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Joining Forces, Two Drug Firms Develop a Once-a-Day AIDS Pill ; FDA Approval Expected By the End of the Year

Posted on: Saturday, 21 January 2006, 09:00 CST

By Justin Gillis

Two drug companies say they have put aside commercial rivalry to achieve a goal that seemed out of reach for 20 years: a single- pill, once-a-day AIDS treatment.

The pill is to contain a regimen of three drugs already available on pharmacy shelves and shown to be effective in multiple studies, including one coming out today in the New England Journal of Medicine. Barring last-minute problems in formulating the pill, doctors expect the government to approve it by the end of the year.

If that happened, it would be a milestone in the development of treatments for HIV, the human immunodeficiency virus, which causes AIDS. The virus has infected 1.1 million people in the United States and more than 40 million around the world, the vast majority of those in poor countries.

When effective AIDS treatments were first devised in the 1990s, patients sometimes had to wake up in the middle of the night to take regimens consisting of 50 or 60 pills administered several times a day with complicated food restrictions. Back then, a once-a-day pill seemed a distant dream, but doctors have long said that it would be a big help in getting more people onto treatment.

Under heavy pressure to simplify treatment regimens, companies have been combining medicines and reducing pill counts for several years. Yet for commercial, rather than scientific, reasons, no company has yet managed to create a single once-a-day pill containing an effective combination of AIDS drugs. As it happened, no single company owned the rights to all the drugs necessary for an optimal combination, and the companies were wary of working together.

Now, two companies say they have combined into one salmon- colored pill the three licensed AIDS drugs that already make up the most-prescribed drug regimen for newly diagnosed HIV patients. The companies recently announced data showing that the pill can achieve adequate blood levels for all three drugs, and today's report in the New England Journal of Medicine adds to a large body of evidence showing that the drug combination is effective with relatively few side effects. The companies are already producing test lots of the pill at a plant in Ontario.

The Food and Drug Administration readily blesses new, more convenient formulations of previously licensed drugs, and approval of the new pill, though it will take several more months, is expected to be routine. The biggest hurdle at this point is making sure the pills have an adequate shelf life, a problem the companies say they are confident they can solve.

"I think it's a huge thing these companies are going to do," said Nelson Vergel, an AIDS treatment activist in Houston. "If they give it at the right price to developing countries, it's going to become the main treatment in the world."

The companies involved, Gilead Sciences Inc. and Bristol-Myers Squibb Co., say they are indeed committed to providing the treatment to poor people overseas. But their immediate goal is to get it on the U.S. and European markets by the end of this year.

If the pill, which does not yet have a name, can get a bigger slice of the market, the potential profit is huge. While the firms have yet to announce a price, some AIDS regimens can cost upwards of $30,000 per patient per year.

The Gilead-Bristol collaboration required a year of complex negotiations, with lawyers involved at every step to make sure the erstwhile competitors did not run afoul of antitrust laws. And repeated tests were needed to get a pill with the right formula to achieve good blood levels.

Gilead has already combined its two drugs into a single pill, so the three-drug regimen is available today as two pills taken once a day. It does not sound arduous, but even for people taking just two pills, the idea of a one-pill-a-day treatment holds some kind of symbolic appeal. "I'm counting the days" until the new pill becomes available, said Lucky Santana, a medical worker in Atlanta who is already on the two-pill combination.

It is not just that people hate swallowing pills; they hate swallowing the co-payments at the pharmacy that go with the pills, and those can run $50 a month for every prescription. Santana expects to save $30 every time he fills a prescription when the new pill becomes available. "That's a tank of gas nowadays," he said.

It is clear, however, that the once-a-day pill will not be right for every patient.

After several years of an AIDS regimen, the virus in a patient's body can develop resistance. Patients who have been on treatment for years often need to switch to more complex regimens than the one in the once-a-day pill. The pill will not be ideal for women of child- bearing age, since it may cause birth defects. And one of the drugs in the regimen can cause a bizarre side effect that bothers some people: exceedingly vivid dreams. "It's like you are there," said Santana, the Atlanta medical worker.

Norbert W. Bischofberger, executive vice president for research and development at Gilead and the man spearheading the one-a-day project, said his firm was "fully committed" to offering the pill at sharply reduced prices in developing countries, noting that it could be a boon for patients without the background to understand a complicated drug regimen.

Source: Buffalo News

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