News (Updated January 31 2010)

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Vaccine 'could cut HIV TB deaths'

A vaccine could cut tuberculosis cases among HIV-positive Africans by almost two-fifths, a US study suggests.

The lung infection is the most common cause of death among HIV patients in the continent.

Journal Aids reports that Dartmouth Medical School research involving 2,000 people found significantly fewer TB cases in vaccinated patients.

An expert said the jab could be a cheaper option for countries struggling to find money for extra anti-HIV drugs.

“ TB is a massive problem - a third of people living with HIV in Africa are infected with it ”
Alvaro Bermejo, International HIV/Aids Alliance

HIV patients are particularly vulnerable to TB because their immune systems are compromised.

The vaccine works by boosting the immune responses of patients who have already been given the BCG vaccine earlier in life.

In itself, the BCG jab may offer some protection against TB, but this is far from certain, and protection may only last a few years after immunisation.

The researchers from Dartmouth Medical School in the US tested it among 2,000 HIV positive patients in Tanzania over a seven-year period.

The number of confirmed TB cases was 39% lower in the vaccinated group.

First vaccine

Professor Ford von Reyn, who led the study, said it was a "significant milestone".

One theory now suggests that patients could be given the booster jab as soon as they are diagnosed with HIV, before antiretroviral drugs are needed.

Alvaro Bermejo, executive director at the International HIV/Aids Alliance, said that the other way of fighting TB in HIV patients might be to give them antiretrovirals earlier, an expensive option compared with a vaccination programme.

He said: "This is a very important finding - it is the first time we are going to have a vaccine which is influential in preventing opportunistic infections in HIV patients.

"TB is a massive problem - a third of people living with HIV in Africa are infected with it.

"The reduction of 39% seen in Tanzania , although not fabulous, is a good result."

Scientists say crack HIV/AIDS puzzle for drugs

* Study solves puzzle that eluded scientists for 20 years

* Finding should help development of new HIV/AIDS medicines

* Allows scientists to see how Merck and Gilead drugs work

By Kate Kelland

LONDON, Jan 31, 2010 (Reuters) - Scientists say they have solved a crucial puzzle about the AIDS virus after 20 years of research and that their findings could lead to better treatments for HIV.

British and U.S. researchers said they had grown a crystal that enabled them to see the structure of an enzyme called integrase, which is found in retroviruses like HIV and is a target for some of the newest HIV medicines.

"Despite initially painstakingly slow progress and very many failed attempts, we did not give up and our effort was finally rewarded," said Peter Cherepanov of Imperial College London, who conducted the research with scientists from Harvard University .

The Imperial and Harvard scientists said that having the integrase structure means researchers can begin fully to understand how integrase inhibitor drugs work, how they might be improved, and how to stop HIV developing resistance to them.

When the human immunodeficiency virus (HIV) infects someone, it uses the integrase enzyme to paste a copy of its genetic information into their DNA, Cherepanov explained in the study published in the Nature journal on Sunday.

Some new drugs for HIV -- like Isentress from Merck & Co <MRK.N> and elvitegravir, an experimental drug from Gilead Sciences <GILD.O> -- work by blocking integrase, but scientists are not clear exactly how they work or how to improve them.

The only way to find out was to obtain high-quality crystals -- a project that had defeated scientists for many years.

"When we started out, we knew that the project was very difficult, and that many tricks had already been tried and given up by others long ago," said Cherepanov.

"Therefore, we went back to square one and started by looking for a better model of HIV integrase which could be more amenable for crystallisation."

The researchers grew a crystal using a version of integrase borrowed from another retrovirus very similar to its HIV counterpart.

It took more than 40,000 trials for them to come up with one a crystal of sufficiently high quality to allow them to see the three-dimensional structure, they said.

They tested the Merck and Gilead drugs on the crystals, and were able to see for the first time how the medicines bind to, and block, integrase.

Almost 60 million people have been infected with HIV and 25 million people have died of HIV-related causes since the beginning of the AIDS epidemic. There is no cure and no vaccine, although drug cocktails can keep patients healthy.

United Nations data for 2008 show that 33.4 million people had HIV and 2 million people died of AIDS. The worst-affected region is sub-Saharan Africa , accounting for 67 percent of all people living with HIV.

