FDA Approves New 800mg PREZISTA® (darunavir) Tablet

             FDA Approves New 800mg PREZISTA® (darunavir) Tablet

PR Newswire

TITUSVILLE, N.J., Nov. 9, 2012

TITUSVILLE, N.J., Nov. 9, 2012 /PRNewswire/ -- Janssen Therapeutics, Division
of Janssen Products, LP, announced today the U.S. Food and Drug Administration
(FDA) has approved a new 800mg tablet of PREZISTA^® (darunavir) for once daily
oral administration for the treatment of human immunodeficiency virus (HIV-1)
in treatment-naive and treatment-experienced adult patients with no darunavir
resistance-associated mutations. PREZISTA^® is always taken with and at the
same time as ritonavir with food and in combination with other HIV medicines.

(Photo: http://photos.prnewswire.com/prnh/20121109/SF07964)

The new tablet strength will allow patients taking PREZISTA^® once daily to
reduce the number of PREZISTA^® tablets by half, taking one 800mg tablet
instead of two 400mg tablets once a day with ritonavir 100mg and other
antiretroviral medications.

The 800mg tablet is expected to be available shortly. Janssen plans to
discontinue the PREZISTA^® 400mg tablet, which will become obsolete as a
result of the introduction of the 800mg tablet. To help physicians and
patients transition to the new tablet, Janssen will provide educational
materials about the new tablet to pharmacies. PREZISTA^® 800mg tablets will be
added to medicines covered by the Janssen Therapeutics Patient Savings Program
as well as those covered by the Johnson & Johnson Patient Assistance

"The single 800mg tablet provides an option for a reduced pill burden and
reflects our ongoing commitment to offer more treatment options for the
diverse population of people living with HIV," said Bryan Baugh, MD, Medical
Director at Janssen Therapeutics.


PREZISTA^® (darunavir) is a prescription medicine. It is one treatment option
in the class of HIV (human immunodeficiency virus) medicines known as protease
inhibitors. PREZISTA^® is always taken with and at the same time as ritonavir
(Norvir^®), in combination with other HIV medicines for the treatment of HIV
infection in adults. PREZISTA^® should also be taken with food.

  oThe use of other medicines active against HIV in combination with
    PREZISTA^®/ritonavir (Norvir^®) may increase your ability to fight HIV.
    Your healthcare professional will work with you to find the right
    combination of HIV medicines
  oIt is important that you remain under the care of your healthcare
    professional during treatment with PREZISTA^®

PREZISTA^® does not cure HIV infection or AIDS and you may continue to
experience illnesses associated with HIV-1 infection, including opportunistic
infections. You should remain under the care of a doctor when using

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

Important Safety Information

What is the most important information I should know about PREZISTA^®?

  oPREZISTA^® can interact with other medicines and cause serious side
    effects. See "Who should not take PREZISTA^®?"
  oPREZISTA^® may cause liver problems. Some people taking PREZISTA^®,
    together with Norvir^® (ritonavir), have developed liver problems which
    may be life-threatening. Your healthcare professional should do blood
    tests before and during your combination treatment with PREZISTA^®. If you
    have chronic hepatitis B or C infection, your healthcare professional
    should check your blood tests more often because you have an increased
    chance of developing liver problems
  oTell your healthcare professional if you have any of these signs and
    symptoms of liver problems: dark (tea-colored) urine, yellowing of your
    skin or whites of your eyes, pale-colored stools (bowel movements),
    nausea, vomiting, pain or tenderness on your right side below your ribs,
    or loss of appetite
  oPREZISTA^® may cause a severe or life-threatening skin reaction or rash.
    Sometimes these skin reactions and skin rashes can become severe and
    require treatment in a hospital. You should call your healthcare
    professional immediately if you develop a rash. However, stop taking
    PREZISTA^® and ritonavir combination treatment and call your healthcare
    professional immediately if you develop any skin changes with these
    symptoms: fever, tiredness, muscle or joint pain, blisters or skin
    lesions, mouth sores or ulcers, red or inflamed eyes, like"pink eye."
    Rash occurred more often in patients taking PREZISTA^® and raltegravir
    together than with either drug separately, but was generally mild

Who should not take PREZISTA^®?

