Johnson & Johnson Announces 10-year Initiative to Help End Tuberculosis, the World’s #1 Infectious Killer

NEW YORK, February 8, 2019 /3BL Media/ - Ahead of the first-ever United Nations (UN) High-Level Meeting on Tuberculosis (TB), Johnson & Johnson announced a comprehensive 10-year initiative in support of the United Nations Sustainable Development Goal target of ending the TB pandemic by 2030. With the goal of saving an estimated 1.8 million lives and preventing 12 million new TB infections in the next decade, Johnson & Johnson will work with partners to improve detection of undiagnosed cases of TB, broaden access to its novel medicine for multidrug-resistant TB (MDR-TB), and accelerate research & development (R&D) to discover next-generation TB treatments.

“TB is the worlds number one infectious killer, and TB and MDR-TB cause major devastation for people, communities and entire countries around the world,” says Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “The good news is TB is both preventable and treatable, and Johnson & Johnson is committed to doing everything we can to create a world free from TB. This new initiative will unleash the power of science and technology to forever change the trajectory of TB.”

Every year, 10 million people fall ill with tuberculosis and approximately 1.6 million people die from the disease. TB is difficult to diagnose, and many of the drugs used today have had historically low cure rates and can lead to debilitating and even fatal side effects. Further, the disease is developing resistance to first-line medicines. Drug-resistant TB (DR-TB) now accounts for approximately one-third of deaths from antimicrobial resistance (AMR), making TB the single largest cause of AMR-related deaths. There is growing consensus that new innovations are urgently needed in order to end the TB pandemic.

This new, comprehensive initiative builds on Johnson & Johnson’s significant investments over two decades in the discovery, development and delivery of bedaquiline, the company’s medicines for the treatment of pulmonary MDR-TB in adults (≥ 18 years of age). When bedaquiline was conditionally approved by the FDA in 2012, it was the first targeted TB medicine with a novel mechanism of action in more than 40 years. Today, it is approved in 56 countries, including those with the highest TB burdens. As part of the company’s commitment to ensure access to bedaquiline for patients who need it, Johnson & Johnson has provided nearly 70,000 courses of treatment to patients in 107 countries.

“Bedaquiline is a significant breakthrough in addressing the scourge of MDR-TB, and we are confident we can build on our innovation, our know-how and our network of committed global collaborators to do even more,” says Jaak Peeters, Global Head, Johnson & Johnson Global Public Health, Janssen-Cilag GmbH. “Our goal is to end the TB epidemic forever by finding and treating patients all over the world.”

Improving Detection of MDR-TB in High-Burden Countries

Every year, approximately 4 million cases of TB – including hundreds of thousands of cases of MDR-TB – go undiagnosed, posing a risk to patients and public health security. As part of its new initiative, Johnson & Johnson is forging new strategic collaborations aimed at finding undiagnosed patients.

The first of these is a new, never-before-announced partnership with Cepheid, a molecular diagnostics company that developed and manufactures the GeneXpert® System for TB. Janssen Pharmaceutica N.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Cepheid will partner in India to train healthcare professionals to improve patient referrals for TB diagnosis and treatment. Further, they will partner in China to improve access to molecular tests for high-risk populations and train healthcare professionals on TB diagnosis and treatment.

Ensuring Affordable Access to Novel MDR-TB Treatment

Johnson & Johnson is also reinforcing its commitment to expand affordable access to bedaquiline to all eligible people with MDR-TB by offering a non-commercial, special-effort price for more than 130 low- and middle-income countries, as well as non-governmental organizations, procuring through the Stop TB Partnership’s Global Drug Facility.

The special-effort price was announced in July in recognition of South Africa’s leadership in the fight against TB and extended to additional countries to help catalyze further action against MDR-TB. In June, South Africa became the first country to recommend an injection-free, bedaquiline-containing regimen for all eligible MDR-TB patients. The special-effort price covers the cost of manufacturing and critically important efforts focused on strengthening health system capacity and ensuring safe and appropriate use of bedaquiline in high-burden countries.

Accelerating R&D to Discover Innovative TB Treatments

Additionally, Johnson & Johnson is building on its track record of successful therapeutic innovation for tuberculosis by significantly accelerating the development of next generation treatments and regimens for children and adults suffering from TB or MDR-TB.

Both internally and through research collaborations with India’s Institute of Microbial Technology and other leading research institutions, the Janssen Pharmceutical Companies of Johnson & Johnson will:

• Conduct pediatric studies for a bedaquiline-containing regimen for the treatment of children infected with MDR-TB,
• Advance a potential next-generation triple-drug regimen to treat and cure people suffering from MDR-TB with the aim of reducing the burden of treatment,
• Advance a potential universal, fast-acting TB regimen to treat and cure all forms of TB, whether drug-sensitive or drug-resistant, and
• Conduct early research into the potential of TB medicines to prevent latent TB infection from becoming active by intercepting and treating this dormant form of the disease.

* GeneXpert® is a trademark of Cepheid.

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About TB & MDR-TB

Tuberculosis (TB) is the world’s deadliest infectious disease. Nearly one-quarter of the world’s population — 1.7 billion people — are infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis. In most of them, the infection is in a dormant state. But every year, 10 million people develop active tuberculosis and approximately 1.6 million people die of it.1

Multidrug-resistant TB (MDR-TB) is a particularly complicated form of the bacterial infection, and is characterized by resistance to at least two of the most powerful drugs in the first-line treatment regimen (isoniazid and rifampicin). Globally, MDR-TB is a growing threat. In 2017, there were more than 450,000 new cases of MDR-TB, and drug-resistant TB now accounts for approximately one-third of all deaths from antimicrobial resistance (AMR).

Many of the drugs used to treat TB, especially MDR-TB, are decades old, have low cure rates and can cause debilitating and potentially even fatal side effects. Injectable antibiotics — which have been part of the first-line drug regimen for treating MDR-TB — cause deafness in as many as 3 out of every 5 people taking them. Other commonly used MDR-TB drugs cause liver and kidney damage and psychosis.

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 @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

About Johnson & Johnson’s Heritage in TB

Johnson & Johnson has a long history of innovating to develop new TB tools and technologies. We are inspired by the legacy of Dr. Paul Janssen, who lost his 4-year-old sister to tubercular meningitis in the 1940s. This tragic event led Dr. Janssen to devote his life to medical research, and ultimately, to found what is now the Janssen Pharmaceutical Companies of Johnson & Johnson. During his lifetime, Dr. Janssen wanted to end TB. Today, the company bearing his name is determined to achieve this mission. Learn more about our work on TB at www.jnj.com/TB.

About Our Global Public Health Approach

Charting a bold new, self-sustainable approach, Johnson & Johnson has established the first fully-dedicated organization within a healthcare company focused on combining innovative R&D, novel access programs & approaches, in-country operations, advocacy and the power of multi-sectoral partnerships to ensure that treatments and technologies are available, affordable and accessible for the world's most under-served populations. Harnessing the extensive resources and expertise from across Johnson & Johnson, its Global Public Health team is using big for good to place an unparalleled focus on accelerating the pace of innovation needed – from discovery to delivery – to make TB and HIV history, eliminate intestinal worms, address mental health and wrestle other public health challenges. Learn more at www.jnj.com/global-public-health and follow us @JNJGlobalHealth.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding bedaquiline (SIRTURO®). 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 the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions 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 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and 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. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.