(Editing by Michael Roddy)

Merck reps banned from US AIDS clinics over drug costs

Jan 25, 2010

WASHINGTON (AFP) - The largest US HIV/AIDS health care provider on Monday accused Merck Pharmaceuticals of price-gouging its AIDS treatment Isentress and banned the drug giant's sales reps from its clinics in protest.

"We've banned representatives from Merck Pharmaceuticals from calling on our physicians in our clinics, which is a common marketing strategy. We are instituting this ban largely because of the egregious pricing policies for their key AIDS drug, Isentress," Ged Kinslea, communications director for the AIDS Healthcare Foundation (AHF), told AFP.

"The drug is a good drug, it has fewer side effects... but it is the single most expensive first-line anti-retroviral treatment for AIDS available in the United States and the developing world," said Kinslea.

An annual course of Isentress costs in the region of 12,870 dollars in the United States , according to AHF.

In Africa, the continent the worst-hit by the global AIDS pandemic, Isentress costs "about 1,100 US dollars per patient, per year and that's about 20 times more than other AIDS drugs in Africa ," said Kinslea.

Isentress was brought to market in the United States in 2007 as a so-called salvage therapy drug -- a treatment for patients for whom other AIDS therapies have not worked or who only sought treatment in the late stages of illness, AHF said.

Last year, the US Food and Drug Administration approved Isentress as a first-line treatment for AIDS, "but the pricing remains at the expensive, salvage-therapy price," said Kinslea.

In the United States , salvage therapy patients account for between 50,000 and 80,000 of the 1.1 million people thought to be HIV positive.

Because the market for salvage therapy is just a fraction of the overall AIDS treatment market, pharmaceutical companies sell their last-chance drugs for a higher price than so-called first line treatments.

When Merck was contacted about the price-gouging accusations, a media representative referred AFP to a statement issued by the company two weeks ago.

In the statement, Merck said AHF's accusations were false, and insisted it had priced Isentress "responsibly ... after consultation with respected leaders in the HIV community."

Gilead Sciences' 3-in-1 HIV treatment became its top drug

January 26, 2010

FOSTER CITY, Calif. (AP) -- Gilead Sciences Inc. said Tuesday its profit climbed 43 percent in the fourth quarter due to rising sales of its three-in-one HIV drug Atripla.

The company said sales of Atripla, which was approved in the U.S. in July 2006, jumped 50 percent compared to the fourth quarter of 2008. It said Atripla became its best-selling drug during the quarter, as revenue surpassed that of an older drug, Truvada.

Gilead said its profit rose to $802.2 million, or 87 cents per share, from $560 million, or 59 cents per share. Excluding restructuring costs the company earned 93 cents per share. Its revenue grew 42 percent to $2.03 billion from $1.43 billion.

According to a Thomson Reuters estimate, analysts expected a profit of 85 cents per share and $1.93 billion in revenue.

Total HIV drug sales advanced 27 percent to $1.62 billion, the company said. Sales of Atripla rose to $697.8 million, and Truvada revenue increased 19 percent to $670.7 million. It also reported $178.3 million in sales of Viread, which was first approved as an HIV drug but was recently cleared as a treatment for hepatitis B. Viread sales picked up 10 percent.

Truvada is a combination of Viread and another Gilead drug, Emtriva. Atripla contains those two drugs and adds a third, Bristol-Myers Squibb Co.'s Sustiva.

Gilead said revenue from its high blood pressure drug Letairis rose 44 percent to $52.2 million, and sales of the angina drug Ranexa totaled $46 million. Revenue from other products, including the fungal infection treatment AmBisome, hepatitis B drug Hepsera, and Emtriva, an older HIV drug, slipped to $159.5 million.

For the year, Gilead said its profit grew 33 percent to $2.64 billion, or $2.82 per share, from $1.98 billion, or $2.06 per share. Revenue increased 31 percent, to $7.01 billion from $5.34 billion.

