UM researchers receive $23.4 million to research AIDS vaccine

Scientists at the University of Maryland School of Medicine will be able to move forward nearly decades-long work on a promising HIV/AIDS vaccine after receiving their biggest research gift ever — $23.4 million from a consortium led by The Bill & Melinda Gates Foundation.
The money was awarded to the university's Institute of Human Virology, headed by Dr. Robert Gallo, who helped discover the human immunodeficiency virus that causes AIDS, and developed the HIV blood test. The funding was announced Thursday at the institute.
Scientists at the IHV began research on the AIDS vaccine in 2002 and have seen major breakthroughs on tests using monkeys.
The vaccine being researched would neutralize many different strains of HIV. The researchers say previous vaccine candidates responded only to single strains or narrow ranges of the disease.
Scientists have long been frustrated by the AIDS virus' ability to mutate. The virus constantly changes the makeup of the proteins on its surface, making it hard for antibodies to attack the disease. Vaccines developed to battle the disease have proved too weak to meet the task.
The IHV vaccine contains a protein that is normally hidden within the AIDS virus but exposes itself when the virus attaches to a cell before attacking it. The protein doesn't change, unlike the proteins on the outer coat of the virus.
The antibodies in the trial vaccine bind to regions common in HIV rather than to the ever-changing protein that may differ in each virus strain.
"Today, we are on the verge on a major breakthrough in HIV/AIDS," said Gov. Martin O'Malley, who announced the grants.
The Bill & Melinda Gates Foundation has donated $16.8 million to the research, while the Army's Military HIV Research Program has given $2.2 million. The National Institutes of Health and others also have contributed funds. The foundation also awarded the IHV $15 million in 2007 to go toward developing the HIV/AIDS vaccine.
A spokesman for the Gates Foundation was not available for comment. To date, the foundation has committed $2.2 billion in grants to HIV/AIDS research, according to a fact sheet provided by the company.
Col. Peter Weina, deputy commander of the Military HIV Research Program, said it decided to partner with the IHV because its current findings seemed promising.
"No one institution is able to do everything well, but by collaborating we can develop the synergies to make a breakthrough we might not be able to do by ourselves," Weina said after Thursday's announcement.
Gallo and scientists at the IHV will conduct the research along with researchers from the Military HIV Program and Sanofi Pasteur, a drug company that specializes in distributing and developing vaccines.
Part of the research will involve testing the vaccine created by IHV scientists to see how it works with a different vaccine tested by Sanofi Pasteur and the Military HIV Research Program in Thailand. That vaccine reduced risk of infection by about a third.
"We thought we might couple them and make theirs work better and help ours as well," Gallo said.
The researchers will also look at how long the vaccine will last in humans. Gallo said it would be hard to provide vaccine boosts to people in Third World countries several times a year.
The money will enable the IHV to move from preclinical work to Phase I and II clinical trials that would include humans.
Initial testing of the vaccine was done by Profectus BioSciences, a Baltimore-based spinoff of the institute which Gallo said will continue to do more testing with the new funding.
Researchers have said they're closer than they have ever been to developing a vaccine.
Medications now enable people living with AIDS to manage the disease and survive for many years. But the drugs are expensive and don't cure people. People with HIV also have a much higher risk of developing certain cancers, such as those of the lung, liver, head and neck.

Top 10 Pharma CEO salaries of 2010

Despite a year fraught with manufacturing issues and drug recalls, Johnson & Johnson CEO Bill Weldon takes the top spot, with $28.7 million in 2010 pay. And Novartis' Daniel Vasella grabs the number two spot thanks to a lucrative golden handshake.
Next year we'll have to say goodbye to a few familiar faces that are making their final appearance on this list. Pfizer's Jeff Kindler won't be back next year, nor will Vasella or Richard Clark of Merck. All of these CEOs will be replaced by new executives that will appear on the list. For example, Ian Read, Pfizer's new CEO, earned more than $17 million last year, even though he didn't become CEO until Dec. 5. George Scangos, formerly of Exelixis and now Biogen Idec CEO, was paid $9.4 million last year--and he didn't come on board until more than halfway through the year.
Others are waiting, too. Allergan's David Pyott ($12.7 million), Bristol-Myers Squibb's Lamberto Andreotti ($11.8 million) and Baxter's Robert Parkinson ($11.5 million) were close to making the list. Click below to get all the details on the top 10 highest paid biotech and pharma CEOs of 2010.
1. Bill Weldon - J&J - $28.7M
2. Daniel Vasella - Novartis - $27M
3. Miles White - Abbott-  $25.6M
4. Jeffrey Kindler - Pfizer-  $24.7M
5. Richard Clark - Merck - $24.6M
6. Robert Coury - Mylan - $22.9M
7. Kevin Sharer - Amgen - $21.1M
8. James Mullen - Biogen Idec - $20M
9. John Lechleiter - Eli Lilly - $16.5M
10. John Martin - Gilead Sciences - $14.2M

