Analysis Provides Additional Data for PREZISTA as Part of HIV Combination Therapy

Toronto (ots/PRNewswire) -

Additional safety and efficacy data for PREZISTA(TM) (darunavir)
300mg tablets, an anti-HIV medication, will be presented Tuesday, 15
August, at the 16th International AIDS Conference (AIDS 2006) in
Toronto, Canada. In an oral presentation, researchers will report
data from patients who had reached 48 weeks of treatment in an ad hoc
pooled analysis from the TMC114-C213 (POWER 1) and TMC114-C202 (POWER
2) studies.

The U.S. Food and Drug Administration (FDA) granted marketing
approval to PREZISTA, a protease inhibitor formerly known as TMC114,
in June 2006. In the U.S., PREZISTA, co-administered with 100 mg
ritonavir (PREZISTA/rtv) and with other antiretroviral agents, is
indicated for the treatment of human immunodeficiency virus (HIV)
infection in antiretroviral treatment-experienced adult patients,
such as those with HIV-1 strains resistant to more than one protease
inhibitor. Health Canada also granted conditional approval to
PREZISTA on July 28, 2006.

Both the US and Canadian approvals were based on the 24-week
analysis of HIV viral load and CD4+ cell counts from the pooled
analysis of the POWER 1 and POWER 2 studies. In Canada, PREZISTA,
co-administered with 100 mg ritonavir and with other antiretroviral
agents, is indicated for the treatment of HIV infection in
treatment-experienced adult patients who have failed prior
antiretroviral therapy.

An application for marketing authorization was filed with the
European Agency for the Evaluation of Medicinal Products (EMEA) in
January 2006. Applications for approval in several other countries
around the world have been submitted or are planned for submission in
the coming months.

48-Week Ad Hoc Analysis Findings

The data to be presented are from the patients in POWER 1 and 2
who had reached 48 weeks of treatment at the time of the ad hoc
analysis. Among 110 patients who had reached 48 weeks of treatment in
the PREZISTA/rtv arm (total n=131) vs. 120 patients who had reached
48 weeks of treatment in the control arm (total n=124),
intent-to-treat data will be presented:

- 61 percent vs. 15 percent had a virologic response defined as equal to
or greater than a 1.0 log10 reduction (90 percent reduction) in viral
load from baseline
- 46 percent vs. 10 percent reached undetectable viral load (less than 50
copies/mL)
- CD4+ cell mean increase of 102 cells/mm3 vs.19 cells/mm3 from baseline

Patients enrolled in the POWER 1 and POWER 2 studies had
previously been treated with at least one protease inhibitor, one
non-nucleoside reverse transcriptase inhibitor (NNRTI) and one
nucleoside reverse transcriptase inhibitor (NRTI), had one or more
primary protease inhibitor mutations, and were failing a PI-based
regimen. Investigator-selected optimised background regimen (OBR) and
control protease inhibitors were chosen based on resistance testing
and prior treatment history. The OBR consisted of at least two NRTIs
with or without enfuvirtide.

Among patients reaching 48 weeks, the most commonly reported
adverse events among patients in the PREZISTA/rtv arm vs. control arm
were diarrhoea (20 percent vs. 28 percent), nausea (18 percent vs. 13
percent), headache (15 percent vs. 20 percent), nasopharyngitis (14
percent vs. 11 percent) and fatigue (12 percent vs. 17 percent).
Discontinuations because of adverse events were 7 percent in the
PREZISTA/rtv arm vs. 5 percent in the control arm.

Sharon Walmsley, M.D., of University Health Network, Ontario,
Canada, who will be presenting the 48-week PREZISTA data, said, "The
sustained efficacy and favourable tolerability profile of PREZISTA
provide treatment-experienced HIV patients with an important new
treatment option."

Important Safety Information

PREZISTA does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.

In studies, PREZISTA was generally well tolerated. Mild to
moderate rash was seen in 7 percent of patients. Some patients
developed severe rash. In clinical studies, 0.3 percent of patients
discontinued due to rash. The most common moderate to severe side
effects associated with PREZISTA include diarrhoea (2.3 percent),
headache (3.8 percent), abdominal pain (2.3 percent), constipation
(2.3 percent), and vomiting (1.5 percent). Four percent of patients
discontinued treatment due to adverse events. People who are allergic
to PREZISTA or any of its ingredients or ritonavir (Norvir) should
not take PREZISTA.

There were few relevant drug-drug interactions with other
medications commonly used in HIV patient populations, such as other
antiretroviral medications, proton pump inhibitors, and H2 receptor
antagonists. Patients should talk to their healthcare provider about
all the medicines they are taking or plan to take, including
prescription and nonprescription medicines, vitamins, and herbal
supplements.

Before taking PREZISTA, patients should tell their healthcare
provider if they have any medical conditions, including diabetes,
liver problems, haemophilia, or allergy to sulfa medicines and should
tell their doctor if they are pregnant or planning to become
pregnant, or are nursing. PREZISTA should be used with caution in
patients with hepatic impairment.

High blood sugar, diabetes or worsening of diabetes, muscle pain,
tenderness or weakness, and increased bleeding in people with
haemophilia have been reported in patients taking protease inhibitor
medicines like PREZISTA. Changes in body fat have been seen in some
patients taking anti-HIV medicines, including loss of fat from legs,
arms and face, increased fat in the abdomen and other internal
organs, breast enlargement and fatty lumps on the back of the neck.
The cause and long-term health effects of these conditions are not
known at this time.

Clinical laboratory safety observed in the PREZISTA group was
comparable to the control group.

Please see full Product Information for more details.

About PREZISTA

PREZISTA was developed by Tibotec Pharmaceuticals Ltd. In the
U.S., it is marketed by Tibotec Therapeutics, a division of Ortho
Biotech Products, L.P. In Canada, it is marketed by Tibotec, a
division of Janssen-Ortho Inc. Pending regulatory approval, Tibotec,
a division of Janssen-Cilag, will commercialise PREZISTA in Europe
and other countries

PREZISTA/rtv is currently in Phase III comparative clinical trials
in treatment-naïve (ARTEMIS) and less treatment-experienced patients
(TITAN) versus Kaletra (lopinavir/ritonavir).

For further information, please visit www.tibotec.com.

About 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. Tibotec is dedicated to the discovery and
development of innovative HIV/AIDS drugs and anti-infectives for
diseases of high unmet medical need.

Tibotec Pharmaceuticals is developing a Global Access Program to
facilitate access to its antiretrovirals for patients living with
HIV/AIDS in developing countries. The Global Access Program for
PREZISTA includes access pricing, registration, medical education for
appropriate use and voluntary licensing.

About Tibotec

Tibotec, a division of Janssen-Cilag, will bring innovative
products for HIV/AIDS to patients in Europe, the Middle East and
Africa. This new division was created within the Janssen-Cilag
companies in October 2005 to focus on patients' and health care
providers' specific needs in this disease domain. The company will
also commercialise medicine against other viral diseases in the
future.

Janssen-Cilag

Janssen-Cilag is a leader in traditional and biological medicines
for disorders such as in gastroenterology, women's health, mental
health and neurology as well as for pain, oncology, haematology and
nephrology.

Contact: Kellie McLaughlin, mobile +1-609-468-8356

Web site: http://www.tibotec.com

ots Originaltext: Tibotec Pharmaceuticals Ltd.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Kellie McLaughlin, mobile +1-609-468-8356