Washington D.C., 2 September 2015. – Johns Hopkins University (JHU) is in the final stages of negotiating an agreement that could threaten the ability of patients globally to access a potential medical breakthrough, said the student group Universities Allied for Essential Medicines (UAEM) on Wednesday.
UAEM, with the support of Médecins Sans Frontières (MSF), Treatment Action Group, the Global TB Community Advisory Board, Public Citizen and individuals from around the world are supporting student activists in urging JHU President Ronald J. Daniels to fulfill the institution’s commitment to advancing global health and promoting innovation. On 3 September, students will present a petition to President Daniels calling on JHU to assure the timely and responsible development of a potentially groundbreaking tuberculosis (TB) drug.
JHU is in the final stages of discussions with biotech company Sequella regarding an agreement to license the university’s rights to a promising TB compound, sutezolid. However, negotiations and details of the agreement remain behind closed doors. Organizations and activists are concerned that terms of the agreement could prevent patients globally from accessing affordable and potentially lifesaving medicine in appropriate regimens. They are urging JHU to ensure publicly that the licensing agreement is non-exclusive and has provisions to ensure appropriate and timely development, affordability, and accessibility of sutezolid.
“We are at a critical moment in the struggle against tuberculosis. As a leader in global health, Johns Hopkins has the potential to save thousands of lives by ensuring their drug is developed as part of the most medically impactful regimen for patients and accessible to those who would benefit most,” said Merith Basey, the executive director of UAEM.
Sutezolid has shown superior activity against drug-resistant TB (DR-TB) as compared to the next best treatment in early studies. Current DR-TB treatment is particularly difficult for patients and providers: it is a two-year treatment including eight months of daily injections and a total of more than 14,600 pills. The cure rate is unacceptably low, with fewer than half of patients receiving treatment being cured. Moreover, many of the medicines have toxic side effects.
With resistance to existing TB drugs growing at an alarming rate, it is vital that new treatments are developed and made accessible. Sutezolid, if appropriately developed, could offer new hope to patients and represent a turning point in managing the global public health crisis posed by DR-TB. TB remains the second leading cause of death from an infectious disease, claiming nearly two million lives each year globally. There is a desperate need for novel and affordable therapies to treat drug-resistant TB. JHU is in a unique position to positively impact sutezolid’s development and accessibility. TB patients worldwide are depending on JHU to not squander this opportunity.
Scientific Information on Sutezolid
Sutezolid is a member of the oxazolidinone family of drugs, which has shown excellent activity against Mycobacterium tuberculosis (MTB), including resistant strains. Linezolid, another drug of the same family, has been shown to be effective in treating DR-TB according to a recent review of scientific literature and meta-analysis. Further, in a subsequent phase 2 randomized study of patients with XDR-TB in South Korea, linezolid-containing regimens lead to significantly improved cure rates as compared to those regimens which did not include linezolid. Evidence from in vitro, animal and a phase 1 study with sutezolid has shown superior activity of this drug against MTB as compared with linezolid and the safety profile of sutezolid is likely superior to that of linezolid. Thus oxazolidinones like sutezolid are poised to become an important part of future regimens to treat TB.