[Ip-health] WSJ: New AIDS Drug Shows Promise But May Prove Unaffordable

[Mike Palmedo]

http://online.wsj.com/article/0,,SB1026076642362837280-search,00.html?collection=wsjie/30day&vql-string=%28fusion+inhibitor%29%3Cin%3E%28article%2Dbody%29


New AIDS Drug Shows Promise,
But It May Prove Unaffordable

By VANESSA FUHRMANS 
Staff Reporter of THE WALL STREET JOURNAL


A new AIDS drug known as T-20 comes with two major distinctions: an
ability to beat down the heartiest forms of the virus, and
record-setting cost.

Doctors and patient advocates call T-20, expected to be approved in the
U.S. and Europe early next year, the most exciting advance in AIDS
treatment in years. That's because despite powerful therapies such as
protease inhibitors, the AIDS virus has kept frightening pace by
mutating into stronger, drug-resistant forms. Around the world, more
than 75% of HIV patients on therapy are believed to carry viruses
resistant to at least one common drug.

T-20 is the first in a new class of drugs called fusion inhibitors that
can suppress these super strains with a novel way of attacking the
virus. But T-20's expected price -- more than the most expensive drugs
currently on the market -- is beginning to create as much buzz as its
effectiveness. Any premium could throw up a serious challenge to access,
this time not in poor countries, but in the U.S., public-assistance
programs say. It's also likely to escalate the debate over how much even
wealthy countries are willing to pay for new advances in AIDS treatment.

Just how much T-20 will cost remains unclear. Its developers, Roche
Holding AG and Trimeris Inc. say they haven't established and won't
announce a price until the drug is approved, in part because they are
still trying to get a handle on how much it costs to make T-20. But
analysts and clinicians say that Trimeris executives have disclosed it
could cost around $12,000 for a year's treatment and that, more
recently, the companies have explored prices as high as $15,000 and
upward. The most expensive antiretroviral treatments on the market
currently cost about $11,000.

That's giving already-strapped state and local AIDS public-assistance
programs pause about covering T-20 in all but extreme cases of
resistance. Most AIDS patients today take a "cocktail" of three or more
types of drugs costing between $10,000 and $16,000 a year. Adding T-20
to the mix, as clinicians are doing in clinical trials, could double the
cost of a year's treatment.

Until now, most state programs automatically have added every new AIDS
drug to their lists of offered treatments. That was even the case when
protease inhibitors and the advent of combination drug therapy triggered
a quantum leap in spending in the mid-1990s. But with T-20, or with any
drug that costs nearly twice a typical therapy, a state program "would
have to take a serious and very hard look before considering it," says
Mark Loveless, medical director of Oregon's state HIV programs.

 For more information about the AIDS conference, see www.aids2002.com
and www.unaids.org
  
  
 
The difference is a heightened scrutiny of prescription-drug costs in
the U.S. -- even for medicines that save or add years to people's lives
such as T-20. That's particularly the case with AIDS treatments.
International pressure forced global drug makers to cut the prices of
AIDS drugs in poor countries by as much as 90%. Now activists are
tilting the spotlight to the U.S. Last week, the AIDS Healthcare
Foundation, the largest nongovernment provider of AIDS medical-care
services in the U.S., filed suit against GlaxoSmithKline PLC alleging
that the company used invalid drug patents to overprice its AIDS drugs.
Glaxo says its patents are valid.

Public-assistance programs say they simply can't afford considerably
more expensive drugs. An estimated 70% of AIDS patients in the U.S.
receive help from these programs or some other form of public aid. But
more patients and rising drug prices already are overtaxing their
budgets and forcing many states to limit access and put patients on
waiting lists. "These programs aren't heading toward a crisis," says
Terje Anderson, executive director of the National Association of People
Living with AIDS. "They're right in it."

