The Global Alliance for TB Drug Development is holding up its new deal with Chiron Corp. as one example of a model under which companies can work with non-profit organizations to develop drugs to treat diseases endemic in less developed countries.
CHIR (Emeryville, Calif.) last week granted Global Alliance (New York, N.Y.) an exclusive worldwide license to develop PA-824 and related nitroimidazole compounds for tuberculosis. CHIR obtained the compounds, which are in preclinical devel-opment, in its acquisition of PathoGenesis Corp. last year. In its pursuit of PA-824, the organization made sure the deal terms were familiar to industry. “It is clear that no for-profit or large pharma is going to develop a compound with this small of a market, and that the public sector has the mission but not the resources to move and market a product,” Global Alliance CEO Maria Freire told BioCentury. &lldquo;We knew we had to strike a deal that was win-win for both sides, and now this rift is being filled.”
Under the deal, Global Alliance will undertake further development of PA-824 and/or its analogs. CHIR has an option to manufacture and commercialize products in developed mar-kets, but will not receive royalties for drugs marketed in LDCs. Global Alliance said the deal positions the organization to reach its goal of developing accessible, affordable TB therapy by 2010. The public-private partnership, created in 2000, will fund development from its $40 million in cash, in addition to in-kind research support that it anticipates it will receive from public and private companies.
According to the organization, PA-824 is widely recognized in the TB community as the most promising treatment candidate for the disease. Beyond the fact that it is novel – no new TB drugs have been developed in more than 30 years – PA-824 has shown bactericidal activity against multidrug resistant M. tuberculosis, whether replicating or static, and oral activity in animal models. The activity against static bacteria is key, according to Global Alliance, because static bacteria are responsible for latent disease, against which current treatments are largely ineffective. This latency is in part responsible for the long treatment duration — 6-9 months — for current therapies. Global Alliance estimates that PA-824 could reduce treatment time, which could reduce treatment costs by as much as 65% and improve compliance.
Freire noted that PA-824 is the first of several new drug candidates that Global Alliance has under negotiation for further development.