Centralised Procedure Authorises
use in all 27 EU Member States, Plus Others

CORK, Ireland--(BUSINESS WIRE)--Tibotec Pharmaceuticals, Ltd.
announced today that the European Commission has granted a
conditional marketing authorisation for PREZISTA™ (darunavir, also known by the
investigational compound number TMC114), a protease inhibitor for
the treatment of HIV-1 infected patients.

This decision by the European Commission through a centralised
procedure, signifies that the treatment is authorised for use in
the European Union (EU), valid in all 27 EU member states. A
conditional marketing authorisation was granted to PREZISTA, taken
in combination with ritonavir and other antiretroviral medicinal
products, because of its benefits for HIV-1 infected patients,
however, more evidence is yet to be provided. Additional safety and
efficacy data will need to be submitted to the EMEA annually until
full authorisation is granted.

The timing of the availability of the product will be decided in
discussions with national authorities and will vary from country to
country.

PREZISTA, co-administered with 100 mg ritonavir is
indicated in combination with other antiretroviral medicinal
products for the treatment of human immunodeficiency virus (HIV-1)
infection in highly pre-treated adult patients who failed more than
one regimen containing a protease inhibitor (PI).

The approval was based on 24-week safety and efficacy data from
POWER 1 and POWER 2, two ongoing, randomised, controlled trials
involving 255 treatment-experienced adults. The results were
supported by a 24-week analysis of the open label trials (POWER 3
analysis) of 327 patients who were initiated at the recommended
dose of 600 mg PREZISTA boosted with 100 mg ritonavir twice
daily.

POWER 1 and 2 Efficacy Results

In a pooled analysis of the POWER 1 and 2 studies, following 24
weeks of treatment:

70 percent of 131 patients in
the PREZISTA arm had a virologic response compared to 21 percent of
124 patients in the control group. Virologic response is defined as
a decrease in viral load of at least 1.0 log10 (90 percent reduction) from baseline.

Three times as many patients in
the PREZISTA arm (45 percent) achieved an undetectable viral load
compared with patients in the investigator-selected PI arm (12
percent). Undetectable was defined as HIV RNA of less than 50
copies/mL.

The mean increase in CD4 cell
counts from baseline was five times higher in the PREZISTA group
than in the control group (92 cells/mm3
vs.17 cells/mm3, respectively).

POWER 3 Efficacy Results

The European Commission decision also was based on supportive
data from the POWER 3 analysis, a non-randomized, open-label
analysis of treatment-experienced patients similar to those of
POWER 1 and POWER 2 and who received darunavir/rtv (600mg/100mg
twice daily). Data from this large cohort (n=327) showed that after
24 weeks:

Additionally, the product labelling includes supportive 48-week
long-term efficacy data from the pooled analysis of POWER 1
and POWER 2 in treatment-experienced patients who received
darunavir /rtv (600mg/100mg twice daily). The 48-week analysis
indicates that:

“The approval of PREZISTA marks
an important step in the management of highly treatment-experienced
patients,” said Professor Margaret
Johnson, Chair of the British HIV Association (BHIVA) Executive
Committee and Clinical Director of HIV/AIDS Services, Royal Free
Hampstead, NHS Trust. “Finding
additional therapy options for highly treatment-experienced
patients is one of the greatest challenges in HIV care today, as
many of these people are currently on treatments which, are either
failing or have already failed. The data presented so far is
promising and PREZISTA will provide a vital new option for these
patients.”

“The approval of PREZISTA
reflects the ongoing commitment of Tibotec to delivering
therapeutic approaches that help people with HIV who have unmet
needs,” said Roger Pomerantz, M.D.,
President of Tibotec.

Important Safety Information

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

In the registrational studies, PREZISTA was generally well
tolerated versus the investigator selected PIs. The majority of the
adverse reactions reported in this data during treatment with
PREZISTA co-administered with 100 mg ritonavir twice daily
were mild to moderate in severity. The most frequently reported
moderate to severe adverse reactions were diarrhoea (2.6%),
vomiting (2.2%) and hypertriglyceridaemia (2.0%). The most commonly
reported adverse reactions of any grade were nausea (7.2%),
diarrhoea (6.6%) and headache (3.3%). Skin rash can also appear but
this is usually mild to moderate. One percent of patients
discontinued treatment due to adverse events. People who are
allergic to darunavir or any of its ingredients, or ritonavir
should not take PREZISTA.

Before taking PREZISTA, patients should tell their doctor 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 not be used in patients
with severe liver problems.

There were some 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 non-prescription medicines, vitamins, and herbal
supplements.

Please see full Product Information for more
details.

About PREZISTA

PREZISTA was developed by Tibotec Pharmaceuticals Ltd. Tibotec,
a division of Janssen-Cilag, will commercialise the product in
Europe, Russia, Switzerland and other countries. The marketing
authorisation holder for PREZISTA in Europe is Janssen-Cilag
International NV. 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.

PREZISTA/rtv is currently in Phase III comparative clinical
trials in treatment-naïve (ARTEMIS)
and less treatment-experienced patients (TITAN) versus Kaletra
(lopinavir/ritonavir). In Phase III studies known as DUET 1 and 2,
darunavir is being studied with an investigational NNRTI, TMC125,
in heavily treatment-experienced patients. Clinical studies on the
use of the product in HIV-infected paediatric patients are also
ongoing.

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.