Just how much a breakthrough drug such as T-20 should cost is hard to
gauge. An innovative treatment's price doesn't take into account the
costs it saves in hospitalization or the economic benefits of increasing
survival rates, doctors say. That Trimeris Chief Executive Dani
Bolognesi, a highly esteemed scientist and champion of the AIDS medical
community, has paired with Roche, which has locked horns with activists
over its pricing policies in developing countries, muddies the picture
more.

"He's not some money-grubbing marketer," says Martin Delaney, founding
director of Project Inform, a San Francisco AIDS advocacy group. "A lot
of people will be leaning on him to make sure it's a fair price."

T-20 isn't expected to be a standard therapy at first; instead, it will
be geared toward patients who no longer respond to other treatments. But
use of drugs such as T-20 is expected to become more widespread as
resistance worsens. Researchers estimate that most patients have
developed resistance to at least one drug, while nearly a third no
longer respond to a cocktail of at least three drugs. As many as 20% of
newly diagnosed patients are contracting resistant strains of the virus,
making them unresponsive to some existing treatments. A group of Spanish
scientists last week said they have identified isolated HIV mutations
that may even be resistant to T-20.

But most patients with resistance are like Sally Brookins, who is 38
years old and a former elementary-school teacher living in Colorado
Springs, Colo. Ms. Brookins discovered she was HIV-positive in 1990,
before more combination therapies that are better able to slow
resistance became standard. "You could only take what was available, and
so I burned through one drug after another," she says.

By early last year, few were working at all. Ms. Brookins's T-4-cell
count, which indicates how depleted a patient's immune system is, had
dropped to 52, well below the 200 threshold into full-blown AIDS. After
one month on T-20, though, it had risen to 100. Today, the count is 215,
the first time in four years it has risen above 200. "It's usually after
18 months that a drug stops working for me," she says. "But here I am,
and my numbers keep going up."

So are those of other patients. In each of two large-scale studies to be
presented in detail Monday at the International AIDS Conference in
Barcelona, twice the number of patients who received T-20 saw their
virus levels fall to below detectable levels than those who didn't. In
the first trial, 37% of those on T-20 experienced such a drop, compared
with 14% in the group without T-20. Clinicians say the result is more
impressive given the high bar Roche researchers set for T-20 in the
studies. Most of the 1,000 patients had shown resistance before entering
the trial. Each was tested to see which drugs they didn't respond to and
put on the best possible combination therapy, then randomly selected to
either receive T-20 in addition to the mix or not.

One reason T-20 is bound to be costly is its manufacturing process. Most
drugs are small molecules that are relatively simple and cheap to
produce. Companies typically mark up the manufacturing cost by 90% to
recoup the millions of dollars that go into discovering and developing a
drug.

T-20 is a different story. Unlike current AIDS drugs, which block
replication of the virus after it infects a cell, T-20 is a synthetic
peptide that stops HIV from entering the cell in the first place. By
binding to part of a specific HIV protein, it blocks the morphing
process the virus has to go through to fuse with the cell, preventing
HIV from penetrating and releasing its genetic material.

But it takes 106 steps -- more than 10 times the usual number of
chemical reactions -- to make the lengthy peptide, making production a
serious factor in its price. Roche refurbished a plant in Boulder,
Colo., just to make T-20. Almost 100,000 pounds of specialized raw
materials are needed to make a little more than 2,200 pounds of the
drug. In all, Roche says it has invested $490 million in T-20's
development and manufacturing.

As Roche and Trimeris meet with managed-care companies, assistance
programs and other groups that help finance AIDS drugs before T-20's
launch, "we'll lay out those complexities and the role T-20 can play,"
says David Reddy, head of Roche's HIV products and disease strategy.
"But clearly as a company, we've made an investment and we need to make
sure that investment is recouped."



-- 
Mike Palmedo
Consumer Project on Technology
Tel: 202-387-8030
Fax: 202-234-5176
P.O. Box 19367
Washington, DC 20036
mpalmedo@cptech.org