Australian researchers report HIV therapy breakthrough

The researchers' study has been published in the latest international Journal of Virology.

New study brings good news about AIDS drugs

"But on the other, people in African countries are likely to be very adherent to therapy if they can get access to treatment, because it is so difficult to get hold of. So the outcome should actually be good."

HIV Patients May Run Out of Drug Options - Study

Thu Mar 3, 2005 07:07 PM ET

LONDON (Reuters) - A growing number of HIV patients in Britain are in danger of running out of treatment options because their virus has become resistant to the drug combinations they have been taking, scientists said on Friday.

A study of more than 16,000 patients treated between 1996 and 2002 showed more and more are running the risk of exhausting all options after switching drug cocktails several times, and will depend on the development of new drugs.

"If you are looking at the number of all patients treated for HIV in the UK, you find 5 to 6 percent who we believe have experienced treatment exhaustion," Professor Caroline Sabin, who headed the study, told Reuters.

"We need to continue to monitor the situation. There needs to be new drugs that are easier to take and less cross-resistant to other drugs."

Most HIV patients are treated with a combination of drugs called highly active antiretroviral therapy (HAART) to help suppress the virus and keep it from damaging the immune system. But resistance develops eventually in most patients.

With only three main classes of drugs used in mainstream HIV treatment, combinations can become exhausted said Sabin, an epidemiologist at London's Royal Free and University College Medical School, who reported the findings in the British Medical Journal.

"While the patient had it under control at some stage, the drugs may (eventually) fail and the patient will need a different combination," Sabin said.

Let The Market Find A Cure For AIDS
Dr. Scott Gottlieb, Forbes/Gottlieb Medical Technology Investor, 03.01.05, 6:30 AM ET


NEW YORK - At the Annual Retrovirus Conference, which ended its 12th get-together last Friday in Boston , there is always an air of optimism, as new drug discoveries are revealed, and researchers report steady progress in battling HIV, the virus that causes AIDS. But this year's mood was bleaker, amid reports of the rising prevalence of virus strains resistant to some or all of our best medicines. It is now clear that the virus, which mutates rapidly to evade our best drugs, may be gaining an advantage over the research community that's trying to fight it.

While there is ample private research into new AIDS medicines, and there are promising therapies in the pipeline, many of the biggest drug companies have scaled back the investments they once made, in lieu of other unmet medical needs with equal or better payoffs and less political risk--such as cancer, Alzheimer's and heart disease. In fact, much of the highly novel work on AIDS is coming out of the biotech industry, which is more able to take outsized risks and less prone to predatory politics. But the collective work of biotechs, however, is still no substitute for the deep resources of the big drugmakers.

Novel work is going to take on increasing importance in the coming years, and policymakers who have shown reckless regard for the costly nature of drug research had better take notice. Nearly 18 years after the first HIV drug hit the market, all of the 20 distinct medicines we have address the same three targets on the same two HIV genes. In fact, 11 of the 20 drugs target proteins that are coded for the same exact gene in HIV, called pol, making it easy for the virus to alter a single gene in its genetic code and to evade most of our best medicines.

The good news: There are nine HIV genes in all, and only one--pol--has been thoroughly picked over. Two of the other nine genes, gag and eng, have been worked on some, but the other seven remain un-drugged, giving researchers plenty of completely new turf on which to work. These include the regulatory genes named tat, rev, nef and vpr, which are all thought to regulate the speed by which HIV is able to replicate itself, and the "accessory" genes vif and vpu, which are less well understood, but believed to control its ability to infect people.

Most of this novel development work is going on inside a few dozen small biotech companies with hardly household names, such as Progenics Pharmaceuticals, Tanox and Panacos Pharmaceuticals (see table below).

In recent years, international health groups, such as the World Health Organization (WHO), and health officials in European and African nations have sought to appropriate the patent rights to AIDS medicines, allowing generic-drug makers, such as India-based Cipla, carte blanche to flout international patent laws and produce knockoff versions of many drugs. The public health goals are noble--to make effective drugs available to impoverished people stricken with AIDS. But there are better ways to subsidize access without arbitrary threats of property seizure. Amid these challenges, being in the industry of producing new medicines for HIV has become fraught with some unusual business risks.

