segunda-feira, junho 26, 2006

TMC114 (Prezista) aprovado pela FDA

US FDA clears J&J's 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.

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 it will charge $6.25 per tablet, which must be taken four times daily (which is $25 per day, total, 24 cents over Reyataz).

Still, other doctors sounded a more cautious note. Dr. Steven Deeks, an associate professor of medicine at the Universityof California, San Francisco, said he plans to delay prescribing the J&J drug for patients who are highly resistant until he can combine it with a second compound. "These drugs typically don't work well alone. They 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 clinical trials that found 70 percent of patients who had tried other therapies improved with Prezista and ritonavir after 24 weeks compared with 21 percent in those who took ritonavir with other protease inhibitors.

Side effects 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 also 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.

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