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Latest Drugs Could Shake Up Cancer Market

http://online.wsj.com/article/SB114920828185069347.html

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By DAVID P. HAMILTON
June 2, 2006

Medicine's newest weapons against cancer -- drugs that "smart bomb" tumors at their genetic weak points -- may soon have a new target: each other.

At the annual meeting of the American Society of Clinical Oncology, which kicks off today in Atlanta, researchers are expected to report clinical data from several new targeted cancer therapies that, if positive, could lead to direct competition for some of the fastest-growing cancer drugs on the market.

The new competition, most of which hasn't received Food & Drug Administration approval, would be good news for cancer patients and their doctors, although it might present headaches for some manufacturers and their investors.

Among the drugs that could face new rivals are Herceptin, Genentech Inc.'s targeted breast-cancer treatment; Erbitux, a colon-cancer drug from Bristol-Myers Squibb and ImClone Systems Inc.; and Gleevec, Novartis AG's pioneering drug that targets a form of leukemia.

Hefty sums are at stake. Many of these drugs have had virtual monopolies, making them cash cows for their creators. Gleevec, for instance, pulled in 2005 sales of $2.2 billion, thanks to its ability to produce dramatic remissions in chronic myeloid leukemia. Herceptin's sales for 2006 are likely to rise to more than $1 billion, after test data last year indicated the drug could halve the risk that tumors would reappear after surgery.

Some experts even hold out hope that increased competition will eventually hold down skyrocketing prices for new cancer therapies, which can cost as much as $100,000 a year per drug. To date, such competition has been virtually nonexistent, allowing companies like Genentech to justify their high prices on the basis of the unique benefits their drugs provide.

Similarities between approved drugs and the new rivals, some of which work on the same genetic targets, may spark price wars. "Among therapies that compete very directly, and where neither has a specific efficacy advantage, there is definitely price competition," says Deborah Dunsire, chief executive of Millennium Pharmaceuticals Inc., Cambridge, Mass.

Christopher Raymond, an analyst with Robert W. Baird & Co., says a more-crowded field of drugs might spark a "major showdown" over prices. "Either payers are going to start pushing back, or market forces will introduce competition," he says. "This could be something that starts one of those dynamics."

Much of the potential competition, if it does arise, is still some time away. For one thing, the challengers haven't yet proven themselves, and most don't have FDA approval. And many would-be rivals so far are aimed mainly at patients who have failed existing treatments. What's more, many of the new targeted drugs may work best in combination with one another.

Cancer specialists have long hoped to develop antitumor cocktails with the new targeted drugs, allowing patients to forgo the rigors of traditional chemotherapy. Ultimately, such cocktails might hold back tumors while producing few side effects, much the way a combination of antiviral treatments can check the AIDS virus.

For patients and doctors, a wider selection of targeted drugs means a greater variety of treatment options -- and a better chance of finding combinations that slow or stop tumor growth.

"More and more of these chemicals and strategies help some of the people some of the time," says Leonard Saltz, a colon-cancer researcher at the Memorial Sloan-Kettering Cancer Center, New York.

Some drugs may be vulnerable to direct competition. Herceptin and an experimental drug from GlaxoSmithKline PLC called Tykerb, for instance, both target a tumor protein called Her2 that regulates cell growth, although Tykerb appears also to block another growth-related protein [Her1 a.k.a. EGF].

Proven success for the new drugs, even in niche patient populations, could pave the way for a broad assault on an established leader like Herceptin. That's what some analysts are starting to suspect from Tykerb. Researchers at the oncology conference will report results from a trial of Tykerb in women whose cancer had progressed despite Herceptin treatment. The trial was halted early because preliminary results were better than expected.

Glaxo isn't saying whether it expects to take on Herceptin directly, but the company and others are testing Tykerb in ways that could highlight any advantages over the Genentech drug. For instance, at the oncology meeting Glaxo also will present data from a test of the drug in women whose breast cancer has spread to the brain, where Herceptin isn't effective because its molecules are too large to cross the blood-brain barrier. Outside researchers also plan studies that will test Tykerb, Herceptin and different combinations of the drugs against breast cancer.

"That broader trial program could be a full-frontal assault on Herceptin," says Mr. Raymond, the analyst. "The angst [for Genentech] has to come from what's next."

Gwen Fyfe, Genentech's vice president for clinical oncology, says she is eager to see the Tykerb data and doubts cancer doctors would "walk away" from Herceptin's proven effectiveness and safety profile.

Similarly, Bristol-Myers Squibb will tout fresh data for its experimental drug dasatinib [a.k.a. Sprycel], designed to overcome Gleevec resistance in some leukemia patients. In fact, a Food & Drug Administration advisory panel, which also is meeting today in Atlanta, will consider whether to recommend early approval of dasatinib for Gleevec-resistant patients.

That is only the opening salvo from Bristol. Over time, the company hopes to take on Gleevec directly and is planning tests of dasatinib as a "first-line" treatment for leukemia, as well as for a rare gastrointestinal cancer also treated by Gleevec. Eventually, the pharmaceutical company plans to test dasatinib against a variety of other cancers, including breast and pancreatic tumors.

A third emerging battleground may be colon cancer. Amgen Inc. has panitumumab, an antibody targeting a growth protein called epidermal growth factor receptor, or EGFR. Panitumumab, which Amgen submitted to the FDA in March, poses a potentially serious threat to Erbitux, an approved EGFR inhibitor. The two drugs appear to be similar, but analysts say Amgen has signaled its willingness to challenge Erbitux aggressively on price. Amgen said it hasn't set a price for panitumumab.
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