News (Updated October 19, 2008)

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Gilead 3Q profit surges as HIV drug sales soar

Thursday October 16, 5:26 pm ET

FOSTER CITY, Calif. (AP) -- Biotechnology company Gilead Sciences Inc. on Thursday said its third-quarter profit shot up 27 percent, as sales of its drugs to treat HIV soared. The results topped Wall Street's expectations, and shares gained in after-hours trading.

For the three months ended Sept. 30, net income was $504 million, or 52 cents per share, compared with $398.3 million, or 42 cents per share, in the year-ago period.

Revenue shot up 30 percent to $1.37 billion, from $1.06 billion for the third quarter of 2007.

Analysts polled by Thomson Reuters, on average, expected profit of 49 cents per share on sales of $1.32 billion.

Gilead said sales of its HIV drugs Atripla and Truvada drove its results, rising 39 percent to $1.23 billion. Of that, Atripla sales shot up 77 percent to $427.6 million, and Truvada sales rose 34 percent to $549.1 million. The company also saw increased sales of its Viread, also an HIV drug, Hepsera, which is used to treat chronic hepatitis B, and AmBiosome, which is used to treat fungal infections.

Gilead shares, which closed the regular session up 8.1 percent at $41.39, continued to gain in aftermarket trading, adding $1.11, or 2.7 percent, to $42.50.

 

Scientists bleak about AIDS vaccine prospects

Tuesday October 14, 1:45 pm ET
By Clare Nullis, Associated Press Writer

CAPE TOWN, South Africa (AP) -- The global economic turmoil is likely to take its toll on AIDS research funding and add to the problems plaguing the search for a vaccine against the virus, scientists warned Tuesday.

Anthony Fauci, director of the U.S. National Institutes of Allergy and Infectious Diseases, said it was impossible to predict whether scientists would ever be able to develop an effective vaccine, as they have for other killers such as smallpox and measles.

"Will there be a guarantee that we will get a vaccine in the classical sense? Realistically you can't say that," Fauci said. "But that doesn't mean we are going to give up trying."

Nine hundred experts are attending the international AIDS vaccine conference in Cape Town, at the epicenter of an epidemic that has infected an estimated 33 million people, of whom 5.5 million are in South Africa.

The economic downturn has added to the gloom among experts deeply frustrated by research setbacks. A recent trial showed that one potential vaccine not only failed to prevent infection but appeared to increase the risk of contracting the virus.

Now there is added concern that philanthropic organizations, like the Bill and Melinda Gates Foundation, who have become major players in health and development projects may cut back on funding.

"It's not good news for research in general and vaccine research in particular," Alan Bernstein, head of the Global HIV Vaccine Enterprise, told the Associated Press.

"It has been a very turbulent year."

Fauci said the National Institutes for Health total AIDS budget this year was $1.5 billion of which $491 million was dedicated to vaccine research. This was up from $703 million in 1998, with $115 million for the vaccine, and $223 million in 1988, with 22 million allocated to developing a vaccine in an era when scientists were still optimistic about success.

Fauci said while he did not expect the U.S. government to cut its spending on AIDS, "the increases in the budget that we had hoped for will not be forthcoming."

And he said he feared the financial downturn would impact on the "enthusiasm and ability of philanthropic research and development."

Fauci rejected criticism from "naysayers" who argue that too much taxpayer money has been spent on the vaccine.

"If you can prevent infection, you are preventing the need for a lifetime of expensive drugs," he said, referring to antiretroviral therapy that can prolong people's lives many years. "If you look historicially, vaccines have been the most cost effective health interventions in history and continue to be so."

And he said it would be wrong to divert funding from vaccine research -- as some prominent scientists have argued -- into male circumcision which can reduce HIV transmission by up to 60 percent.

"We tend not to think of either or," he said.

Dramatic results from trials into male circumcision prompted the United Nations last year to recommend that government embrace it as part of their AIDS prevention armory. But African countries that are keen to embark on mass male circumcision complain they lack the resources and the medical expertise needed. Funding programs from international donors are still in their infancy.

 

After setbacks, hunt for AIDS vaccine pushes on

by Fran Blandy Fran Blandy Sat Oct 18, 10:55 pm ET

wpe16.jpg (18486 bytes)CAPE TOWN, (AFP) – One year after a puzzling setback in the hunt for an AIDS vaccine, researchers say their defeats have forced them to look for entirely new ways of creating a defence against the disease.

After nearly 30 years, 25 million deaths and billions of dollars spent with no vaccine to show for it, scientists at this year's international AIDS Vaccine Conference said they were turning to novel approaches to overcome their defeats.

"We are in the middle of quite a profound shift of mindset in the research community," said Alan Bernstein, director of the Global HIV Vaccine Enterprise, an alliance of organisations working on a vaccine.

Speaking to AFP on the sidelines of the meeting that ended Friday in Cape Town, he said that startling setbacks had forced scientists to delve into sophisticated new research to tackle the disease.

Last year scientists were forced to abandon two advanced clinical trials of a vaccine by pharmaceutical company Merck, after it appeared to actually heighten the risk of AIDS infection.

"The Merck result was such a surprise and everyone was kind of knocked off their horses... What happened no one could have predicted," Mitchell Warren of the AIDS Vaccine Advocacy Coalition said.

"They still don't understand exactly what happened. That finding forces people to realign and look at new ways and new approaches to how we are going to find an AIDS vaccine because it was so surprising."

About 30 other clinical trials are underway around the world, but the most watched is a study in Thailand that began in 2003, with results expected next year.

That study is the biggest ever, with 16,000 people enrolled. Scientists say that whatever the outcome, it will provide valuable information on the pandemic, which most agree won't see a vaccine for decades.

Meanwhile, Warren says the failure of the Merck trial has already forced scientists to rethink their basic assumptions about how vaccines work.

