Johnson & Johnson, TB Alliance Form Partnership to Push New TB Drug Through Clinic
Johnson & Johnson, the diversified healthcare giant, is forming a partnership with the nonprofit TB Alliance to share expertise and resources needed to finish clinical trials aimed at developing the first new drug for tuberculosis in more than 40 years.
The announcement from J&J (NYSE : JNJ) is being made this morning in Seattle at the Pacific Health Summit, the invitation-only gathering of 250 of the world’s leading scientists, public health officials, and businesses focused on global health. This is the first big announcement to come from this event, known as the “Davos” of global health, which I previewed yesterday.
J&J’s Tibotec division and the TB Alliance will focus their energy on a drug called TMC207. This product recently passed a mid-stage clinical trial of 47 patients, in which almost half of people with multidrug resistant forms of TB had no evidence of the bacterial invader in their mucus or phlegm after eight weeks of treatment, compared with one out of 10 who did that well on placeo (9 percent). The findings, published recently in the New England Journal of Medicine, suggest the treatment may have what it takes to be the first approved drug with a new way of working against the disease since the 1960s.
About 1.5 million people worldwide die each year from TB lung infections, making it one of the world’s deadliest diseases, along with HIV and malaria. Drug companies traditionally haven’t invested much in the field because it offers far less profit potential than diseases that are more common in wealthy countries, like cancer and diabetes.
“We see tremendous potential in this collaboration and in the future of TMC207 as part of a critically-needed new TB regimen,” said Mel Spigelman, president and CEO of the TB Alliance.
The TB Alliance, based in New York, generated $30.8 million in public support and other revenue in 2007, according to its annual report. It has partnerships with other pharmaceutical companies like Bayer, GlaxoSmithKline, and Novartis. The J&J drug is designed to block a protein called ATP synthase, essentially interfering with an enzyme the TB pathogen needs to get its energy supply.
The treatment is one of two TB drug candidates currently in clinical trials, along with thousands more being screened or synthesized at earlier stages of development, according to the TB Alliance. The organization’s goal is to make TB treatment less onerous. Current treatment regimens require patients to take four different medicines for six months to eradicate the bug, making it difficult for sufferers to comply with doctors’ orders, which, in turn, helps the pathogen develop resistance. The TB Alliance hopes to bring down the treatment time to four months, and eventually two months, similar to the treatment course required for many other bacterial infections.
Under the terms of the deal, J&J will continue to develop TMC207 for multidrug resistant TB and development costs will be split between the organizations. Assuming the drug wins regulatory approval, the company will establish an access program to ensure that poor people around the world who need it will be able to get it, the TB Alliance and J&J said in a joint statement. The two organizations will continue to collaborate on earlier-stage R&D to find more drug candidates as well.