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Cabenuva

Treatment for HIV Infection

Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV

Cork,Ireland, April 29, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) has been submitted by ViiV Healthcare for the investigational once-monthly, injectable, two-drug regimen of Janssen’s rilpivirine and ViiV’s cabotegravir for the treatment of HIV in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The submission is based on the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal Phase 3 studies that included more than 1,100 patients from 16 countries. These studies demonstrated that the combination of rilpivirine and cabotegravir, injected monthly, was as effective as a standard of care, daily, oral three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.

“We believe this once-monthly injectable regimen has the potential to offer many people living with HIV a treatment option that does not require taking pills every day,” said Brian Woodfall, M.D., Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. “In our quest to change the trajectory of health for humanity, we will continue to innovate in the field of HIV. We look forward to working with ViiV and the FDA on the steps needed to get the first long-acting injectable HIV treatment to patients.”

This novel regimen is being co-developed as part of a collaboration between Janssen and ViiV Healthcare. The two companies plan to submit regulatory applications for the two-drug regimen of rilpivirine and cabotegravir to the European Medicines Agency, Health Canada and other global agencies in the coming months.

As part of the regulatory submission package to the FDA, a second NDA was submitted for an oral tablet formulation of cabotegravir that would be taken once-daily as an oral lead-in with the already-approved oral tablet formulation of rilpivirine (marketed by Janssen as EDURANT®).

About ATLAS (NCT02951052)
ATLAS is a Phase 3, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable rilpivirine and cabotegravir dosed every four weeks compared to continuation of current oral anti-retroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population). Subjects were required to be virally suppressed for six months or longer, on a first or second regimen, with no prior failure.

About FLAIR (NCT02938520)
FLAIR is a Phase 3, randomized, open-label, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting, injectable rilpivirine and cabotegravir in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq® compared to continuation of the oral dolutegravir-based treatment regimen. The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).

About rilpivirine long-acting

Rilpivirine long-acting is an investigational, injectable, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.

About cabotegravir

Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting, prolonged-release formulation for intramuscular injection and also as a once-daily oral tablet for short-term use prior to long-acting injection.

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 and follow us at www.twitter.com/JanssenGlobal. Janssen Biopharma Inc., and Janssen Sciences Ireland UC are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Notice to Investors Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. 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 UC, any of the other 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 30, 2018, 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. None of 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.

Source: Janssen Pharmaceutical Companies of Johnson & Johnson

Posted: April 2019

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