Bristol-Myers, now a pure pharma, to post results

By LINDA A. JOHNSON, AP Business Writer an 26, 2010

TRENTON , N.J. – Bristol-Myers Squibb Co., the world's No. 15 drugmaker by revenue, reports fourth-quarter earnings Thursday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: Like many other pharmaceutical companies, Bristol-Myers is seeing generic competition cut into sales of some of its top drugs, with more competitors to come — particularly in 2012. That's when blood thinner Plavix, the world's second-bestselling medication, loses U.S. patent protection.

But unlike most of its competitors, the New York company has chosen to narrow its focus, transforming itself into a biopharmaceutical company with its "String of Pearls" strategy to acquire biotech drugs. Other companies instead are diversifying by entering businesses such as vaccines or consumer and animal health products.

Toward that end, in December Bristol traded away its remaining shares in its former Mead Johnson infant nutrition business. Bristol-Myers traded its remaining 170 million shares of Mead Johnson stock to investors who owned Bristol-Myers shares, then retired those shares. That enabled Bristol to reduce the number of its outstanding shares to 1.7 billion from about 1.98 billion, a move that will boost earnings per share this year.

The tax-free, cashless transaction, coming shortly after its $2.1 billion September acquisition of Medarex Inc., leaves Bristol a purely biopharmaceutical company. Medarex has promising antibody technology used to make biologic drugs and is developing treatments for immune system diseases and cancer.

But right after the Mead Johnson transaction, Bristol reduced its forecast of earnings per share from continuing operations for all of 2009, to $1.51 to $1.56, compared to a previous range of $1.72 to $1.77.

Bristol still has more than $8 billion available for deals.

In November, it signed one worth up to $1 billion over time with Alder Biopharmaceuticals Inc. to develop the latter's experimental drug for rheumatoid arthritis.

Bristol-Myers also got U.S. approval to sell Abilify, its No. 2 drug, to treat autism-related irritability in children aged 6 to 17.

Also during the fourth quarter, it launched its new diabetes drug, Onglyza, in Europe . The drug, which competes with Merck & Co.'s blockbuster Januvia in the DPP-4 inhibitor class, was launched in the U.S. last summer.

BY THE NUMBERS: Analysts polled by Thomson Reuters expect, on average, earnings per share of 41 cents and revenue of $5.12 billion. In the year-earlier period, earnings per share were 63 cents, partly because of a one-time 17-cent gain, while revenue was $5.25 billion.

ANALYST TAKE: Analyst Steve Brozak of WBB Securities says the company's December reduction in its profit forecast "pretty much said it all."

"They have the cash to buy products, partnerships, other companies," and need to start doing so frequently, he said, adding that he really liked the Medarex acquisition.

"That did show some vision," Brozak said.

UBS analyst Marc Goodman is more positive, noting the company's sales growth is diversified, coming from several products "with solid growth potential, including Orencia for rheumatoid arthritis, Onglyza, No. 2 seller Abilify for schizophrenia, plus cancer and HIV drugs.

"We like the specialty pharma, partner-driven business model to diminish risk and believe management will continue to do smart, strategic, and accretive deals," Goodman writes.

He says the company has three drugs in development that could drive growth after Plavix, taken by millions to prevent heart attacks, gets U.S. generic competition. Goodman sees a modest rise for the stock, now at about $24.50, with a 12-month target price of $27.

"Management has done a good job extracting value from the Mead Johnson split-off," Goodman adds.

WHAT'S AHEAD: Analysts will be watching to see how well Onglyza sells, given Januvia's big head start and heavy marketing.

Bristol is awaiting approval of belatacept, its heavily touted experimental drug to prevent rejection of kidney transplants, in May.

And the company also has data on several drugs coming out soon, including a study testing its Sprycel, which is approved for patients with chronic myeloid leukemia who weren't helped by other treatments, in patients newly diagnosed with the cancer. That study compares Sprycel with Gleevec, a blockbuster cancer drug sold by Novartis AG.

Theratechnologies says FDA delays fat drug review date

Reuters Jan 25, 2010 - Theratechnologies Inc, a Canadian biotechnology firm, said U.S. health regulators will reschedule its meeting to review its marketing application for tesamorelin to treat excess abdominal fat in HIV-infected patients with lipodystrophy.

The Montreal-based company said the Food and Drug Administration's delay is entirely procedural and is not related to the marketing application submitted in May last.

