Data Published in The Lancet Shows High Efficacy at 96 Weeks for First Investigational Two-Drug, Long-Acting Injectable HIV Regimen

Long-term data from the Phase 2b LATTE-2 study demonstrated comparable antiviral activity to daily, oral 3-drug combination

Data presented as an oral late breaker at the 9^th International AIDS Society Conference, 23-26 July 2017, Paris, France

CORK, Ireland, 24 July 2017 – Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that a regimen of two investigational long-acting, injectable formulations of HIV medicines —Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir — given together every 4 or 8 weeks was as effective as 3-drug oral antiretroviral therapy (ART) at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA <50 copies per mL). Results published in The Lancet show that if approved, this first two-drug, long-acting regimen could offer a highly effective suppressive maintenance therapy for people living with HIV.

Viral suppression was achieved in 94 percent of those (n=108) receiving injections every eight weeks, warranting further investigation. Virologic response was also achieved by 87 percent (n=100) of those receiving injections every four weeks versus 84 percent (n=47) receiving oral ART therapy. In an unprecedented outcome, no virologic non-responders to the long-acting regimen were observed in the four-week group, as determined by the stringent FDA snapshot algorithm. Few virologic non-responders were seen in the eight-weekly group (n=5 [4%]).These results highlighted that the two-drug, long-acting regimen offered durability of virologic response throughout almost 2 years of treatment.

“Results published in The Lancet strengthen the evidence that a two-drug, long-acting regimen may offer an effective and acceptable alternative for people who have achieved viral suppression but struggle with daily, oral regimens to control their HIV,” said Paul Stoffels M.D., Chief Scientific Officer, Johnson & Johnson. “Non-adherence to treatment remains a challenge for many people living with HIV and one of the main drivers of resistance to HIV medicines. Our hope is to make HIV treatment manageable for all by developing innovative solutions like long-acting regimens.”

In LATTE-2, patients with HIV-1 viral suppression on oral medication (cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to long-acting injections every four or eight weeks, or to daily oral cabotegravir taken with abacavir and lamivudine.

High satisfaction was reported in the study by those receiving the two-drug, long-acting regimen, which suggests it may provide a preferred alternative for many people living with HIV who may not wish to consider taking life-long oral therapy. The data are based on the observed case data set of subjects who completed questionnaires at week 48 and week 96.

The two-drug, long-acting regimen was generally well tolerated, with no drug-related serious adverse events and few adverse event-related withdrawals. While injection-site reactions (ISRs) were common (four-weekly group, 97% of patients; eight-weekly group, 96% of patients), they were transient in nature, and mild or moderate in severity. The long-term acceptability of administering chronic intramuscular injections to patients was also demonstrated in LATTE-2, with very few withdrawals resulting from ISRs (two patients [<1%]), through 96 weeks.

The most commonly reported non-ISR adverse events were nasopharyngitis (four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%; eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine group, 20%), and headache (four-weekly group, 23%; eight-weekly group, 25%; oral cabotegravir plus abacavir/lamivudine group, 25%).

Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), are currently examining the safety and efficacy of four weekly dosing with the two-drug, injectable regimen. For more information on the clinical trials, please visit: www.clinicaltrials.gov.

These results will be presented in an oral abstract session at the 9^th International AIDS Society Conference on HIV Science (IAS 2017) at 12:00 on Monday 24 July 2017. Please visit jnj.com/HIV for additional details on the breadth of science being presented by Johnson & Johnson companies and its partners.

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About the LATTE 2 clinical trial (NCT02120352)
LATTE-2 is an ongoing Phase 2b, multicenter, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/mL during 20-week Induction Period (IP) with daily oral cabotegravir (CAB) 30 mg plus abacavir/lamivudine 600 mg/300 mg were randomized 2:2:1 to intramuscular injections every 4 weeks (long-acting cabotegravir 400 mg plus rilpivirine 600 mg; two 2-mL injections) or every 8 weeks (long-acting cabotegravir 600 mg plus rilpivirine 900 mg; two 3-mL injections), or to continue receiving three-drug, oral ART in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the maintenance period. Antiviral activity, protocol-defined virologic failures and safety events through 96 weeks for the maintenance population were key secondary endpoints.

