BY MAUREEN ROUHI
Barely 18 months old, the Global Alliance for TB Drug Development is moving quickly toward its goal of new antituberculosis drugs by 2010. Last month, it signed a deal with Chiron, Emeryville, Calif., that gives the alliance license to develop the nitroimidazopyran PA-824 into a new drug to treat TB. And according to the alliance's chief executive officer, Maria C. Freire, discussions are under way to bring four other lead compounds into the alliance's portfolio.
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Aware of PA-824's potential, the alliance devised a win-win business strategy for all parties.
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The alliance's speedy and strategic moves underscore its zealous determination to achieve its goals. It also demonstrates the reasonableness of the alliance's business strategy, which could serve as a model for meeting neglected public needs.
The alliance was conceived in Cape Town, South Africa, by representatives from around the world who gathered in February 2000 to discuss the treatment of tuberculosis. There, a call was made to develop new drugs within the decade. And a commitment was made to create within the year a nonprofit group to accelerate drug discovery and development.
In October 2000, the alliance was launched in Bangkok with a precise mission: By 2010, bring to market new, affordable drugs that will reduce the treatment period from nine months to two months, work against latent infections, and/or be effective against drug-resistant strains of Mycobacterium tuberculosis.
In the interim, researchers at PathoGenesis Corp., Seattle, and elsewhere described the potent activity of PA-824. The work was a breakthrough, in light of the 30-year drought in new compounds to treat TB. It galvanized the TB community into believing that new drugs are within reach.
PathoGenesis was a small company that could not further develop PA-824 alone. In fall 2000, Chiron acquired PathoGenesis and with it PA-824, a compound with promise against a disease that's killing one person every 15 seconds, but a drug that Chiron also couldn't move along on its own for business reasons.
Enter the alliance. Aware of PA-824's potential, it devised a win-win business strategy for all parties. For a fee, the alliance gets exclusive worldwide rights to develop PA-824. Acting as a virtual R&D organization, the alliance has lined up resources to undertake toxicological studies and scale-up of the chemistry. As development progresses, the alliance will identify partners for all associated activities, such as clinical testing and drug manufacturing.
If the drug proves successful, Chiron will receive royalties from sales to developed markets: the U.S., Europe, Canada, Japan, Australia, and New Zealand. It will not take royalties from sales to countries in which tuberculosis is endemic. However, Chiron has a "grant-back" option. After certain milestones, it can take back the rights to develop and commercialize the compound by repaying the investments made by the alliance up to that point. But the option can be exercised only for the developed markets. The alliance will continue development for the endemic markets, because "our goal is for the compound to be developed for the people who absolutely need it," Freire says.
"Chiron does not expect that PA-824 will be a humongous moneymaking drug," Freire says. The market for TB drugs right now is $450 million per year, and it will grow to about $700 million in 2010, she explains. These numbers are not inconsequential, but they also do not a blockbuster make. But if PA-824 fulfills its promise, "Chiron would have given people in endemic countries access to a compound that otherwise wouldn't have been an arrow in their quiver," she adds.
Chiron had been considering other partners to develop PA-824. What tipped its decision toward the alliance, Freire believes, is the alliance's unparalleled motivation. "The urgency that the alliance feels to develop new drugs is not only contagious but also palpable," she says. "We're just very hungry" to move promising leads through the development pipeline. Within the next few months, she hopes to reach agreement on four more compounds: two that are derivatives of known tuberculosis drugs and two that are novel.
Taking PA-824 to launch may cost up to $300 million, so the alliance is actively raising funds. It's also getting in-kind contributions from government institutions. With starting capital of $40 million, a scientific advisory committee that reads like a who's who in tuberculosis, stakeholders with tremendous commitment, and a flexible organization with transparent motives, the alliance "has the resources at this stage of the game to pull off what we believe needs to be done," Freire says.
Of course, many things can go wrong between discovery and launch. But with potentially five lead compounds in the portfolio, a robust worldwide research community that's unraveling the chemistry and biology of tuberculosis, and a global commitment to fight this scourge, there is great optimism for the alliance's success.
March 24 is World Tuberculosis Day. The theme for 2002--"Stop TB, fight poverty"--emphasizes that TB is primarily a disease of the poor and that fighting it is one way to alleviate poverty. "There is no longer any doubt that any new tuberculosis drugs would revolutionize the struggle against resurgent tuberculosis," Freire says in a statement marking World Tuberculosis Day 2002. "By leveraging new scientific innovations, we can save millions of lives and expand the economic possibilities for scores of nations.
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