The meeting was originally scheduled for Feb. 24 and the FDA is to complete its review of the New Drug Application by March 29 under the Prescription Drug User Fee Act.

AFRICA : HIV prevention gel fails huge clinical trial

31 January 2010

Following the world's largest international clinic trial into an HIV preventative gel, scientists have concluded that it is not effective. The four-year trial was conducted in four African countries, ended in September last year, involved 9,385 women and proved controversial in Zambia .

The discouraging findings follow a previous smaller trial in the US . It concluded that the vaginal microbicide PRO 2000 could reduce the risk of HIV infection by 30%.

But in a statement last month the Microbiocides Development Programme or MDP said clinical trials carried out at six research centres in Zambia, South Africa, Tanzania and Uganda revealed that the risk of HIV infection in women supplied with PRO 2000 gel "was not significantly different than in women supplied with placebo gel". The gel was provided by the US company Endo Pharmaceuticals.

"Vaginal microbicide is a product intended for use before sexual intercourse to help reduce HIV infection, as it is clear that condom promotion alone has not controlled the epidemic," said the MDP, a not-for-profit partnership of 16 African and European research institutions.

"The gel was given to participants together with a package of prevention against HIV infection that included free condoms, counselling for safer sex negotiation and sexual health throughout the trial," it added in a statement.

Participants in the trial - funded by the UK Department for International Development and the Medical Research Council - were randomly assigned to a PRO 2000 gel or placebo gel group, and were asked to use the gel before each sexual act. They were evaluated regularly and are being informed of the outcome.

The MDP said no microbicide had yet been shown to be effective against HIV infection. "This trial shows conclusively that PRO 2000 gel is of no added benefit, ending scientific speculation about its clinical importance."

Dr Sheena McCormack of the Medical Research Council, chief investigator of the trial known as MDP 301, described the results as disheartening. "Nevertheless we know this is an important result and it shows clearly the need to undertake trials which are large enough to provide definitive evidence for whether or not a product works."

Dr Maureen Chisembele, principal investigator of the Zambian site, said nearly 60% of all people living with HIV-Aids in sub-Saharan Africa were women, who would also be disappointed by the result.

Following the 14 December announcement, a research ethics committee in Zambia moved to dismiss claims that 46 out of 1,332 Zambian women involved had been infected with HIV as a result of their participation in the research.

University of Zambia Biomedical Research Ethics Committee acting chair Dr James Munthali said in a statement there was no cause to believe this was true. The trial had been approved, had met all ethical requirements and had followed well-documented procedures "such as six-monthly progress reports, annual renewals, adverse events reporting, protocol deviations reporting and reports from an independent Data and Safety Monitoring Board".

The results of the trial will be presented at international conferences and published in a peer-reviewed scientific journal.

Zambia : Halt HIV/AIDS Microbicide testing – Chief Mwanachingwala

Chief Mwanachingwala of Mazabuka has asked Microbicide Development Programme (MDP)’s management to stop any further clinical trials on the prevention of HIV/AIDs in the district as they are helping the situation.

The Chief said during a heated District Development Coordinating Committee (DDCC) co-chaired by District Commissioner, Tyson Hamaamba and Mayor, Shadreck Mwiinga that MDP should consider conducting the trials elsewhere and not in Mazabuka.

This was after the chief asked MDP officials to tell the meeting whether there is a microbicide that is currently effective to block the transmission of the virus on women.

The Chief said it was wrong for the MDP to continue conducting clinical trials when the drugs are not helping in blocking HIV transmission but increasing its incidence rate as the poor and illiterate women think the drugs would help in blocking the transmission of the virus.

A number of HIV/AIDS negative women volunteer became positive after being the MDP injected them with the microbicide believed to be potent against the virus.

The development has caused an up roar in sections of society with the traditional leader being in the lead against the campaign.

Meanwhile, various stakeholders took MDP to task to explain what mechanism have been put in place to compensate the women that contracted HIV and AIDs during the failed clinical trial.

The stakeholders observed that it would be unfair for the organisation abandon the victims without helping them.

But MDP Project Coordinator, Rose Kasonde said the organisation would not abandon the victims.

