Health Canada Approves PREZISTA* Once Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1

     - Approval based on pivotal ARTEMIS study that demonstrated 84 per
        cent of patients taking PREZISTA in combination with ritonavir
               reached an undetectable viral load at 48 weeks -

    TORONTO, April 7 /CNW/ - Tibotec, a division of Janssen-Ortho Inc.,
announced today that Health Canada has approved PREZISTA(*) (darunavir) for use
in treatment-naive adults (those who have never taken HIV medication before),
dosed once daily in combination with other antiretroviral agents. The new
indication for PREZISTA includes a new tablet strength of 400 mg to support
the recommended dosing regimen.
    PREZISTA, dosed at 600 mg twice daily, co-administered with 100 mg
ritonavir twice daily, is already approved in treatment-experienced patients.
In treatment naive adults, PREZISTA will be dosed at 800 mg (two 400 mg
tablets) once daily, co-administered with 100 mg ritonavir once daily and with
other antiretroviral agents. As a result of the new indication, PREZISTA is
now indicated for the treatment of human immunodeficiency virus (HIV-1)
infection, regardless of treatment history.
    "With the introduction of PREZISTA in Canada two years ago, the medical
community welcomed a well-tolerated and effective option for
treatment-experienced patients living with HIV. It's encouraging that now we
can offer PREZISTA as part of combination therapy to an even broader patient
population who may benefit from the treatment," said Dr. Anita Rachlis,
Professor, Department of Medicine and Division of Infectious Diseases,
Sunnybrook Health Sciences Center, University of Toronto.

    About ARTEMIS

    The new indication for PREZISTA was based on data from the pivotal
ARTEMIS trial. In this randomized, controlled, open-label Phase 3 study, 84
per cent of treatment-naive HIV-1 infected adults taking PREZISTA/ritonavir
800 mg/100 mg once daily with TRUVADA(R) reached an undetectable viral load
((less than)50 copies/mL) at week 48, compared with 78 per cent of patients
taking KALETRA(R) (lopinavir/ritonavir) 800 mg/200 mg once daily (or 400
mg/100 mg twice daily) with TRUVADA. The study demonstrated non-inferiority of
PREZISTA/ritonavir compared to KALETRA(R). The mean difference in response
between the treatment groups was statistically significant.(i)
    In treatment-naive adult patients, the most common side effects ((greater
than or equal to) 2 per cent) of at least moderate intensity ((greater than or
equal to) Grade 2) in the PREZISTA/ritonavir arm were diarrhea (6 per cent),
headache (5 per cent), abdominal pain (4 per cent), nausea (3 per cent),
vomiting (2 per cent), and rash (2 per cent).(ii)
    Since the first reports on AIDS in the early 1980s, considerable progress
has been made with significant improvement in survival rates. HIV/AIDS is
becoming more of a manageable chronic illness because of the effectiveness of
combining antiretrovirals from different classes in highly active
antiretroviral therapy (HAART). However, several challenges still remain. Many
patients cannot tolerate the side effects experienced with existing
medications. In the ARTEMIS study, diarrhea was among the most common adverse
events. Moderate to severe treatment-related diarrhea occurred less frequently
in patients treated with PREZISTA/ritonavir, compared to KALETRA(R).(iii)
    Eric Johnston was diagnosed with HIV at the age of 34, and is a member of
the Board of Directors of the Canadian AIDS Society. "For many years, an HIV
diagnosis was a death sentence - but as more effective treatment options
become available, hope for patients grows. Finding an effective and
well-tolerated treatment, like I found with PREZISTA, has allowed me to live
my life as normally as possible," said Mr. Johnston.

    About HIV/AIDS

    Acquired Immune Deficiency Syndrome (AIDS) is an illness caused by a
chronic infection with a retrovirus (HIV, Human Immunodeficiency Virus). The
breakdown of the immune system resulting from HIV leads to increased
susceptibility to other infections and immune disorders. UNAIDS estimates that
approximately 33 million people worldwide were infected with HIV in 2007.(iv)
It is estimated that between 2,300 and 4,500 new HIV infections occurred in
Canada in 2005 compared with 2,100 to 4,000 in 2002.(v) In Canada, there were
an estimated 78,000 people living with HIV infection by the end of 2007.(vi)

    Tibotec - Division Of Janssen-Ortho Inc.

    Tibotec, a division of Janssen-Ortho Inc., is dedicated to delivering
innovative virology therapeutics that improve Canadian patients' survival and
quality of life and that address serious unmet health care needs.

    Tibotec Pharmaceuticals Ltd.

    Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical
research and development company. The Company's main research and development
facilities are in Mechelen, Belgium, with offices in Yardley, PA, USA. Tibotec
is dedicated to the discovery and development of innovative HIV/AIDS drugs and
anti-infectives for diseases of high unmet medical need.

    (*) All trademark rights used under license.


    (i)   Ortiz R, DeJesus E, Khanlou H et al. Efficacy and safety of once-
          daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-
          naive HIV-1-infected patients at week 48.
          AIDS 2008;22(12):1389-1397.
    (ii)  Ibid.
    (iii) Ibid.
    (iv)  UNAIDS/WHO AIDS epidemic update 2007,
          retrieved February 26, 2009.
    (v)   Public Health Agency of Canada,,
          Retrieved March 2, 2009.
    (vi)  AIDS epidemic update 2008. 1-362. 2008. UNAIDS / WHO (World Health

For further information:

For further information: Suzanne Frost, Tibotec - Division of
Janssen-Ortho Inc., (416) 449-9444,; Marsha Knoll, Edelman,
(416) 979-1120, ext. 329,

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