Janssen Pharmaceutical Companies of Johnson & Johnson announce authorization for REKAMBYS ® (rilpivirine injection) in combination with VOCABRIA ® ( cabotegravir injection and tablets) from ViiV Healthcare in the European Union for the treatment of HIV-1 infection in virally-inhibited adults. 2 The approval marks the first time that people living in Europe with HIV will be able to receive prolonged injectable therapy eliminating the need for daily oral tablets.

“Great strides have been made in the way HIV has been managed and viewed over the past 30 years. However, for many people with or at risk of HIV, prejudice and discrimination persist and often prevent them from being heard or seeking treatment, ”says Giovanni Guaraldi *, associate professor of infectious diseases and head of the Metabolic Clinic - HIV from Modena, Italy. "With this extended duration protocol, people living with HIV may no longer need daily therapy, while maintaining viral load suppression with just 12 or six days of injection per year and eliminating the daily booster." of their condition. As the drugs continue to improve, I hope they will lead to significant developments, especially for people who still face discrimination. "

Highlighting the need for a less frequent dosing regimen, the largest outcome study of HIV patients to date conducted by ViiV Healthcare, Positive Perspectives Wave 2, found that when participants were asked about their treatment aspirations and their perceptions of innovative medicines, 55 percent (n = 1306/2389) would prefer an extended duration protocol. 3 Additionally, 58 percent (n = 1394/2389) noted that taking anti-HIV drugs daily is a constant reminder of their illness, while 38 percent (n = 906/2389) of participants reported that anxiety about taking medication every day can decrease their chances of disclosing their condition to others. 4

"We are very pleased with the decision of the European Commission to approve this extended duration injectable therapy," said Paul Stoffels, MD, vice chairman of the board, chief scientist, Johnson & Johnson. “At Janssen, we are deeply proud of this authorization and the progress made in addressing some of the greatest health challenges of our time. We will continue to strengthen our 25-year commitment to change the course of the HIV epidemic through our passionate pursuit of innovation, from long-term remission to effective HIV prevention. "

The marketing authorization is based on the results of the pivotal Phase 3, FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which recruited more than 1,200 participants from 16 countries. 1,5,6 The combination of injections of rilpivirine and cabotegravir is indicated for viro-inhibited adults (HIV-1 RNA less than 50 copies / mL), following a stable antiretroviral protocol, without present or past evidence of resistance viral to, or virologic failure with, non-nucleoside reverse transcriptase inhibitor and integrase inhibitor type agents.

Janssen's extended-lasting rilpivirine in combination with ViiV Healthcare's extended-lasting cabotegravir has been co-developed in collaboration with ViiV Healthcare and strengthens Janssen's portfolio of delivering innovative drugs to the HIV community.

* Professor Giovanni Guaraldi is a consultant paid by Janssen. He received no honorarium for his contribution to the media.

About ATLAS (NCT02951052)

ATLAS is an open-label, active-controlled, multi-center, parallel-group, non-inferiority, Phase 3 study designed to evaluate the antiviral activity and safety of the injectable combination of rilpivirine and prolonged cabotegravir. , dosed every four weeks, compared to the continuation of current oral antiretroviral therapy of two nucleoside reverse transcriptase inhibitors, plus one integrase strand transfer inhibitor, one non-nucleoside transcriptase inhibitor inverse, or a protease inhibitor, in people who are virally inhibited. 7The primary endpoint of the ATLAS study is the proportion of participants with a plasma HIV-1 RNA level ≥50 c / mL according to the FDA Snapshot algorithm at week 48 (absence, switchover or dropout = failure, population exposed in intention to treat). Participants had to be viro-inhibited for at least six months and undergo a first or second treatment, without previous failure. 7

About ATLAS-2M (NCT03299049)

ATLAS-2M is a randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority Phase 3 study designed to assess the non-inferior antiviral activity and safety of rilpivirine and cabotegravir over time. extended period given every eight weeks, compared to rilpivirine and extended duration cabotegravir given every four weeks during 48 weeks of treatment in 1,045 adults living with HIV-1. 8Participants had to be viro-inhibited for at least six months and undergo a first or second treatment, without previous failure. The primary endpoint of the study is the proportion of participants with an HIV-1 RNA level ≥50c / mL according to the FDA Snapshot algorithm at week 48 (intention-to-treat population). 1.8

ATLAS-2M is being carried out in research centers in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, in Sweden and the United States.

