[Ip-health] Copying the generics: FDA OKs new 1-a-day dose of 3-drug combination to fight AIDS

[Ira Glazer]

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/07/13/MNG20JU7ON1.DTL&type=printable

"Ironically, the generic companies have created a new wave of innovation"


A quarter-century after the discovery of AIDS, the Food and Drug
Administration approved for the first time on Wednesday a single pill
that can be taken just once a day by some patients to keep their HIV
infections in check.

A combination of two AIDS drugs made by Gilead Sciences Inc. of Foster
City and a third antiviral medicine from rival Bristol-Myers Squibb Co.
of New York, the new three-in-one pills should be ready for sale within
a week.

They will be sold under the name Atripla, and the two companies said
they will sell the new pill at the same price that its three components
together cost today: $1,051 for a 30-day supply.

"It's great news,'' said Mark Cloutier, executive director of the San
Francisco AIDS Foundation. "These are the most commonly recommended
drugs in triple therapy today."

The announcement is a milestone in the history of AIDS treatment. When
researchers first discovered in 1996 that combinations of three drugs
could save lives, it was not uncommon for an AIDS patient to take 30
pills a day.

Such a regimen is very difficult to keep consistently, so patients would
forget to take pills, and the virus would quickly develop mutations that
rendered the medicines less effective.

In the 10 years since, the drugs have become easier to take, with fewer
pills needed each day, but the newest pill is the simplest regimen ever
devised. There are currently more than 400,000 Americans living with an
AIDS diagnosis.

The three drugs combined into one include:

-- Efavirenz -- originally approved in 1998 and sold by Bristol-Myers
under the name Sustiva.

-- Tenofovir -- approved in 2001 and sold by Gilead under the name Viread.

-- Emtricitabine -- approved in 2003 and sold by Gilead under the name
Emtriva.

Since 2004, Gilead has been selling tenofovir and emtricitabine in a
double combination called Truvada.

Combining Truvada and Sustiva into one pill will not only make it easier
for patients to be sure not to miss a dose, it will save them money. "It
is one less co-pay, one less deductible, every time you have a
prescription filled," Cloutier said.

According to Gilead research and development Vice President Norbert
Bischofberger, about 13 percent of AIDS patients in the United States
take Truvada and Sustiva today, and the combination is prescribed to 60
percent of those in this country who are taking antiviral medications
for HIV for the first time.

All three drugs have potentially serious side effects, but the three are
each considered to be among the safest and most easily tolerated AIDS
medications available today.

Although the new drug is the first once-a-day AIDS treatment, Indian
drugmakers were the first to come up with the idea of combining three
drugs into a single pill. In 2003, the World Health Organization
endorsed Cipla's Triomune -- a combination of generic copies of three
older AIDS medications -- as an easy to administer treatment for people
in poor countries. Two Triomune pills are required per day.

"Ironically, the generic companies have created a new wave of
innovation," Cloutier said.

Last week, the FDA approved its first twice-a-day, three-in-one pill for
sale to President Bush's $15 billion overseas AIDS initiative, which has
refused to purchase the low-cost Cipla drug. The newly approved pill,
produced by Indian drugmaker Aurobindo Pharma, is deemed safer than
Triomune.

"We absolutely think it was worth waiting for," said Dr. Mark Dybul, the
acting Global AIDS coordinator in charge of the administration's program.

The FDA also approved a version of Atripla for sale to developing
countries. The pill will be produced in a white color, instead of the
salmon color of those to be sold in wealthier markets. Gilead plans to
sell the new white pill at cost, but the price has not been announced
pending negotiations with Merck & Co., which holds rights to efavirenz
in many poor countries.

Martin Delaney, founder of Project Inform in San Francisco, said that
the latest approval of Atripla is important because, for the first time,
U.S. drugmakers are cooperating on a better AIDS treatment. It took an
Indian drug maker to produce Triomune, because it ignored the fact that
the ingredients found in its pill were patented by different, competing
companies.

"The fact that two American companies have collaborated here is a good
model for the future," Delaney said.