Activists have recently been joined in demanding such action by leading investors, who fear a failure to respond adequately could damage company reputations and jeopardize future profits.

GSK's second price cut in seven months brings the cost of Combivir to governments, non-governmental organizations and many employers down to 90 U.S. cents per patient a day from $1.70.

The medicine -- a combination of AZT and 3TC -- is central to many triple-drug therapies that have turned HIV infection into a manageable condition in the West but are largely unavailable in developing countries.

The price for the two component drugs, when sold separately, will also come down by 38 and 45 percent respectively to 75 and 35 cents a day in the 63 countries eligible for the scheme.

British-based GSK, which has stated in the past it would not sell AIDS drug sales at a profit in the developing world, said the price cuts were made possible by continuing improvements in manufacturing processes and economies of scale.

Industry critics were skeptical of this.

"Glaxo may say they have found some new way to bring down the price, but it's kind of funny when you consider that two years ago generic companies had already figured out how to make it at a much lower price," said Daniel Berman of Medecins Sans Frontieres.

Berman said any price reduction was welcome, and cheaper Combivir would be a particular help in those countries where generic -- or non-patented -- products were not available.

But GSK's medicine remained more costly than generics, with India's Ranbaxy Laboratories Ltd. offering the same treatment at 73 cents a day in a tablet approved by the World Health Organisation, he said.

TINY SALES

Equity analysts said the move would not have any financial impact for GSK. UBS Warburg estimates its sales of HIV drugs to the developing world are under 40 million pounds ($63.82 million) a year, or less than 0.2 percent of group revenue.

Richard Feachem, executive director for the Global Fund to fight AIDS, Tuberculosis and Malaria said GSK's move was another step toward expanding access of antiretrovirals to millions of people who needed them.

"This must be matched by increased resources to finance the purchase of medications," he said in a statement.

Despite steep price cuts for poor countries in recent years and competition from generics, combination therapy remains out of reach for the vast majority of those in the developing world.

The AIDS pandemic has killed 3.1 million people around the world and 42 million people were estimated to be living with HIV/AIDS at the end of 2002, 29.4 million of them in Africa.

UNAIDS, the United Nations agency spearheading the battle against the disease, calculates that by 2007 the world will have to find some $15 billion a year to successfully treat and combat AIDS in low and middle income countries.

S.AFRICAN CONCERNS

In South Africa, which with some 4.7 million people infected has the highest AIDS caseload, activists said GSK's price cuts did not go far enough.

Nathan Geffen, a spokesman for the Treatment Action Campaign, said the move would have little impact because the South African government has so far refused to provide AIDS drugs in public hospitals.

"The bad thing is that this still doesn't apply to the private sector, and that is the only place where most South Africans can get their antiretrovirals at the moment," he said.

South Africa's AIDS emergency would continue to worsen until there was full competition with generics, he added.

DNA-C contains DNA that codes for particular proteins that are part of the viral cell, according to Kraehenbuhl, a researcher at the Institute of Biochemistry at Lausanne University.

"We are going to inject genetic information from the AIDS virus to trigger antibodies in the host's cells," he told Reuters Health.

Kraehenbuhl said about 160 healthy volunteers -- half in London and half in the Swiss city of Lausanne, where EuroVacc is based -- will test the vaccine for safety in June and early next year.

Half of the group at London's St. Mary's Hospital, Imperial College and half of the group at Lausanne University Hospital's clinical immunology department will test DNA-C, and the others will test the NYVAC vaccine, he said.

In a second trial slated for 2004, healthy volunteers will receive DNA-C as a primer followed by a NYVAC booster, again to test for safety. Pre-clinical trials have shown that NYVAC can prevent viral infection in macaques.

In 2005, the DNA-NYVAC combination will be tested in new trials in Switzerland, the Netherlands, the UK, Spain, Italy, Germany and Sweden, using hundreds of volunteers who are at high risk of HIV infection -- including homosexuals, drug users and sex workers.

Volunteers' rate of infection will be monitored and compared with others from similar groups who have not been given the vaccine.

If the vaccine is effective, EuroVacc will then vaccinate large sections of the population in Tanzania, Rwanda, South Africa, China and Russia.

More than 30 research teams in eight European countries have been involved in the EuroVac program, which started in 2000 and was precursor to the EuroVacc Foundation, founded in 2002. The organization had to add a second "c" to the end of its name to avoid confusion with the EuroVac vacuum cleaner company.

Scientists think an effective vaccine against HIV, which has infected more than 40 million people worldwide, is the only hope for controlling the disease. But VaxGen's AIDSVAX, the only candidate vaccine so far to reach the last stage of clinical testing, has failed to protect most of those in whom it was tested.

 

Press Release

Source: Agouron Pharmaceuticals, Inc.

