But they’re wrong. Tuberculosis and HIV/AIDS – as well as malaria -- are global pandemics. With the passage of time, they have become even more virulent as the bugs develop resistance to once-effective drugs. And global commerce and international travel have aided and abetted the spread of these diseases.

Fortunately, many nations, philanthropic organizations and non-government agencies have backed disease-eradication efforts for years. And though progress may seem slow, nobody’s giving up.


Malaria made headlines last month when global health and business leaders attending the World Economic Forum in Davos, Switzerland announced a three-year program to rapidly expand malaria prevention and treatment efforts in the 30 hardest hit countries in Africa. They predict that this effort could save 3.5 million lives over the next five years.

According to a report prepared by Malaria No More and McKinsey & Co. that provided a detailed business analysis of the situation, these goals could be realistically achieved for about $2.2 billion annually over five years. (Current spending is about $1 billion per year.)

This may be one of the first times that anyone has viewed disease control (or elimination) as a business endeavor, but the report makes a strong case for the rapid scale-up of proven malaria-control means, including insecticide-treated mosquito nets, targeted insecticide spraying and anti-malarial medicines. The Roll Back Malaria Implementation Support Team will coordinate the program through public-private partnerships to help malaria-endemic countries come up with business plans (and financing) to scale-up malaria control.

Another new program was launched at this year’s World Economic Forum – and this one targets AIDS. The initiative, called aids2031, will determine the steps that need to be taken now in order to “change the face of AIDS” by 2031, 50 years after the first case of AIDS was reported. The steering committee intends to release its recommendations – An Agenda for the Future – in 2009.

Despite our finest efforts, “HIV continues to spread and to destabilize whole sections of the globe,” explained Stefano Bertozzi, chairman of the aids2031 steering committee, in prepared remarks. “We are committed to a simple premise: what works best to generate short-term results is often not the best way to reverse the epidemic in the long run,” he said. “We are looking at everything with new lenses and fresh perspectives.”


Well, what about AIDS? Is it spreading or not? The aids2031 committee seems to think so, but the World Health Organization (WHO) doesn’t. In late November 2007, the WHO dropped its estimate of the number of cases worldwide from 39 million to 33 million. That statement, in turn, sparked a debate on counting methods, which projected the total number of AIDS cases from data gathered on relatively small groups of people (infected pregnant women who came to clinics, for instance). Although these numbers aren’t entirely accurate, the conclusion apparently remains the same: New HIV infections have been dropping since they peaked in the late 1990s, but the number of people living with AIDS has increased due to effective antiviral drugs.

That does not mean that the epidemic is over. Still, AIDS advocates worry that the lower numbers might instill a false sense of security in the AIDS community, especially among those organizations that are funding R&D programs. But so far, that scenario hasn’t materialized.

In fact, R&D funding has increased significantly over the last 10 years or so. For instance, the International AIDS Vaccine Initiative (IAVI) says that funding for AIDS vaccine research quadrupled between 1997 and 2007. Today, more than 30 clinical trials of various AIDS vaccine candidates are being conducted in two dozen countries. Perhaps one of these experimental compounds will prove to be a winner.

Money for HIV prevention programs – especially in the developing world -- also continues to flow. In mid-November 2007, for instance, the Bill & Melinda Gates Foundation committed $50 million to expand HIV prevention efforts in China. And in December, it granted $5.2 million to the HIV Collaborative Fund for AIDS treatment and prevention services in sub-Saharan Africa. (The tables in this article highlight major funding efforts for global health in 2007, in which the Gates Foundation continues to play a leading role.)


Long-term strategies such as HIV prevention programs are necessary components of disease-eradication measures, of course, but short-term efforts are also critical. In both instances, public-private partnerships play an important part: They are designed to share the risks and costs of developing new drugs and vaccines for pandemic diseases. Malaria, AIDS and tuberculosis (TB) hit developing nations the hardest, but these countries have neither the healthcare infrastructure nor the financial resources to put up a fight. And pharmaceutical companies, which certainly have the skills necessary to make effective medicines for these scourges, don’t want to participate because the financial returns would be negligible.

That’s where public-private partnerships (PPPs) come into the picture. The first of these –the International AIDS Vaccine Initiative – was formed in 1996. Since then, dozens of PPPs have come to life – including the Global Fund to Fight AIDS, Tuberculosis & Malaria; the Global Alliance for TB Drug Development; the Malaria Vaccine Initiative; and the Medicines for Malaria Venture. But more are needed.

One of the newer players in the field is BIO Ventures for Global Health (BVGH), which was spun out of the Biotechnology Industry Organization (BIO) in 2004, with financial backing from the Gates Foundation and the Rockefeller Foundation. BVGH’s mission is to help innovative biotech companies create business strategies for developing new therapies, vaccines and diagnostics for infectious diseases that principally target developing nations. It accomplishes this by bringing together companies, public-private partnerships, donors and investors.

Importantly, BVGH uses a market-based approach to drug development for so-called neglected diseases. The organization even creates business models for specific diseases that aim to quantify the financial and social returns possible for a firm that chooses to enter this space.

In October 2006, for example, BVGH published a study that evaluates the market for a tuberculosis vaccine, which is quite substantial and could even break the $1 billion barrier. The study, Tuberculosis Vaccines: The Case for Investment, analyzes the demand for such a product, its impact on public health, and the return on investment that can be expected.

