Janssen Collaborates With ViiV Healthcare to Develop Two-Drug Single Tablet Regimen for the Maintenance Treatment of People Living With HIV

PR57044

CORK, Ireland, June 12, 2014/PRN=KYODO JBN /--

   Janssen R&D Ireland Ltd announced today that they have entered into a

collaboration with ViiV Healthcare to develop and commercialize a new single

tablet regimen containing Janssen's Non-Nucleoside Reverse Transcriptase

Inhibitor rilpivirine (marketed as EDURANT(R)) and ViiV's Integrase Inhibitor

dolutegravir(marketed as TIVICAY(R)) as the sole active ingredients for the

maintenance treatment of people living with Human Immunodeficiency Virus (HIV).

The companies will further investigate development of this drug combination for

pediatric use.

    If successfully developed and approved by regulatory authorities, this

treatment could offer people living with HIV who are virologically suppressed

an option to switch from a standard three-drug therapy to a two-drug,

Nucleoside Reverse Transcriptase Inhibitor (NRTI)-sparing antiviral regimen.

    "HIV remains a significant medical challenge, and our goal is to find new

treatment regimens for patients," says Paul Stoffels, Chief Scientific Officer,

Johnson & Johnson and Worldwide Chairman, Janssen. "We are pleased to

collaborate with ViiV Healthcare in pursuing this shift in the HIV treatment

paradigm and reaffirm our commitment to collaborate and develop new HIV

treatments and fixed-dose regimens."

    Formulation and clinical development for the single tablet regimen will

begin in the coming months.

    Since the beginning of the HIV epidemic, almost 75 million people have been

infected with the HIV virus.[1] It is estimated that 35 million people are

currently living with HIV globally, with 2.5 million people becoming newly

infected each year.[1],[2],[3]

    Standard HIV-drug therapy contains three active components: a backbone of

two NRTIs, plus either a Non-Nucleoside Reverse Transcriptase Inhibitor

(NNRTI), Protease Inhibitor (PI) or Integrase Inhibitor (INI).

    About EDURANT(R)

    EDURANT(R) (rilpivirine) is a prescription HIV medicine that is used with

other antiretroviral medicines to treat Human Immunodeficiency Virus-1

(HIV-1)in adults:

     - 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(R) 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(R)

    - EDURANT(R) is not recommended for patients less than 18 years of age

    EDURANT(R) 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(R) is right for you.

    Important Safety Information

    Can EDURANT(R) be taken with other medicines?

    EDURANT(R) may affect the way other medicines work and other medicines may

affect how EDURANT(R) works and may cause serious side effects. If you take

certain medicines with EDURANT(R), the amount of EDURANT(R) 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(R) or other HIV medicines

that are like it. To help get the right amount of medicine in your body, you

should always take EDURANT(R) with a meal. A protein drink alone does not

replace a meal.

    Do not take EDURANT(R) if:

    Your HIV infection has been previously treated with HIV medicines

    You are taking any of the following medicines:

     - Anti-seizure medicines: carbamazepine (Carbatrol(R), Equetro(R),

Tegretol(R), Tegretol-XR(R), Teril(R), Epitol(R)), oxcarbazepine

(Trileptal(R)), phenobarbital (Luminal(R)), phenytoin (Dilantin(R),

Dilantin-125(R), Phenytek(R))

    - Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater(R), Rifamate(R),

Rimactane(R), Rifadin(R)), rifapentine (Priftin(R))

    - Proton pump inhibitor (PPI) medicine for certain stomach or intestinal

problems: esomeprazole (Nexium(R), Vimovo(R)), lansoprazole (Prevacid(R)),

omeprazole (Prilosec(R), Zegerid(R)), pantoprazole sodium (Protonix(R)),

rabeprazole (Aciphex(R))

    - 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(R), a medicine to treat some bacterial infections).

Talk to your doctor or pharmacist about the right amount of EDURANT(R) 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(R)

    - Medicines to block acid in your stomach, including cimetidine

(Tagamet(R)), famotidine (Pepcid(R)), nizatidine (Axid(R)), or ranitidine

hydrochloride (Zantac(R)). Take these medicines at least 12 hours before or at

least 4 hours after you take EDURANT(R)

    - Any of these medicines (if taken by mouth or injection): clarithromycin

(Biaxin(R)), erythromycin (E-Mycin(R), Eryc(R), Ery-Tab(R), PCE(R),

Pediazole(R), Ilosone(R)), fluconazole (Diflucan(R)), itraconazole

(Sporanox(R)), ketoconazole (Nizoral(R)), methadone (Dolophine(R)),

posaconazole (Noxafil(R)), telithromycin (Ketek(R)),voriconazole (Vfend(R))

    This is not a complete list of medicines. Before starting EDURANT(R), 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(R), 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(R) will harm your unborn baby.

