JHU holds several patents for the drug, sutezolid, and has agreed to a license deal with the MPP. The license would enable open non-exclusive licenses with multiple drug developers—including product development organizations, companies and governments—to conduct research and develop drug combinations that include sutezolid. It marks the first such open license for a TB drug held by an American university, and the first open license for a TB drug through the MPP. The MPP, an organization funded by UNITAID, has a mandate to increase innovation and access to drugs through voluntary patent licensing.
“This is a significant achievement after more than two years of advocacy stemming from a UAEM student-led petition brought forward by this group,” said Merith Basey, executive director for UAEM North America. “We commend JHU for shifting its stance to prioritize a public health-driven path for the development of this lifesaving drug, and we call on similar leading universities to leverage their significant role in ensuring future access and affordability of medicines such as this one for people worldwide.”
Sutezolid has shown promise in Phase Ila clinical trials, but research stalled for several years while Pfizer held rights on the drug. Since 2013, when Pfizer signed an exclusive license with Sequella, a biotech company, no new studies of sutezolid have been successfully conducted. The primary patent on sutezolid expired in 2014, but Pfizer, Sequella and JHU still hold secondary patents and clinical data on the drug.
Current TB regimens require combinations of drugs to successfully treat TB; JHU’s licensing deal with the MPP would allow for open research on drug combinations that include sutezolid, which is part of the oxazolidinone class.
Groups such as UAEM, MSF’s Access Campaign, TAG, TB CAB, Public Citizen and JHU students and alumni have, for years, called on JHU to license sutezolid as broadly as possible and with a public health approach.
While the JHU and MPP agreement is a major step forward, these groups are concerned that the deal contains no strong safeguards to ensure that any treatments developed will be made affordable for all the people who need them.
“This agreement has the potential to greatly improve current treatment options, but it can only be truly effective if the treatments created are made accessible to people living with TB everywhere,” said Judit Rius Sanjuan, US manager & legal policy adviser at MSF’s Access Campaign.
“Strong pricing and access safeguards should be a key component of any licensing agreement put together by the MPP. Without them, people in urgent need of new TB treatments will remain at the mercy of whatever group or company acquires a sublicense and its definition of affordability, which is often very different from what we as a community would consider affordable and changes arbitrarily depending on country income status,” said Wim Vandevelde, chair of the TB CAB.
Public health groups are advocating for a single affordable global price for any treatment brought to market through this deal. “We are putting drugmakers on alert, including the first that will benefit from this agreement,” said Peter Maybarduk, access to medicines director at Public Citizen. “We will hold you accountable to a global definition, our definition of affordability. Patients everywhere, including here in the United States, need to have access to this treatment.”
They are also calling on Pfizer and Sequella to act in the interest of public health. “We urge Pfizer and Sequella to provide open access to all existing data on sutezolid,” said Lindsay McKenna, senior TB/HIV project officer at TAG. “These data are critical to expediting sutezolid’s development. Without them, researchers will have to redo studies, wasting precious resources and time.”
TB is the leading infectious disease cause of death globally, and new medicines to treat drug-resistant strains of TB are urgently needed. Current treatments for drug-resistant TB (DR-TB) can last up to two years and include up to eight months of daily injections. Even when patients are able to tolerate these grueling and often toxic regimens, fewer than half of those treated are cured. The development of new TB drugs like sutezolid is critical to the advancement of safer and more effective TB treatment regimens. TB is treated with regimens rather than a single medicine.
Sutezolid marks the first drug that, if developed, could use the 3P Project approach, which is an alternative way designed by MSF and others to fund and incentivize research and development for TB regimens. 3P addresses some of the shortcomings of the current drug development landscape and aims to ensure the resulting treatments are affordable and accessible to all by de-linking R&D costs from prices and sales.
About UAEM: Universities Allied for Essential Medicines is a global grassroots movement of university students and academics organizing for public control over medicine and its pricing to ensure that publicly-funded medical research meets the needs of people everywhere. UAEM seeks to: 1) Promote access to medicines for people in developing countries by changing norms and practices around university patenting and licensing; 2) Ensure that university medical research meets the needs of the majority of the world's population; 3) Empower students to respond to the access and innovation crises. Find out more at http://uaem.org/
About MSF: Doctors Without Borders, an international medical humanitarian organization, has been fighting TB for over 30 years and is now one of the biggest non-government providers of TB care worldwide. MSF currently treats this infectious disease in 24 countries, including India, Central African Republic, South Africa and Uzbekistan.
About TB CAB: The Global Tuberculosis Community Advisory Board is a group of strong, research-literate community activists from HIV and TB networks around the world. The TB CAB works in an advisory capacity to researchers and product developers conducting trials of new TB drugs and diagnostic technologies, and provides input on study designs, early access, regulatory approval, post marketing, and implementation strategies.
About TAG: Treatment Action Group is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS and its two major coinfections, tuberculosis and hepatitis C virus. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.
About Public Citizen: Public Citizen is a consumer advocacy organization with more than 400,000 members and supporters and a forty-five year history representing the public interest before congress, federal agencies and the courts. Topics of organizational focus include trade, environment, money in politics and prescription drug access, safety and efficacy, among others.