FDA Approves New, More Convenient Formulation Of Widely Used HIV Medicine, VIRACEPT(R)

Wednesday April 30, 7:03 pm ET

By Ransdell Pierson

NEW YORK (Reuters) - Shares of tiny Epimmune Inc.  jumped on Thursday after Merck & Co Inc. ( agreed to test Epimmune molecules to see if they can stimulate the immune system to fight diseases.

Shares of Epimmune closed up 26 cents, or 22 percent, to $1.46 on the Nasdaq.

Epimmune will deliver Merck samples of its epitopes -- tiny snippets of proteins taken from viruses, bacteria or tumors.

Merck will then use its own drug-delivery technology to see if the epitopes can be used as therapeutic vaccines to coax the body's immune system to attack specific diseases.

Neither company identified the diseases Merck will test the molecules against.

Epimmune, based in San Diego, received an unspecified evaluation fee from Merck, which has not formally licensed the epitopes but could elect to do so in the future if Epimmune is willing.

"The indication so far is that Epimmune's technology can potentially enhance immune response in the body, and that's critical for vaccines," said Merck spokeswoman Janet Skidmore. She declined to provide details of the partnership arrangement.

Epimmune last summer reached a similar arrangement with Aventis Pasteur, the vaccine division of Franco-German drugmaker Aventis SA (AVEP.PA).

It is allowing Aventis to evaluate whether its epitopes could be used as vaccines to stimulate the body to attack tumor cells.

Meanwhile, Epimmune is in the early research stage of using its epitopes to develop its own vaccines to treat lung cancer and HIV, the virus that causes AIDS.

"It would likely take until 2010 or 2011 for our vaccines to reach the market," if they prove successful, Michael McClurg, a senior Epimmune executive, said in an interview.

Vaccines are typically loaded with antigens, which are fairly large proteins found in specific viruses, bacteria or tumor cells that the body's immune system recognizes as foreign matter. Immune-system soldiers, called T-cells, then attack and remove the entire invading organism.

But T-cells often fail to recognize such antigens and therefore do not attack, thereby giving pathogens and tumors continued free reign.

McClurg said his company specializes in identifying highly specific regions of antigens, or epitopes, that apparently can send a much stronger signal to the immune system than the full antigen.

The epitopes, made up of a specific chain of amino acids, are chemically modified by Epimmune to make them even more visible to T-cells, and then used as a therapeutic vaccine.

McClurg said Epimmune, with only enough cash on hand to finance the company's research another nine months to a year, hopes more partnership deals with drugmakers will help finance its activities for years to come.

NEW YORK (Reuters Health) - Despite widespread calls for increased HIV prevention services in prisons, few programs have actually been put in place, according to two Emory University researchers.

Currently, health experts estimate that 25 percent of people living with HIV in the United States pass through correctional facilities each year. And the percentage of prison inmates who are confirmed to have AIDS is four times higher than in the general population, according to the report published in the American Journal of Public Health.

With these facts in mind, public health advocates see correctional facilities as ideal places to instill HIV prevention messages with the hopes of thwarting HIV transmission among prison inmates and among the general population after inmates are released.

In addition, many believe that prisons offer healthcare professionals an opportunity to get HIV- infected individuals into treatment programs.

One primary, but controversial, part of HIV prevention is promoting safer sex practices, including using condoms.

Currently, only two state prison systems -- Mississippi and Vermont -- and five city and county jail systems -- New York, Philadelphia, San Francisco, Los Angeles and Washington, D.C. -- make condoms available to male inmates, according to the authors of the report, Drs. Ronald L. Braithwaite and Kimberly R. J. Arriola, who are both at Emory's Rollins School of Public Health in Atlanta, Georgia.

One possible barrier to an increase in such programs, according to Braithwaite and Arriola, is that there continues to be stigma associated with discussion of HIV and AIDS, particularly in correctional settings where many risky behaviors, such as injection drug use and unprotected anal intercourse, are not allowed.

"Bold and progressive risk reduction policy action is required by correctional policy makers to advance the health and well-being of incarcerated populations and, ultimately, the community at large," they add.

Braithwaite and Arriola recommend that state prisons adopt a mandatory HIV testing system.

To date, only 16 states and the federal prison system have such policies in place. Such testing, the authors contend, could reveal numerous undiagnosed cases of HIV infection that could be treated.

The team also suggests that correctional facilities should take steps to see that inmates continue to receive HIV treatment after they leave prison.

"Some correctional systems supply released inmates returning to their community with only 5 days' medication," they write. "This is woefully inadequate."

In addition, the authors recommend that correctional facilities open their doors to community-based organizations to provide HIV/AIDS education and prevention services. Training programs for prison personnel might also heighten staff sensitivity to the needs of such volunteer educators, they point out.

"Prevention specialists are frequently humiliated and negatively stereotyped by correctional officers," according to the researchers.

Ultimately, only the collaboration between inmates, correctional officials, public health officials and community service providers will help "establish a seamless system of prevention and treatment services that transcends prison walls," Braithwaite and Arriola conclude.

SOURCE: American Journal of Public Health 2003;93:7-11.