For more information, please see https://clinicaltrials.gov/ct2/show/NCT03299049 .

About FLAIR (NCT02938520)

FLAIR is a Phase 3, randomized, open-label, multicenter, parallel-group, non-inferiority study designed to evaluate the antiviral activity and safety of the intramuscular injection combination of rilpivirine and prolonged cabotegravir in virus-inhibited adults living with HIV after 20 weeks of ViiV Healthcare's Triumeq ® induction therapy (abacavir / dolutegravir / lamivudine), compared to prolongation of dolutegravir therapy by oral administration. 9The primary endpoint of the FLAIR study is the proportion of participants with a plasma HIV-1 RNA level ≥50 c / mL according to the FDA Snapshot algorithm at week 48 (no, change or discontinuation = failure, population exposed in intention to treat [ITT-E]). 9

About rilpivirine and long-lasting rilpivirine

The oral formulation of rilpivirine is also approved for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients aged 12 years and over, weighing at least 35 kg and with a viral load ≤ 100,000 HIV-RNA copies / mL. 10

Extended Duration Rilpivirine is an intramuscular injection sustained release suspension developed by Janssen Sciences Ireland Unlimited Company, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor whose mechanism is to interfere with an enzyme called reverse transcriptase, which in turn prevents the virus from multiplying. The EU marketing authorization is the second received by the extended-term, single-monthly dose rilpivirine and cabotegravir protocol approved by Health Canada under the trade name CABENUVA ® for the treatment of HIV infection. 1 in virologically stable and viro-inhibited adults. 11

Administration and dosage of rilpivirine and cabotegravir

The rilpivirine injection used in combination with the cabotegravir injection will be the first comprehensive long-lasting single dose or once every two months regimen for people with HIV-1 inhibition. Rilpivirine and cabotegravir injections are given as two intramuscular (IM) injections into the buttocks by a healthcare professional during the same visit. Before the injections are given, oral tablets of rilpivirine and cabotegravir are taken for about a month (at least 28 days) to assess drug tolerability.

About cabotegravir

Cabotegravir is an investigational integrase inhibitor developed by ViiV Healthcare for the treatment of HIV-1 in virally-inhibited adults, and being evaluated in combination with rilpivirine injection as an extended-lasting formulation. 12

Integrase strand transfer inhibitors, such as cabotegravir, inhibit HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T lymphocytes). This step is essential in the HIV replication cycle and is also responsible for the onset of chronic infection.

Important Safety Information

Please see the Summary of Product Characteristics for full prescribing information of EDURANT ® (rilpivirine) https://www.medicines.org.uk/emc/product/4968/smpc

About Johnson & Johnson Janssen Pharmaceutical Companies

At Janssen, we are creating a future in which illness is a thing of the past. We are the pharmaceutical companies of Johnson & Johnson. We work tirelessly to make that future a reality for patients around the world, fighting disease through science, using ingenuity to improve access to treatment, and combating desperation with determination. We focus on medical areas where we can have a major impact, namely cardiovascular disorders and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology and pulmonary hypertension. More information at www.janssen.com/emea . Follow all our news on www.twitter.. Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Sciences Ireland Unlimited Company are part of the Janssen pharmaceutical companies of Johnson & Johnson.

