[Ip-health] Public Health Groups Welcome JHU & MPP Agreement for Development of Promising New TB Drug

Merith Basey merith at essentialmedicine.org
Tue Jan 24 17:55:37 PST 2017

*Doctors Without Borders/Médecins Sans Frontières (MSF)*

*Contact: Brienne Prusak: +1-212-763-5769 <(212)%20763-5769>*

*Public Health Groups Welcome Johns Hopkins University and Medicines Patent
Pool Agreement for Development of Promising New TB Drug*

*While deal marks a critical step in the fight against TB, health groups
warn that the deal lacks safeguards that would ensure worldwide

*WASHINGTON, JANUARY 24, 2017—**Public health groups, including
Universities Allied for Essential Medicines (UAEM), Doctors Without
Borders/Médecins Sans Frontières’ (MSF) Access Campaign, Treatment Action
Group (TAG), the Global TB Community Advisory Board (TB CAB) and *Public
Citizen*,** welcomed today’s announcement by Johns Hopkins University (JHU)
and the Medicines Patent Pool (MPP) of an agreement that could expedite the
research and development of a promising tuberculosis drug and lead to
improved treatment options for people living with TB.*

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

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

“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
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

*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.

*To read the Medicines Patent Pool statement see here:*

*Merith Basey MSc*
Executive Director, North America
Universities Allied for Essential Medicines <http://uaem.org/>
merith at uaem.org
@uaem @globalDiaBEATes

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