[Ip-health] Gilead's new $130 per pill (use daily) for pulmonary arterial hypertension

[james.love@keionline.org]

This is Andrew Pollack's recent story on Gilead's new $130 per pill (use
daily) for pulmonary arterial hypertension.   The price of this drug,
which is a once daily pill, is roughly the average per capita income in
the United States, leaving nothing else for food, housing, clothing or
having a beer at the local bar.

  Jamie

http://www.nytimes.com/2007/06/16/business/16gilead.html

By ANDREW POLLACK
Published: June 16, 2007
Gilead Sciences won approval yesterday for a new drug to treat a
life-threatening lung disease, stealing a march on another company,
Encysive Pharmaceuticals, which learned yesterday that its similar drug
would not be approved yet.

The Gilead drug, Letairis, is a treatment for pulmonary arterial
hypertension, which affects about 100,000 Americans, according to the Food
and Drug Administration. It can cause severe shortness of breath and heart
failure and, if untreated, leads to death in about three years, Gilead
said.

The approval of Letairis is a big step in an effort by Gilead, one of the
largest biotechnology companies, to diversify beyond its successful drugs
for H.I.V. and AIDS into drugs for heart and lung diseases. Its AIDS drugs
accounted for about 70 percent of its $3 billion in revenues last year.

Gilead obtained Letairis, also known as ambrisentan, by acquiring Myogen,
a small Colorado biotech company, last year for $2.5 billion.

Although pulmonary arterial hypertension is a fairly rare disease, there
are already several treatments available for it, including Pfizer=92s
Revatio, which contains the same ingredient as its impotence pill, Viagra.

Gilead=92s Letairis is likely to compete most directly against Tracleer, a
drug sold by the Swiss-based Actelion. Both drugs are so-called endothelin
receptor antagonists, which work by relaxing blood vessels. The drug
Thelin, developed by the Houston-based Encysive, works the same way.

Late yesterday, Encysive said that the F.D.A. had declined to approve the
drug, recommending instead another clinical trial to prove the drug=92s
efficacy.

This is the third time the F.D.A. has declined to give the go-ahead to
Thelin, which is approved in Europe and Canada. Because of the multiple
delays, Encysive lost a big lead over Gilead in the race for approval.

Gilead said its clinical trials showed that Letairis caused fewer cases of
liver damage than Actelion=92s drug. Nevertheless, the F.D.A., warning abou=
t
liver damage and birth defects, is requiring Gilead to control carefully
the distribution of the drug. Patients who use it are supposed to have
blood tests for liver damage every month.

Gilead said Letairis, a once-a-day pill, will cost $3,940 a month, about
the same as Tracleer, which is also known as bosentan. The company said it
was establishing programs to help uninsured or underinsured patients
obtain the drug.

Pulmonary arterial hypertension is marked by extremely high blood pressure
in the arteries that supply blood to the lungs. That makes it hard for
people to breathe or exert themselves. It also puts a strain on the heart
that eventually leads to heart failure and death.

The available drugs, including Letairis, can improve the ability of people
to perform daily chores but do not restore normal health. In clinical
trials Letairis improved the distance people could walk in six minutes by
an average of 20 to 60 meters, or roughly 5 percent to 20 percent. The
drug also slowed the disease.

Geoffrey Meacham, an analyst with JPMorgan, estimated that worldwide sales
could reach $1 billion by 2010. He wrote yesterday that the label for the
drug captured its =93first-class profile.=94

GlaxoSmithKline sells the drug outside the United States.

Actelion=92s Tracleer had sales in 2006 of about $722 million, up more than
40 percent from 2005.

The approval of Letairis was announced after the close of trading.
Gilead=92s shares rose 19 cents, to $80.83, in regular trading and then mor=
e
than $1.50 after hours. Encysive shares fell 50 cents, to $4.10, in
regular trading and another 25 cents after hours.