World Health Organization Recommends the Use of Bedaquiline-Containing Treatment Regimens For All Drug-Resistant Tuberculosis Patients

16 DECEMBER 2019, BEERSE, BELGIUM – Johnson & Johnson recognizes the World Health Organization (WHO)’s Rapid Communication indicating that all-oral regimens containing Johnson & Johnson’s SIRTURO® (bedaquiline) are the preferred treatment options for all patients with multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant TB (RR-TB).

This decision – based on programmatic data shared by countries, particularly South Africa, and research and technical partners – expands the use of bedaquiline in shorter treatment regimens to replace injectable agents. WHO has advised national TB programs to phase out the use of injectable-containing short-course regimens, which have been known to cause toxic side effects for patients.

“This is a landmark moment for drug-resistant TB patients,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “It has been nearly 20 years since our scientists began the effort to identify the compound that would become bedaquiline. We hope that the next 20 years sees the world truly turn the tide on the TB epidemic. We look forward to doing our part to make this happen.”

The Rapid Communication was released in advance of updated consolidated drug-resistant TB treatment guidelines, expected in 2020, to help national TB programs to begin planning for a rapid transition to what WHO calls “more effective, less toxic and easier to implement” regimens.

In line with treatment guidelines released by WHO in March 2019, bedaquiline remains a “Group A” medicine for long-course regimens for patients with pulmonary MDR-TB. Individualized longer regimens, which should contain bedaquiline as a prioritized drug, are recommended for patients with extensive TB disease, severe forms of extrapulmonary TB, those with resistance to fluoroquinolones, or who have been exposed to treatment with second-line drugs.

“The decision from WHO reiterates the importance and value of bedaquiline as a vital component of modernized DR-TB treatment regimens,” said Jaak Peeters, Head of Johnson & Johnson Global Public Health, Janssen-Cilag GmbH. “Johnson & Johnson is committed to working closely with countries and partners to continue scaling up access to bedaquiline for more patients, building on significant and rapid progress in 2019. We look forward to further accelerating our efforts in 2020.”

Johnson & Johnson’s Commitment to TB
Johnson & Johnson has been a committed partner in the global fight against TB for more than two decades. When bedaquiline received accelerated regulatory approval from the U.S. Food & Drug Administration (FDA) in 2012, it was the first targeted TB drug with a novel mechanism of action developed in more than 40 years.

To date, Johnson & Johnson has provided more than 184,000 courses of bedaquiline to 138 countries, including the 30 countries with the highest burden of multidrug-resistant TB (MDR-TB). Notably, the Company has provided 105,000 courses of treatment, free of cost, to 80 countries through a four-year donation program, operated in partnership with the U.S. Agency for International Development and JSC Pharmstandard.

Johnson & Johnson is also working closely with governments and other partners in high-burden low- and middle-income countries to build critical health systems capacity and capabilities – by training health workers, improving diagnosis, and raising awareness and reducing stigma around TB at the community level. We are also working to ensure the appropriate use of bedaquiline through effective stewardship to help prevent resistance to the medicine from developing.

Looking to the future, greater innovation will be needed – both in the lab and on the ground – to end the TB epidemic. In September 2018, Johnson & Johnson announced a 10-year initiative aimed at continuing to broaden treatment access, improving patient finding, and advancing R&D to develop new tools that will be needed to end TB. In support of this, in October 2019, the Company announced its commitment to invest $500 million in the development and delivery of innovations to combat both HIV and TB.

About MDR-TB
TB is the world’s deadliest infectious disease, claiming 1.5 million lives globally in 2018 – and growing resistance to the most powerful first-line medicines is further compounding this public health challenge. In 2018, there were approximately half a million new cases of drug-resistant TB, approximately half of which occurred in three countries: India (27%), China (14%) and the Russian Federation (9%). Drug-resistant TB now accounts for approximately one-third of all deaths from antimicrobial resistance (AMR). Currently, only one in three patients with DR-TB is diagnosed.

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. www.jnj.com

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.

Learn more at http://www.janssen.com/. Follow us at www.twitter.com/JanssenUS and 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 any of the Janssen Pharmaceuticals 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 commercial success and of obtaining regulatory approvals; 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; manufacturing difficulties and delays; 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 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. None of the Janssen Pharmaceuticals Companies nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.