Cautions Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to rilpivirine. The reader is cautioned not to place undue reliance on forward-looking statements. These statements are based on current expectations regarding future events. If the underlying assumptions turn out to be incorrect or if any known or unknown risks or uncertainties materialize, actual results could differ materially from the expectations and projections of Janssen-Cilag International NV and Janssen Research & Development, the other pharmaceutical companies. Janssen and / or Johnson & Johnson. Risks and uncertainties include, but are not limited to, the challenges and uncertainties inherent in product research and development, including uncertainty regarding clinical success and obtaining regulatory approvals; uncertainty about business success; difficulties and delays in manufacturing; competition, including technological advances, new products and patents obtained by our competitors; patent challenges; concerns about the efficacy or safety of products leading to product recalls or regulatory action; changes in the behavior and purchasing habits of buyers of health care products and services; changes in existing laws and regulations, including healthcare reforms around the world; as well as trends towards containing health care costs. A list and more detailed descriptions of these risks, uncertainties and other factors are set out in Johnson & Johnson's annual report on Form 10-K for the year ended December 29, 2019, including in the sections headed “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors ”in the latest quarterly report filed by the company on Form 10-Q and in documents subsequently filed by the company with the United States Securities and Exchange Commission (SEC). Copies of these documents are available online at in the latest quarterly report filed by the company on Form 10-Q and in documents subsequently filed by the company with the United States Securities and Exchange Commission (SEC). Copies of these documents are available online at in the latest quarterly report filed by the company on Form 10-Q and in documents subsequently filed by the company with the United States Securities and Exchange Commission (SEC). Copies of these documents are available online atwww.sec.gov and www.jnj.com , or on request from Johnson & Johnson. The pharmaceutical companies Janssen and Johnson & Johnson disclaim any obligation to update any forward-looking statements as a result of new information or future events or developments.

References

1 Swindells S, Andrade-Villanueva JF, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. DOI: 10.1056 / NEJMoa1904398.

2 European Medicines Agency. Summary of notice for Rekambys.

3 De los Rios, P., Okoli, C., Young, B., Allan, B., Castellanos, E., Brough, G., Eremin, A., Corbelli, GM, Hardy, WD, and Van de Velde , N. (2020). Treatment aspirations and attitudes towards innovative medications among people living with HIV in 25 countries. Population Medicine, 2 (July), 23. https://doi.org/10.18332/popmed/124781.

4 De Los Rios P, Okoli C, Castellanos C et al. Physical, Emotional and Psychosocial Challenges Associated with Daily Dosing of HIV Medications and Their Impact on Indicators of Quality of Life: Findings from the Positive Perspectives Study. AIDS and Behavior. 2020.

5 Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. DOI: 10.1056 / NEJMoa1909512.

6 Overton ET et. al. Cabotegravir and rilpivirine every 2 months is non inferior to monthly: ATLAS-2M study. Presented at CROI 2020.Available at: https://www.croiconference.org/abstract/cabotegravir-rilpivirine-every-2-months-is-noninferior-to-monthly-atlas-2m-study/ . Last consulted in December 2020.

7 Swindells S et al. (2019) Long-Acting Cabotegravir + Rilpivirine For Maintenance Therapy: Atlas Week 48 Results. Oral presentation, the Annual Conference on Retroviruses and Opportunistic Infections (CROI).

8 Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03299049 . Last consulted in December 2020.

9 Orkin C et al. (2019) Long-Acting Cabotegravir + Rilpivirine For Hiv Maintenance: Flair Week 48 Results. Oral Presentation at the Annual Conference on Retroviruses and Opportunistic Infections (CROI).

10 Summary of Product Characteristics for EDURANT®. Available at: https://www.medicines.org.uk/emc/product/4968/smpc . Last consulted in December 2020.

11 Drugs. Cabenuva FDA Approval Status. Available at: https://www.drugs.com/history/cabenuva.html . Last consulted in December 2020.

12 European Medicines Agency. Summary of the opinion (Rekambys). Available at: https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rekambys_en.pdf . Last consulted in December 2020.

CP-197548

Date of preparation: December 2020

The text of the press release resulting from a translation should in no way be considered official. The only authentic version of the press release is that of the press release in its original language. The translation will always have to be compared to the source text, which will set a precedent.

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