[Ip-health] Latest Drugs Could Shake Up Cancer Market

[Joana Ramos]

<snip>

> 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.

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

Latest Drugs
Could Shake Up
Cancer Market
By DAVID P. HAMILTON
June 2, 2006; Page A13
Wall Street Journal

(copied as fair use)

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.
[Rival Therapies]

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.

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, 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.

--Ron Winslow contributed to this article.

Write to David P. Hamilton at david.hamilton@wsj.com1
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--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
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