New license agreement advances development of investigational TB treatment

The Medicines Patent Pool announced in a press release today that the organization has signed a license agreement with Johns Hopkins University to advance the development of the investigational tuberculosis treatment sutezolid.

The agreement allows for nonexclusive licenses with multiple drug developers to investigate and develop TB drug combinations that include sutezolid, according to a Doctors Without Borders/Médecins Sans Frontières’ (MSF) press release. The announcement comes years after MSF and other public health groups, including Universities Allied for Essential Medicines (UAEM), Treatment Action Group (TAG), the Global TB Community Advisory Board (TB CAB) and Public Citizen, called on Johns Hopkins University (JHU), which holds a patent for the use of sutezolid with Pfizer, to broadly license the drug. It is the first open license for a TB treatment held by an American university and through the Medicines Patent Pool (MPP).

“This is a significant achievement after more than 2 years of advocacy stemming from a UAEM student-led petition brought forward by this group, “Merith Basey, MSc, executive director for UAEM North America, said in the release. “We commend JHU for shifting its stance to prioritize a public healthdriven 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 is an oxazolidinone antibiotic that is in the same class as linezolid (Pfizer) — a commercially available drug. In early-stage testing, sutezolid was more potent and less toxic than linezolid, the release said. Despite showing promise in phase 1 and 2a trials, there have been no new successful studies evaluating the drug since 2013, when Pfizer signed an exclusive license with the biotech company Sequella. Pfizer, Sequella and JHU hold several secondary patents on sutezolid, but the primary patent expired in 2014.

According to Greg Perry, MMP’s executive director, the global response to the TB epidemic is currently limited due to a lack of treatment options. Therefore, better therapies are an “urgent global public health priority,” he said in the release.

Mario Raviglione, MD
Mario Raviglione

“The [MMP-JHU] agreement is an extraordinary step as it seeks to jump start currently stalled development on a compound that showed promise in early stage trials,” Mario Raviglione, MD, director of WHO’s Global TB Programme, said in the release. “The current scarcity of treatment options is threatening to derail the WHO’s global targets to slash TB deaths by 95% over the next two decades. We are in urgent need of new and better combination regimens, especially for patients with multidrug-resistant TB, and the inclusion of sutezolid might bring great benefit.”  

Although public health groups agree that the new license is a step forward, they remain concerned that the deal does not ensure new treatments will be made affordable for all patients.

“Strong pricing and access safeguards should be a key component of any licensing agreement put together by the MPP,” Wim Vandevelde, chair of the TB CAB, said in the release. “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.”

Public health groups are calling for a single and affordable global price for any treatment developed through the deal, and are encouraging Pfizer and Sequella to “act in the interest of public health,” according to the release.

“We urge Pfizer and Sequella to provide open access to all existing data on sutezolid,” Lindsay McKenna, MPH, senior TB/HIV project officer at TAG, said in the release. “These data are critical to expediting sutezolid’s development. Without them, researchers will have to redo studies, wasting precious resources and time.”

Reference:

Wallis RS, et al. PLoS One. 2014;doi:10.1371/journal.pone.0094462.

Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.

The Medicines Patent Pool announced in a press release today that the organization has signed a license agreement with Johns Hopkins University to advance the development of the investigational tuberculosis treatment sutezolid.

The agreement allows for nonexclusive licenses with multiple drug developers to investigate and develop TB drug combinations that include sutezolid, according to a Doctors Without Borders/Médecins Sans Frontières’ (MSF) press release. The announcement comes years after MSF and other public health groups, including Universities Allied for Essential Medicines (UAEM), Treatment Action Group (TAG), the Global TB Community Advisory Board (TB CAB) and Public Citizen, called on Johns Hopkins University (JHU), which holds a patent for the use of sutezolid with Pfizer, to broadly license the drug. It is the first open license for a TB treatment held by an American university and through the Medicines Patent Pool (MPP).

“This is a significant achievement after more than 2 years of advocacy stemming from a UAEM student-led petition brought forward by this group, “Merith Basey, MSc, executive director for UAEM North America, said in the release. “We commend JHU for shifting its stance to prioritize a public healthdriven 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 is an oxazolidinone antibiotic that is in the same class as linezolid (Pfizer) — a commercially available drug. In early-stage testing, sutezolid was more potent and less toxic than linezolid, the release said. Despite showing promise in phase 1 and 2a trials, there have been no new successful studies evaluating the drug since 2013, when Pfizer signed an exclusive license with the biotech company Sequella. Pfizer, Sequella and JHU hold several secondary patents on sutezolid, but the primary patent expired in 2014.

According to Greg Perry, MMP’s executive director, the global response to the TB epidemic is currently limited due to a lack of treatment options. Therefore, better therapies are an “urgent global public health priority,” he said in the release.

Mario Raviglione, MD
Mario Raviglione

“The [MMP-JHU] agreement is an extraordinary step as it seeks to jump start currently stalled development on a compound that showed promise in early stage trials,” Mario Raviglione, MD, director of WHO’s Global TB Programme, said in the release. “The current scarcity of treatment options is threatening to derail the WHO’s global targets to slash TB deaths by 95% over the next two decades. We are in urgent need of new and better combination regimens, especially for patients with multidrug-resistant TB, and the inclusion of sutezolid might bring great benefit.”  

Although public health groups agree that the new license is a step forward, they remain concerned that the deal does not ensure new treatments will be made affordable for all patients.

“Strong pricing and access safeguards should be a key component of any licensing agreement put together by the MPP,” Wim Vandevelde, chair of the TB CAB, said in the release. “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.”

Public health groups are calling for a single and affordable global price for any treatment developed through the deal, and are encouraging Pfizer and Sequella to “act in the interest of public health,” according to the release.

“We urge Pfizer and Sequella to provide open access to all existing data on sutezolid,” Lindsay McKenna, MPH, senior TB/HIV project officer at TAG, said in the release. “These data are critical to expediting sutezolid’s development. Without them, researchers will have to redo studies, wasting precious resources and time.”

Reference:

Wallis RS, et al. PLoS One. 2014;doi:10.1371/journal.pone.0094462.

Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.