New Brunswick, N.J. (September 29, 2023) – Johnson & Johnson (the “Company”) (NYSE: JNJ) today confirmed its intent not to enforce patents it owns and controls for SIRTURO® (bedaquiline) in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries1,2.
The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of SIRTURO® without a concern that the Company will enforce its bedaquiline patents, provided the generic versions of SIRTURO® produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries.
“Underdiagnosis remains the most significant barrier to treatment, with nearly two-thirds of the 450,000 people who develop MDR-TB each year not diagnosed and enrolled on treatment,” said Howard Reid, Global Head, Global Public Health & Social Impact, Johnson & Johnson. “This addresses any misperception that access to our medicine is limited or restricted and builds on our decade of investments in collaborative efforts to help countries sustainably scale up access and bring people living with MDR-TB into treatment.”
Johnson & Johnson introduced SIRTURO® (bedaquiline), the first targeted tuberculosis (TB) medicine with a novel mechanism of action in more than 40 years, in 2012 after years of focused investments in R&D. In partnership with many others, the Company has spent the past decade investing in critical TB systems capacity, such as healthcare professional training, resistance testing and surveillance, and supply chain security, to help bring people into treatment while not compromising the effectiveness as drug resistance increases globally.
Today, thanks to years of investments, collaboration, and responsible use of our intellectual property, bedaquiline is the backbone of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen.
Most recently, Johnson & Johnson granted Stop TB Partnership´s Global Drug Facility`s (GDF) a license that enabled GDF to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries. The Company will continue to invest in innovative capacity building, surveillance and patient finding efforts that drive access and appropriate use of bedaquiline.
References:
1 World Bank Income Classifcation set on 1 July 2022: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups
2 The list of low- and middle-income countries is available upon request.
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Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements as they 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 current expectations. A list and descriptions of risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other 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. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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