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While most drugmakers have stepped in to make their HIV treatments available to developing countries at no-profit prices, they have not been willing to sign on to schemes that put at risk profits in first-world markets that should have the ability to fund the expensive R&D enterprise that produces these drugs. This has often put drugmakers at odds with international groups, like the WHO, which have been eager to give away today's medicines with scarce regard to what it does to the incentives that keep investment capital flowing into new development.

Biotech companies and the investors that back them already embrace outsized bets on risky markets and very early-stage science fraught with uncertainty. For these investors, political risks are a smaller measure. But for the big drugmakers, who take closer stock of the business climate, politics weighs more heavily.

While there is still plenty of profit to be made from better HIV drugs, not to mention a powerful public health mission, political risk is one more calculation considered when big companies allocate increasingly stretched R&D budgets across different diseases. And for those who believe government-funded research will fill the gap, our own National Institutes has a comparatively slim track record to the private sector, given the enormous sums it, too, has spent.

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There is a model for what happens when politics invades business practices. European nations chased their big drug industry to our shores through decades of predatory policies just like those being aimed at makers of AIDS drugs. Having realized what they wrought, the Europeans are now bending over backward to coddle the burgeoning biotech companies that are growing up in the void.

For Europe , it may be too little too late. The robust life-sciences sector they squandered may be gone for good. If present policies continue around the globe, the same may soon be true for HIV drug development in the world of big pharma.

Scott Gottlieb is a physician and editor of the Forbes/Gottlieb Medical Technology Investor. He is a fellow at the American Enterprise Institute and a former senior official at the U.S. Food and Drug Administration and Medicare program. Dr. Gottlieb may own stock or consult with firms that advise the companies mentioned in this article.

U.S. Says Expects to Approve More Generic AIDS Drugs

Wed Mar 2, 2005 05:05 PM ET

By Anna Willard

WASHINGTON (Reuters) - The United States expects to approve more generic AIDS drugs in coming months, the head of U.S. AIDS policy said on Wednesday, a move which would allow them to be included in a $15 billion U.S. anti-HIV program.

South Africa's Aspen Pharmacare, Africa's biggest generic drugs maker, in January became the first company to win regulatory approval from the U.S. Food and Drug Administration for its life-prolonging AIDS drugs.

Activists have urged the FDA to speed up the process so that millions of people in poor countries living with the disease can have access to the drugs, less expensive copies of branded drugs developed in the United States and elsewhere.

U.S. Global AIDS Coordinator Randall Tobias told the House of Representatives Appropriations subcommittee on foreign aid he expected more approvals to follow the Aspen Pharmacare decision.

"We have put a lot of effort into hand-holding with generic companies around the world to encourage them so my guess is in the next few months we will see more generics approved," he said. "The first company to apply was approved ... and we expect more."

Last year, the United States announced a fast-track scheme for copycat drugs to get the FDA seal of approval for safety and quality, a move that allows recipients of U.S. grants to use the cheaper medicines rather than brands in developing countries.

Activists are skeptical about the agency's role since the World Health Organization already has its own "pre-qualification" scheme for AIDS drugs and they say the FDA is moving too slowly.

"Cost effectiveness is very important but the Bush Administration's process has turned out to be anything but fast track," said David Bryden, director for the Global AIDS Alliance. "It has yet to provide any meaningful results and the (Aspen Pharmacare) drug in question is still not in use in any of the affected countries."

Generic antiretroviral drugs can costs as little as $140 per patient a year in poor nations compared to $470 for branded products, according to ActionAid.

About 38 million people worldwide, including 25 million in sub-Saharan Africa, are living with HIV/AIDS. The number of people receiving the drugs in poor countries has jumped 75 percent in the past year, according to the United Nations.

OTHER COUNTRIES MUST PAY

The Bush Administration's $15 billion five-year AIDS initiative targets select countries in Africa and the Caribbean and Vietnam.

The United States also contributes to a separate Global Fund to fight AIDS, Tuberculosis and Malaria. The size of the U.S. contribution depends on the contributions made by other countries, with Washington funding up to a maximum of one third of the fund's overall operating budget.

Tobias said it was not clear whether donations from other countries would allow the United States to use all of the $435 million Congress has set aside for the fund in the budget for the 2005 fiscal year.

"We really need to encourage the rest of the world to step up," he said.

The Bush Administration has until July 31 to decide how much of the money it will use.

Bush asked for $300 million in its budget for the 2006 fiscal year which starts on Oct.1, far less than the $1.5 billion the fund was hoping for.