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South Africa’s Health Products Regulatory Authority approves the dapivirine ring developed by the International Partnership for Microbicides

South Africa’s Health Products Regulatory Authority approves the 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, particularly in sub-Saharan Africa

The International Microbicides Partnership 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) is pleased with the approval by the South African Health Products Regulatory Authority (SAHPRA) of the once-monthly dapivirine vaginal ring developed by the nonprofit non-profit International Partnership for Microbicides, Inc. (IPM), for use by women aged 18 and over 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, gives women a new option to decide which method best meets their individual needs.

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

“There is a clear need for new prevention options to protect the most vulnerable,” said Martin Fitchet, MD, head of global public health, Johnson & Johnson.[1] “Johnson & Johnson has supported IPM’s efforts to help enable rapid access to the ring – in South Africa and beyond – which could help women reduce their risk of contracting HIV and make moving forward to end this outbreak once and for all.”

The ring contains dapivirine, a drug previously developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. In 2004, Janssen Sciences Ireland Unlimited Company provided the International Partnership for Microbicides, a not-for-profit product development partnership, with a non-exclusive, royalty-free license to develop dapirivine as a vaginal microbicide. This license extended to an exclusive worldwide rights agreement in 2014, ensuring that any dapivirine product will be available at low cost in resource-limited settings.[2]

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

Johnson & Johnson’s collaboration with IPM underscores the company’s decades-long unwavering commitment to advancing innovation from the lab to the last mile of healthcare delivery in the fight against HIV. We have developed nine anti-HIV drugs and continue to support and advance new treatment and prevention options, and work with vulnerable communities on the front lines of the HIV epidemic through initiatives such as DREAMS Thina Abantu Abashathe MenStar Coalition and the New Horizons Collaboration.

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

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About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are creating a future where illness is a thing of the past. We are the pharmaceutical companies of Johnson & Johnson, working tirelessly to make that future a reality for patients around the world by fighting disease with science, improving access with ingenuity, and healing despair with heart. We focus on the areas of medicine where we can make the biggest difference: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology and pulmonary hypertension.

Learn more about www.janssen.com. follow us on @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 that good health is the foundation for vibrant lives, thriving communities and progress. That’s why, for more than 130 years, we’ve focused on the well-being of people at all ages and at every stage of life. Today, as the largest and most widely-located healthcare company in the world, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and make healthy minds, bodies and environments accessible to everyone, everywhere. We unite our hearts, our science and our ingenuity to profoundly change the trajectory of human health. Learn more at www.jnj.com. follow us on @JNJNews.

Cautions Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the 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 differ 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 obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents obtained by competitors; patent challenges; product efficacy or safety issues resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of healthcare products and services; changes in applicable laws and regulations, including global healthcare reforms; and trends in health care cost containment. A list and additional 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 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 documents 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.]neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.

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

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