New HIV drug for resistant patients

WASHINGTON (Reuters) – U.S. health officials on Friday
approved the use of a new HIV drug, made by Johnson & Johnson,
in combination with related therapies to help treat patients
who do not first improve with other treatment.

The drug, Prezista, is a protease inhibitor designed to
treat resistant strains of HIV, the virus that causes AIDS.

The approval marks the New Jersey-based drugmaker’s first
entry into the $1.5 billion U.S. market for protease
inhibitors, a class of drugs designed to suppress the virus and
prevent it from replicating.

Also known as TMC114, the drug is given with a low dose of
an older protease inhibitor called ritonavir, which slows the
breakdown of Prezista in the body, increasing its concentration
in a patient’s system, the Food and Drug Administration said.

The human immunodeficiency virus that causes AIDS infects
close to 40 million people worldwide, with more than 1 million
in the United States. The U.S. Centers for Disease Control and
Prevention estimates that 40,000 Americans become infected with
HIV each year.

While many HIV therapies are now available, AIDS
specialists and activists have said resistance to them is
becoming a problem because the virus can quickly mutate and
current drugs can become ineffective.

TRIAL RESULTS

JP Morgan analyst Michael Weinstein, in a note to clients
on Wednesday, forecast Prezista sales of $65 million in the
second half of 2006 and peak sales of $800 million to $900
million.

“I really expect it to be used quite widely even with the
indication that it has,” Dr. Tim Wilkin of Weil-Cornell Medical
College, New York, who helped conduct one of the Prezista
clinical trials, said in an interview before the approval.

J&J said the drug, which will be taken in combination with
other HIV drugs, will have a wholesale cost of $25 a day.

Still, other doctors sounded a more cautious note.

Dr. Steven Deeks, an associate professor of medicine at the
University of California, San Francisco, said he plans to delay
prescribing the J&J drug for patients who are highly resistant
to existing HIV drugs until he can combine it with a second
compound that would work for these patients.

He said these drugs need to be partnered with another
effective drug. “For many patients with truly highly resistant
HIV, there is no drug yet to partner with it,” Deeks said in an
interview on Friday.

The FDA said it approved Prezista based on two six-month
trials that found 70 percent of patients who had tried other
therapies improved when they added Prezista and ritonavir to
their drug cocktails compared with 21 percent of those who took
ritonavir with other protease inhibitors.

In a separate release, Roche Holding AG said the trial
showed that its anti-HIV drug Fuzeon, in combination with
Prezista and ritonavir, resulted in undetectable virus levels
in up to two-thirds of patients who had become resistant to
other drugs.

Side effects of Prezista can include diarrhea, nausea and
headache as well as mild to serious skin rashes. The risks for
patients who have not undergone other treatments first is
unknown, the agency said.

J&J must also conduct post-marketing studies, it said.

Prezista is the first of three advanced compounds in J&J’s
HIV franchise, which aims to combat HIV drug resistance.

Prezista will be followed by TMC125, a non-nucleoside
reverse transcriptase inhibitor typically used in combination
with other drugs expected to be launched in late 2008.

That will be followed by TMC278, a second non-nucleoside
reverse transcriptase inhibitor.

J&J also is studying Prezista in comparison to currently
approved protease inhibitors.

Shares in the company were up 66 cents, or 1 percent, at
$61.98 in after-hours trade on the Inet exchange after earlier
closing up 14 cents at $61.32 on the New York Stock Exchange.