License agreement with Medicine Patent Pool will speed clinical development of drug considered promising for improved treatment of tuberculosis responsive and resistant to existing drugs
With all regimens to treat tuberculosis requiring multiple drugs, and all but two of those drugs tracing their lineage to the middle of the last century, excitement was high in 2012 when Pfizer pharmaceutical company released results of its first study of a new drug, sutezolid, in TB patients showing the drug to be safe and effective against the disease. Between the side effects of existing drugs and growing rates of resistance to some making regimens both challenging to complete and ineffective, getting new medicines into the field is seen as essential to fighting the disease in its drug-sensitive as well as its drug-resistant forms. And while sutezolid belonged to the same class as an existing drug, linezolid, early studies indicated that it was both less toxic and more effective against tuberculosis.
But the encouraging news about sutezolid was followed by a lull that frustrated TB researchers, advocates and patients. While the drug was included in proposed studies of new regimens, Pfizer, which, with Johns Hopkins University held the joint patent for the drug’s use in combination TB treatment, did not hurry to make it available to clinical trial groups that included the international Centers for Disease Control and Prevention-backed TB Clinical Trials Consortium, the nonprofit TB Alliance, and the U.S. Department of Health and Human Services funded AIDS Clinical Trials Group — ACTG.
The treatment and research advocacy organization Treatment Action Group highlighted Pfizer’s inaction in its 2013 Tuberculosis Treatment Pipeline Report, and, when Pfizer sold the drug to another pharmaceutical company, joined the Global TB Community Advisory Board in writing to the executives of that company, the Maryland-based Sequella, Inc., urging them to make the drug available to researchers. Public health groups that included Public Citizen and Médecins Sans Frontières joined members of the student group Universities Allied for Essential Medicines in petitioning John Hopkins University to make an agreement that would speed development of and access to the drug and keep it affordable. In a Lancet letter last year, alumnus Jane Andrews, of the Tulane School of Medicine and Universities Allied for Essential Medicines urged the University to follow a model that separates the cost of developing a drug from the price consumers pay for it established by the Medicines Patent Pool, a global public health organization backed by the United Nations and supported by UNITAID, that had just expanded its mandate to TB drugs.
On Tuesday, Johns Hopkins and the MPP announced an agreement that would do that, granting the organization a royalty free licence making the drug available for testing across countries and drug developers researching the medicine in combination with others for treatment of tuberculosis.
The groups that had urged action to get the drug out of limbo — UAEM, MSF Access Campaign, TAG, TB CAB and Public Citizen hailed the move, in a statement citing the potential for agreement to advance treatment options for TB, but also expressing reservations that the agreement did not do enough to ensure that those treatment options would be affordable to the people who need them.