About cabotegravir
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare as a long-acting, nanosuspension formulation for intramuscular injection for the treatment and prevention of HIV.

About EDURANT^® (Rilpivirine)
EDURANT^® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:

• Who have never taken HIV medicines before, and
• Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load.

EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.

It is important that you remain under the care of your healthcare professional during treatment with EDURANT®.

EDURANT® is not recommended for patients less than 12 years of age.

EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.

Please read Important Safety Information below, and talk to your healthcare professional to learn if EDURANT® is right for you.

Important Safety Information

Can EDURANT® be taken with other medicines?
EDURANT® may affect the way other medicines work and other medicines may affect how EDURANT® works and may cause serious side effects. If you take certain medicines with EDURANT®, the amount of EDURANT® in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT® or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT® with a meal. A protein drink alone does not replace a meal.

Do not take EDURANT® if:

• Your HIV infection has been previously treated with HIV medicines
  

• You are taking any of the following medicines:

  • Anti-seizure medicines: carbamazepine (Carbatrol^®, Equetro^®, Tegretol^®, Tegretol-XR^®, Teril^®, Epitol^®), oxcarbazepine (Trileptal^®), phenobarbital (Luminal^®), phenytoin (Dilantin^®, Dilantin-125^®, Phenytek^®).
    
  • Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater^®, Rifamate^®, Rimactane^®, Rifadin^®), rifapentine (Priftin^®) Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium^®, Vimovo^®), lansoprazole (Prevacid^®), omeprazole (Prilosec^®, Zegerid^®), pantoprazole sodium (Protonix^®), rabeprazole (Aciphex^®).
    
  • More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate.
    
  • St. John’s wort (Hypericum perforatum).

• Especially tell your doctor if you take:

  • Rifabutin (Mycobutin^®), a medicine to treat some bacterial infections). Talk to your doctor or pharmacist about the right amount of EDURANT^® you should take if you also take rifabutin.
    
  • Medicines used to treat HIV.
    
  • An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take EDURANT^®.
    
  • Medicines to block acid in your stomach, including cimetidine (Tagamet^®), famotidine (Pepcid^®), nizatidine (Axid^®), or ranitidine hydrochloride (Zantac^®). Take these medicines at least 12 hours before or at least 4 hours after you take EDURANT^®.
    
  • Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin^®), erythromycin (E-Mycin^®, Eryc^®, Ery-Tab^®, PCE^®, Pediazole^®, Ilosone^®), fluconazole (Diflucan^®), itraconazole (Sporanox^®), ketoconazole (Nizoral^®), methadone (Dolophine^®), posaconazole (Noxafil^®), telithromycin (Ketek^®), voriconazole (Vfend^®).

This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Before taking EDURANT®, also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT® will harm your unborn baby.

You and your healthcare professional will need to decide if taking EDURANT® is right for you.

Do not breastfeed if you are taking EDURANT®. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby.

What are the possible side effects of EDURANT®? EDURANT® can cause serious side effects including:

• Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain).
• Depression or mood changes. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide), or have tried to hurt yourself.
• Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment. Liver problems were also reported during treatment in some people without a history of liver disease. Your healthcare professional may need to do tests to check liver function before and during treatment.
• Changes in body shape or body fat have been seen in some patients taking HIV medicines. The exact cause and long-term health effects of these conditions are not known.
• Changes in your immune system (immune reconstitution syndrome).
• Your immune system may get stronger and begin to fight infections. Tell your healthcare professional right away if you start having any new symptoms of infection.
• Other common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare professional.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).

Please see full Product Information for more details.

About Janssen
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.

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 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 the Janssen Pharmaceutical Companies and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new indications and therapeutic combinations; 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 behaviour 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 description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the year ended January 1, 2017, including under “Item 1A Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements,” 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.