Net Effect - Pharmaceutical Executive

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Net Effect


Pharmaceutical Executive


The groups went away—but soon returned with a new deal: If Novartis would contribute access to compounds in its library, the Wellcome Trust, the Singapore Economic Development Board, and MMV would finance the research. Novartis accepted. Herrling says, "If we start now, we will be ready in 10 to 15 years with drugs that work on a different target."

Increasingly, public–private partnerships are also expanding their reach to biotechs. For example, in October 2006, MMV and the Broad Institute of Harvard and MIT announced a new partnership with Genzyme, focusing on four early-discovery projects.

"As an industry, biotech has become more positioned to give," says James Geraghty, senior vice president of Genzyme and team leader for its Humanitarian Assistance for Neglected Diseases initiative. "It is now incumbent on us to help, particularly in getting researchers to overcome the 'valley of death,' and get compounds in development."

In this way, pharma is set to play a bigger role in fighting the disease—because it can and because the world will demand it. "If the industry wants to be perceived as a part of the solution for broader society, it should use much more energy, innovation, and creativity to help the world's poor," says Leisinger.

But even as more companies begin working on tomorrow's malaria treatments, the future remains murky for vaccines.

Vaccine Trials

Ripley Ballou has been pursuing his vaccine dreams with the GSK candidate for 25 years. Here's how it works: RTS,S contains the circumsporozoite protein of p. falciparum—the most common and deadly strain of malaria—fused to the hepatitis B virus surface antigen and formulated in GSK's adjuvant system AS02A. The vaccine diminishes the parasite's ability to develop in the human liver by inducing the production of antibodies and white blood cells.

Although still in trials, GSK's vaccine is already controversial. Compared with the vaccines that wiped out epidemics like polio, it is not particularly effective. In trials involving 2,000 children in southern Mozambique, the vax reduced malaria by 35 percent and severe malaria by 49 percent.

That is at once a low number for a vaccine and a high number in the context of malaria. The results have polarized the public health community. Some say the testing of RTS,S is the most exciting malaria development in a generation, with the potential to reduce child mortality by a third, and infections by tens of millions. But others argue that implementing an only partially effective vaccine is a fool's errand both economically and ethically. The millions of dollars would be better spent on bed nets and other proven prevention tools, they say.

"It's not an ideal vaccine," says Laurence Slutsker, MD, chief of the malaria branch at the Centers for Disease Control and Prevention. "But it's a vaccine that actually had some durability of effect—that's never been demonstrated before in malaria."

And vaccine development in general tends to be iterative. "The history of vaccines is that there's always constant improvement, better safety, better efficacy, easier to deliver—that's how the vaccine field has progressed," says Ballou.

Yet that may not be the best strategy, especially when funds and interest are scarce. Some in the field have called for better understanding of disease mechanisms. John McNeil, MD, scientific director of the PATH Malaria Vaccine Initiative, says that there needs to be less "mindless empiricism." But that's the process that led to GSK's next vaccine, GSK369796, or N-tert butyl isoquine, which is seven years behind RTS,S. It differs from RTS,S by directing more antigens at the blood stage of the parasite.

Other vaccine approaches are even farther out. For example, the biotech Sanaria is developing a method for extracting attenuated sporozoites from the mosquito in hopes of using them to stimulate a sustained antibody response. "From a scientific point of view," says McNeil, "we have not been more excited about an approach in malaria vaccine R&D basically ever."


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