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Selected news articles which highlight important policy issues.

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News for the week of 06-15-2006

Betting on a New Cancer Drug
Wall Street Journal, 6-15-06

Editor's Notes:

This article is a wonderful example of the boom–bust cycle of patent driven medical innovation. The lure of patent–protected profits gives companies the incentive to engage in risky biomedical research, to say nothing of navigating the rocky shoals of FDA approval.

Still, all good things must end, and when patents expire generic competition sends a branded drug's price into free fall, producing yet more consumer surplus. And, of course, patent expiries send companies scrambling to come up with new medicines that can help offset lost revenues. All–in–all this is a win–win situation for consumers and companies alike.

Bristol–Myers Squibb is just one of many companies adjusting to major patent expirations in recent years. Once an industry leader in oncology drugs, BMS is desperately trying to regain its position after key patents on drugs like Taxol expired. In fact, BMS is betting that its rebirth will be lead by a new drug designed to improve on—and compete with—one of the leading cancer drugs on the market, Gleevec.

For decades, Bristol–Myers was the king of oncology. Then it lost patent protection on its blockbuster medications and its lead in research to nimbler biotech companies. Now the company is hoping that a long–planned comeback in cancer research can drive a turnaround from one of the darkest periods in its corporate history.

Dasatinib (whose tentative trade name is Sprycel) isn't a silver bullet for the company's woes, but it represents a promising first result from years of expensive research. Developed in Bristol-Myers's own labs, dasatinib has already won approval from a Food and Drug Administration advisory panel and is expected to win full FDA approval by June 28, just 3 years after it was first tested in patients. That would make it one of the fastest trips ever through the U.S. regulatory process...

A major effort was directed at dasatinib, which was discovered by immunologists at Bristol-Myers and then found to have a molecular structure that led company scientists to believe it could inhibit two cancer causing genes. One is known as src, which is active in the breast and other solid tumors; the other is abl, which is what Gleevec blocks in patients with chronic myelogenous leukemia, or CML. Applied to human cancer cells in a test tube, the drug produced stunning results: It was as much as 300 times more potent than Gleevec. A big question was whether such potency, and its ability to home in on several mutations of the abl gene, would make it too toxic for patients.

In late 2003, doctors at M.D. Anderson Cancer Center, Houston, and the University of California at Los Angeles, began testing it in the first patients. Six months later, they saw the first major response: the drug had sharply reduced levels of the mutant gene from patients' bone marrow. "We knew we had a direct impact on the disease," says Robert LaCaze, the company's vice president for global oncology marketing. "It was a lot sooner than we had anticipated."

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