Multi-partner collaboration aims to advance the discovery and development of critically-needed innovative TB antibiotics
BEERSE, BELGIUM, 23 JULY 2019 – As part of the Company’s 10-year initiative to drive progress against tuberculosis (TB), Johnson & Johnson today announced that it has launched an international research consortium to discover and develop new TB antibiotics in collaboration with eight European academic and biotechnology partners. Co-funded by Europe’s Innovative Medicines Initiative (IMI) and Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), the initiative—called RESPIRI-TB—is the first in a series of new collaborations that Johnson & Johnson is undertaking to advance TB research and development.
TB is the world’s deadliest infectious disease, killing an estimated 1.6 million people in 2017 alone.[i] Current TB treatment regimens have suboptimal cure rates because they are lengthy, complex and difficult for patients to adhere to, and growing resistance to first-line treatments is compounding this challenge. Drug-resistant TB (DR-TB) is the single biggest contributor to the rising global health challenge of antimicrobial resistance (AMR).
“Over the past half century, just two new TB medicines have been developed. To achieve the ambitious global goal of ending TB, we urgently need many more innovative therapies,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “No single company or institution holds all the answers. As we did in the case of HIV, we need to work together to advance the very best science as quickly as possible. We are proud to be a founding partner in the RESPIRI-TB consortium, and we look forward to working with our global partners to develop the necessary TB treatments of the future.”
The ultimate goal of the RESPIRI-TB collaboration is to help enable the development of a new, more efficient combination drug regimen to cure multidrug-resistant TB (MDR-TB), with a focus on shortening treatment duration and minimizing the likelihood of resistance. To this end, the partners will work to advance the discovery and early-stage development of new compounds from different drug classes that could be used – in combination with each other or with existing therapies, such as Janssen’s bedaquiline. Bedaquiline was the first novel TB medicine to be approved in more than 40 years and, today, is one of the last lines of defense against MDR-TB.
The new consortium includes nine research teams spanning five European countries with expertise in mycobacterial diseases and drug target investigation, as well as project management. In addition to Janssen, members include: Leiden University Medical Center and the University of Leiden (Netherlands, which will serve as the project coordinator); University of Antwerp, Belgium; Sorbonne University, France; Medical University of Vienna, Austria; University of Copenhagen, Denmark; Mitologics, France; and FFUND B.V., Netherlands.
In addition to RESPIRI-TB, the research consortium will also work to build a pipeline of drug candidates for the non-TB mycobacterial (NTM) species M. avium and M. abscessus through a second project, RESPIRI-NTM. Although NTM infections are less prevalent than TB, currently available treatments for NTM infections are suboptimal, underscoring the urgent need for new therapeutic options.
“Tuberculosis and related diseases represent a major threat to public health worldwide, and a collaborative approach is essential if we are to develop new, safe and effective treatments,” said Pierre Meulien, Executive Director, IMI. “I am delighted that the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners in RESPIRI-TB and RESPIRI-NTM have come together to form the type of strategic, multi-sector alliances we need to boost the world’s response to the threat of these serious infectious diseases.”
IMI is supporting the development of a number of multi-partner research consortia under its AMR Accelerator program that aim to speed TB drug development across the R&D spectrum – from discovery/early-stage development (i.e., RESPIRI-TB) to later-stage translational development – with the overarching goal of dramatically improving TB treatment regimens.
Together, these and other company-specific and collaborative R&D efforts will help drive critical and necessary TB innovation. This is in line with the current draft of the World Health Organization’s Global Strategy for TB Research and Innovation, which is currently undergoing review and is expected to be finalized for adoption by the World Health Assembly in May 2020.
About RESPIRI-TB / RESPIRI-NTM
Europe’s Innovative Medicines Initiative (IMI) announced the creation of the IMI Antimicrobial Resistance (AMR) Accelerator program in July 2018. The RESPIRI-TB and RESPIRI-NTM projects aim to support one of the pillars of the AMR Accelerator, which is to develop a portfolio of new drug candidates and improve the pipeline of drug development for tuberculosis (TB) and non-TB mycobacterial (NTM) diseases. The projects will run for six years, concluding in 2025.
IMI funding is being provided via the IMI 2 Joint Undertaking (grant numbers 853903 and 853932), which receives support from the European Union’s Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Janssen contributes directly to the RESPIRI projects and does not receive funding from IMI.
Further details of the projects are available on: http://www.imi.europa.eu/.
Johnson & Johnson’s TB Commitment
Johnson & Johnson has long been committed to the fight against DR-TB, including by developing Janssen’s SIRTURO® (bedaquiline). Since its U.S. approval in 2012, the company has delivered more than 125,000 courses of bedaquiline to 127 countries, including the 30 highest-burden countries (as of May 2019). Bedaquiline is approved in 61 countries, with pending regulatory submission in over a dozen more, and regulatory pathways have been identified for all UN Member States.
In support of global efforts to end TB, Johnson & Johnson announced a comprehensive 10-year commitment in September 2018. Through innovative partnerships and collaborations, Johnson & Johnson is working to broaden access to bedaquiline; support efforts to properly diagnose the millions of TB cases that currently go undetected – and thus untreated – every year; and accelerate the development of next-generation TB treatments and regimens. These efforts are intended to save an estimated 1.8 million lives and prevent 12 million new TB infections over the next decade.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at https://twitter.com/JNJGlobalHealth.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Janssen Pharmaceutica N.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the launch of an international research consortium to combat tuberculosis. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica N.V., and of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including the uncertainty of clinical success and of obtaining regulatory approvals; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Janssen Pharmaceutical Companies, Johnson & Johnson and their affiliates do not undertake to update any forward-looking statement as a result of new information or future events or developments.