\ Bill & Melinda Gates Medical Research Institute

NEWS RELEASE 12/9/20 – MEDICINES PATENT POOL SUBLICENSES SUTEZOLID, AN INVESTIGATIONAL DRUG FOR TB TREATMENT, PAVING THE WAY FOR CLINICAL DEVELOPMENT

Geneva and Cambridge MA-- (Wednesday 9 December 2020) –The Medicines Patent Pool (MPP) and the Bill & Melinda Gates Medical Research Institute (Gates MRI) signed an agreement today to advance the development of investigational sutezolid-containing TB drug regimens, especially for low- and middle-income countries, where most people with TB live. The drug candidate sutezolid, in combination with other drugs, could potentially be used as an all-oral, shortened regimen for all forms of TB, including multidrug-resistant TB (MDR-TB).

In October 2019, MPP and Pfizer entered into a license agreement, which granted MPP rights to sublicense to third parties the patents and know-how relating to the use of sutezolid (formerly known as PNU-100480), a promising antibiotic drug candidate, in combination with other agents for the prevention and/or treatment of TB. Gates MRI is the first recipient of such a sublicense. The sublicence allows Gates MRI to access Pfizer’s existing preclinical, phase 1 and phase 2a clinical study data and results with the aim of further developing this potential component of future TB regimens, should the data be supportive.

“We need better TB treatments in our arsenal to address the resistant strains of TB bacteria,” said MPP’s Executive Director Charles Gore. “If we are to outpace this killer disease that claims 4,500 lives every day, we need to have promising drugs in the TB R&D pipeline at all times. Sutezolid is one such candidate and MPP is excited that Gates MRI is undertaking development program to study it for TB.”

“Gates MRI is proud to sublicense sutezolid from MPP. We look forward to studying this promising drug candidate, consistent with our ultimate goal to accelerate the end of TB and in the interim, bring hope to the millions suffering from this serious infectious disease. We intend to pursue development of a TB regimen that may include sutezolid as we attempt to tackle drug-sensitive and drug-resistant tuberculosis,” said Dr. Charles Wells, Clinical Development Leader at the Bill & Melinda Gates Medical Research Institute.

According to the World Health Organization, TB is one of the top 10 causes of death worldwide. In 2019, 10 million people fell ill with TB, and 1.4 million died from the disease. MDR-TB remains a public health crisis and a health security threat, with nearly 465,000 incident cases in 2019.

About the Medicines Patent Pool (MPP)

MPP is a United Nations-backed public health organisation working to increase access to, and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.

To date, MPP has signed agreements with ten patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC).

About Bill & Melinda Gates Medical Research Institute

Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization focused on medical research to accelerate product development for diseases and disorders that disproportionately affect the world’s poorest populations -- malaria, tuberculosis, diarrheal diseases and maternal and newborn child health disorders — conditions that combined cause ten deaths every minute. https://www.gatesmri.org/