Introgen has only doled out about $150 million for research and development. The other $350 million came from other cancer antagonists, such as the National Cancer Institute, the Southwest Oncology Group in San Antonio and even French drug giant Aventis.
Meanwhile, Introgen was able to hang onto 100 percent of Advexin's commercial rights, Nance says.
"Introgen really leveraged the investments of others," Nance adds. "We were fortunate to not have to use all of our cash on development."
Once revenue from Advexin starts rolling in, Introgen will tackle its biggest project yet: a new and larger manufacturing plant that can produce Advexin plus Introgen's other treatments already in the FDA pipeline, Nance says.
"The question is then: Where do we want to site a larger production facility?" Nance says.
The answer: He doesn't know yet.
But one thing is for sure, Nance says. The multimillion-dollar plant, which will at first measure about 100,000 square feet, will need to have plenty of room to grow.
"I sure would like to keep it in Texas, but I haven't gone beyond that," Nance says. "In '05 or '06, we'll start to give it serious consideration."
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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.
AMERICAN-STATESMAN STAFF
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.
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