The big announcement was made at the BIO International Convention, where top policy and health leaders gathered to discuss the future of pandemic preparedness and antimicrobial resistance. The new lab, established through Shionogi's group company Qpex Biopharma, is set to boost their capabilities in infectious disease and pandemic preparedness.
The new Shionogi Qpex Lab will expand the existing R&D facility for Qpex Biopharma, located at the SD Tech by Alexandria mega campus in the city. In 2023, Shionogi Inc., a New Jersey-based subsidiary, acquired Qpex Biopharma, bringing along Qpex's novel internally discovered pipeline, including an investigational beta-lactamase inhibitor. This acquisition has significantly expanded Shionogi's antimicrobial pipeline and strengthened their R&D capabilities.
During the BIO panel discussion, which included representatives from the White House Office of Pandemic Preparedness and Response Policy, BARDA, and CIDRAP, Shionogi highlighted the urgent need for new antimicrobial research and development.
Shionogi infectious disease research
“It is vital that we invest in the development of new medicines to help mitigate future threats, including pandemics and antimicrobial resistance. In addition, we must lower barriers and create incentives to support the training and development of the next generation of scientists and researchers, particularly in antimicrobial resistance, or AMR, where the workforce has been declining for decades,” said Phyllis Arthur, executive vice president and head of healthcare policy and programs at BIO.
Michael Dudley, president and CEO of Qpex, emphasized the importance of addressing both known and emerging health threats.
“We need to address known health threats, including antibiotic-resistant bacteria, as well as prepare for rapidly emerging threats that could lead to future pandemics. This is a landmark opportunity to build upon the excellent track record of our organizations in discovering innovative antimicrobial drugs and bringing them to patients,” he said.
Antimicrobial resistance
“Together, with our government and academic partners, we have the capabilities and the capacity to face the known public health crises of today and to prepare for the impact future pathogens may have on society.”
The world is more connected than ever, increasing the risk of global health events. Pathogens that can spread rapidly have the potential to destabilize economies, threaten national security, and cause millions of deaths. Infectious diseases are becoming harder to treat, and antimicrobial resistance (AMR) already causes 1.27 million deaths annually. Without action, AMR could kill over 10 million people each year by 2050. The antibiotic R&D pipeline has been declining, creating an urgent need for new treatments.
Shionogi has a long history of discovering and introducing novel antibiotics and innovative medicines for HIV, influenza, and COVID-19 since the 1950s. The Qpex senior leadership team has worked together for over 25 years and completed four regulatory approvals for antibiotics in the past decade.
Pandemic preparedness
John Keller, senior executive officer and senior vice president of R&D at Shionogi, said: “Combining the deep expertise of the Qpex team with Shionogi’s decades of successful infectious disease R&D in Japan, this expansion has the potential to accelerate critically needed innovation in infectious disease like never before.
“In the race between antibiotic drug development and increasing resistance, the pathogens are winning. If new antibiotics are not discovered and developed, we cannot overcome this public health crisis and are at risk of jeopardizing global health security.”
The expansion of Shionogi’s US presence will also enhance their ability to form partnerships with both public and private sector researchers. Qpex's antibiotic clinical development programs are funded by BARDA under a contract with the US Department of Health and Human Services. Recently, Qpex announced additional funding from BARDA to support the advancement of its antibiotic development programs.
Public health security
Addressing AMR is critical as it poses a major health burden globally. In 2019, bacterial AMR was responsible for 1.27 million deaths. Infections caused by carbapenem-resistant gram-negative bacteria are often fatal. If no action is taken, AMR could kill 10 million people annually by 2050, with treatment costs reaching $412 billion annually up to 2035.
Shionogi is one of the few large pharmaceutical companies continuing to focus on anti-infectives research and development. For over 60 years, Shionogi has been committed to developing antimicrobial therapies and remains dedicated to fighting AMR.
Shionogi's latest move to enhance its infectious disease research capabilities in the US highlights the company's commitment to tackling current and emerging health threats, providing new hope for combating antimicrobial resistance and future pandemics.