  oDo not take PREZISTA^® if you are taking the following medicines:
    alfuzosin (Uroxatral^®), dihydroergotamine (D.H.E.45^®, Embolex^®,
    Migranal^®), ergonovine, ergotamine (Cafergot^®, Ergomar^®),
    methylergonovine, cisapride (Propulsid^®), pimozide (Orap^®), oral
    midazolam, triazolam (Halcion^®), the herbal supplement St. John's wort
    (Hypericum perforatum), lovastatin (Mevacor^®, Altoprev^®, Advicor^®),
    simvastatin (Zocor^®, Simcor^®, Vytorin^®), rifampin (Rifadin^®,
    Rifater^®, Rifamate^®, Rimactane^®), sildenafil (Revatio^®) when used to
    treat pulmonary arterial hypertension, indinavir (Crixivan^®),
    lopinavir/ritonavir (Kaletra^®), saquinavir (Invirase^®), boceprevir
    (Victrelis™), or telaprevir (Incivek™)
  oBefore taking PREZISTA^®, tell your healthcare professional if you are
    taking sildenafil (Viagra^®, Revatio^®), vardenafil (Levitra^®, Staxyn^®),
    tadalafil (Cialis^®, Adcirca^®), atorvastatin (Lipitor^®), rosuvastatin
    (Crestor^®), pravastatin (Pravachol^®), or colchicine (Colcrys^®,
    Col-Probenecid^®). Tell your healthcare professional if you are taking
    estrogen-based contraceptives (birth control). PREZISTA^® might reduce the
    effectiveness of estrogen-based contraceptives. You must take additional
    precautions for birth control, such as condoms

This is not a complete list of medicines. 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.

What should I tell my doctor before I take PREZISTA^®?

  oBefore taking PREZISTA^®, tell your healthcare professional if you have
    any medical conditions, including liver problems (including hepatitis B or
    C), allergy to sulfa medicines, diabetes, or hemophilia
  oTell your healthcare professional if you are pregnant or planning to
    become pregnant, or are breastfeeding

       oThe effects of PREZISTA^® on pregnant women or their unborn babies
         are not known. You and your healthcare professional will need to
         decide if taking PREZISTA^® is right for you
       oDo not breastfeed. It is not known if PREZISTA^® can be passed to
         your baby in your breast milk and whether it could harm your baby.
         Also, mothers with HIV should not breastfeed because HIV can be
         passed to your baby in the breast milk

What are the possible side effects of PREZISTA^®?

  oHigh blood sugar, diabetes or worsening of diabetes, and increased
    bleeding in people with hemophilia have been reported in patients taking
    protease inhibitor medicines, including PREZISTA^®
  oChanges in body fat have been seen in some patients taking HIV medicines,
    including PREZISTA^®. The cause and long-term health effects of these
    conditions are not known at this time
  oChanges in your immune system can happen when you start taking HIV
    medicines. Your immune system may get stronger and begin to fight
    infections that have been hidden
  oThe most common side effects related to taking PREZISTA^® include
    diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not
    a complete list of all possible side effects. If you experience these or
    other side effects, talk to your healthcare professional. Do not stop
    taking PREZISTA^® or any other medicines without first talking to your
    healthcare professional

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please refer to the ritonavir (Norvir^®) Product Information (PI and PPI) for
additional information on precautionary measures.

Please see full Prescribing Information for more details, available at

About Janssen Therapeutics
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in HIV and other infectious
diseases. Driven by our commitment to patients, we develop innovative
products, services and healthcare solutions to help people throughout the
world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division
of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of
Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and
follow us on Twitter at @JanssenUS.

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 Products, LP
and/or Johnson & Johnson. Risks and uncertainties include, but are not limited
to, general industry conditions and competition; economic factors, such as
interest rate and currency exchange rate fluctuations; 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; trends toward
health care cost containment; increased scrutiny of the health care industry
by government agencies; manufacturing difficulties or delays; and product
efficacy or safety concerns. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended January 1,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson &
Johnson.Neither Janssen Products, LP nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments.

SOURCE Janssen Therapeutics

Website: http://www.JanssenTherapeutics.com
Contact: Ilona Rubino, +1-609-730-6620, irubino@its.jnj.com, or Pam Van
Houten, +1-609-730-7902, pvanhou5@its.jnj.com; or Investor Contacts, Louise
Mehrotra, +1-732-524-6491, or Stan Panasewicz, +1-732-524-2524
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