The Private Market for Tuberculosis Drugs

Tuberculosis (TB) is widely considered a public health concern and its treatment a public sector responsibility. But according to a study published today in the journal PLoS ONE, the private sector for TB treatment is ignored at our peril. Across 10 high-burden countries, there is as much TB drug volume in the private sector as in the public sector—and at least a third of all private sector dosages of first-line TB drugs fall outside of national and international treatment recommendations. Any resulting drug misuse could be responsible for many treatment failures and for escalating the emergence of multidrug-resistant TB (MDR-TB), which is further worsening the TB epidemic.
The research, conducted by the TB Alliance and IMS Health (a healthcare market research and consulting-services firm), is the first detailed study of the private TB drug market across multiple high-burden countries. Sixty percent of the world’s TB burden is present in the 10 study countries (Bangladesh, China, India, Indonesia, Pakistan, Philippines, Russian Federation, South Africa, Thailand, and Viet Nam).
TB treatment requires lengthy, supervised treatment to maximize cure rates and minimize the development of drug resistance, and in low-income settings this task is thought to be more achievable in the public sector. By contrast, the private sector treatment landscape in these countries is largely unregulated and fragmented; for example, the study detected 111 different first-line TB drug dosages and combinations, compared to the 14 deemed necessary by the Stop TB Partnership’s Global Drug Facility.
“The private sector is keeping alive the confusion that existed previously in the public sector,” said Dr. William Wells, the study’s lead author and Director of Market Access at the TB Alliance. “With this new baseline understanding of the TB drug market, we can no longer ignore the private sector’s critical role in the access equation for TB treatment and in the task of protecting both current drugs and new regimens from the development of resistance.”
Other key findings revealed that:

•     The public and private sectors are both major channels of treatment for TB patients. Nearly equal amounts of TB drugs are dispensed in the public and private sectors (enough to treat 67 percent vs. 66 percent of estimated incidence, respectively). The size of the private sector for TB drugs varies between countries, but has been steady within most countries over the past 5 years.
•     Four of the biggest high-burden countries – India, Indonesia, Pakistan, and Philippines – had particularly large private sectors. Enough TB drugs are sold in their private sectors to treat all, or nearly all, incident TB patients with a full TB drug regimen. This is without even considering the 60 to 80 percent coverage by the public sector.
•     Few patients receive MDR-TB treatment in the public sector—and the data reveal that the private sector is not stepping in to fill the gap. Private sector sales have the capacity to cover only ~1-10% of MDR-TB patients (or 0%, in three study countries) with anything approaching a full regimen. However, with new, rapid diagnostics becoming available, this market may expand rapidly, thus highlighting the urgency for action now.

“During the past decade, the world has seen a reawakening of TB drug development efforts, and the first wave of new TB treatments will be introduced within the next few years,” said Dr. Mel Spigelman, President and CEO of the TB Alliance. “This study fills a critical gap in our knowledge base.”
“Most countries covered in this study have public-private mix (PPM) programmes for TB care,” said Mario Raviglione, Director of the Stop TB Department at the World Health Organization. “Based on country experiences, these programmes have shown good results in optimizing TB management by private care providers. However, the size of the response is not commensurate with the size of the challenge; there is enormous scope to expand these programmes urgently. Private providers following best practices should be supported through accreditation and access to free TB drugs from the public sector, while those not doing so should be regulated. Greater government and international support is needed for these efforts and also for improved regulatory oversight and quality assurance of TB drugs. A dual track approach of collaboration and regulation is the logical way forward. We ought to make private providers responsible partners of the public sector in controlling TB and MDR-TB”.
About Tuberculosis
TB kills nearly 2 million people each year, mostly in the developing world. One of the drivers of the epidemic is the old and inadequate treatment. There have been no new TB drug classes for nearly 50 years and the current regimens available take 6-9 months, and are too long and complex for resource-poor settings. Because of that, many patients are unable to complete their drug regimen, which leads to drug resistance, an emerging global health threat. The treatment for drug-resistant TB can take two years or longer, involve multiple drugs and injectables, and is much more expensive than the first-line treatment. According to WHO, there were 440,000 cases of multidrug-resistant TB in 2008; for those MDR-TB patients who were able to access MDR-TB treatment, at least a third still died.
About the Global Alliance for TB Drug Development
The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, the United Kingdom Department for International Development, the United States Agency for International Development, the European Commission, and the United States Food and Drug Administration. For more information please visit http://www.tballiance.org.