European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naïve Adults With HIV-1

Cork, Ireland, November 27 (ots/PRNewswire) - The Committee for
Human Medicinal Products (CHMP) has issued a positive opinion
recommending approval for once-daily dosing of 800 mg PREZISTA(R)
(darunavir) with low-dose ritonavir as part of combination therapy in
treatment-naïve adults (those who have never taken HIV medication
before). Darunavir, a protease inhibitor, was developed by Tibotec
Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the
organisation responsible for marketing the brand in Europe.

The positive opinion from the CHMP, the committee responsible for
the scientific assessment of new medicinal products, will be reviewed
by the European Commission, which then has authority to approve
medicines for use throughout the European Union.

The CHMP's positive opinion is based on 48-week analyses of
plasma HIV RNA levels and CD4+ cell counts from the ongoing,
randomised, controlled, open-label phase III trial ARTEMIS in
antiretroviral treatment-naïve HIV-1-infected adults. Patients
received 800 mg darunavir once daily with 100 mg ritonavir as part of
combination therapy.

Darunavir, co-administered with low dose ritonavir, is currently
indicated in combination with other antiretroviral medicinal products
for the treatment of HIV-1 infection in highly pre-treated adult
patients who failed more than one regimen containing a protease
inhibitor (PI). Darunavir was given conditional approval by the
European Commission in February 2007. The full marketing
authorisation from the European Commission for treatment-naïve adult
patients is expected in the coming months.

Important Safety Information

In the registrational studies, darunavir was generally well
tolerated versus the investigator selected PIs. The majority of the
adverse reactions reported in patients who initiated therapy with
darunavir 600 mg co-administered with 100 mg ritonavir twice daily
were mild to moderate in severity. Thirty percent of the patients
experienced at least one adverse drug reaction (at least grade 2 in
severity and considered by the investigator at least possibly related
to darunavir co-administered with 100 mg ritonavir). The most
frequently (greater than or equal to 2 percent) of those reported
adverse reactions were diarrhoea (3.9 percent), hypertriglyceridaemia
(3.8 percent), rash (2.8 percent), nausea (2.6 percent),
hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6
percent of the patients discontinued treatment due to adverse
reactions.

Before taking darunavir, patients should tell their doctor if
they have any medical conditions, including liver problems, including
hepatitis B or C, diabetes, symptoms of infections, change in body
fat, haemophilia, musculoskeletal problems, or allergy to sulfa
medicines and should tell their doctor if they are pregnant or
planning to become pregnant or planning to become pregnant, or are
nursing.

Darunavir should not be used in patients allergic
(hypersensitive) to darunavir or ritonavir or 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. 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.

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

Please see full Summary of Product Characteristics for more
details.

About Tibotec Pharmaceuticals

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

About Tibotec, a division of Janssen-Cilag

Tibotec, a division of Janssen-Cilag, brings innovative products
for HIV/AIDS to patients in Europe, the Middle East and Africa
focusing on patients' and healthcare providers' specific needs in
this disease domain. The company will also commercialise medicines to
combat other viral diseases in the future.

About Janssen-Cilag

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

Tibotec Pharmaceuticals amd Janssen-Cilag are subsidiaries of the
Johnson & Johnson family of companies.

(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
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 Company's expectations and projections. Risks and uncertainties
include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate
fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign health
care reforms and governmental laws and regulations; and trends toward
health care cost containment. 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 December 30, 2007. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov,
http://www.jnj.com or on request from Johnson & Johnson. The Company
does not undertake to update any forward-looking statements as a
result of new information or future events or developments.)

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

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Media Contact: Hans Vanavermaete, +32(0)15-461-017 (office),
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