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South Africa Health Products Regulatory Authority Approves Dapivirine Ring Developed by the International Partnership for Microbicides
South Africa Health Products Regulatory Authority Approves Dapivirine Ring Developed by the International Partnership for Microbicides

The dapivirine ring is the first long-acting HIV prevention option designed specifically for women

Women bear a disproportionate burden of the global HIV epidemic, especially in sub-Saharan Africa

International Partnership for Microbicides developed the dapivirine ring through an exclusive license from the Janssen Pharmaceutical Companies of Johnson & Johnson

NEW BRUNSWICK, NJ, March 11, 2022 – Johnson & Johnson (the Company) welcomes the approval from the South African Health Products Regulatory Authority (SAHPRA) of the once-monthly dapivirine vaginal ring, developed by the not-for-profit International Partnership for Microbicides, Inc. (IPM), for use by women ages 18 and older to help reduce their risk of contracting HIV. The dapivirine ring, which is the first discreet, long-acting HIV prevention method designed exclusively for women, offers women a new option when deciding which method best meets their individual needs.

The approval of the dapivirine ring in South Africa is an important step in the decades-long fight against HIV, which is one of the most significant challenges in global health. In 2020, 1.5 million people contracted HIV, and women face persistently high rates of the virus, especially in sub-Saharan Africa. In South Africa, nearly 2,700 women 15 years of age and older contract HIV every week.

“There is a clear need for new prevention options to protect the most vulnerable," said Martin Fitchet, M.D., Head of Global Public Health, Johnson & Johnson.[1] “Johnson & Johnson has been supporting IPM’s efforts to help enable timely access to the ring – in South Africa and beyond – which could help empower women to reduce their risk of contracting HIV, and drive progress toward ending this epidemic once and for all.”

The ring contains dapivirine, a medicine previously developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. In 2004, Janssen Sciences Ireland Unlimited Company provided the International Partnership for Microbicides, a non-profit product development partnership, with a non-exclusive, royalty-free license to develop dapirivine as a vaginal microbicide. That license expanded to an exclusive worldwide rights agreement in 2014, ensuring that any dapivirine-based product will be made available at low-cost in resource-limited settings.[2]

The dapivirine ring received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA CHMP) through the EU-M4all procedure (Medicines for use outside the European Union), Prequalification from the World Health Organization (WHO), a WHO recommendation for use and an approval in Zimbabwe.

Johnson & Johnson’s collaboration with IPM underscores the Company’s steadfast, decades-long commitment to advancing innovation from the lab to the last mile of health delivery in the fight against HIV. We have developed nine HIV medicines and are continuing to foster and advance new treatment and prevention options, and work with vulnerable communities on the frontlines of the HIV epidemic through initiatives such as DREAMS Thina Abantu Abasha, the MenStar Coalition and the New Horizons Collaborative.

To learn more about Johnson & Johnson’s commitment to make HIV history, please visit JNJ.com/HIV.

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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 www.janssen.com. Follow us at @JanssenUS and @JanssenGlobal. Janssen Sciences Ireland Unlimited Company is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of the dapivirine vaginal ring. 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 Sciences Ireland Unlimited Company, 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 January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Report 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. None of Janssen Sciences Ireland Unlimited Company, [Janssen Pharmaceuticals, Inc.], 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.

[1] The legal employing entity is Cilag GmbH International
[2] Johnson & Johnson did not develop the ring, does not own the rights to the product, and is not responsible for its commercialization.

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