"People are really grappling with new ways of doing things," he said.

In the past vaccines have either caused the body to develop antibodies that kill a disease, or to attack infected cells to kill them off before a disease spreads.

But HIV mutates at every turn, making it almost impossible to design a vaccine to attack it.

Bernstein said the most exciting new research involves newly discovered defences in the human body called the innate immune system, which serves as an early warning system for invading diseases.

That system could provide a way to stop HIV, if scientists found a way to trigger it early enough, he said.

"We now know we may have only hours, at most days, before we have a window of opportunity to stop HIV. So that's reason to think this early warning system might be critical to activate if we are going to design a vaccine," he said.

The disappointments in the quest for a vaccine have sparked calls for an end to the research, with critics arguing the money could be better spent on other prevention or treatment efforts.

But Anthony Fauci, one of the world's top AIDS researchers at the US National Institutes of Health, insisted that a vaccine would eventually provide the world's best defence against the disease.

The NIH, the main global funder of HIV vaccine research, spent 1.5 billion on the field in 2008.

"If you look historically, vaccines have been the most cost-effective health interventions in history," by preventing the incredible financial burden of treating diseases, Fauci said.

 

TB vaccine trials kick off amid funding woes

Source: IRIN

JOHANNESBURG, 17 October 2008 - Clinical trials of a new tuberculosis (TB) vaccine recently kicked off in Kenya, meanwhile international TB researchers and activists are worried by funding gaps that may worsen in the global financial crisis.

In the first stage of human testing, known as Phase I trials, the new vaccine will be tested for safety on healthy adults with no previous history of TB in Kombewa, near Kisumu in western Kenya .

Researchers hope the candidate vaccine, which has already undergone similar testing in the United States , will improve immunity in people who have already received the standard Bacille Calmette Guerin (BCG) vaccine, created in 1921 and used the world over.

"Many people have been vaccinated with BCG but it is no longer as effective as it once was," said Oya Yavuz, director of corporate communications and investor relations for the Dutch vaccine company Crucell N.V., which has partnered the Aeras Global TB Vaccine Foundation in the testing process.

In Africa , TB is the biggest killer of people living with HIV, who are 50 times more likely than HIV-negative people to develop TB, according to the World Health Organisation (WHO). Without proper treatment, 90 percent of those co-infected with HIV and TB usually die within months, according to the international health body.

According to Yavuz, phase II clinical trials, in which larger samples sizes will be used, should begin in Cape Town , South Africa , in coming weeks. These trials will be conducted in adults with a history of active TB, in the hope that they will show an increased immunity to future episodes of the disease.

Funding worries and silver linings

The trials were announced just days after Francoise Barre-Sinousi, a co-discoverer of AIDS and recent Nobel Prize winner, told international journalists that the current global financial crisis could lead to further funding shortfalls in the fight against TB.

The declining US dollar and the global financial uncertainty are expected to slow the pace of TB research said the Treatment Action Group, a US-based AIDS research and policy think-tank. The group released a report earlier this week analysing funding trends from 2005 to 2007, and noted that investment in research and development in the TB field was slowing, and said this was likely to be exacerbated by the devaluing dollar.

Judith Mandelbaum-Schmid, spokeswoman for the Stop TB Partnership, said she could not comment on the impact of the crisis on the fight against TB, but said a funding shortage was apparent long before the current economic meltdown.

The WHO's annual stock-taking report on the fight against TB, released in March, cited the stagnation of funding in all but five high-burden countries, creating a global funding gap of at least a $328 million, which was likely to widen.

However, not all the news is bad. Hassan Mahomed, clinical director for the South African TB Vaccine Initiative at the University of Cape Town, agreed with Mandelbaum-Schmid that it might be too soon to tell how funding would be affected, but commented that so far there had actually been a slight benefit for foreign-funded researchers.

"There has been a paradoxical beneficial effect because of the weakening of the [South African] rand against the dollar and [British] pound," said Mahomed, who has seen the dollars and pounds funding his research going farther as the rand weakened.

 

 

 

Brazil's President in Mozambique to launch AIDS drug factory

Thu Oct 16, 2:37 pm ET

wpe13.jpg (9709 bytes)JOHANNESBURG (AFP) – Brazil's President Luiz Inacio Lula da Silva arrived Thursday in Mozambique to launch a project to make anti-AIDS drugs in the southern African country, the foreign ministry said.

Brazil, long considered a model in the fight against AIDS, will invest 23 million dollars to build a factory to produce generic medications, the foreign ministry said.

Lula will sign the deal launching the project on Friday, with production of drugs expected to begin before the end of 2009.

He is also due to preside over the opening of an office for the Oswaldo Cruz Foundation, known as Fiocruz, which is managing the project.

The factory will be built with Brazilian technology, but the raw materials to produce the drugs will come from India, a ministry spokesman told AFP.

"Brazil plans to invest 23 million US dollars (17 million euros) in four phases in the Maputo factory. About four million dollars has been earmarked for the first stage of the project, and that money will be available by the end of this year," the spokesman said, speaking on condition of anonymity.

The factory will produce eight anti-retroviral drugs. Mozambican technicians will be trained by Farmanguinhos, a Fiocruz laboratory, which is attached to the Brazilian health ministry.

When the two countries signed the deal last month, Brazilian authorities said they planned for the factory to supply drugs across Africa.

According to government figures, Mozambique's HIV prevalence rate among the 16-to-49 age group is estimated at more than 16 percent.

Experts once feared that Brazil could suffer a similarly severe epidemic, but now only 0.61 percent of Brazilians in the same age bracket are infected with AIDS.

Brazil has undertaken aggressive prevention programmes and about one-third of Brazilians living with AIDS receive free treatment.

 


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