The organization has also published a study, Closing the Global Health Innovation Gap, that lays out a strategy by which biotech companies can make substantial contributions to the discovery and development of new therapies for neglected diseases. And, BVGH is co-sponsoring a conference in March 2008, the Partnering For Global Health Forum, which aims to bring together the major players in this field for frank discussions on how to address the innovation gap.


There are several reasons why most biotech firms have shied away from the global health arena – but chief among them is the financial hurdle. Companies need market incentives in order to justify investments in R&D, and the financial markets for new drugs for pandemic diseases don’t exist. “For many of these diseases, there are no paying customers,” explained BVGH president and CEO Christopher Earl, formerly a managing director at venture capital firm Perseus-Soros BioPharmaceutical Fund.

However, it is possible to create the appropriate incentives – and governments of the leading industrialized nations (the G8) have already “poured billions into procurement for vaccines and drugs,” Earl said. These can take the form of guaranteed purchase contracts, or “pull contracts,” which essentially assure a market for a given product.

In February 2007, the finance ministers from five industrialized nations announced a plan that committed $1.5 billion for buying yet-to-be-developed vaccines for developing countries. “Advanced market commitments (AMC) guarantee there will be a buyer for a new vaccine,” he continued. The first of these will be used to buy vaccines for pneumococcal diseases, such as pneumonia and meningitis. But programs like this don’t mature overnight, and it will probably be 2010 before pneumococcal vaccines reach their ultimate destination.

Another incentive could come from priority review vouchers, which are the subject of legislation included as an amendment in the new PDUFA reauthorization, Earl said. Sponsored by Senators Sam Brownback and Sherrod Brown, these transferable vouchers will be awarded to any company that gets approval for a novel drug or vaccine for a neglected tropical disease. Importantly, a voucher (which can be sold) entitles the bearer to a priority review for another product. The value of the voucher could be a compelling incentive for companies and even non-profit groups to develop new medicines for these neglected diseases.

Meanwhile, the companies and organizations that are already involved in devising new treatments for pandemic diseases are making some headway – and the financial support for these programs is still substantial.

Take tuberculosis, for instance. In late December 2007, U.S. President Bush approved $153 million to support global tuberculosis (TB) control programs in 2008. He also pledged $150 million to The Presidential Emergency Plan for AIDS Relief (PEPFAR) to address the TB/HIV co-epidemic in 2008. (This is in addition to the $30 billion in funding for PEPFAR that Bush requested in May 2007.)

Governments don’t provide all the support for drug development programs, of course. Pharma giant Eli Lilly and Co., for instance, is a big player in the TB arena. Lilly created a public-private partnership, called the Lilly MDR-TB Partnership, in 2003 with the express purpose of fighting multi-drug resistant TB (MDR-TB) by increasing the supply of drugs, training health care personnel and raising public awareness of prevention, diagnosis and proper treatment. In June 2007, Lilly also established a not-for-profit research organization (in the form of a public-private partnership) to focus on early-phase TB drug discovery (including for resistant strains).

Lilly already supplies the WHO with two antibiotics that are used to fight MDR-TB – capreomycin and cycloserine. It’s also set up manufacturing partnerships (which encompass technology transfer) for these drugs in South Africa, China and Russia. Still, the bacteria that cause tuberculosis will eventually develop resistance to these drugs, as well. In fact, they are already popping up: Cases of extensively drug-resistant TB (XDR-TB) have been reported in South Africa and in industrialized nations. (The American TB patient who caused an international furor in May 2007 was infected with XDR-TB.)

That situation makes the case for a new TB vaccine all the more compelling – even though one has been available for about 80 years. BCG vaccine, which is a live, weakened strain of Mycobacterium bovis (which is similar to M. tuberculosis), was developed in the 1930s. It is effective in reducing the likelihood and severity of TB in infants and young children, but not in older individuals.

It’s no surprise, then, that a number of organizations are focused on developing new TB vaccines. Aeras Global TB Vaccine Foundation, for instance, is a product development partnership that works with both public and private sectors to develop vaccine candidates. Reportedly, it has the largest TB vaccine pipeline anywhere, with six candidates in or near the clinic. And, thanks to a $200 million commitment from the Gates Foundation in September 2007, Aeras has the financial clout to work on all these projects.

Most recently, Aeras and its partners initiated two Phase I clinical trials. Together with Intercell AG and Statens Serum Institut, Aeras initiated a trial of a subunit vaccine, called hyVac4-IC31 (or AERAS-404), which is based on a recombinant fusion molecule (consisting of M. tuberculosis’ immunodominant antigens Ag85B and TB10.4) and formulated with Intercell’s adjuvant IC31. Aeras and Dutch partner Crucell N.V. also initiated a BCG-Ad35 prime boost trial of their AdVac-based vaccine (or AREAS-402) in December 2007.

According to Jerald Sadoff, president and CEO of Aeras, “If you are exposed to TB, you have a 30 percent chance” of contracting the disease. “The first use of a [new] vaccine would be to decrease that 30 percent to 1-5 percent,” that is, to actually prevent the infection. It’s the most powerful approach, he said, “but I’m not sure we can do that.”

The next use for a vaccine, Sadoff continued, is to prevent the disease from occurring in individuals who are already infected. “The BCG vaccine was designed to do that, but it doesn’t do it very well. It prevents disseminated forms of TB but not pulmonary ones.” Here, Aeras is developing a recombinant BCG vaccine that expresses bacterial antigens that are important in early stages of the disease, with the goal of making it safer and more potent. Aeras is also testing a number of prime boost regimens, which are intended to enhance the activity of the existing BCG vaccine and elicit a cell-mediated response.