Dr Kasonde said all the victims would receive counselling services and would be refered to the government health centres offering Anti Retroviral Therapy.
ZANIS

Canada , Gates Foundation scrap HIV vaccine plant

The Canadian Press
 
Jan. 28 2010

TORONTO — The federal government and the Gates Foundation have agreed not to proceed with plans to fund construction in Canada of a facility to make pilot lots of experimental HIV vaccines, sources have told The Canadian Press.

Several sources said that portion of the Canadian HIV Vaccine Initiative will not proceed at this time, but the two parties are committed to finding other ways to collaborate in the as-yet elusive quest for an HIV vaccine.

The project, first announced in February 2007, was to cost nearly $90 million, with $28 million of that coming from the Gates Foundation. It was part of the larger Canadian HIV Vaccine Initiative, a project for which Canada had earmarked $111 million.

Confusion has surrounded the future of the proposed vaccine production facility since late last week, when four short-listed groups were notified they were not successful in their bids. A statement announcing that the project would not go ahead was briefly posted on the Public Health Agency of Canada's website, but was quickly pulled down.

Neither the federal government nor the Gates Foundation has confirmed that the decision has been taken. And neither Prime Minister Stephen Harper nor Bill Gates, billionaire founder of the Gates Foundation, would take questions on the issue after they met privately Thursday at the World Economic Forum in Davos , Switzerland .

But the issue was reportedly on the agenda for the meeting.

"My understand is that both the Gates Foundation and the government of Canada -- and I can't speak for either one of them of course -- my understanding is both of them remain committed to a partnership," said Dr. Alan Bernstein, executive director of the New York-based Global HIV Vaccine Enterprise.

"And that they're now going to have a fresh look at the partnership in the light of several things."

Bernstein, a Canadian, is the former head of the Canadian Institutes of Health Research and as such is well acquainted with research capacity and facilities across the country. He said the decision not to go ahead was based on the calibre of the bids that came forward.

"My understanding is that they looked at the applications and decided that they weren't acceptable, for reasons that I don't know. And I really don't know," he insisted.

The short-listed groups were from the International Centre for Infectious Diseases, based in Winnipeg; the International Consortium on Anti-Virals, based at Trent University in Peterborough, Ont.; Laval University in Quebec City and the University of Western Ontario in London.

Three of the four bidders have acknowledged publicly they were informed by the head of the Public Health Agency of Canada, Dr. David Butler-Jones, that their bids were rejected. And a couple have indicated they were told it was due to shortcomings in the bids.

It appears other issues may have also played into the decision, among them questions about whether the special manufacturing facility was the best way to spend the available money.

The idea behind the plant was that there was a belief there was insufficient capacity, globally, to make pilot lots of future experimental HIV vaccines. Pilot lots are required for the clinical trials needed to prove whether a vaccine is safe and works and can be licensed.

The plant would not have been used to make commercial lots of HIV vaccines if and when any are brought to market; that would be the job of the pharmaceutical industry.

But Bernstein said it isn't clear how great the need for test lot production capacity actually is. There are commercial contractors who can make pilot lots of vaccine, if future HIV vaccine candidates are made in traditional ways, he said.

If a more novel technique is used, getting test lots made might be more difficult, Bernstein acknowledged. But given that it's not clear what techniques will be used to make future HIV candidate vaccines, how many there will be and how soon they will come forward, "the demand ... is at best unclear and it needs a careful look."

Bernstein said the issue of how to make pilot lots of future HIV vaccines is being looked at as part of his organization's review of its strategic plan. That review is currently underway.

The Canada-Gates Foundation partnership was structured in such a way as to fit in with the goals of an earlier iteration of the Global HIV Vaccine Enterprise's strategy plan, he said.

While Bernstein acknowledged the decision will be a bitter blow to the consortiums that hoped to secure the project, he doesn't see the decision as a setback in the search for an HIV vaccine.

"I don't think that's entirely a bad thing, because time has moved on and science moves on," he said.

"And so while the applicants might be disappointed, understandably, I think the basic elements of the (Canada-Gates) partnership are intact.... This is a major commitment on the part of the government of Canada to HIV vaccines."

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