    You and your healthcare professional will need to decide if taking

EDURANT(R)is right for you.

     - Do not breastfeed if you are taking EDURANT(R). 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(R)?

    EDURANT(R) can cause serious side effects including:

     - 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(R) 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(R) or any other medications without first talking to your

healthcare professional.

     You are encouraged to report negative side effects of prescription drugs

to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

     Please see full Product Information for more details:

     http://www.edurant.com/sites/default/files/EDURANT-PI.pdf

     About EDURANT(R) (rilpivirine)

     Rilpivirine was developed by Janssen R&D Ireland Ltd, one of the Janssen

Pharmaceutical Companies.

     The registered formulation of rilpivirine is a 25 mg film-coated tablet

taken orally once daily. Marketed as EDURANT(R), rilpivirine is indicated, in

combination with other ARVs, for the treatment of HIV-1 in ARV treatment-naive

adult patients. In most countries, including US and EU, this indication is

further restricted to patients with a viral load ＜ 100,000 copies/ mL.

     Rilpivirine is available in the United States (US) and the European Union

as part of a once daily fixed dose antiretroviral combination with Gilead

Sciences Inc's tenofovir and emtricitabine. This combination, known as

COMPLERA(R) (US) or EVIPLERA(R), was granted marketing authorisation from the

Food and Drug Administration in August 2011, with Gilead Sciences Inc being the

marketing authorisation holder in the US, and from the European Commission in

November 2011, with Gilead Sciences International Ltd. being the marketing

authorisation holder in Europe, Middle East and Africa.

     About TIVICAY(R) (dolutegravir)

     TIVICAY(R) (dolutegravir) is an integrase inhibitor indicated for use in

combination with other antiretroviral agents for the treatment of HIV-1 in

adults and children aged 12 years and older weighing at least 40 kg. Integrase

inhibitors block HIV replication by preventing the viral DNA from integrating

into the genetic material of human immune cells (T-cells). This step is

essential in the HIV replication cycle and is also responsible for establishing

chronic infection. It is available as a small, yellow, 50 mg tablet.

Importantly, it can be taken with or without food and at any time of the day.

     About Janssen

     At Janssen, we are dedicated to addressing and solving some of the most

important unmet medical needs of our time in infectious diseases and vaccines,

oncology, immunology, neuroscience, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services

and healthcare solutions to help people throughout the world.

     (This press release contains "forward-looking statements" as defined in

the Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could

vary materially from the expectations and projections of Janssen R&D Ireland

Ltd, any of the Janssen Pharmaceutical Companies and/or Johnson & Johnson.

     Risks and uncertainties include, but are not limited to: economic factors,

such as interest rate and currency exchange rate fluctuations; competition,

including technological advances, new products and patents attained by

competitors; challenges inherent in new product development, including

obtaining regulatory approvals; challenges to patents; changes in behavior and

spending patterns or financial distress of purchasers of health care products

and services; changes to governmental laws and regulations and domestic and

foreign health care reforms; general industry conditions including trends

toward health care cost containment; and increased scrutiny of the health care

industry by government agencies.

     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

fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our

subsequent filings with the Securities and Exchange Commission. Copies of these

filings are available online at http://www.sec.gov, http://www.jnj.com or on

request from Johnson & Johnson. None of 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. World Health Organization. Global summary of the AIDS epidemic.

Available at: http://www.who.int/gho/hiv/en/ [http://www.who.int/gho/hiv/en ].

Last accessed June 2014.

     2. Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism.

Prog Lipid Res 2003; http://www.ncbi.nlm.nih.gov/pubmed/12547652 42(2):81-92.

     3. World Health Organization. Global summary of the AIDS epidemic.

Available at: http://www.who.int/hiv/data/2012_epi_core_en.png. Last accessed

June 2014.

    MEDIA CONTACT:

    Ronan Collins

    +47-488-42500

    rcollin5@its.jnj.com

    INVESTOR RELATIONS:

    Stan Panasewicz

    +1-732-524-2524

    Louise Mehrotra

    +1-732-524-6491

    Source: Janssen R&D Ireland Ltd